(89 days)
The VisiSheath Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The device is also intended for use in the introduction and support of intravascular catheters.
The VisiSheath™ Dilator Sheath is a single lumen polymer sheath used independently or as a support for an inner sheath to facilitate tissue dilation. One end is terminated with a 45° angle cut, while the other end is blunt. Both ends contain a metallic radiopaque marker band to enable fluoroscopic identification of tip location and orientation. An additional exterior mark aligned with the tip of the 45° angle cut permits visual identification of sheath orientation. There are multiple diameter and length options available.
The provided 510(k) summary for the VisiSheath Dilator Sheath indicates that it is a Class II medical device and that there are no established performance standards under Section 514 for these types of devices. Therefore, the information provided does not include specific predetermined acceptance criteria or a detailed study proving the device meets such criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the submission relies on functional testing to demonstrate performance.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
Since specific numerical acceptance criteria (like sensitivity/specificity targets) are not provided, this table will reflect the general statement made in the submission.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional as Intended | "All device functional test results for the VisiSheath™ Dilator Sheath met specified requirements." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the functional testing conducted ("device functional testing"). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) as the tests described are laboratory-based functional tests, not clinical studies with patient data.
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. Functional testing typically relies on engineering specifications and direct measurement, rather than expert judgment for ground truth establishment.
4. Adjudication method for the test set
This information is not applicable as the testing involves functional measurements against specifications, not human interpretation 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
No such study was conducted or reported. This device is a physical medical instrument (dilator sheath), not an AI-powered diagnostic tool, so MRMC studies and AI-related performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For functional testing, the "ground truth" would be the engineering specifications and design requirements for the device's physical properties and performance (e.g., tensile strength, flexibility, dimensions, radiopacity, ability to dilate tissue).
8. The sample size for the training set
This is not applicable. The device is a physical medical instrument, meaning there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).