(214 days)
The KODAK DirectView CR Mammography Feature together with KODAK DirectView CR Mammography Cassette comprise a device which, when used in conjunction with a KODAK DirectView CR System and a mammographic x-ray machine, generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.
The Carestream CR Mammography Cassette with SNP-M1 Screen is a structured needle phosphor detector used in conjunction with the Kodak DirectView CR Mammography Feature on Kodak DirectView CR Systems for generating digital mammographic images. The Carestream CR Mammography Cassette SNP-M1 Screen is used in the same manner as a traditional screen-film cassette when performing radiographic patient exposures and will be used in the DirectView CR Systems: CR850, readers problem on on and Elite CR readers using the Kodak DirectView CR Mammography Feature.
The provided text describes a Special 510(k) submission for the Kodak DirectView CR Mammography System by Carestream Health, Inc. The submission is for a modification to an existing device, specifically a new storage phosphor screen (SNP-M1) for mammography. The document focuses on showing substantial equivalence to the predicate device (Kodak DirectView CR Mammography System: P080018/S001).
However, the provided text does not contain specific acceptance criteria or an explicit study proving performance against such criteria. The document states:
"Performance testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. Non-clinical physical laboratory testing was conducted to assess performance. Clinical image evaluation was also conducted. Predefined acceptance criteria was met and demonstrated that the device is substantially equivalent to and as safe and as effective as the predicate device."
This statement confirms that performance testing and clinical image evaluation were done, and predefined acceptance criteria were met, but it does not provide the details of those criteria or the study results.
Therefore, I cannot populate the requested information. The document focuses on demonstrating substantial equivalence through technological characteristics comparison and a general statement that acceptance criteria were met, rather than detailing the specific performance metrics and study design/results.
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.