Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner (investigational device) against the commercially available 2D and 3D predicate devices. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new CARESTREAM Cone Beam Computed Tomography (CBCT) scanner in the US. The study was designed in accordance with the FDA Guidance titled Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, issued on August 6, 1999.
Detailed description
The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner (investigational device) against the commercially available 2D and 3D predicate devices. The study undertaken will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 2D imaging functionality by comparing against the predicate CARESTREAM DRX-1 GOS detector used on adult cadaver specimens to capture the image pairs. The study will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 3D imaging functionality by comparing against the reference PHILLIPS Multi Detector Computed Tomography (MDCT) scanner used on adult cadaver specimens (body part) to capture 3D volumetric exams using the anatomy of both upper and lower extremity specimens. The adult cadaver specimens will receive multiple x-ray exposures using the predicate devices for both 2D and 3D imaging. Target images from cadaver specimens will be reviewed by radiologist readers to rate diagnostic image quality, and the data will be included in a comparative evaluation. The live human subject portion of the study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which will receive only one 3D volumetric exam using the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) scanner. Target images will be reviewed by radiologist readers to rate diagnostic image quality according to a radiologist reader scale applicable to 3D volumetric imaging.
Interventions
RADIATIONRadiation
Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT). Human subjects will be imaged with CARESTREAM Cone Beam Computed Tomography (CBCT) 3D only.
Sponsors
Carestream Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject 18 years or older * Subject has provided informed consent * Subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion in the images. * Subject(s) may have a metal screw, plate or artificial joint
Exclusion criteria
* Subject is pregnant * Not able or willing to provide Informed Consent, or consent is withdrawn * Not able to collect all required case information * Subject has a history of high radiation exposure: * Has undergone radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radlex Scale for Diagnostic Quality Ratings - 2D Images | 12 weeks after last image capture | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
| Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution | 12 weeks after last image capture | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
| Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK | 12 weeks after last image capture | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
| Radlex Scale for Diagnostic Quality Ratings - 3D Images SND | 12 weeks after last image capture | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Predicate & Invest.- Cadavers 2D & 3D Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph. Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT. | 35 |
| Investigational - Human Subjects 3D Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only. | 13 |
| Total | 48 |
Baseline characteristics
| Characteristic | Predicate & Invest.- Cadavers 2D & 3D | Investigational - Human Subjects 3D | Total |
|---|---|---|---|
| Age, Customized 18 years or older | 35 participants | 13 participants | 48 participants |
| Sex/Gender, Customized Gender Unknown (not collected) | 35 participants | 13 participants | 48 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 35 | 0 / 13 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 | 0 / 13 |
Outcome results
Primary
Radlex Scale for Diagnostic Quality Ratings - 2D Images
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 12 weeks after last image capture
Population: 140 total image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for each of the above two arms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate - Cadavers 2D | Radlex Scale for Diagnostic Quality Ratings - 2D Images | 3.4093 units on a scale | Standard Error 0.0601 |
| Investigational - Cadavers 2D | Radlex Scale for Diagnostic Quality Ratings - 2D Images | 3.4179 units on a scale | Standard Error 0.0602 |
p-value: 0.92t-test, 2 sided
Primary
Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 12 weeks after last image capture
Population: 140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers \& Human Subjects 3D-FDK arm above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate - Cadavers 2D | Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK | 3.5277 units on a scale | Standard Error 0.0316 |
| Investigational - Cadavers 2D | Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK | 3.5353 units on a scale | Standard Error 0.0372 |
p-value: 0Equivalence test
Primary
Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 12 weeks after last image capture
Population: 140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers \& Human Subjects 3D-High Resolution arm above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate - Cadavers 2D | Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution | 3.5457 units on a scale | Standard Error 0.0316 |
| Investigational - Cadavers 2D | Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution | 3.8377 units on a scale | Standard Error 0.0211 |
p-value: 0t-test, 1 sided
Primary
Radlex Scale for Diagnostic Quality Ratings - 3D Images SND
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 12 weeks after last image capture
Population: 140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers \& Human Subjects 3D-SND arm above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate - Cadavers 2D | Radlex Scale for Diagnostic Quality Ratings - 3D Images SND | 3.5277 units on a scale | Standard Error 0.0316 |
| Investigational - Cadavers 2D | Radlex Scale for Diagnostic Quality Ratings - 3D Images SND | 3.6319 units on a scale | Standard Error 0.0333 |
p-value: 0.012t-test, 1 sided