(28 days)
The HI-TORQUE WHISPER VIEW GUIDE WIRE is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
The guide wire is comprised of a stainless steel tapered core with a flexible tip, jacketed by tungsten-loaded polyurethanc on the distal portion and polytetrafluoroethylenc (PTFE) on the proximal portion of the wire. The polyurethane is covered with a hydrophilic coating to increase lubricity. The guide wire is 190 cm long with a maximum outer diameter of 0.0145. The guide wires are available with cither a straight distal tip that is shapeable, or a preformed 'J' distal tip shaped specifically for accessing the coronary sinus.
The provided text describes a 510(k) submission for a medical device, the HI-TORQUE® WHISPER VIEW™ Guide Wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing a separate de novo study with novel acceptance criteria.
Therefore, the information you're requesting regarding explicit acceptance criteria and a detailed study proving the device meets them, especially in the context of AI/ML performance, ground truth, and expert adjudication, is not present in this document. The submission relies on verification testing to show equivalence to the predicate device.
Here's an analysis based on the provided text, addressing your points where possible, and indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable metrics. The implicit criteria are that the device performs equivalently to the predicate device in terms of safety and effectiveness. | "The results of verification testing demonstrate that the HI-TORQUE® WHISPER VIEW™ Guide Wire meets established acceptance criteria and performs in a manner equivalent to the predicate device." "No new safety or effectiveness issues were raised during testing." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not provided.
- Data provenance: Not provided (e.g., country of origin, retrospective/prospective). The document describes "verification testing," but details about the test set are absent.
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/not provided. The submission is for a physical medical device (guide wire) and not an AI/ML-based diagnostic system that would typically involve establishing ground truth from expert interpretations of data.
4. Adjudication method for the test set
- This information is not applicable/not provided. As above, this pertains to expert review of data for AI/ML systems.
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
- No. This is a physical device, not an AI/ML application. An MRMC study is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a physical device, not an AI/ML algorithm.
7. The type of ground truth used
- Not explicitly stated in the sense of 'ground truth' for an AI/ML system. For a physical medical device, "ground truth" would relate to the physical and functional properties of the device meeting engineering specifications and performance expectations. The document refers to "verification testing" comparing the device to its predicate.
8. The sample size for the training set
- Not applicable/not provided. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/not provided. As above, this is for an AI/ML model.
Summary from the document:
The submission focuses on demonstrating substantial equivalence of the HI-TORQUE® WHISPER VIEW™ Guide Wire to the predicate device, HI-TORQUE® WHISPER™ Guide Wire (K030019). The modifications are an increased tungsten load in the polyurethane coating and a change in the tempering method for the stainless steel wire core.
The study (referred to as "verification testing") demonstrated that the modified device:
- "meets established acceptance criteria" (though these criteria are not detailed in the provided text).
- "performs in a manner equivalent to the predicate device."
- Raised "no new safety or effectiveness issues."
This implies that the "acceptance criteria" were primarily related to the physical, mechanical, and functional performance of the guide wire, ensuring it operates safely and effectively in the same way as the predicate device. The evidence for meeting these criteria comes from internal "verification testing" conducted by the manufacturer, rather than external clinical trials or studies involving human experts interpreting diagnostic output.
§ 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.