(63 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 an analysis of the provided text regarding the AXERA 2 Access System, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only states that the device "met all performance testing acceptance criteria" and lists the types of tests performed. It does not detail the specific numerical acceptance criteria (e.g., "tensile strength of X N") or the exact reported device performance values. Therefore, a complete table as requested cannot be constructed from the given information.
However, based on the text, we can infer the categories of tests and the general outcome:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing (Modified AXERA 2) | Met all criteria (specific values not provided in document) |
| - Device functionality | Met functionality requirements |
| - Deployment forces (needle, plunger) | Met deployment force requirements |
| - Tensile strength (Latchwire to Anchor) | Met tensile strength requirements (parallel and nonparallel) |
| - Compressive strength (handle/anchor) | Met compressive strength requirements |
| - Torque loading (handle/anchor) | Met torque loading requirements |
| - Access needle functionality | Met access needle functionality requirements |
| - Access needle integrity | Met access needle integrity requirements |
| - Tensile strength (access needle) | Met access needle tensile strength requirements |
| Bench Testing (Unmodified AXERA 2) | Met all criteria (specific values not provided in document) |
| - Accessory functionality | Met accessory functionality requirements |
| - Deployment forces (heel) | Met deployment force requirements |
| - Release forces (heel) | Met release force requirements |
| - Tensile strength of multiple joints | Met tensile strength requirements |
| - Access needle integrity | Met access needle integrity requirements |
| - Compressive strength (plunger lockout) | Met compressive strength requirements |
| - Corrosion resistance | Met corrosion resistance requirements |
| - Guidewire resistance to fracture | Met fracture resistance requirements |
| - Latchwire/guidewire resistance to flexing | Met flexing resistance requirements |
| - Tensile strength (Latchwire distal coil to core wire) | Met tensile strength requirements |
| - Tensile strength (Latchwire proximal coil, latch, and core wire) | Met tensile strength requirements |
| - Biocompatibility testing | Met biocompatibility requirements |
| Simulated Use Testing (Unmodified AXERA 2) | Established short-term safety and clinical performance |
| - Cadaveric model studies | Successfully performed |
| Clinical Evaluations (Unmodified AXERA 2) | Established short-term safety and clinical performance, and long-term safety/re-access (retrospective cohort) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Bench Testing): The document does not specify the exact sample sizes (number of units) used for each individual bench test. It only states that "test units" were used "following sterilization."
- Test Set (Simulated Use): "a cadaveric model" (singular) was used.
- Test Set (Clinical Evaluations):
- Short-term safety and clinical performance: "multiple clinical evaluations were conducted." The exact number of patients is not provided.
- Long-term safety and re-access: "retrospectively studied in a smaller cohort of patients." The exact number of patients for this cohort is not provided.
- Data Provenance: The document does not explicitly state the country of origin for the clinical or cadaveric data. It generally refers to "preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations." Given the FDA submission, it can be inferred that the data would be acceptable to the US regulatory body, but the origin itself is not specified as, for example, "US data." The clinical studies are described as both "preliminary" and "retrospective," indicating a blend of prospective and retrospective aspects for different evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify that "experts" were used to establish ground truth in the context of device performance in bench, cadaver, or clinical studies, nor does it list their qualifications. The testing appears to be objective measurements (e.g., tensile strength, deployment forces) and observations of safety and performance. For the clinical evaluations, the "ground truth" would likely be based on clinical outcomes, investigator assessments, and patient data rather than a separate expert panel establishing a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable/not specified. The testing described primarily involves objective device performance measurements and clinical observations rather than subjective assessments requiring adjudication (like image interpretation).
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 catheter introducer, not an AI-powered diagnostic or treatment assistance system. Therefore, MRMC studies with AI assistance are not relevant to its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- Bench Testing: Engineering specifications, physical performance metrics, and established manufacturing standards (e.g., for tensile strength, component integrity, functionality).
- Simulated Use (Cadaveric Model): Observational outcomes related to device performance in tissue (e.g., successful access, shallow path creation).
- Clinical Evaluations: Clinical outcomes, safety data (adverse events), and efficacy observations (successful vascular access, hemostasis, ability to re-access) gathered from actual patient procedures. The document mentions "short term safety and clinical performance" and "long term safety, as well as the ability to access and re-access."
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set in the AI sense. The development of the device would involve iterative design and testing, but not a "training set" in the context of AI.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the AI sense for this device. The "ground truth" for its design and manufacturing would be based on engineering principles, material science, clinical needs, and regulatory requirements.
§ 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).