(56 days)
The Carestream DRX-1 System is intended to capture for display radiographic images of human anatomy. It 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, tomography and angiography applications.
The Carestream DRX-1 System is a digital imaging system to be used with diagnostic x-ray systems. It includes a Carestream DRX-1 System Detector (flat panel digital detector), Carestream DRX-1 System Console (operator console) and Carestream DRX-1 System Interface Box (generator interface or Interface Box). Images captured with the flat panel digital detector can be communicated to the operator console via tethered connection or wireless.
The provided document is limited in the detail it offers regarding acceptance criteria and the comprehensive study design. However, I can extract the information that is present.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Performance testing was conducted to verify the design input requirements and to validate the Carestream DRX-1 System conformed to the defined user needs and intended uses. Predefined acceptance criteria was met and demonstrated that the Carestream DRX-1 System is as safe, as effective, and performs as well as or better than the predicate device." And for clinical testing: "Results of clinical testing demonstrated there were no significant differences observed between the Kodak DirectView CR 850 System and Carestream DRX-1 System with respect to clinical acceptance or the ability to diagnose."
However, the specific "predefined acceptance criteria" (e.g., specific metrics like SNR, spatial resolution improvements, or diagnostic accuracy thresholds) and their corresponding numerical results for the Carestream DRX-1 System are not detailed in this document. The reported performance is a general statement of meeting criteria and no significant difference from the predicate.
| Acceptance Criteria (Specifics Not Provided) | Reported Device Performance |
|---|---|
| Safety | Met (as safe as predicate) |
| Effectiveness | Met (as effective as predicate) |
| Performance (bench testing) | Met (performs as well as or better than predicate) |
| Clinical Acceptance | No significant difference from predicate |
| Ability to Diagnose | No significant difference from predicate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "Clinical Testing" was performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified. The term "clinical testing" implies expert evaluation, but the number or specific roles (e.g., radiologists) are not detailed.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Implied by the "no significant differences observed... with respect to clinical acceptance or the ability to diagnose" statement when comparing to the predicate, which suggests human readers evaluated both systems. However, a formal MRMC study design (e.g., number of readers, specific protocols) and its details are not explicitly described.
- Effect size of human readers with AI vs. without AI assistance: Not applicable/Not mentioned. This device is a digital radiography system, not an AI-assisted diagnostic tool. The comparison is between two digital imaging systems.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Not applicable. The Carestream DRX-1 System is described as a complete digital imaging system (detector, console, interface). It's not an algorithm intended for standalone performance evaluation in the context of AI. The performance testing was for the integrated system.
7. Type of Ground Truth Used
- Type of Ground Truth: The document refers to "clinical acceptance" and "ability to diagnose," implying a clinical assessment by human experts (likely radiologists) as the ground truth for comparison. There is no mention of pathology or outcomes data.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not specified. This device is a digital radiography system, not a machine learning algorithm that requires a separate training set. Performance was evaluated for its imaging capabilities.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. See point 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.