(22 days)
To process (develop) medical imaging films for viewing by physicians. This may be used in the imaging modalities of Ultrasound, X-Ray, Nuclear Medicine, Computed Tomography, Mammography, Cardiology, and Magnetic Resonance.
All currently marketed automatic film processors have the same basic components, including a feed and detection mechanism, a processing system consisting of chemical tanks and transport racks, a washer, a dryer, a receiving bin, and controls and indicators. Major subsystems include water supply, temperature regulation, chemical replenishment, and solution circulation.
The device performs standard photographic processing of previously exposed sheets or rolls of silver-halide based films. The processed films contain acquired anatomical images for viewing by physicians, typically of the radiological discipline specialty. The photographic processing (developing) technique employed by these automatic processors is the same as all devices manufactured by several companies, and has gone basically unchanged in approximately fifteen years. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then ejected for viewing and archival purposes.
The Agfa family of automatic film processors also offers additional features such as daylight handling and processing, laser film recorder docking, and automatic film handling for various types and sizes of imaging films used in the above radiographic applications. Some models offer the E.O.S. (Environmentally Optimized System) feature. This feature employs an additional fixer tank technique that reduces fixer solution consumption and waste.
This document, K981280, is a 510(k) summary for Agfa's Automatic Film Processors. It states the intended use of the device and describes its basic components and function. However, it does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. This document serves as a regulatory submission confirming substantial equivalence to existing devices, not a performance study report.
Therefore, I cannot provide the requested information from the given text.
§ 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.