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The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

The AXERA RX is a device that is comprised of a flexible tip, anchor mechanism, shaft and handle with control features.

The provided text describes modifications to an existing device (AXERA 2 Access System to AXERA RX Access System) and various tests performed to demonstrate substantial equivalence to its predicate. However, it does not provide explicit acceptance criteria in a table format, nor does it detail a study that proves the device meets specific numerical acceptance criteria in the way an AI/ML device would be evaluated for metrics like sensitivity, specificity, or AUC.

Instead, the document focuses on engineering and performance testing for a medical device (catheter introducer). Therefore, much of the requested information regarding AI/ML device evaluation is not applicable or cannot be extracted from this text.

Here's an attempt to answer the questions based on the provided text, highlighting where information is absent or not applicable:

1. Table of acceptance criteria and reported device performance

The document states: "The AXERA RX Access Device met all performance testing acceptance criteria." However, it does not provide a table detailing those acceptance criteria or specific numerical performance results. It only lists the types of tests performed.

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

• Test Set Description: The document refers to "Bench testing," "Simulated use testing on a cadaveric model," and "Clinical investigations."
• Sample Size for Bench Testing: Not specified.
• Sample Size for Cadaveric Model: Not specified.
• Sample Size for Clinical Investigations: Not specified, but a "smaller cohort of patients" was used for the retrospective study.
• Data Provenance:
  • Bench testing: Likely in-house laboratory.
  • Simulated use testing: Cadaveric model (source/country not specified).
  • Clinical investigations: Patients, but country of origin and whether prospective or retrospective for the initial investigations are not specified. The long-term safety study was explicitly retrospective.

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 a physical medical instrument, not an AI/ML imaging device requiring expert ground truth for interpretation. The "ground truth" (or "reference standard") for this device would be direct physical measurement, engineering standards, and direct observation of device performance in simulated and clinical settings.

4. Adjudication method for the test set

Not applicable. This device is a physical medical instrument. Adjudication methods like "2+1" are relevant for expert review of AI/ML outputs, not for device performance testing like tensile strength or functionality.

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 is not an AI/ML device that assists human readers.

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

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

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

For the various tests performed, the "ground truth" would be:

• Bench Testing: Engineering specifications, ISO standards, validated measurement techniques (e.g., force gauges, calipers, visual inspection for functionality).
• Simulated Use (cadaveric): Observable performance relative to intended function (e.g., successful access, no damage to surrounding tissue, hemostasis).
• Clinical Investigations: Clinical outcomes data, typically adverse event rates, success rates of access, and achievement of hemostasis.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set. The "unmodified AXERA RX design features" mentioned undergoing preliminary animal studies, cadaver assessments, and clinical investigations could be considered analogous to prior data that informed the design, but this is distinct from AI/ML training data.

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

Not applicable (as it's not an AI/ML device). For the foundational understanding of the device's design and performance (which could be loosely considered 'training' in an engineering context), the ground truth was established through:

• Engineering principles and design specifications.
• Pre-clinical studies (animal and cadaveric models) where physiological responses and anatomical interactions serve as the "truth."
• Prior clinical evaluations of the unmodified device, where actual patient outcomes and medical assessments provided the "truth."

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