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CL-S1200 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

30.9 inch Color Digital Mammography LCD Monitor 4200 x 2800 (landscape)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display including mammography.
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.
Luminance and the color mura correction functions will help achieve uniformity on the whole screen.
A glass filter protects the surface of the LCD panel.

The provided document is a 510(k) premarket notification for a medical display monitor (JVCKENWOOD 12MP Color Digital Mammography LCD Monitor CL-S1200). It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

However, the document does NOT contain information about a study proving the device meets clinical acceptance criteria related to AI performance, human reader improvement with AI, or standalone AI performance.

The "acceptance criteria" discussed in the document are limited to physical laboratory tests for display monitor performance (e.g., spatial resolution, pixel defects, luminance, color tracking). These tests are conducted on the device itself (the monitor), not on an AI algorithm that processes medical images.

Therefore, I cannot fulfill all parts of your request because the provided text does not contain the necessary information regarding:

• A table of acceptance criteria for AI performance and reported device performance for AI.
• Sample size used for the test set and data provenance for AI testing.
• Number of experts and qualifications for establishing ground truth for AI testing.
• Adjudication method for AI test set.
• MRMC comparative effectiveness study results (effect size of human readers improvement with AI).
• Standalone AI performance results.
• Type of ground truth used for AI testing.
• Sample size for AI training set.
• How ground truth for AI training set was established.

Based on the provided text, the only "acceptance criteria" and "study" information available is for the display monitor's technical performance, not for an AI algorithm's performance.

Here's what can be extracted regarding the display monitor's acceptance criteria and proof of meeting them:

1. Table of Acceptance Criteria and Reported Device Performance (for the Display Monitor):

The document lists various performance test items and the methods used to evaluate them. It implies that the device met these criteria through testing. While specific numerical results are not provided in a table, the Conclusion states: "The results of the performance testing and the verification demonstrate that the subject device is substantially equivalent to the currently marketed predicate device." This implicitly confirms that the device met the performance standards expected for a device deemed substantially equivalent.

2. Sample size used for the test set and the data provenance (for the Display Monitor):

• Sample Size: This is likely a single device (the JVCKENWOOD 12MP Color Digital Mammography LCD Monitor CL-S1200) that underwent these physical laboratory tests. The concept of a "test set" as in a dataset for AI is not applicable here.
• Data Provenance: The tests are physical laboratory tests conducted by the manufacturer (JVCKENWOOD Corporation) in Japan. The data is prospective, as it's generated specifically for this regulatory submission.

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

• Experts: Not applicable in the context of physical display testing. The ground truth for these tests is based on the physical properties of the display and established objective measurement standards (e.g., ISO, AAPM-TG18, IDMS). Personnel performing the tests would be qualified engineers or technicians.

4. Adjudication method (for the Display Monitor):

• Adjudication Method: Not applicable. These are objective physical measurements per established standards.

5. MRMC comparative effectiveness study results (for the Display Monitor):

• MRMC Study: Not applicable. This document does not describe an MRMC study comparing human reader performance with and without this display monitor, or with AI assistance. It focuses solely on the technical specifications and substantial equivalence of the monitor itself.

6. Standalone (algorithm only without human-in-the loop performance) (for the Display Monitor):

• Standalone Performance: Not applicable. This device is a display monitor, not an AI algorithm.

7. The type of ground truth used (for the Display Monitor):

• Ground Truth: Objective physical measurement standards and industry guidelines (e.g., AAPM-TG18, ISO 13406-2, IDMS 1.03, IEC 62563-1) serve as the "ground truth" or reference for evaluating the display's performance.

8. The sample size for the training set (for the Display Monitor):

• Training Set Sample Size: Not applicable. This device is a hardware product (display monitor), not a machine learning model that requires a training set.

9. How the ground truth for the training set was established (for the Display Monitor):

• Training Set Ground Truth Establishment: Not applicable, as there is no training set for a display monitor.

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