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The Intended Use for the Innovasive Y-Knot Suture Clip is for use in general soft tissue approximation and /or ligation with #1 and #2 braided polyester suture.

The device consists of two distinct assemblies, both of which are required to properly deploy and use the device. These assemblies are the Y-Knot assembly and the handle.

Y-Knot assembly: The shaft portion of the assembly consists of the connector, outer tube, pull rod, shaft tube end, adapter, spring pin and dowel pin. These components are used to support the implant portion of the device and aid in the deployment of the Y-Knot when ready for use. The materials for each of these components are listed on each drawing. The shaft assembly is also fitted with two threaders. This allows the Y-Knot to be threaded with the suture when ready for use. The threaders pass through the inner member of the Y-Knot. When suture is passed through the loop of the threader, the threader is withdrawn. This results in the suture passing through and exiting the inner member. The threader is then discarded.

The implant portion consists of two components, the Y-Knot inner member and the sleeve. The inner member is molded of acetal. The sleeve portion of the device consists of machined acetal.

Handle: The handle will be offered as a reusable component. The handle is a device intended to be connected to the Y-Knot assembly connector and is used to deploy the device. The handle will be offered in two versions. One will be a limited reusable plastic handle constructed of Radel polysulfone material and a stainless steel locking mechanism. A second version, will be an all stainless steel reusable handle for long term reuse.

The Innovasive Devices Y-Knot Suture Clip, identified by K973313, is intended for use in general soft tissue approximation and/or ligation with #1 and #2 braided polyester suture. The device's performance was evaluated through two primary mechanical tests: Static Strength and Fatigue Strength.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The provided document does not explicitly state the specific sample sizes used for the static and fatigue strength tests. The data provenance is also not specified; however, the tests were conducted to support a 510(k) submission to the FDA, indicating an industry-standard laboratory setting for such testing. The study appears to be prospective, as it involved physical testing of the device.

3. Number of Experts and Qualifications for Ground Truth for Test Set

Not applicable. The ground truth for this device's performance is based on mechanical engineering principles and direct physical measurements of strength and fatigue, not human expert interpretation.

4. Adjudication Method for Test Set

Not applicable. As the ground truth relies on quantitative mechanical testing, there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a mechanical suture clip, and its performance is evaluated through physical characteristics, not human reader interpretation of images or other data. Therefore, an MRMC study is not relevant.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was conducted. The performance data presented (Static Strength and Fatigue Strength) directly measures the mechanical properties of the Y-Knot Suture Clip itself, compared to traditional knots, without any human-in-the-loop interaction for the device to function.

7. Type of Ground Truth Used

The ground truth used was based on direct mechanical measurements (e.g., force required for failure, cycles to failure under specified loads) and comparison to a predicate device (Ethibond Extra polyester suture) utilizing traditional knots.

8. Sample Size for the Training Set

Not applicable. The device's performance is determined by its mechanical design and materials, which are not "trained" in the way an algorithm is. Therefore, there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a mechanical device of this nature, there is no ground truth to establish for such a set.

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