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CL-S500 and MS-S500 are intended to be used in displaying 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.

CL-S500 : 21.3 inch Color LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
It minimizes luminance unevenness and color unevenness by Uniformity Correction Function to achieve the uniformity of luminance and color on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC quideline is conducted

MS-S500 : 21.3 inch Monochrome LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait)
High-luminance monochrome LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
It minimizes luminance unevenness by Uniformity Correction Function to achieve the uniformity of luminance on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC guideline is conducted.

The acceptance criteria for the JVC Kenwood CL-S500 (color) and MS-S500 (monochrome) LCD monitors, intended for medical image display in digital mammography PACS, digital breast tomosynthesis, and FFDM, are based on a comparison to a predicate device (CCL550i2/ K160326) and adherence to established display quality standards (AAPM-TG18 and ISO13406-2).

The study primarily focuses on demonstrating substantial equivalence by comparing the technical specifications and performance of the new devices to the predicate device and relevant industry standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" as a separate, quantitative target for each metric beyond direct comparison to the predicate device or a reference to a standard (e.g., AAPM-TG18 passing criteria). However, the "Explanation of Differences" column in the substantial equivalence comparison tables implicitly suggests the acceptance criteria where the new device must be equivalent to or better than the predicate, or meet the requirements of the specified standard.

Note: For metrics not explicitly listed in the comparison table, such as Spatial Resolution, Pixel Defects, Artifacts, etc., the document refers to studies conducted according to specific standards (AAPM-TG18, ISO13406-2, VESA 2001). The "reported device performance" for these would be that the devices "pass" or "meet" the requirements of those standards.

2. Sample size used for the test set and the data provenance:

The document describes the testing performed on the devices themselves rather than on a dataset of medical images. The "test set" here refers to the actual monitors.

• Sample size: Not explicitly stated as a number of units, but implied to be representative production units. The statement "Quantitative evaluation and visual evaluation are done before the shipment" (for both CL-S500 and MS-S500) indicates that each unit undergoes testing.
• Data provenance: The performance data for the CL-S500 and MS-S500 are results of physical tests and measurements performed by JVC KENWOOD Corporation in Japan, as indicated by the company's address and the "Date Prepared" for the 510(k) summary. These are prospective tests on the manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable in the context of this submission. The "ground truth" for evaluating these monitors is defined by established technical measurement standards (e.g., AAPM-TG18 guidance, DICOM GSDF, ISO13406-2, VESA 2001) and comparisons to known specifications of a predicate device, not by expert human interpretation of medical images displayed on the monitors.

4. Adjudication method for the test set:

Not applicable. The product is a hardware display, and its performance is evaluated by objective technical measurements against established standards, not by human adjudication of diagnostic interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This submission is for a medical display monitor, not an AI-powered diagnostic algorithm. Therefore, no MRMC study on human reader performance with or without AI assistance was performed or is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is for a display monitor, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's performance is objective technical specifications and adherence to established industry standards for medical displays. These include:

• DICOM Grayscale Standard Display Function (GSDF): For grayscale-to-luminance function conformance.
• AAPM Task Group 18 (AAPM-TG18) Guidance: For various display characteristics like luminance response, angular dependency, uniformity, reflection, and veiling glare.
• ISO13406-2 and Flat Panel Display Measurement Standard [VESA 2001]: For pixel defects.
• Predicate Device Specifications: For demonstrating substantial equivalence to a previously cleared device.

8. The sample size for the training set:

Not applicable. This is a hardware device (display monitor), not a machine learning algorithm.

9. How the ground truth for the training set was established:

Not applicable. This is a hardware device (display monitor), not a machine learning algorithm.

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