(90 days)
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a nominal diameter of 014" and available in: 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. The wire is constructed from a stainless steel core wire. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with polytetrafluoroethylene.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating:
Device: ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Distal Tip Pull Test | Not explicitly stated, implied to be comparable to the predicate device. | "met the acceptance criteria and performed similar to the predicate HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." "performed in a manner equivalent the predicate ACS HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." |
| Distal Tip Turns-to-Failure Test | Not explicitly stated, implied to be comparable to the predicate device. | "met the acceptance criteria and performed similar to the predicate HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." "performed in a manner equivalent the predicate ACS HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." |
| Rotational Accuracy Test | Not explicitly stated, implied to be comparable to the predicate device. | "met the acceptance criteria and performed similar to the predicate HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." "performed in a manner equivalent the predicate ACS HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." |
| Tip Flexibility Test | Not explicitly stated, implied to be comparable to the predicate device. | "met the acceptance criteria and performed similar to the predicate HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." "performed in a manner equivalent the predicate ACS HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating." |
Note on Acceptance Criteria: The document implies that the acceptance criteria for the new device were to perform similarly or equivalently to the predicate device (HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating) in these specific bench tests. The exact quantitative thresholds for "acceptance" are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document only states "Bench testing was performed."
- Data Provenance: The origin of the data (e.g., country) is not specified. The testing described is "bench testing," which implies laboratory-based, non-clinical data. It is therefore prospective in nature, as the tests were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. This device is a guide wire, and the testing described is bench testing of its physical and mechanical properties against a predicate device. There is no "ground truth" in the clinical sense established by human experts for this type of test. The ground truth essentially rests on the established performance characteristics of the predicate device.
4. Adjudication Method for the Test Set:
Not applicable. As described above, this was bench testing of physical properties, not a clinical study requiring adjudication of expert opinions.
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 clearance of a medical device (guide wire), not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance metrics are not relevant.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device. The "performance" being discussed is the physical performance of a guide wire.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is the established performance characteristics and safety profile of the predicate device, the HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating. The new device was tested to demonstrate equivalent performance to this predicate.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. (See #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.