(28 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 based on the provided text, focusing on the changes made to the AXERA 2 Access System.
It's important to note that the provided documents are a 510(k) summary and acceptance letter, which typically focus on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria usually seen for novel devices or significant changes. The information available is based on the description of testing performed for the modifications.
Acceptance Criteria and Reported Device Performance
The provided text states: "The AXERA 2 Access Device met all performance testing acceptance criteria." However, specific numerical acceptance criteria and their corresponding reported device performance values are not explicitly detailed in the text. The summary lists the types of tests performed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device Functionality | Met all criteria |
| Corrosion Resistance (Latchwire) | Met all criteria |
| Flex Conditioning (Latchwire) | Met all criteria |
| Latchwire Resistance to Flexing | Met all criteria |
| Tensile Strength of Latchwire to Anchor (parallel and non-parallel) | Met all criteria |
| Tensile Strength of Latchwire Distal Coil to Core Wire | Met all criteria |
| Tensile Strength of Latchwire Proximal Coil, Latch, and Core Wire | Met all criteria |
| Compressive Strength (Handle/Anchor) | Met all criteria |
| Accessory Functionality (prior testing) | Met all criteria |
| Deployment Forces (heel, needle, plunger) (prior testing) | Met all criteria |
| Release Forces (heel) (prior testing) | Met all criteria |
| Tensile Strength of Multiple Joints (anchor, heel, plunger, plunger tube, needle, guidewire, dilator adapter) (prior testing) | Met all criteria |
| Access Needle Integrity (prior testing) | Met all criteria |
| Compressive Strength (plunger lockout) (prior testing) | Met all criteria |
| Torque Loading (handle/anchor) (prior testing) | Met all criteria |
| Corrosion Resistance (guidewire) (prior testing) | Met all criteria |
| Guidewire Resistance to Fracture (prior testing) | Met all criteria |
| Guidewire Resistance to Flexing (prior testing) | Met all criteria |
| Biocompatibility (prior testing) | Met all criteria |
| Preliminary Animal Studies (non-GLP) (prior testing) | Established short-term safety and clinical performance |
| Cadaver Assessments (prior testing) | Established short-term safety and clinical performance |
| Clinical Investigations (prior testing) | Established short-term safety and clinical performance; long-term safety and re-access ability retrospectively studied in a smaller cohort |
Note: The document states that "all performance testing acceptance criteria" were met, but it does not specify what those criteria were (e.g., minimum tensile strength, maximum deployment force range).
Study Details
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Sample size used for the test set and the data provenance:
- Bench Testing: The document mentions "test units" were used for the various bench tests (device functionality, tensile strength, corrosion, etc.). The specific number of units used for each test is not provided.
- Preliminary Animal Studies & Cadaver Assessments: Not specified, but referred to as "prototypes of a similar design and configuration."
- Clinical Investigations: The document mentions "multiple clinical evaluations were conducted" for short-term safety and performance. For long-term safety and re-access ability, it was "retrospectively studied in a smaller cohort of patients." The specific number of patients or cases in these clinical evaluations and the retrospective study is not provided.
- Data Provenance: Not explicitly stated for all studies. Clinical investigations imply human data, likely from medical centers. The animal studies and cadaver assessments are explicitly mentioned. The country of origin for the clinical data is not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For device performance testing, "ground truth" is typically established by engineering specifications and objective measurements rather than expert consensus on individual cases. For clinical studies, the "ground truth" would be clinical outcomes, and the experts involved (e.g., physicians conducting the procedures, interpreting results) are implied but not explicitly detailed in terms of number or specific qualifications (like "radiologist with 10 years of experience").
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable to the descriptions of bench testing provided. For clinical studies, no adjudication method is mentioned.
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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:
- An MRMC comparative effectiveness study is not relevant here as the AXERA 2 Access System is a medical device (catheter introducer), not an AI-powered diagnostic imaging tool. Therefore, terms like "human readers" and "AI assistance" do not apply.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The AXERA 2 Access System is a mechanical medical device, not an algorithm or software. It requires human-in-the-loop for its intended use.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing: The ground truth for bench tests would be the established engineering specifications and physical measurements, designed to ensure the device performs as intended (e.g., materials withstand certain forces, dimensions are correct, no corrosion).
- Clinical/Animal/Cadaver Studies: The ground truth would be clinical outcomes related to safety and performance (e.g., ability to access the vessel, hemostasis, absence of complications, confirmed by medical observation and records).
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The sample size for the training set:
- This question is not applicable to a mechanical medical device. The device is not "trained" in the machine learning sense. Design and development are based on engineering principles and iterative testing.
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How the ground truth for the training set was established:
- This question is not applicable for the reasons stated above (not an AI/ML 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).