(20 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. The System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
The AXERA is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
The provided text describes a Special 510(k) for a device modification of the AXERA Access System. It focuses on engineering and performance testing to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic performance with AI. Therefore, most of the requested information regarding acceptance criteria, sample size, ground truth, and expert evaluation for an AI-based study is not available in the provided document.
Here's a breakdown of what can be extracted based on the given text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Device Functionality | Met acceptance criteria |
| Deployment Forces (heel, needle, plunger) | Met acceptance criteria |
| Release Forces (heel) | Met acceptance criteria |
| Flex Conditioning (latchwire) | Met acceptance criteria |
| Tensile Strength (multiple joints: latchwire, anchor, heel, plunger, needle) | Met acceptance criteria |
| Compressive Strength (handle/anchor) | Met acceptance criteria |
| Torque Loading (handle/anchor) | Met acceptance criteria |
| Corrosion Resistance | Met acceptance criteria (from prior testing) |
| Biocompatibility | Met acceptance criteria (from prior testing) |
2. Sample size used for the test set and the data provenance
- Test Set Size: Not specified for each individual test. The document states "test units" were used but does not provide a specific number for each test or overall.
- Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting. There is no information regarding country of origin or whether it was retrospective or prospective in the context of human data, as no human data was primary to this specific modification submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for this device modification was based on engineering specifications and physical performance measurements, not expert human interpretation for an AI system.
4. Adjudication method for the test set
- Not applicable. The testing described is physical performance testing against predetermined engineering specifications, not a subjective evaluation requiring adjudication.
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
- No. This was not an AI-based study. It was a device modification submission based on bench testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual catheter introducer system, not an AI algorithm.
7. The type of ground truth used
- The "ground truth" was derived from engineering specifications and objective physical measurements (e.g., forces, strengths, flexibility) established for the device's intended function.
8. The sample size for the training set
- Not applicable. No training set for an AI algorithm was involved.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI algorithm was involved.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study described is primarily a bench testing evaluation for a device modification to the AXERA Access System. The modifications included changing the needle material from nitinol to stainless steel, a minor change in the Needle Lumen Anchor (NLA) geometry and manufacturing process, and the addition of marking holes.
The study aimed to confirm that these modifications did not adversely affect the device's performance characteristics. A series of engineering tests were conducted on the modified AXERA device, including:
- Device functionality
- Deployment forces (heel, needle, plunger)
- Release forces (heel)
- Flex conditioning (latchwire)
- Tensile strength of multiple joints (latchwire, anchor, heel, plunger, needle)
- Compressive strength (handle/anchor)
- Torque loading (handle/anchor)
Additionally, prior testing results for corrosion resistance, flex conditioning, tensile testing, compressive strength, and biocompatibility were referenced as also having met acceptance criteria. Preliminary animal studies (non-GLP) and cadaver assessments, along with clinical investigations, were also mentioned as part of the broader evaluation history of the AXERA system, though not specifically for this modification.
The conclusion was that "All acceptance criteria were met and test results demonstrated that the modified AXERA met performance requirements for its intended use. No new issues of safety or effectiveness were raised." This indicates that the device's performance after modification remained consistent with its original design and intended use, and therefore demonstrated substantial equivalence to the predicate device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).