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The M-Y Sheath is intended to enable delivery of interventional and diagnostic devices into the human vasculature, excluding coronary and neuro vasculature.

The M-Y Sheath is a contralateral access guiding sheath with a proximal hemostatic valve and an integrated fixed wire at its distal end. The fixed wire is attached to the sidewall of the sheath and extends beyond the distal tip of the sheath and is used to provide sheath support during use. The wire distal end is first introduced through the ipsilateral in-dwelling femoral sheath introducer. then snared and externalized through an in-dwelling contralateral sheath introducer, thereby allowing the sheath to be positioned over the bifurcation by gentle simultaneous pushing and pulling the device using a "flossing" technique. Once the M-Y sheath tip is positioned at the desired location in the contralateral vasculature. the wire can be externally secured (e.g. using a pin vise), thereby providing stability and support when advancing interventional tools (e.g. angioplasty balloons, stents, etc.). The M-Y Sheath is compatible to fit through a standard 7 French femoral sheath introducer placed in the ipsilateral leg. The M-Y Sheath luminal diameter is sized to be compatible with 5 French therapeutic and diagnostic devices.

The document provided describes the M-Y Sheath, a catheter introducer, and its performance testing for a 510(k) premarket notification (K190369). The information provided focuses on demonstrating substantial equivalence to a predicate device through various performance, biocompatibility, and sterilization tests. It does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts.

Therefore, many of the requested elements are not applicable to the information contained in the provided text.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each test. It refers to general "testing" and "evaluations."

• Biocompatibility testing: Per applicable requirements of ISO 10993. (Sample size not specified for each specific test within this standard).
• Bench testing: Does not specify sample sizes for individual attribute tests.
• Sterilization and Transportation testing: Does not specify sample sizes.
• Clinical simulation bench model: Does not specify sample size (e.g., number of simulated procedures).
• In-vitro 3-D anatomy simulation model: Does not specify sample size (e.g., number of devices tested, number of simulated procedures).

Data Provenance: The studies are described as "bench testing," "in-vitro," and "clinical simulation bench model," indicating laboratory or simulated environments, not human clinical trials. The origin is implicitly the manufacturer (RAM Medical Innovations, Inc.) or its contracted testers. The data is retrospective in the sense that it was collected prior to this submission, but it's not data from patient records.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts

Not applicable. This device is not an AI/ML device that requires ground truth established by medical experts. The testing involves physical properties, material compatibility, and functional performance in simulated environments. The "ground truth" for these tests is based on engineering specifications, recognized standards (ISO), and observable physical outcomes (e.g., "Pass/Fail," successful deployment, absence of leakage).

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not an AI/ML device requiring expert adjudication of results. The tests have objective 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

Not applicable. This device is a physical medical instrument (catheter introducer), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's testing is based on:

• Engineering specifications and design requirements: For mechanical performance, dimensions, and visual requirements.
• International Standards (ISO): Specifically ISO 10993 (biocompatibility), ISO 11135-1 (sterilization), and ISO 594-2 (hub/luer fittings).
• Objective physical measurements and observations: For leakage, tensile strength, fracture, flexing, radiopacity, corrosion, etc.
• Pre-defined acceptance criteria: For the successful completion of simulated use and clinical simulation models.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. This device does not involve a "training set."

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