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The device is intended to display medical images from endoscopic camera systems and other compatible medical image systems.

The device is a medical grade monitor for real-time use during endoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, doctor's offices, clinics and similar medical environments.

The MDEC-2523 is a medical grade monitor with a 23,8 inch color TFT-LDC screen size and is intended to display medical images from endoscopic or laparoscopic camera systems and other compatible medical image systems.

The MDEC-2523 consists of an LCD panel and LED backlight integrated into a plastic housing body with an internal metal chassis structure, that also integrates the electronics, sensors, and interconnections. The MDEC-2523 encloses user controls that are used to control and configure the device via the embedded on screen display (OSD) software. The device has a glass cover to protect the LCD panel and allow easy cleaning. The MDEC-2523 is powered by means of an internal power supply.

This monitor displays color video images that are output from medical imaging systems on the LCD (liquid crystal display) panel.

The provided document is a 510(k) premarket notification letter from the FDA regarding a medical LCD monitor (MDEC-2523). It primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to regulatory standards.

Crucially, this document does not include information about a study proving the device meets acceptance criteria related to a clinical performance claim, specifically one involving AI, human readers, or ground truth establishment based on expert consensus, pathology, or outcomes data.

The acceptance criteria and study described in the input prompt are typically associated with devices that make diagnostic or therapeutic claims based on analyzing medical images or data, often involving AI or software. This document is for an LCD monitor, which is a display device. Its performance is assessed through electrical safety, EMC, environmental, and software testing to ensure it correctly displays images without introducing new safety or effectiveness concerns, rather than evaluating its accuracy in diagnosing conditions or improving human reader performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study as outlined in the prompt's nine points because the provided text does not contain this type of study information.

The non-clinical performance testing conducted for this device, as stated in the document, includes:

• Electrical safety testing (ANSI AAMI E560601-1)
• EMC testing (IEC 60601-1-2 Edition 4.1)
• Environmental testing (Climate, shock and vibration, packed, thermal analysis)
• Software testing
• Usability/human factors

The document explicitly states: "Clinical study - Not Applicable." This further confirms that the type of study outlined in the prompt (involving expert consensus, mrmc, standalone performance etc.) was not performed or required for this device.

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