(66 days)
The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.
The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is a steerable guide wire with a nominal diameter of 0.035 inches and three lengths: a 145, a 190 cm and a 300 cm exchange length.
The provided text describes a 510(k) submission for a medical device, the ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire, and thus does not contain information about software or AI. Therefore, most of the requested fields related to AI/software performance studies are not applicable.
Here's the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Distal Tip Pull Test | Maintain performance similar to predicate device | Met acceptance criteria, performed similar to predicate device |
| Turns-to-Failure Test | Maintain performance similar to predicate device | Met acceptance criteria, performed similar to predicate device |
| Rotational Accuracy Test | Maintain performance similar to predicate device | Met acceptance criteria, performed similar to predicate device |
| Tip Flexibility Test | Maintain performance similar to predicate device | Met acceptance criteria, performed similar to predicate device |
Note: The document states that the new device "met the acceptance criteria and performed similar to the predicate Wholey Hi-Torque Standard® Guide Wire" for all listed tests, implying that the acceptance criteria were set based on the performance of the predicate device. Specific numerical acceptance values or performance metrics are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This was bench testing, not a clinical study involving human data.
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. Ground truth for bench tests is based on engineering specifications and physical measurements, not expert human assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was bench testing.
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 is a physical medical device (catheter guide wire), not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For bench tests, the ground truth is established by engineering standards, physical measurements, and comparison to the predicate device's known performance.
8. The sample size for the training set
Not applicable. This is a physical medical device.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical 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.