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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 2 is a device that is comprised of a Latchwire, anchor mechanism, shaft and handle with control features.

The provided text describes the AXERA 2 Access System, a catheter introducer device, and its substantial equivalence to a predicate device. The document focuses on bench testing and prior studies rather than a detailed clinical study with acceptance criteria and a "device performance" section in the traditional sense of a diagnostic or AI device.

However, I can extract the information based on the provided text's focus for a medical device regulatory submission.

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

For the AXERA 2 Access System, the acceptance criteria are related to specific bench tests and its ability to meet performance requirements for its intended use, based on the predicate device. The document explicitly states that the device met all acceptance criteria.

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

• Bench Testing (current submission): The sample sizes for each specific bench test (Latchwire attachment, tensile strength, procedural sheath insertion) are not provided. The data provenance is "following sterilization of test units," implying lab-based, controlled testing. No country of origin is specified.
• Bench Testing (predicate device): Sample sizes are not provided for the various bench tests listed. Data provenance is implied to be lab-based.
• Preliminary Animal Studies and Cadaver Assessments: The text mentions "preliminary animal studies (non-GLP)" and "cadaver assessments," stating they were "conducted using prototypes of a similar design and configuration." Sample sizes are not specified.
• Clinical Investigations: "Multiple clinical evaluations were conducted" for short-term safety and performance. Sample size is not specified.
• Retrospective Study: "The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients." The exact sample size of this "smaller cohort" is not specified. Data provenance is retrospective.

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)

This section is not applicable as the studies described are for a medical device (catheter introducer) focusing on mechanical performance, safety, and functionality, not a diagnostic or AI device requiring expert-established ground truth on images or patient outcomes in that specific manner. The "ground truth" for bench tests would be the physical properties and performance metrics. For animal/cadaver/clinical studies, it would be direct observation of device function, safety, and patient outcomes by medical professionals.

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

Not applicable for the types of studies described (bench testing, animal/cadaver assessments, clinical evaluations of a mechanical device). Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of data (e.g., medical images) by multiple readers.

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 catheter introducer, not an AI or imaging-related diagnostic tool that would involve human readers or AI assistance in interpretation.

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

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

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

• Bench Testing: The ground truth for bench tests is the objective physical measurements and functional performance against predefined engineering specifications.
• Preliminary Animal Studies & Cadaver Assessments: The ground truth would be direct observation of the device's interaction with tissue, its ability to create an access path, and any observed complications or successes, likely assessed by researchers/medical professionals conducting the studies.
• Clinical Investigations: The ground truth would include direct observation of device functionality, success of arterial access, hemostasis, and patient outcomes (e.g., complications, adverse events) as documented by clinicians.
• Retrospective Study: The ground truth would be patient outcomes data (e.g., long-term safety, re-access capability) extracted from medical records.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

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