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RadiForce GS320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.

RadiForce GS320 is a 54cm (21.3") Monochrome LCD display for medical image viewing. GS310 displays high-definition medical imaging.

The provided document is a 510(k) summary for a medical display monitor (EIZO NANAO CORPORATION Monochrome LCD Monitor, RadiForce GS320), not a device that utilizes AI or provides diagnostic interpretations. Therefore, many of the requested fields regarding acceptance criteria, study details, expert involvement, and ground truth are not applicable to this type of device and are not present in the submission.

The 510(k) process for a monitor like this focuses on demonstrating substantial equivalence to a predicate device through technical specifications and intended use, rather than clinical performance studies that directly assess AI accuracy or human reader improvement.

Here's the information that can be extracted or noted as not applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For medical display monitors, "acceptance criteria" and "reported device performance" are typically defined by technical specifications and adherence to standards, rather than clinical accuracy metrics. The comparison is primarily against a predicate device's technical specifications.

The key acceptance criterion here is demonstrating "substantial equivalence" to the predicate device (RadiForce G310, K060845), meaning the new device has similar technological characteristics and intended use, and does not raise new questions of safety or effectiveness. The reported performance of the GS320 is compared directly against the specifications of the GS310. The submission states: "Comparison table of the principal characteristics of 2 devices in Attachment 1 shows that new and predicate devices are substantially equivalent in the areas of technical characteristics, general functions." The modifications noted are a slightly larger panel size and a lower contrast ratio, with the submission implicitly arguing these do not negate substantial equivalence for the intended use.

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

N/A. This is a medical display monitor, not an AI or diagnostic device that would typically undergo testing with a "test set" of patient data. The evaluation is based on engineering specifications and comparison to a predicate device.

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

N/A. No ground truth or expert evaluation of diagnostic performance is mentioned or required for this type of device submission.

4. Adjudication method for the test set

N/A. No test set for diagnostic performance is mentioned.

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

N/A. This is not an AI-assisted device.

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

N/A. This is a medical display monitor, not an algorithm.

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

N/A. Ground truth is not relevant for a medical display monitor's 510(k) submission, which focuses on technical specifications and substantial equivalence.

8. The sample size for the training set

N/A. This device does not involve a training set as it's a hardware monitor, not a machine learning algorithm.

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

N/A. Not applicable for a hardware device.

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