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8MP Color LCD Displays C811W, C811WT, PA27 and PA27T are intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. They are an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T. The displays are not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

The C811WT. PA27T. C811W. PA27 are 8MP Color LCD Displays, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners that have been validated for use with the display.

The displays are equipped with a 27-inch color LCD panel with a fine pixel pitch. They use the latest generation of LED backlight panels. The built-in brightness stabilization control circuits make sure the brightness of these displays is stable in their life, so the products meet the demands of high precision medical imaging.

For C811WT. PA27T. C811W. PA27. the only difference is the capacitive touch screen.

C811WT, PA27T have the same capacitive touch screen. C811W, PA27 don't have a capacitive touch screen.

The difference between C811WT and PA27T is only different customers which results in the two models. The difference between C811W and PA27 is only different customers which results in the two models.

The provided text describes the acceptance criteria and a study proving the device meets these criteria for the Shenzhen Beacon Display Technology Co., Ltd.'s 8MP Color LCD Displays (C811W, C811WT, PA27, PA27T).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the "Test" column, and the reported device performance is presented in the "C811W", "C811WT", "PA27", and "PA27T" columns. The predicate device (Barco MDPC-8127) is also listed for comparison of technological characteristics.

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

The document does not explicitly state a sample size in terms of a number of distinct display units tested within each model group (C811W, C811WT, PA27, PA27T). The results are presented as single values for each model, implying that these are representative measurements from the tested devices.

The data provenance is from bench testing conducted on the newly submitted devices and compared against the specifications of a predicate device. Regarding country of origin, the manufacturer is Shenzhen, Guangdong, China. The testing itself would likely have been performed in a lab setting, possibly in China or by a certified testing facility collaborating with the manufacturer. The document does not specify if the data is retrospective or prospective, but as it's for a 510(k) submission, it would be considered prospective with respect to the regulatory approval process.

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

This information is not applicable as the study described is a technical performance assessment of display characteristics, not a clinical study involving human interpretation of medical images or ground truth established by medical experts. The "ground truth" for these tests are objective, measurable physical properties of the displays, governed by established test methods and standards (e.g., IDMS 1.03).

4. Adjudication method for the test set

This information is not applicable for the same reasons as #3. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers assess cases, and a process is needed to resolve discrepancies. This document describes objective bench testing.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the technical performance of a medical display, not a clinical diagnostic aid involving AI or human reader performance.

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

This is not applicable. The device is an LCD display, not an algorithm. Its "performance" is its ability to accurately render visual information, which is evaluated through the technical tests detailed.

7. The type of ground truth used

The ground truth used for this technical performance assessment is based on objective measurements of physical display characteristics as defined by industry standards, specifically the "TPA Guidance" and "IDMS 1.03" (International Display Measurement Standard). Examples include:

• Pre-defined target luminance (e.g., 500 cd/m²)
• Reference sRGB color space
• Calibrated measurement equipment to determine values like MTF, pixel defect counts, deviation percentages, and color errors against established benchmarks.

8. The sample size for the training set

This information is not applicable. The device is a hardware display, not a machine learning model that requires a training set.

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

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

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