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510(k) Data Aggregation
(121 days)
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.
Here's a breakdown of the acceptance criteria and study information for the AXERA 2 Access System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device "met all performance testing acceptance criteria." However, it does not explicitly list the specific quantitative acceptance criteria alongside the reported performance for each individual test. It's implied that for each test listed, the device's performance was deemed acceptable.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Device functionality satisfactory | Met acceptance criteria |
| Flex conditioning (Latchwire) | Met acceptance criteria |
| Latchwire resistance to flexing | Met acceptance criteria |
| Tensile strength of Latchwire to Anchor (parallel and non-parallel) | Met acceptance criteria |
| Tensile strength of Latchwire distal coil to core wire | Met acceptance criteria |
| Tensile strength of Latchwire proximal coil, latch, and core wire | Met acceptance criteria |
| Accessory functionality | Met acceptance criteria |
| Deployment forces (heel, needle, plunger) | Met acceptance criteria |
| Release forces (heel) | Met acceptance criteria |
| Flex conditioning (guidewire) | Met acceptance criteria |
| Tensile strength of multiple joints (anchor, heel, plunger, plunger tube, needle, guidewire, dilator adapter) | Met acceptance criteria |
| Access needle integrity | Met acceptance criteria |
| Compressive strength (handle/anchor, plunger lockout) | Met acceptance criteria |
| Torque loading (handle/anchor) | Met acceptance criteria |
| Corrosion resistance | Met acceptance criteria |
| Guidewire resistance to fracture | Met acceptance criteria |
| Guidewire resistance to flexing | Met acceptance criteria |
| Biocompatibility | Met acceptance criteria |
| Safety (from simulated use, animal, and clinical studies) | Confirmed safety (simulated use, animal studies, clinical investigations) |
| Clinical performance (short-term) | Established (clinical investigations) |
| Ability to access and re-access (long-term safety) | Retrospectively studied in a smaller cohort of patients, implying acceptable long-term safety and access/re-access. |
2. Sample Size Used for the Test Set and Data Provenance:
- Bench Testing: No specific sample sizes are provided for the bench tests.
- Simulated Use Testing: Performed on a "cadaveric model." The exact number of cadavers is not specified.
- Preliminary Animal Studies: No specific sample size is provided. The studies were conducted using "prototypes of a similar design and configuration."
- Cadaver Assessments: No specific sample size is provided. The assessments were conducted using "prototypes of a similar design and configuration."
- Clinical Investigations: The document mentions "Multiple clinical evaluations were conducted" and "The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients." No specific sample sizes for these cohorts are provided.
- Data Provenance: The document does not explicitly state the country of origin for any of the studies or if they were retrospective or prospective, beyond the "smaller cohort" for long-term safety being studied retrospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not provide details on the number or qualifications of experts used to establish ground truth for any of the testing. For cadaveric and clinical studies, it can be inferred that healthcare professionals (e.g., surgeons, interventionalists) would have evaluated the device, but their specific roles, number, or qualifications are not mentioned.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth from experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done, as this device is a medical access system, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is inherent to its design and how it's used by a human operator, not a standalone AI algorithm.
7. The Type of Ground Truth Used:
- Bench Testing: The ground truth for bench testing would be objective measurements and defined engineering specifications.
- Simulated Use Testing (Cadaveric Model): The ground truth would be the observed physical outcomes and successful performance of the device in a cadaver, likely assessed by medical professionals.
- Preliminary Animal Studies: The ground truth would be physiological and anatomical observations in live animals regarding safety and performance.
- Clinical Investigations: The ground truth would be clinical outcomes, safety endpoints, and successful procedural completion, as determined by medical professionals treating patients.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This device is a physical medical device and does not have a training set.
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