(10 days)
The GR17 is an amorphous Selenium-based direct conversion Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
The GR17 is a 17 inch by 17 inch digital delector. It is intended to convert X-rays into efectrical signals to create usable images for diagnostic use.
The provided text is a 510(k) summary for the ANRAD CORPORATION GR17 Digital Detector, submitted in 2004. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on clinical and non-clinical testing. However, the document does not provide specific acceptance criteria or detailed results from the studies that prove the device meets such criteria.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot Populate. The 510(k) summary states "Based on the Clinical Study Report dated September 8, 2004, the GR17 Digital Detector is substantially equivalent to the predicate device." and "The testing of the GR17 Digital Detector demonstrates that the performance is substantially equivalent to the predicate devices cited above." However, it does not define specific acceptance criteria (e.g., a certain sensitivity/specificity, SNR, MTF values) nor does it report specific performance metrics against any such criteria. It only asserts substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot Populate. The document mentions a "Clinical Study Report dated September 8, 2004" but does not provide any details about the sample size, type of study (retrospective/prospective), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot Populate. This information is not present in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot Populate. This information is not present in the provided text.
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
- Cannot Populate. This information is not present in the provided text. The device is a "Solid State X-Ray Imager (Flat Panel / Digital Imager)", meaning it's a hardware detector, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be applicable to this device type. The document states it is "intended to replace radiographic film/screen systems," implying a comparison to traditional film.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot Populate. The device is a hardware detector, not an algorithm. Standalone performance for an algorithm is not applicable here. The "performance" mentioned would refer to the image quality characteristics of the detector itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot Populate. This information is not present in the provided text.
8. The sample size for the training set
- Cannot Populate. This information is not present in the provided text. As this is a hardware device (detector), the concept of a "training set" in the context of machine learning is not directly applicable. If it refers to data used to optimize hardware parameters, that information is not provided.
9. How the ground truth for the training set was established
- Cannot Populate. (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.