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The Guiding Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.

The Guiding Sheath is intended for intravascular use for the introduction of interventional/diagnostic devices to the human vasculature. The Guiding Sheath is designed to work as a vessel introducer and a guiding catheter. It consists of a lubricous inner liner made from Teflon, and a stainless steel coil over the inner liner. The outer shaft consists of colored Polyether block amide. A Radiopaque Marker band is attached to the distal end of the shaft for radiopacity. The Distal end of the shaft is atraumatic. The Proximal end of the catheter is attached to a Hemostatic Valve. The device is available in three inner diameter sizes of 4Fr, 5Fr, and 6Fr; consisting of 0.063", 0.076" and 0.087" (throughout the shaft) respectably. A lubricious hydrophilic coating shall be applied to the outer diameter of the Catheter Sheath for improved trackability through the vasculature. The device contains a separate Dilator shaft made of two different materials depending on the size. For the 4Fr, Grilamid is used for the body and the Luer attached to the proximal end as well. For the 5Fr and 6F, high densiy polyethylene (HDPE) is used for the body and the Luer attached to the proximal end as well. The distal end of the Dilator is tapered for ease of access to the vessel. The device is available in lengths of 45cm and 90cm. The device is supplied sterile and is intended for single use.

The document provided describes a medical device, the TXM Guiding Sheath, and its testing for substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, and therefore does not include details such as a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or training set specifics.

Here is an analysis of the acceptance criteria and study that was conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-AI/ML medical device (catheter introducer), and its acceptance criteria are based on meeting performance standards for physical attributes, safety, and biocompatibility, rather than diagnostic accuracy metrics like sensitivity or specificity.

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

The document describes bench testing and biocompatibility testing.

• Bench Testing: The sample sizes for each specific bench test are not explicitly stated in the provided text. However, it indicates that testing was performed on "non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2)." This implies a test set composed of new devices and aged devices. The provenance is internal laboratory testing.
• Biocompatibility Testing: The sample sizes (e.g., number of animals for in-vivo tests or replicates for in-vitro tests) are not explicitly stated. The provenance is internal laboratory testing following ISO standards.

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

Not applicable. This is a medical device, not an AI/ML diagnostic or prognostic tool. The "ground truth" for these performance tests is defined by meeting physical specifications, regulatory standards (ISO, ASTM), and biological safety parameters, which are assessed by technical personnel and validated according to established test methodologies.

4. Adjudication Method for the Test Set

Not applicable. This is a medical device performance and safety evaluation against predefined standards, not a diagnostic assessment requiring expert adjudication of results. Each test outcome (e.g., pass/fail, quantitative measure) is evaluated against its specific acceptance criterion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study (comparing human readers with and without AI assistance) is relevant for AI/ML-powered diagnostic devices, not for a physical medical device like a guiding sheath.

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

No. This concept applies to AI/ML algorithms, not physical medical devices.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by:

• Pre-established engineering specifications (e.g., dimensions, strength).
• Compliance with recognized international standards (e.g., ISO 10555, ASTM F88, ISO 10993 for biocompatibility) and internal test methods that align with these standards.
• Biological responses in validated in-vitro and in-vivo models (for biocompatibility).

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML algorithm involved that would require a training set. The device itself is the product being tested.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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