Healthy
Conditions
Brief summary
The purpose of this clinical study is to evaluate the imaging performance of the Carestream PRO 3543 Detector and Carestream PRO 3543C Detector (referred to as the investigational devices) as compared to the currently marketed Carestream DRX-1 Detector (referred to as the predicate device). Both detectors are flat panel digital imaging devices. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new detectors 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 clinical study is to evaluate the imaging performance of the investigational devices as compared to the currently marketed predicate device. The evaluation will consist primarily of comparing the diagnostic image quality of pediatric and adult cadaver studies and adult live human subject studies acquired under the same exposure technique. Under the same position and radiological technique, pediatric and adult cadaver studies, and adult live human subject studies, using double-exposed images will be acquired to evaluate the diagnostic image quality of the investigational device versus the predicate device. Target images will be assembled and reviewed in a side-by-side Comparative Evaluation to statistically confirm the findings of this evaluation. The live human subject portion of this study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which they will have two (2) x-rays taken.The first x-ray will follow standard technique using the cleared predicate detector currently in use at the site. Following the first x-ray, we will take one additional x-ray of the same part of the body with one (1) of the investigational detectors. The x-ray from the investigational detector will not be used to diagnose. If the x-ray obtained by the standard DR x-ray detector shows any unforeseen, unusual or abnormal findings, these findings will be communicated to the subject and their doctor by USPS mail. Reason for Observational Study Type: There are three (3) physical detectors being used in this study. Each detector is 35 centimeters by 43 centimeters. None of the subjects will given a detector. All subjects are healthy volunteers recruited by flyer. All subjects will be imaged with the same predicate detector and one (1) of the investigational detectors.
Interventions
RADIATIONRadiation
Live subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector. Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
Sponsors
Carestream Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* X-ray images of nearly identical positioning and exposure * No visible image artifacts * Subject 21 years or older * Subject has provided informed consent * Subject is in good general health (is able to be still to reduce the potential of motion in the images) * Subject is able to stand for two (2) x-rays
Exclusion criteria
* Images that are not clinically acceptable for clinical radiographic reading as determined by the Principal Investigator. * Subject is pregnant or suspicious of being pregnant * Subject 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: * Subject has undergone radiation therapy * Subject has had two (2) or more CT scans within the past year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radlex Scale for Diagnostic Capability Ratings | 9 weeks after last x-ray capture | 1-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-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-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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pair Preference Rating Scale | 9 weeks after last x-ray capture | During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Predicate & Invest.-GOS Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector. | 8 |
| Predicate & Invest.-CsI Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector. | 10 |
| Predicate & Invest.-Cadavers GOS & CsI Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector. | 3 |
| Total | 21 |
Baseline characteristics
| Characteristic | Predicate & Invest.-GOS | Predicate & Invest.-CsI | Predicate & Invest.-Cadavers GOS & CsI | Total |
|---|---|---|---|---|
| Age, Customized 21 years and older | 8 participants | 10 participants | 3 participants | 21 participants |
| Sex/Gender, Customized Unknown | 8 participants | 10 participants | 3 participants | 21 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 / 8 | 0 / 10 | 0 / 3 |
| serious Total, serious adverse events | 0 / 8 | 0 / 10 | 0 / 3 |
Outcome results
Primary
Radlex Scale for Diagnostic Capability Ratings
1-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-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-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: 9 weeks after last x-ray capture
Population: A total of 177 image pairs were included for the reader study. Of the 177 pairs, 160 were cadaver image pairs. A total of seventeen (17) adult live human subject pairs were included in the reader study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate | Radlex Scale for Diagnostic Capability Ratings | 3.0610 units on a scale | Standard Error 0.014 |
| Investigational | Radlex Scale for Diagnostic Capability Ratings | 3.0633 units on a scale | Standard Error 0.0141 |
p-value: 0.415t-test, 2 sided
Secondary
Pair Preference Rating Scale
During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative.
Time frame: 9 weeks after last x-ray capture
Population: cadavers and live human subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate | Pair Preference Rating Scale | 0.1333 units on a scale | Standard Error 0.0209 |
p-value: 0t-test, 1 sided