(26 days)
The device is intended to capture for disgraphic images of human anatomy including both pediatric and adult patients. The device is intended for use in general projections 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 4343 and DRX Plus 4343C Detectors. Images captured with a flat panel digital detector can be communicated to the operator console via tethered or wireless connection.
The provided text describes the Carestream DRX-1 System with DRX Plus 4343 Detectors, which is a diagnostic imaging system utilizing digital radiography (DR) technology. The submission is a 510(k) premarket notification, indicating the device is substantially equivalent to a predicate device and therefore does not require a full PMA application.
Here's an analysis of the acceptance criteria and study information provided:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Acceptance criteria were identified for weight, pixel size, resolution, pixel pitch, total pixel area, usable pixel area, MTF (at various spatial resolutions), DQE (at various spatial resolutions), sensitivity, ghosting, boot-up time, operating temperature, exposure latitude, signal uniformity, and dark noise (ADC)."
However, the document does not provide a specific table detailing the acceptance values for these criteria and the exact reported performance values. It only states that "Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device."
Without the specific numerical values for acceptance criteria and reported performance, a precise table cannot be generated. The text indicates a qualitative assessment of meeting acceptance criteria.
Study Information Summary
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly mentioned in terms of the number of images or cases. The testing appears to be non-clinical (bench testing) rather than a study involving a patient test set.
- Data Provenance: The study was non-clinical bench testing. There is no mention of patient data, country of origin, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was non-clinical bench testing, not a study evaluating diagnostic performance against expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This was non-clinical bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states: "Clinical studies were not submitted because the non-clinical data was sufficient to demonstrate substantial equivalence to the predicate device." The system is a DR imaging system, not an AI-assisted diagnostic tool for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The testing described is "non-clinical (bench) testing" focused on the physical and image quality characteristics of the device itself (detector and system), not its performance in a diagnostic workflow with human readers. The performance evaluation is of the device's technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical bench testing, the "ground truth" was established by "desired performance with respect to image quality, intended use, workflow related performance, shipping performance, and general functionality and reliability, including both hardware and software requirements." These are based on industry standards and specified device requirements, rather than clinical ground truth (like pathology or expert consensus on patient cases).
8. The sample size for the training set:
- Not applicable. This document describes the testing of a medical imaging device (DR system), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See answer to #8).
§ 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.