(79 days)
The device is intended to capture for display radiographic images of human anatomy including both pediatric and adult patients. The device is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. Excluded from the indications for use are mammography, fluoroscopy, and angiography applications.
The Carestream DRX-1 System is a diagnostic imaging system utilizing digital radiography (DR) technology that is used with diagnostic x-ray systems. The system consists of the Carestream DRX-1 System Console (operator console), flat panel digital imager (detector), and optional tether interface box. The system can be configured to register and use any of the two new DRX Plus 2530 and DRX Plus 2530C Detectors. Images captured with a flat panel digital detector can be communicated to the operator console via tethered or wireless connection.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that predefined acceptance criteria were met for a range of aspects. While specific numeric targets for all criteria are not explicitly stated, the summary indicates successful performance against these criteria.
| Acceptance Criteria Category | Specific Criteria (where mentioned) | Reported Device Performance |
|---|---|---|
| Non-Clinical (Bench) Testing | - Weight | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. |
| - Pixel size | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. | |
| - Resolution | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. | |
| - Pixel pitch | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. | |
| - Total pixel area | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. | |
| - Usable pixel area | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. | |
| - MTF (at various spatial resolutions) | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. | |
| - DQE (at various spatial resolutions) | Met predefined acceptance criteria; demonstrated to deliver quality images equivalent to the predicate. | |
| - Sensitivity | Met predefined acceptance criteria; demonstrated to deliver quality images equivalent to the predicate. | |
| - Ghosting | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. | |
| - Boot-up time | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. | |
| - Operating temperature | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. | |
| - Exposure latitude | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. | |
| - Signal uniformity | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. | |
| - Dark noise (ADC) | Met predefined acceptance criteria, demonstrated safety, effectiveness, and performance as good as or better than predicate. | |
| - Image Quality | Demonstrated to deliver quality images equivalent to the predicate. | |
| - Intended Use | Conformed to specifications. | |
| - Workflow-related performance | Conformed to specifications. | |
| - Shipping performance | Conformed to specifications. | |
| - General functionality and reliability (hardware and software) | Conformed to specifications. | |
| Clinical Study (Reader Study) | - Diagnostic image quality (RadLex rating) | Mean RadLex rating for both subject devices and predicate device were "Diagnostic (3)" with very little variability. |
| - Equivalence to predicate device | Statistical tests confirmed equivalence between the mean ratings of the subject devices and the predicate, and equivalence in beam detect mode ("On" and "Off"). | |
| - Percentage of Diagnostic/Exemplary images (subject devices) | 98% of DRX Plus 2530 responses were Diagnostic (3) or Exemplary (4). 96% of DRX Plus 2530C responses were Diagnostic (3) or Exemplary (4). | |
| - Comparative performance to predicate (subject vs. predicate) | 71% of DRX Plus 2530 responses were equivalent to or favored the predicate. 68% of DRX Plus 2530C responses were equivalent to or favored the predicate. | |
| Regulatory Compliance & Safety | - Conformance to specifications | Conformed to its specifications. |
| - Safety and Effectiveness | Demonstrated to be as safe and effective as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 162 acquired images (cadaver and pediatric phantom).
- Data Provenance: The images were acquired at the University of Rochester Medical Center in Rochester, NY. The study used adult cadavers (2) and pediatric phantoms. This indicates a prospective data acquisition specifically for the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Three (3)
- Qualifications: Board certified radiologists. (No specific years of experience are mentioned).
4. Adjudication Method for the Test Set
The document states that the images were "evaluated by three (3) board certified radiologists using a graduated 4 point scale based on diagnostic image quality." However, it does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus). It sounds like individual ratings were collected, and then the mean RadLex rating was calculated, implying that each individual rating contributed rather than a formal consensus being reached for each image.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- Was an MRMC study done? Yes, a reader study was performed comparing the investigational devices (DRX Plus 2530 and DRX Plus 2530C Detectors) to the predicate device (DRX Plus 3543 Detector) using three board-certified radiologists.
- Effect Size of human readers improve with AI vs without AI assistance: This information is not applicable as the study described is for a digital radiography detector system, not an AI-assisted diagnostic tool. The study focuses on comparing the image quality of different hardware detectors.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the device is a hardware detector system, not a standalone algorithm. The study evaluated the image quality produced by the hardware, which then humans interpret.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established through expert consensus (implicit in the rating by multiple radiologists) on the "diagnostic image quality" using a RadLex rating scale. It's important to note this is not "pathology" or "outcomes data" but rather a subjective assessment of image quality by qualified experts.
8. The Sample Size for the Training Set
The document does not provide information regarding a training set size. This is expected as the submission is for a hardware device (detector), and the testing described focuses on its performance characteristics and image quality, not the training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (as this is a hardware device submission), this information is not applicable.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.