(87 days)
X-Ray Film Development
SRX-701 Film Processor
The provided text is a 510(k) clearance letter from the FDA for the Konica SRX 701 Automatic X-ray Film Processor. It does not contain any information about acceptance criteria, device performance studies, or AI/algorithm-related details.
This device is an X-ray film processor, which is a physical piece of equipment for developing X-ray film, not a software algorithm or an AI-powered diagnostic device. Therefore, the questions regarding ground truth, expert consensus, sample size for training sets, or comparative effectiveness studies with AI assistance are not applicable to this particular device.
To directly answer your request based on the provided text, while acknowledging its limitations:
1. A table of acceptance criteria and the reported device performance
- Information Not Available: The document is a clearance letter, not a study report. It does not contain acceptance criteria or reported device performance metrics. Its purpose is to state that the device is "substantially equivalent" to legally marketed predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Available: No such information is present as this is not a study report for an AI/diagnostic algorithm.
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)
- Information Not Available: Not applicable to an X-ray film processor.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Available: Not applicable.
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
- Information Not Available: Not applicable, as this is an X-ray film processor, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Not Available: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information Not Available: Not applicable.
8. The sample size for the training set
- Information Not Available: Not applicable.
9. How the ground truth for the training set was established
- Information Not Available: Not applicable.
§ 892.1900 Automatic radiographic film processor.
(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.