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The VSII system is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.

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The provided text is a 510(k) summary for the Visionsense Ltd.'s VSII System, a stereoscopic vision system for general endoscopic and laparoscopic surgical procedures. It primarily focuses on demonstrating substantial equivalence to a predicate device (ELRAN 01 Stereoscopic Laparoscope) rather than detailing performance studies and acceptance criteria for entirely new device claims.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided document. The 510(k) process for substantial equivalence often relies on demonstrating that the new device performs "as safe and effective" as the predicate, rather than establishing entirely new performance benchmarks through extensive studies typically associated with novel or high-risk devices.

Here's what can be extracted and what is missing:

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

Missing: Specific quantitative acceptance criteria (e.g., minimum resolution, field of view, illumination levels, specific accuracy metrics for stereoscopy) and the quantitative results of the VSII System against these criteria. The document states "Performance data demonstrates," but does not provide the specifics of this data or the defined acceptance thresholds.

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

Missing: The document does not mention any specific "test set" in the context of device performance evaluation, nor does it provide details on sample size or data provenance (country of origin, retrospective/prospective). The assessment appears to be based on a comparison to the predicate device's established performance rather than a new standalone clinical study.

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

Missing: This information is not provided because there is no mention of a "test set" and corresponding ground truth establishment by experts for the VSII system in this summary.

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

Missing: Not applicable, as no test set or expert adjudication is described.

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

Missing: This is not applicable to the VSII System, which is a stereoscopic vision system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

The document does not describe a "standalone" algorithmic performance study in the context of AI. The VSII system is a viewing system, not an algorithm. The "performance data" mentioned is likely related to engineering tests and optical characteristics to ensure similar performance to the predicate device.

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

Missing: No "ground truth" in the clinical AI sense is mentioned, as there are no diagnostic claims or classifications being made by the device itself that would require clinical ground truth.

8. The sample size for the training set

Missing: Not applicable, as this is a hardware vision system, not an AI model that undergoes "training."

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

Missing: Not applicable for the same reason as above.

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