(90 days)
RADIFOCUS Torque Device is intended to facilitate guidewire manipulation during interventional procedures.
RADIFOCUS Torque Device is a supportive device intended to facilitate guide wire manipulation during interventional procedures. This product consists of a cap that screws onto the main body of the device (handle) to apply a clamping force on the guide wire. The cap is made of polypropylene and the handle is made of polyoxymethylene. The torque device can be used for the guide wires with diameters of 0.010" to 0.038". RADIFOCUS Torque Device is sterilized with ethylene oxide.
The provided text describes a 510(k) submission for the RADIFOCUS Torque Device, a medical device intended to facilitate guidewire manipulation. It specifically states that no clinical tests were performed or deemed necessary for this submission. The evaluation relies on non-clinical performance testing and comparison to a predicate device.
Therefore, the requested information regarding acceptance criteria and a study proving device performance cannot be fully provided in the context of a clinical study with human subjects, given that no such study was conducted or required.
However, based on the provided text, I can infer the "acceptance criteria" and "study" refers to the non-clinical performance testing conducted.
Here's the breakdown of what can be extracted from the provided text regarding the non-clinical performance testing:
1. A table of acceptance criteria and the reported device performance:
The document states: "The RADIFOCUS Torque Device tested met the predetermined acceptance criteria." While the specific numerical or qualitative acceptance criteria for each test are not detailed, the results are uniformly positive.
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Appearance | Meets predetermined criteria | Meets acceptance criteria |
| Fixed strength of guide wire | Meets predetermined criteria | Meets acceptance criteria |
| Fixed strength of cap | Meets predetermined criteria | Meets acceptance criteria |
| Fixable dimension | Meets predetermined criteria | Meets acceptance criteria |
| Guide wire damage | Meets predetermined criteria | Meets acceptance criteria |
| Collet release | Meets predetermined criteria | Meets acceptance criteria |
| Torque slip force | Meets predetermined criteria | Meets acceptance criteria |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document only mentions "Performance testing was conducted."
- Data provenance: Not specified. It's implied to be internal testing by the manufacturer (Terumo Medical Products (Hangzhou) Co., Ltd.) given the context of a 510(k) submission and the lack of external study details. The testing is retrospective in the sense that it was conducted before the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as there was no clinical study involving human subjects or expert assessment of clinical outcomes. The "ground truth" for the non-clinical performance tests would be the established engineering specifications and measurement standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable for non-clinical performance testing of a medical device. Adjudication methods are typically used in clinical studies for interpretation of imaging or clinical events.
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:
- This is not applicable. The device is a physical torque device, not an AI-assisted diagnostic tool. No MRMC study was mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is not an algorithm or AI. The performance testing was for the physical device.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" was established by predetermined specifications and engineering standards for mechanical performance (e.g., strength, dimensions, torque).
8. The sample size for the training set:
- This is not applicable as there was no AI/algorithm that required a training set. This is a physical medical device.
9. How the ground truth for the training set was established:
- This is not applicable for the same reason as above.
§ 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.