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The Applied Medical EVS is a single-use sheath intended for percutaneous access to the perioheral vascular system. The EVS is designed to assist in the placement and removal of therapeutic instrumentation.

The device consists of three major components: a sheath with deployable mesh funnel, an obturator with deployable mesh umbrella and a hemostasis valve with luer port.

The provided text is a 510(k) summary for the "Applied Medical Expanding Vascular Sheath" (EVS) and does not contain information related to software or AI-driven diagnostic devices. Therefore, it does not include the details typically found in studies evaluating acceptance criteria for such devices, such as:

• Acceptance Criteria Table and Reported Device Performance: No quantitative performance metrics like sensitivity, specificity, or AUC are present.
• Sample Size and Data Provenance for Test Set: Information regarding a test set sample size, country of origin, or whether data was retrospective or prospective is absent.
• Number of Experts and Qualifications for Ground Truth: There is no mention of experts establishing ground truth for a test set.
• Adjudication Method: No adjudication method is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no MRMC study or effect size mentioned, as this device is a physical medical instrument, not an AI diagnostic tool.
• Standalone Performance: The concept of "standalone performance" for a physical sheath device as applied to AI algorithms is not applicable here.
• Type of Ground Truth: The ground truth concept as used for AI evaluation (e.g., pathology, outcomes data) is not relevant to this type of device.
• Sample Size for Training Set: There is no training set for a physical device.
• How Ground Truth for Training Set was Established: Not applicable.

Based on the provided text, the "acceptance criteria" and "study" are focused on mechanical, safety, and biocompatibility tests to demonstrate substantial equivalence to a predicate device.

Here's an interpretation of what could be considered "acceptance criteria" and the "study" for this type of device, drawn directly from the text:

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

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

The document does not specify sample sizes for the mechanical, safety, and biocompatibility tests. It also does not mention data provenance (country, retrospective/prospective), as these tests are typically performed in a laboratory setting on manufactured units.

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):

Not applicable. Ground truth as typically defined for AI/diagnostic devices does not apply to the mechanical and biological testing of a physical medical device like an introducer sheath. The "ground truth" for such tests would be established by validated test methods and standards.

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

Not applicable. This is not a diagnostic device requiring expert adjudication.

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:

No, an MRMC study was not done. This is a physical medical device, not an AI diagnostic algorithm.

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

Not applicable. This pertains to software devices, not a physical introducer sheath.

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

The "ground truth" for the EVS's evaluation would be based on:

• Mechanical performance standards: e.g., tensile strength, burst pressure, deployment force, as per relevant ISO or ASTM standards.
• Biocompatibility standards: e.g., cytotoxicity, irritation, sensitization, as per ISO 10993 series.
• Functional performance: successful deployment, hemostasis, ease of insertion, as measured against design specifications and predicate device performance.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI algorithm.

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

Not applicable. This is a physical device, not an AI algorithm.

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