(23 days)
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic procedures.
The HI-TORQUE BALANCE TREK™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wire with a maximum diameter of 0.014″ and available in: 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. 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 HI-TORQUE BALANCE TREK™ Guide Wires:
There are no specific acceptance criteria or performance metrics quantified in the provided text. The document describes a medical device submission (510(k)) where the focus is on demonstrating "substantial equivalence" to a predicate device, rather than proving a device meets specific quantitative performance targets.
The study described is not a typical clinical trial or AI performance study. It's a series of in vitro bench tests and in vivo performance evaluations designed to show the new device performs similar to a predicate device.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Performs similar to the predicate device (ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating) | "met the acceptance criteria and performed similar to the predicate device" |
| Meeting acceptance criteria in functional tests: Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test, and Tip Flexibility Test | "The results from the tests demonstrated that the new The HI-TORQUE BALANCE TREK™ Guide Wires met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE BALANCE HEA VYWEIGHT™ Guide Wire." |
| No new safety or effectiveness issues raised | "No new safety or effectiveness issues were raised during the testing program." |
Important Note: The document does not provide numerical acceptance criteria (e.g., "distal tip pull strength must be >X Newtons") nor does it provide quantitative results from the tests (e.g., "distal tip pull strength measured Y Newtons"). The primary "acceptance criteria" is stated as performing "similar to" or "equivalent to" the predicate device.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the sample size used for the in vitro bench testing or in vivo performance evaluations.
- Data Provenance: The data provenance is not specified (e.g., country of origin, retrospective or prospective). Given it's a 510(k) submission focused on bench and "in vivo performance evaluations," it's likely a mix of laboratory testing and potentially animal studies or early human use if the "in vivo performance evaluations" refer to that, though details are absent. It is not explicitly stated as retrospective or prospective human patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable. This study focuses on device engineering performance, not interpretation of clinical data by experts.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "tests" are functional engineering performance tests, not clinical assessments requiring adjudication.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable. This is not an AI-assisted device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (guide wire), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" here is the functional performance of the predicate device and established engineering specifications for guide wires. The new device's performance was compared against the predicate's performance in specific functional tests. The goal was to show similarity/equivalence.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable.
§ 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.