(142 days)
The device is indicated for producing full-bleed thermal wax prints in various sizes from medical image signal inputs.
Color point 820 PS, 830 Ps and Professional Colorpoint 2 Model 04.
The provided document is a 510(k) clearance letter from the FDA for the Seiko Instruments, Inc. ColorPoint 820PS and 830PS Color Printer. This document specifically states the device is an "Unclassified Procode: 90 LMC" and is intended for "producing full-bleed thermal wax medical image signal inputs."
Based on the content of these documents, it is not possible to provide the requested information about acceptance criteria and a study proving the device meets those criteria. This type of FDA clearance letter does not typically contain detailed performance specifications, clinical study results, or information regarding ground truth and expert reviews for medical devices.
The FDA 510(k) clearance process for unclassified devices like this color printer often relies on substantial equivalence to a predicate device rather than extensive clinical efficacy studies with predefined acceptance criteria for performance metrics.
Therefore, I cannot populate the table or answer the specific questions about the study from the given 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.