(107 days)
The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.
The VSI Torque Device is a two-part oblong-shaped, medical grade plastic device designed to be used with guidewires ranging in size from 0.014" - 0.038". The two halves of the torque device snap together and the device is then placed onto a guidewire. One half of the device is rotated to lock it onto the guidewire. The VSI Torque Device provides additional control of the movement of the guidewire.
The provided text describes the VSI Torque Device and states that its design has been qualified through "tensile and torque testing, dimensional verification, and visual inspection to verify the performance of the device." However, the text does not include specific acceptance criteria or detailed results of these tests such as numerical targets or reported performance values. It only states that "The results of the verification testing and biomaterial assessment did not raise new safety or performance questions."
Therefore, I cannot populate a table with acceptance criteria and reported device performance.
Here's what can be extracted from the provided text:
- Study Title: Not explicitly named, but the studies relate to "tensile and torque testing, dimensional verification, and visual inspection" of the VSI Torque Device.
- Purpose of Study: To verify the performance of the device and ensure substantial equivalence to predicate devices.
Here's a breakdown of the other requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text | Not specified in the provided text (The text only states that results "did not raise new safety or performance questions.") |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The studies described are engineering verification tests, not clinical studies requiring expert ground truth establishment in the traditional sense for medical imaging or diagnostic devices.
4. Adjudication method for the test set:
- Not applicable/Not mentioned. This is typically relevant for studies involving human interpretation or subjective assessments.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies mentioned are engineering verification tests.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the described "tensile and torque testing, dimensional verification, and visual inspection" are standalone engineering tests of the device itself. There is no algorithm involved here; it's a physical device.
7. The type of ground truth used:
- For "tensile and torque testing, dimensional verification, and visual inspection," the ground truth would typically be established specifications, engineering drawings, and material properties. For example, a specified tensile strength, a precise dimension from a blueprint, or a visual standard for acceptable finish. The document does not detail these specific ground truths.
8. The sample size for the training set:
- Not applicable. This is an engineering device, not a machine learning model, so there is no 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.