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The Microperimeter MP-3 is indicated for use as: Color retinography Fixation examiner Fundus-related microperimetry

The Microperimeter MP-3performs the following basic functions: Color retinography Fixation examiner Fundus-related microperimetry

The provided text does not contain detailed acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for a medical device efficacy study (e.g., sensitivity, specificity, accuracy targets).

Instead, the document is a 510(k) premarket notification summary for the Nidek Microperimeter MP-3, asserting substantial equivalence to a predicate device (MP-1 MICROPERIMETER). The "testing" referred to is primarily bench testing to demonstrate that the modified device (MP-3) meets its functional specifications, performance requirements, and complies with applicable international standards for safety and electrical compatibility, and that its performance is "as well as" the predicate device.

Here's an attempt to answer your questions based on the provided text, highlighting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It focuses on the device's functional integrity and compliance with safety standards, and equivalence in performance to the predicate device.

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

The document refers to "bench testing" and "all necessary safety tests" and "all the necessary performance tests." It does not specify a sample size, test set, or data provenance (e.g., country of origin, retrospective/prospective clinical data). This suggests that the testing was likely internal engineering and quality assurance testing rather than a clinical study with human subjects.

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

This information is not provided. Given that the testing mentioned is primarily "bench testing" and "functional specifications," it's unlikely that external experts were involved in establishing "ground truth" in a clinical sense.

4. Adjudication method for the test set

This information is not provided.

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

There is no indication of an MRMC comparative effectiveness study, AI assistance, or human reader improvement in the provided text. The device described does not appear to be an AI-driven diagnostic aid that would typically involve such a study design. It's a diagnostic instrument for acquiring images and microperimetry data.

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

This concept is not applicable to the device described. The Microperimeter MP-3 is an instrument operated directly by a human. The "automatic alignment and focusing" mentioned are features of the device's operation, not a standalone AI algorithm generating interpretations.

7. The type of ground truth used

The concept of "ground truth" in a clinical diagnostic sense (e.g., pathology, outcomes data) is not explicitly addressed. The testing focused on verifying the device's functional integrity, compliance with technical standards, and performance against its own specifications and the predicate device's established performance. For example, light hazard compliance would be against ISO standards, and image acquisition would be verified against internal specifications for image quality.

8. The sample size for the training set

This information is not applicable as the device is not described as having an AI component that would require a "training set."

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

This information is not applicable for the same reason as above.

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