(101 days)
The GORE® DrySeal Flex Introducer Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
The GORE® DrySeal Flex Introducer Sheath consists of an introducer sheath with the GORE® DrySeal Valve attached, a twist style locking dilator, and a syringe. The introducer sheath is a composite tube which consists of a flat stainless steel wire reinforced hydrophilic coated Pebax® outer tube and PTFE liner with a tapered leading tip and marker band incorporated within the sheath material to allow identification under fluoroscopy. The sheath is attached to the GORE® DrySeal Valve.
The GORE® DrySeal Valve is comprised of an outer silicone tube and an inner film tube. The region between the silicone tube and film tube is pressurized by injecting 2.5 mL of saline into the space, using the provided syringe, during procedural preparation of the device.
The dilator has a tapered leading end and provides dilatation of the access vessel while providing a smooth transition from the guidewire to the introducer sheath leading tip. The dilator is 0.035" guidewire compatible and has a locking mechanism which mates with, and secures to, the DrySeal Valve. The sheath hub is embossed with its French size and a visual marker on the trailing end of the dilator shaft that ensures correct combination of the dilator within the sheath.
The provided text describes a medical device, the GORE® DrySeal Flex Introducer Sheath, and its FDA 510(k) premarket notification. However, it does not contain a typical "study" proving the device meets specific acceptance criteria in the format usually seen for AI/ML or diagnostic device performance claims (e.g., sensitivity, specificity, AUC, human reader performance).
Instead, the document details a bench study used to demonstrate the device's substantial equivalence to predicate devices, focusing on engineering and material characteristics rather than diagnostic or human performance.
Therefore, many of the requested fields cannot be directly answered from the provided text, as the focus is on a hardware medical device rather than a software algorithm or a diagnostic tool requiring expert ground truth and comparative effectiveness studies.
Here's an attempt to extract and interpret the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Performance Data / Predicate Device Comparison" section, which lists the tests performed to demonstrate substantial equivalence. The "Reported Device Performance" is stated as "the subject device performed as intended and was substantially equivalent to the predicate devices." No specific numerical performance metrics (like percentage of tensile strength, level of lubricity) are reported in the document; only that the tests were performed and the device met the implied criteria for equivalence.
| Acceptance Criteria (Implied by Test Performed) | Reported Device Performance |
|---|---|
| Critical Dimensions - IDs and Lengths | Performed as intended, substantially equivalent to predicate devices. |
| Compatibility with Devices - Sheath Dimensions | Performed as intended, substantially equivalent to predicate devices. |
| Guidewire Compatibility | Performed as intended, substantially equivalent to predicate devices. |
| Sheath Tip to Dilator Transition | Performed as intended, substantially equivalent to predicate devices. |
| Radiodetectability | Performed as intended, substantially equivalent to predicate devices. |
| Tortuosity | Performed as intended, substantially equivalent to predicate devices. |
| Kink Resistance | Performed as intended, substantially equivalent to predicate devices. |
| Peak Tensile Force - Critical Junctions | Performed as intended, substantially equivalent to predicate devices. |
| Dilator to Valve Locking Tensile Strength | Performed as intended, substantially equivalent to predicate devices. |
| Dilator Removal Force | Performed as intended, substantially equivalent to predicate devices. |
| System Freedom from Leakage | Performed as intended, substantially equivalent to predicate devices. |
| Lubricity | Performed as intended, substantially equivalent to predicate devices. |
| Particulation | Performed as intended, substantially equivalent to predicate devices. |
| Usability | Performed as intended, substantially equivalent to predicate devices. |
| Shelf life | Performed as intended, substantially equivalent to predicate devices. |
| Biocompatibility Evaluation | Performed as intended, substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
The document states a "bench study" was performed. It does not specify sample sizes for this bench study. The data provenance is internal testing by W.L. Gore & Associates, Inc. (the manufacturer). This is a retrospective evaluation of the device's physical properties.
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 and not provided. The "ground truth" for this type of device (an introducer sheath) relates to its physical performance characteristics (e.g., dimensions, tensile strength, freedom from leakage), which are established through engineering specifications and objective measurements, not expert human interpretation like in diagnostic imaging.
4. Adjudication method for the test set
This information is not applicable and not provided. As the "ground truth" is based on objective physical measurements and engineering specifications, there is no need for expert adjudication in the traditional sense.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation tasks, which is not the function of an introducer sheath.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument, not a software algorithm.
7. The type of ground truth used
The ground truth is based on engineering specifications, material science properties, and objective physical measurements (e.g., dimensions, force measurements, leakage tests, biocompatibility standards).
8. The sample size for the training set
This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning algorithms, not for the physical testing of an introducer sheath. The bench study evaluates the final manufactured device against predetermined performance standards.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As explained above, there is no "training set" in the context of this device's evaluation.
§ 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).