(27 days)
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.
The HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVESAL™ Guide Wires guide wires with a 0.014'' diameter 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. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J".
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the HI-TORQUE BALANCE® guide wires:
It's important to note that the provided text is a 510(k) summary for a medical device (guide wires), not a scientific paper detailing a clinical study for an AI/ML powered medical device. Therefore, many of the requested categories are not applicable or the information is not present within this type of regulatory submission. The "device" in this context is a physical medical instrument, not a software algorithm.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
The document states: "The results of the verification testing demonstrate that the HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires meet the established acceptance criteria and performs in a manner equivalent to the predicate device."
However, the specific acceptance criteria (e.g., tensile strength, fracture resistance, lubricity values) and the quantitative reported performance of the device against these criteria are not provided in this 510(k) summary. It only states that the device "meets the established acceptance criteria."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Meets established criteria; performs equivalently to predicate device. |
Study Details (as inferable for a non-AI medical device submission)
Given this is a physical medical device and not an AI/ML product, many of the AI-specific questions are not applicable. The "study" here refers to pre-clinical verification testing and a demonstration of substantial equivalence to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. Verification testing would involve testing a certain number of guide wire samples, but the exact quantity is not detailed in this summary.
- Data Provenance: Not applicable in the sense of patient data. The "data" comes from physical engineering and performance tests on the manufactured guide wires. There's no country of origin of "data" in this context, as it's product testing.
- Retrospective or Prospective: Not applicable for device verification testing.
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)
- Number of Experts & Qualifications: Not applicable. For a physical medical device, "ground truth" isn't established by expert consensus on patient data. It's established by engineering specifications, material standards, and performance test protocols. The "experts" would be the engineers and quality assurance personnel performing and validating the tests, but these roles and numbers are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 are used for human review of clinical data, typically in AI/ML validation. For device verification, engineers follow defined test methods and specifications.
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. This is a physical guide wire, not an AI-powered diagnostic or assistive tool.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. There is no algorithm to run in standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For this type of device, the "ground truth" would be defined by the pre-established engineering specifications, material properties, and functional performance benchmarks (e.g., specific thresholds for torqueability, tip flexibility, lubricity, radiopacity, tensile strength, etc.) that the device must meet.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. There is no training set for this 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.