(56 days)
The MM/MMA/Color Series Digital Flat Panel Display System™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. This device must not be used for primary image diagnosis in mammography
The MM/MMA/Color Series Digital Flat Panel Display System™ is a flat panel hiresolution LCD monitor system for displaying medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale and color image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
The provided text describes a 510(k) summary for the MM/MMA/Color Series Digital Flat Panel Display System. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in performance testing sections of a 510(k) submission.
The document outlines:
- General information about the submission (date, submitter).
- Trade name, common name, and classification.
- Predicate devices used for substantial equivalence comparison.
- A brief description of the device as a flat panel high-resolution LCD monitor system for displaying medical images, consisting of an LCD monitor and a graphic control board.
- Indications for Use, explicitly stating it's for displaying and viewing digital medical images for review and analysis, and not for primary image diagnosis in mammography.
- Technological characteristics, mentioning it's software and components, does not contact the patient, and provides ample opportunity for human intervention.
- A conclusion of substantial equivalence to predicate devices based on the information provided, and adherence to voluntary safety standards (UL, EN, IEC, FCC, CE, VCC, MIC).
- A hazard analysis classifying potential hazards as Minor.
The FDA letter and "Indications for Use" form further confirm receipt and substantial equivalence determination for marketing, reiterating the stated indications for use.
Therefore, based solely on the provided text, I cannot complete the requested table and answer the study-related questions, as this information is not present. The document focuses on regulatory classification, substantial equivalence to predicate devices, and general safety/intended use, rather than detailing specific performance acceptance criteria and a study demonstrating their fulfillment.
Missing Information:
- Acceptance criteria (e.g., luminance, contrast ratio, uniformity, resolution).
- Any performance specifications or reported device performance against such criteria.
- Details of any study (clinical or technical performance) that would involve test sets, ground truth, experts, or comparative effectiveness.
- Sample sizes for test or training sets.
- Ground truth establishment methods for any potential studies.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(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).