(90 days)
This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
The ASAHI Astato XS 40 Peripheral Guide Wire in this submission has a coil-type distal end. The coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the quide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). The distal end is coated with a hydrophilic coating. The ASAHI Astato XS 40 guide wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter of 0.36 mm.
This document is a 510(k) Summary for a medical device called the "ASAHI Astato XS 40" guide wire. It details the device's characteristics and its comparison to predicate devices to demonstrate substantial equivalence, rather than a study designed to meet specific acceptance criteria for AI performance.
Therefore, the requested information points regarding AI acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to this document as it describes a traditional medical device (guide wire) and not an AI/ML-driven device.
However, I can extract the acceptance criteria and performance data for the physical device as described in the document.
1. A table of acceptance criteria and the reported device performance
The document states that "The in vitro bench tests demonstrated that the ASAHI Astato XS 40 met all acceptance criteria and performed similarly to the predicate devices." While specific numeric acceptance criteria are not provided, the following tests were performed:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength | Met acceptance criteria |
| Torque Strength | Met acceptance criteria |
| Torqueability | Met acceptance criteria |
| Tip Flexibility | Performed similarly to secondary predicate, ASAHI Astato 30 |
| Coating Adhesion/Integrity | Met acceptance criteria |
| Catheter Compatibility | Met acceptance criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "in vitro bench tests" but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as this is not an AI/ML device requiring expert-established ground truth. The tests performed are engineering-based performance tests for a physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this is not an AI/ML device requiring adjudication of results.
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
This information is not applicable as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as the "ground truth" for a physical device like a guide wire would be established by physical measurements and engineering standards, not typical "ground truth" as understood in AI/ML performance evaluation.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.