(7 days)
The Radius .018 Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Radius .018 Cougar Wires are compatible with all currently approved and marketed PTCA/PTA balloon catheters which are labeled for use with an .018 guidewire.
The Radius .018 Cougar Wire is constructed from a composite stainless steel and Nitinol core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is hydrophilic coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.
Here's the analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: Radius .018 Cougar Wire (PTCA Guidewire)
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Performance Tests Performed) | Reported Device Performance |
|---|---|
| Tensile Strength | Performed and met criteria |
| Torque Strength | Performed and met criteria |
| Torqueability | Performed and met criteria |
| Tip Flexibility | Performed and met criteria |
| Coating Adherence/Integrity | Performed and met criteria |
Note: The document states, "the proposed Radius .018 Cougar Wire meets the minimum requirements that are considered adequate for its intended use." This indicates that the device's performance in these in vitro tests met the pre-defined acceptance criteria, even though the specific numerical results or thresholds are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions that "the following in vitro performance tests were performed." It does not provide the number of devices or iterations tested for each performance criterion.
- Data Provenance: The tests are described as "in vitro performance tests," meaning they were conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are typically relevant for clinical studies, not in vitro device performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this document describes in vitro performance testing of a medical device, not a study involving human interpretation or subjective assessment where expert-established ground truth would be necessary. The ground truth for these tests would be determined by objective physical measurements against established engineering specifications.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies where there is subjective interpretation and a need to resolve discrepancies between human readers. The tests performed here (Tensile Strength, Torque Strength, etc.) are objective physical measurements.
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. The document describes the premarket notification for a PTCA guidewire, which is a physical medical device. It does not involve AI or human readers, so an MRMC comparative effectiveness study for AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As mentioned in point 5, the device is a physical guidewire and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance tests (Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence/Integrity) would be based on engineering specifications and established industry standards for guidewire performance. These are objective, measurable characteristics, not subjective interpretations requiring expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
This information is not applicable. The document describes the performance testing of a physical medical device, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
§ 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.