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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. However, it states that the device is unchanged from its predicate device (AXERA Access System, K121521) and relies on the predicate's performance data. Therefore, the details below pertain to the predicate device's testing.

There is no detailed information provided regarding specific acceptance criteria or a dedicated study documenting the predicate's performance against those criteria in a format suitable for the requested table. The document only generally states that the predicate "met all performance testing acceptance criteria."

Therefore, for aspects related to specific acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment, the information is synthesized from the general descriptions provided. Many fields will state "Not specified" due to the lack of granular detail in the submission for the AXERA 2 that references the predicate's testing.

Acceptance Criteria and Study for AXERA 2 Access System (Based on Predicate Device AXERA Access System K121521)

Since the AXERA 2 Access System is stated to be "unchanged for the predicate device" and its performance data relies entirely on the predicate, the acceptance criteria and study information below refer to the predicate device's testing. The submission for AXERA 2 does not provide specific numerical acceptance criteria or detailed study results for the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific numerical acceptance criteria and reported performance values are not detailed in the provided document. The document broadly states that the predicate device met "all performance testing acceptance criteria" and "performance requirements for its intended use."

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

• Bench Testing: Not specified.
• Preliminary Animal Studies (non-GLP): Not specified. Prototypes of a similar design and configuration were used.
• Cadaver Assessments: Not specified. Prototypes of a similar design and configuration were used.
• Clinical Investigations: Two types of clinical evaluations were conducted:
  • Short-term safety and clinical performance: "Multiple clinical evaluations" were conducted. Sample size not specified. Data provenance (country of origin) not specified. Stated as clinical investigations, implying prospective in nature.
  • Long-term safety, access, and re-access: "Retrospectively studied in a smaller cohort of patients." Sample size not specified. Data provenance (country of origin) not specified.

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

• Not specified. The document does not mention the number or qualifications of experts for establishing ground truth in any of the testing types.

4. Adjudication Method for the Test Set

• Not specified. The document does not describe any adjudication methods used for the test sets.

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

• No, an MRMC comparative effectiveness study was not done. The device is a physical catheter introducer, not an AI or imaging device where human readers would typically be involved in interpreting data with or without AI assistance. The clinical studies focused on device performance metrics in patients.

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

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

7. The Type of Ground Truth Used

• Bench Testing: Engineering specifications and established test methodologies.
• Preliminary Animal Studies & Cadaver Assessments: Direct observation of device interaction with biological tissue.
• Clinical Investigations (Short-term & Efficacy): Clinical outcomes (e.g., time to hemostasis, ambulation), direct observation of device performance in patients, and patient safety data.
• Clinical Investigations (Long-term): Retrospective analysis of patient outcomes and device function over time.

8. The Sample Size for the Training Set

• Not applicable. The device is a physical medical device; there is no "training set" in the context of machine learning or algorithms. The preliminary animal studies and cadaver assessments used prototypes, which could be considered an early stage of development and refinement, but not a "training set" in the computational sense.

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

• Not applicable. As above, no "training set" in the computational sense. The "ground truth" for the device's design and engineering would have been based on clinical needs, engineering principles, and performance requirements for catheter introducers.

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