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JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

JUSHA-C350G LCD Monitor , JUSHA-C350 LCD Monitor , C350G LCD Monitor , C350 LCD Monitor is the display system with the high resolution monitor (3 megapixels) with electronic capabilities for evaluation of high resolution medical images, high luminance (800 cd/m²) and 281.47 trillion colors, built-in DICOM standard LUT. JUSHA-C350G LCD Monitor contains CGA function, it is specially made by JUSHA, it can automatic identify gray and color signals, then gray area calls DICOM LUT and color area calls GAMMA2.2 LUT. In addition, JUSHA-C350G has ambient brightness adapting, 3D LUT color calibration, real-time DICOM automatic calibration, Full-screen brightness equalization, presence induction and focusview function, with these this display can automatic adjustment according to different requirements in order to achieve the best results. The product is consisted of the following components: - 21.3" Color TFT LCD Panel - DMX0704AR0/main board/REV1.1 - JUSHA-C350G LCD Monitor software - Power Adapter - Data Cable. The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2. IEC 60601-1-2 Edition 4:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

The document provided is a 510(k) summary for a medical LCD monitor, the JUSHA-C350G, and does not describe an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device.

Specifically, the document focuses on demonstrating substantial equivalence of the JUSHA-C350G LCD Monitor to a predicate device (JUSHA-C33C) based on performance specifications and compliance with electrical safety and EMC standards. It explicitly states that "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." and "The subject of this premarket submission, JUSHA-C350G, does not require animal or clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information for an AI/ML device, as this document pertains to a medical display monitor and does not involve AI/ML technology or associated performance criteria for such systems.

If you have a document describing an AI/ML medical device, please provide it, and I will do my best to extract the relevant information.

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