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The Surge-free Aspiration Adapter is a filter protected flow restriction orifice used during cataract surgery to prevent/neutralize vacuum surges in the aspiration line.

The Surge-free Aspiration Adapter is a filter protected flow restriction device intended to be placed between the handpiece and aspiration tubing used during phacoemulsification surgery. The Surge-free Aspiration Adapter prevents/neutralizes vacuum surges in the aspiration line resulting from the sudden clearing of occlusions.

The provided text is a 510(k) premarket notification for a medical device called the "Surge-free Aspiration Adapter." This document focuses on demonstrating the substantial equivalence of the new device to existing legally marketed predicate devices, rather than detailed performance study results against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be fully extracted from the provided text. The document primarily describes the device, its intended use, and compares its technological characteristics to predicate devices. It does not contain information about a performance study with acceptance criteria.

However, I can provide the partially available information:

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

The document does not provide specific acceptance criteria or quantitative performance data. It describes the effect of the device: "Reduction in vacuum surges resulting from release of aspiration tubing occlusions."

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

This information is not present in the document.

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 present in the document.

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

This information is not present in the document.

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

This information is not present in the document. This device is not an AI-assisted diagnostic tool; it's a mechanical adapter for surgical equipment.

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

This information is not present in the document. This device is not an algorithm.

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

This information is not present in the document.

8. The sample size for the training set

This information is not present in the document.

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

This information is not present in the document.

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