(57 days)
C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
5MP LCD Monitors C510S, G510S, CB5MP, MB5MP, C516S, G516S are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography. These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 2560 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable and the calibration is continuous, so these products meet the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
The provided text describes a 510(k) premarket notification for medical display monitors and does not contain information about the acceptance criteria and study proving device meets the criteria. This document focuses on demonstrating substantial equivalence to a predicate device through comparison tables and performance testing rather than defining acceptance criteria and presenting a study with specific performance metrics against those criteria.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets the acceptance criteria based on the provided text.
Here's why the requested information is not available:
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Acceptance Criteria and Reported Device Performance: While the document presents detailed technical specifications of the proposed devices (e.g., resolution, contrast ratio, maximum luminance, DICOM calibrated luminance) and compares them to a predicate device, it does not explicitly state these specifications as "acceptance criteria" against which a study's results are evaluated. The document focuses on showing that the proposed device's characteristics are comparable to or within an acceptable range of the predicate device's characteristics. There is no specific table labeled "acceptance criteria" and "reported device performance."
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Sample Size and Data Provenance for Test Set: Performance testing was conducted, but the document does not mention a "test set" in the context of clinical images or patient data. The tests are bench tests on the display monitors themselves (e.g., measuring luminance, uniformity, response time). Therefore, there is no sample size for an image-based test set or data provenance (country of origin, retrospective/prospective).
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Number and Qualifications of Experts for Ground Truth: Since the performance testing comprises bench tests on the display's physical and optical characteristics, there is no "ground truth" derived from expert interpretation of medical images. The evaluation is based on technical measurements.
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Adjudication Method: Not applicable, as there are no expert interpretations requiring adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document explicitly states: "No animal or clinical testing is needed for C510S, CB5MP, MB5MP, C516S, G516S." Therefore, no MRMC study or human reader performance evaluation (with or without AI assistance) was performed.
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Standalone (Algorithm Only) Performance: This is a medical display monitor, not an AI algorithm. Therefore, standalone algorithm performance is not applicable.
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Type of Ground Truth Used: The ground truth for the performance testing consists of technical standards and measurements (e.g., DICOM Part 3.14, AAPM TG18 guideline measurements) for display characteristics. It is not expert consensus, pathology, or outcomes data.
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Sample Size for Training Set: Not applicable. These are display monitors, not an AI model that requires a training set.
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How Ground Truth for Training Set was Established: Not applicable, as there is no training set.
The document primarily demonstrates substantial equivalence to a predicate device based on technical specifications and adherence to relevant industry standards for display performance in diagnostic radiology, as outlined in the bench tests described.
§ 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).