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21.3 inch Monochrome Digital Mammography 5M pixel LCD Monitor with sub-pixel driving techniques enabling 15M subpixels to be driven independently, MS55i2 (ML21055, MD211G5) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

MS55i2 (ML21055, MD211G5) is a 21.3-inch monochrome LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.

Here's an analysis of the provided text regarding the acceptance criteria and study for the JVCKENWOOD MS55i2 monitor.

The document describes a 510(k) premarket notification for a medical display monitor. The "study" in this context refers to product verification and validation testing to ensure the monitor meets specified technical performance criteria, rather than a clinical study involving human readers or patient outcomes, as is common for AI-powered diagnostic devices.

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes physical and performance testing of a medical display monitor against established industry standards and specifications, rather than a clinical study.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: This information is not explicitly provided. For device verification and validation of a monitor, it would typically involve testing of a representative sample of units (e.g., a few units from a production batch or prototypes) to ensure consistency and compliance with specifications. The document repeatedly says "Refer to actual data" for various metrics, indicating that tests were performed, but the number of devices or iterations tested is not stated.
• Data Provenance: The device manufacturer, JVC KENWOOD Corporation, is located in Yokohama-shi, Kanagawa, Japan. The testing was conducted internally or by a contracted lab to verify the monitor's technical specifications. This is a retrospective testing of the device's technical performance against established engineering and quality standards rather than a prospective clinical data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This is not applicable as the "ground truth" for a medical display monitor's performance is established by technical standards and specifications (e.g., AAPM-TG18, ISO13406-2, DICOM GSDF), not by expert consensus on clinical images. The "ground truth" refers to the target values or acceptable ranges for physical characteristics like luminance, contrast, uniformity, etc., as defined by these standards.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies where multiple human readers interpret medical images and their opinions need to be reconciled for a ground truth. For a device like a monitor, performance is measured against objective, quantitative technical specifications using calibrated measuring equipment.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study assesses the clinical impact of an AI algorithm on human reader performance when interpreting medical cases. The JVCKENWOOD monitor is a display device, not an AI algorithm. Its performance is evaluated based on its ability to accurately render images according to technical standards.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done

• Yes, in essence. The "study" described is a standalone technical performance evaluation of the monitor itself (the "device-only" performance) against physical and display quality specifications. It measures inherent characteristics of the monitor (e.g., luminance, contrast, uniformity, grayscale response, etc.) without human interaction to "interpret" or diagnose. The device's ability to meet these technical specifications is its "standalone performance."

7. The Type of Ground Truth Used

• The ground truth used is primarily technical specifications and established industry standards. Specifically, references are made to:
  • AAPM-TG18 (American Association of Physicists in Medicine Task Group 18): For luminance response, luminance uniformity, geometrical distortion, reflectance, veiling glare, chromaticity, and stability.
  • DICOM GSDF (Grayscale Standard Display Function): For grayscale conformance.
  • ISO13406-2: For pixel dropouts and pixel fill factor.
  • Manufacturer's own internal specifications for other characteristics (e.g., maximum luminance, contrast ratio, viewing angle, noise).
  • Safety standards like UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE.

8. The Sample Size for the Training Set

• This is not applicable. Training sets are relevant for machine learning or AI algorithms. This document describes the validation of a hardware device (a monitor), which does not involve a training set.

9. How the Ground Truth for the Training Set Was Established

• This is not applicable for the same reason as #8.

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