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The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal arteries while maintaining hemostasis during diagnostic and interventional procedures.

The Fortress Introducer Sheath System consists of an introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a hydrophobic silicone coating on the outer surface of the distal 30cm portion.

The provided text describes the regulatory clearance for the Fortress Introducer Sheath System (7F and 8F sizes) and does not contain information about an AI/ML powered medical device. Therefore, a table of acceptance criteria and reported device performance related to AI/ML capabilities, or details about a study evaluating such a device, cannot be extracted from this document.

The document discusses the substantial equivalence of the Fortress Introducer Sheath System (7F and 8F) to a predicate device (6F Fortress Introducer Sheath System, K153197). The performance data presented are for non-clinical tests related to the mechanical properties, biocompatibility, sterilization, and shelf-life of the physical device.

Here's an analysis of what can be extracted from the document, recognizing that it doesn't pertain to an AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance (as non-AI/ML)

Since this is a non-AI/ML device, "acceptance criteria" here refers to specific tests and relevant standards the device must meet. The "reported device performance" is that the device met these criteria, demonstrating substantial equivalence to the predicate.

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

• Test Set Sample Size: Not explicitly stated for each test, but it is implied that sufficient samples were tested to meet the requirements of the standards listed. These are physical device tests, not data-driven AI/ML tests.
• Data Provenance: The tests are non-clinical (laboratory-based) and conducted to international and internal standards. Provenance is therefore the testing conducted by the manufacturer and/or external laboratories. The country of origin for the device manufacturer is Germany.

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

• This information is not applicable as the document describes physical device testing, not an AI/ML product requiring expert ground truth for image or data analysis. Usability evaluation (IEC 62366-1:2015) would involve human users, but the number and qualifications of those users are not specified, nor are they "experts establishing ground truth" in the AI/ML sense.

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

• This is not applicable as the document describes physical device testing. The results are determined by compliance with specified test methods and acceptance criteria rather than 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:

• This is not applicable as the device is a physical medical introducer sheath system, not an AI/ML product intended to assist human readers.

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

• This is not applicable as the device is a physical medical introducer sheath system, not an AI/ML algorithm.

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

• This is not applicable as the document describes physical device testing. The "ground truth" or reference for evaluating performance against is defined by the technical specifications outlined in the referenced international standards and internal requirements.

8. The sample size for the training set:

• This is not applicable as the device is a physical medical introducer sheath system and does not involve AI/ML requiring a training set.

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

• This is not applicable as the device is a physical medical introducer sheath system and does not involve AI/ML requiring a training set.

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