(29 days)
The Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This guidewire is not intended for use in the coronary arteries or neurovasculature.
The Guidewire is constructed of a stainless steel core wire and a platinum coil welded/brazed in place over the core wire. The coil may cover the entire core wire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum Tungsten marker bands may be placed under the coil to aid in visualization.
The provided text describes a 510(k) Premarket Notification for a vascular guidewire and does not contain information about a study involving an AI-powered device or software. The document pertains to a physical medical device (guidewire) and its substantial equivalence to predicate devices based on physical and performance characteristics.
Therefore, many of the requested categories for AI/software-related studies cannot be filled as they are not applicable to the provided document.
Here's an attempt to answer the questions based only on the provided text, noting where information is absent or irrelevant:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Safety and Performance" as a section and describes how substantial equivalence was based on a comparison to predicate devices and "comparative bench testing." The specific tests performed are listed, but no explicit numerical acceptance criteria or performance metrics are provided for these tests within the given text.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength A | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Torque Strength B | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Torqueability C | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Tip Flexibility D | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Coating Integrity E | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Corrosion Testing F | (Not explicitly stated, but deemed substantially equivalent to predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "comparative bench testing" and "Physical testing has been conducted to confirm the proposed products performance characteristics." However, it does not specify the sample size, data provenance, or whether the tests were retrospective or prospective.
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)
Not applicable. This document describes the testing of a physical medical device (guidewire) against predicate devices, not an AI or software algorithm requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, this is not a study involving expert adjudication for a test set in the context of AI/software performance. The evaluation is based on bench testing of physical properties.
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 document describes the premarket notification for a physical guidewire, not an AI-assisted device or software that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm described in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical bench testing, the "ground truth" would be the direct measurements obtained from the various tests (Tensile Strength, Torque Strength, etc.) which are then compared to established specifications for such devices or to the predicate device's performance. It is not expert consensus, pathology, or outcomes data in the context of diagnostic interpretation.
8. The sample size for the training set
Not applicable. This document does not describe the development or testing of an AI or software device that would require a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set for an AI/software device is described.
§ 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.