(44 days)
Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on the film/thermal paper. This device is not intended for mammography use.
Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on 8x10" sized film/thermal paper. It does not incorporate laser scanning unit. The control unit processes and controls image data and performs control of the whole device. This device is not intended for mammography use.
The provided text describes a 510(k) premarket notification for a medical image hardcopy device, the Digital Printer P6000D series Model P6000DU. However, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
This document is a regulatory submission for substantial equivalence to a predicate device, focusing on technical characteristics and compliance with general safety standards, rather than performance studies against specific acceptance criteria.
Therefore, I cannot extract the information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies from the provided text.
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). 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.