(7 days)
The DXSS Automatic X-ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. This is the sole purpose of this device.
Dental automatic radiographic film processor
The provided text describes a 510(k) submission for the "DXSS Automatic X-ray Film Processor" and a letter from the FDA stating its substantial equivalence to a predicate device. However, this document does not contain any information regarding acceptance criteria, a study proving device performance, sample sizes, data provenance, ground truth establishment, or expert involvement as requested.
The submission is for an automatic radiographic film processor, which is a physical device that develops, fixes, washes, and dries X-ray film. It is not an AI/ML-enabled diagnostic device that would typically undergo the types of studies described in the request (e.g., MRMC studies, standalone performance with specific metrics like sensitivity/specificity).
Therefore, I cannot provide the requested information from this document. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on specific performance metrics established through clinical or technical studies for an algorithm.
§ 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.