(48 days)
The 5MP Color LCD Monitors C53S+, C53SP+ and 5MP Monochrome LCD Monitors G53S+, G53SP+ 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 C53S+, C53SP+, G53S+, G53SP+ 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 2048 x 2560. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable in their lives and the calibration is continuous, so these products meet the demand of high precision medical imaging. For C53SP+ and G53SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen. Model variations are distinquished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional glass screen. For example, C53S+ is a color LCD monitor; G53SP+ is a monochrome LCD monitor with the additional glass screen.
The document describes the premarket notification (510(k)) for Shenzhen Beacon Display Technology Co., Ltd.'s 5MP Color and Monochrome LCD Monitors (C53S+, C53SP+, G53S+, G53SP+). However, this document does not contain information about an AI/algorithm-driven device, nor does it detail a study proving adherence to specific acceptance criteria for such a device in the context of AI model performance. Instead, it focuses on the substantial equivalence of the monitors to a predicate device, primarily through bench testing of display characteristics.
Therefore, I cannot provide the requested information as it pertains to an AI/algorithm efficacy study, acceptance criteria for an AI model, sample sizes, expert involvement, or MRMC studies, because this document is about medical display monitors and their technical specifications, not an AI software or algorithm.
The document states:
- Device Type: 5MP Color LCD Monitors C53S+, C53SP+; 5MP Monochrome LCD Monitors G53S+, G53SP+. These are hardware display devices, not AI algorithms.
- Intended Use: "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." This reinforces that the device is a display and not an AI component.
- Performance Testing: The "Performance Testing" section (page 16) outlines the tests conducted on the monitors themselves, such as "conformance to DICOM GSDF," "calibrated luminance," "luminance non-uniformity," "chromaticity non-uniformity," "temporal response," "spatial noise," "reflection coefficient," "veiling glare," and "spatial resolution." These are all standard display performance tests.
- No clinical or animal testing: The document explicitly states "No animal or clinical testing is needed for C53S+, C53SP+, G53S+, G53SP+." This further confirms that no studies involving human or animal subjects (which would be typical for evaluating an AI's impact on diagnostic performance) were conducted or required.
The request's parameters (acceptance criteria for an AI model, sample sizes for AI test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to the content of this document.
§ 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).