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SurgiS/S™ is intended to be used for implantation to reinforce soft tissue. It is intended for one-time use.

SurgiS/S™ is supplied in sheet form in sizes ranging from 16 cm² to 360 cm². The device is packaged in sterile sealed pouches.

The provided text is a 510(k) Premarket Notification for the SurgiSIS™ Surgical Mesh. However, it does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and a specific study proving the device meets those criteria, especially in the context of AI, expert evaluations, and sample sizes for training/test sets.

The document focuses on demonstrating substantial equivalence to predicate devices through similar intended use and technological characteristics, and by passing a panel of tests for biocompatibility, integrity, and performance. It does not describe explicit numerical acceptance criteria, nor does it detail a study using AI or involving human readers as would typically be found in more modern submissions for AI/ML-driven medical devices.

Based on the provided text, here’s an attempt to answer the questions, highlighting where information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document globally states "a panel of tests" of "SurgiS/S™ material," but no specific sample sizes for these tests are provided.
• Data Provenance: Not specified. This would typically be from laboratory testing on the device material itself.

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

• Number of Experts: Not applicable. The "ground truth" for a material device like SurgiSIS™ during its 1998 submission would be based on validated laboratory testing methods, not expert consensus on image interpretation or diagnosis.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Clinical adjudication is not relevant for the type of material testing described. Laboratory tests have pre-defined pass/fail criteria.

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

• MRMC Study: No. This is a 1998 510(k) for a surgical mesh material. AI assistance, human reader studies, and MRMC designs are not relevant to this type of device and were not part of the regulatory pathway for such products at that time.

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

• Standalone Study: No. As mentioned, this device is a surgical mesh material, not an algorithm or AI product.

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

• Type of Ground Truth: For the material tests (biocompatibility, integrity, performance), the "ground truth" would be established through scientific testing methodologies and established standards (e.g., ISO standards for biocompatibility, mechanical test standards for integrity) with clear pass/fail criteria.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML product developed using training sets.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

Study Proving Device Meets Acceptance Criteria:

The document briefly states: "The SurgiS/S™ material was subjected to a panel of tests to assess biocompatibility, integrity, and performance. SurgiS/S™ passed the requirements of all tests."

This indicates that a series of in vitro and potentially in vivo tests (for biocompatibility) were conducted. However, the 510(k) summary does not provide details about these specific tests, their methodologies, the exact acceptance criteria employed, or the specific results. The clearance was based on the applicant's assertion that it passed these tests and demonstrated substantial equivalence to predicate devices, which had already established safety and effectiveness.

In summary, the provided document is a regulatory submission for a traditional medical device (surgical mesh) from 1998. It does not contain information related to AI/ML device testing, which typically involves the detailed performance metrics, expert evaluations, and dataset specifics you've asked for.

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