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The 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

Beacon LCD monitor (G22S+, G22SP+, C22S+, C22SP+) is for viewing medical images other than those of mamography. Its using the latest generation of LED back light panel, with the resolution 1600 x 1200 (landscape), 1200 x 1600 (portrait), built-in brightness stabilization circuit, the monitor can guarantee the stable brightness and persistent calibration throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, making the image and display clearer. The monitor supports DVI-D, DP and VGA.

Model variations are distinguished by characters. G means the Monochrome monitor, C means the Color monitor, and P means the monitor with an additional glass screen. For example, G22S+ is a monochrome LCD monitor; C22SP+ is a color LCD monitor with the additional glass screen.

The provided text describes a 510(k) premarket notification for a medical display monitor, not an AI/ML-driven device. Therefore, the information typically required to describe acceptance criteria and a study proving an AI/ML device meets those criteria (e.g., sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not present in this document.

The document focuses on demonstrating substantial equivalence of the Beacon 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) to predicate devices (EIZO RadiForce GX240 and RX250/RX250-AR). This is done by comparing:

• Intended Use: Showing it's identical to the predicate devices (displaying digital images for review, analysis, and diagnosis by trained medical practitioners, excluding mammography).
• Technological Characteristics: Comparing specifications like screen technology, resolution, brightness, contrast ratio, inputs, etc., and explaining that any differences do not affect safety or effectiveness.
• Performance Testing (Bench Tests): These tests are conducted on the device itself to verify its physical display characteristics against established guidelines (AAPM TG18), and not really a study assessing diagnostic performance assisted by AI.

To directly answer your request based on the provided document:

There is no information in this document about:

1. A table of acceptance criteria and reported device performance for an AI/ML device. The "Performance Testing" section describes bench tests on the display's physical characteristics, not diagnostic performance metrics for an AI system.
2. Sample sizes used for a test set and data provenance: No AI/ML test data or patient data is mentioned. The "test set" here refers to the actual monitor units undergoing bench tests.
3. Number of experts used to establish ground truth and qualifications: Not applicable for a display monitor's bench testing.
4. Adjudication method for the test set: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted as this is a display monitor, not an AI assistance tool.
6. Standalone (algorithm only without human-in-the-loop) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of diagnostic "ground truth" for AI. The "ground truth" for the display itself would be defined by performance standards like DICOM GSDF and TG18 guidelines.
8. Sample size for the training set: Not applicable as there is no AI/ML training involved.
9. How ground truth for the training set was established: Not applicable.

Summary of Device Performance (from "Performance Testing" section):

The document states that the bench tests performed on the G22S+, G22SP+, C22S+, C22SP+ include:

• Verification of conformance to DICOM GSDF (in accordance with AAPM TG18 guideline).
• Measurement of luminance non-uniformity characteristics (TG18 guideline).
• Measurement of chromaticity non-uniformity characteristics (TG18 guideline).
• Measurement of chromaticity at the center of the display screen at 5%, 50%, and 95% of maximum luminance.
• Visual check for miscellaneous artifacts (TG18 guideline).
• Measurement of spatial resolution (MTF).
• Maximum number allowed for each type of pixel defects/faults.

Reported Device Performance:

The document broadly states: "The test results showed that G22S+, G22SP+, C22S+, C22SP+ are with display characteristics equivalent to those of the predicate device... each of which was determined that it would not affect observer's performance." Specific numerical acceptance criteria and the exact measured values are not provided in this excerpt, only the types of tests performed and the general conclusion of equivalence.

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