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C310S, C316S and C616W are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.

G310S and G316S are intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.

3MP LCD Monitors C310S, G310S, C316S, G316S are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography. These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 1536 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so these products meet the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer. 6MP Color LCD Monitor C616W is a 30-inch TFT LCD monitor, which is specifically designed to provide the high definition image output for general radiography.

This product has been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 3280 x 2080. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so this product meets the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

C310S and C316S have the same color LCD panel and similar functionality. For C310S and C316S, the difference is the main board and design principle.

G310S and G316S have the same monochrome LCD panel and similar functionality. For G310S and G316S, the difference is the main board and design principle.

C310S and G310S have the same main board and design principle.

C316S and G316S have the same main board and design principle.

The provided text describes a 510(k) summary for several LCD medical displays (C310S, G310S, C316S, G316S, C616W) which are claimed to be substantially equivalent to a previously cleared device (K240310). The information does not detail an AI-powered device or a study involving human readers or comparative effectiveness for AI assistance. Instead, it focuses on the technical specifications and performance of the LCD monitors.

Therefore, the following information is extracted and parts that are not relevant to an AI/ML powered device or are not provided in the text are explicitly stated as such.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implied by the "Description" column, indicating what was measured, and the "Test result" column, which uniformly states "PASS". This suggests that the measured performance met the predetermined criteria for each test.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The tests performed are physical laboratory tests on the display embedded software using DBI Calibration Feedback System on the monitors, not a test on a test set of medical cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the device is an LCD monitor, not an AI / image analysis software requiring expert annotation for ground truth. The tests are technical performance evaluations of the display.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as it's not relevant for the type of device being described (an LCD monitor).

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an LCD monitor, not an AI or AI-assisted diagnostic tool.

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

No, a standalone performance study was not done as this device is an LCD monitor, which is a display hardware, not an algorithm.

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

The ground truth for the performance tests of the LCD monitors is based on pre-determined technical criteria and industry standards (e.g., DICOM Part 3.14, AAPM Task Group 18 guideline, manufacturer's typical data). This is not a "ground truth" derived from medical diagnosis but from established engineering and display performance metrics.

8. The sample size for the training set

This information is not applicable as the device is an LCD monitor and does not involve AI/ML models that require a training set.

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

This information is not applicable as the device is an LCD monitor and does not involve AI/ML models that require a training set and ground truth generation.

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C310S, C316S and C616W are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.

G310S and G316S are intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.

3MP LCD Monitors C310S, G310S, C316S, G316S are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography.

These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 1536 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so these products meet the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

6MP Color LCD Monitor C616W is a 30-inch TFT LCD monitor, which is specifically designed to provide the high definition image output for general radiography. This product has been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 3280 x 2080. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so this product meets the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

C310S and C316S have the same color LCD panel and similar functionality. For C310S and C316S, the difference is the main board and design principle. G310S and G316S have the same monochrome LCD panel and similar functionality. For G310S and G316S, the difference is the main board and design principle. C310S and G310S have the same main board and design principle. C316S and G316S have the same main board and design principle.

The provided text describes K240310 for Shenzhen Beacon Display Technology Co., Ltd.'s LCD Monitors (C310S, G310S, C316S, G316S, C616W) but does not contain acceptance criteria or study details regarding AI/algorithm performance.

The submission focuses on establishing substantial equivalence to predicate devices through technical comparisons and bench testing of display characteristics. There is no mention of an AI/algorithm component requiring performance studies with human readers, ground truth establishment, or clinical evaluations.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device or a study proving it meets them, as the provided text pertains to LCD monitors themselves, not an AI component.

The document does contain the following relevant information regarding the LCD monitors' performance:

The performance testing was done via bench tests and focused on the display characteristics of the monitors.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a pass/fail form with numerical targets. Instead, it states that the devices (C310S, G310S, C316S, G316S, C616W) were tested to verify "display characteristics equivalent to those of the predicate devices" and that they "meet DICOM Part 3.14 and other standards." The reported performance is implicitly shown through the comparison tables (Tables 1, 2, and 3) by comparing the proposed devices with their respective predicate devices.

Here's an example of some performance characteristics from the provided tables. For a full list, please refer to the "General Comparison" tables in the original document.

Example Table of Reported Device Performance (Partial - C310S/C316S Color LCD Monitors):

Note: The "Explanation of Differences" column in the original tables addresses specific instances where the proposed device's performance differs numerically from the predicate but is considered substantially equivalent (e.g., "Different Panel" or "Different design scheme" for brightness/contrast differences, which are then justified by passing TG18 guideline tests).

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

• Sample Size: Not specified. The document states "the bench tests were performed on C310S, G310S, C316S, G316S, C616W," implying one or more units of each model. It does not mention a large sample size of images or cases, as this is a device for displaying images, not an image analysis algorithm.
• Data Provenance: Not applicable in the context of image data. The testing was conducted on the physical monitors themselves, measuring their optical characteristics.

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

• Not applicable. The ground truth for evaluating display performance is based on established technical standards (e.g., DICOM Part 3.14, AAPM TG18 guideline) and objective measurements, not subjective expert interpretation of medical images on the device.

4. Adjudication method for the test set:

• Not applicable. Performance was assessed against objective technical specifications and standards using bench tests, not through human adjudication of diagnostic outcomes.

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. This is not an AI device. The submission does not describe an MRMC study.

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

• No. This is not an AI algorithm.

7. The type of ground truth used:

• Technical Standards and Objective Measurements: The "ground truth" for the display devices' performance is their conformance to established industry standards like DICOM Part 3.14 and the AAPM Task Group 18 (TG18) guideline for assessment of display performance. This includes measurements of spatial resolution (MTF), pixel defects, luminance characteristics (maximum, minimum, achievable, recommended), DICOM GSDF conformance, and color tracking.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. No training set was used.

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