(41 days)
Intended to be inserted in the peripheral vasculature to provide a conduit for the insertion of endovascular devices
The GORE Introducer Sheath with Silicone Pinch Valve is an introducer sheath comprised of a sheath with an attached valve system. hemostasis caps and a dilator. The tip of the dilator is tapered to facilitate atraumatic insertion of the sheath. The valve system helps maintain hemostasis during endovascular procedures. The hemostasis caps contain various size holes that allow for various size devices to be introduced while maintaining hemostasis. The GORE Introducer Sheath with Silicone Pinch Valve is supplied as a sterile, single use device.
The document describes the GORE Introducer Sheath with Silicone Pinch Valve and its 510(k) submission for substantial equivalence. It does not contain information about a study with acceptance criteria and reported device performance in the context of an AI/ML device. Instead, it describes general device integrity testing for a conventional medical device.
Therefore, many of the requested fields cannot be filled.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "All device integrity test results for the GORE Introducer Sheath with Silicone Pinch Valve met specified requirements." (Specific requirements and results are not detailed.) |
Missing Information: The document states that "All device integrity test results ... met specified requirements," but it does not define what those specific requirements (acceptance criteria) were, nor does it provide the detailed reported performance data against those criteria. This is common for 510(k) summaries, which often only state that tests were passed.
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not applicable/specified. The tests mentioned are "device integrity testing," which typically involves laboratory testing of the physical device rather than studies on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable. The "ground truth" for device integrity testing is typically established by engineering specifications and laboratory measurement standards, not expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Engineering specifications and laboratory test standards for "device integrity testing."
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not an AI/ML device; it's a conventional medical introducer sheath.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable.
Summary of the Study Mentioned:
The document mentions "device integrity testing" performed by W. L. Gore & Associates, Inc. The purpose of these tests was to demonstrate that the GORE Introducer Sheath with Silicone Pinch Valve met its specified requirements for device integrity. The conclusion states that "All device integrity test results... met specified requirements," supporting the claim of substantial equivalence to predicate devices. However, the specifics of these tests, including detailed protocols, acceptance criteria, raw data, or sample sizes, are not provided in this summary. This type of testing typically assesses physical properties, mechanical integrity, and functionality (e.g., hemostasis, ease of insertion, durability) of the device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).