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The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit fracture device is indicated to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.

Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is a sterile, single-use, implant construct. The implants are composed of three components: a Plug type lateral button and a medial button, two stainless steel fixation devices and an ultrahigh molecular weight polyethylene (UHMWPE) suture tape. The suture tape has a one-way sliding knot to facilitate reduction. The kit also contains a polyester suture attached to one of the fixation devices to enable passing the medial button from the lateral side to the medial side and a 3.5 mm drill tip passing pin to enable preparation of the fibula and the tibula and the tibia. The eyelet in the passing pin enables delivery of the medial button from the lateral side.

This document is a 510(k) premarket notification for a medical device called the "INVISIKNOT Ankle Syndesmosis Repair Kit." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.

It is crucial to understand that this document describes a traditional medical device (an implantable surgical kit), not an AI/ML-driven device. Therefore, the standard elements requested in the prompt regarding AI/ML device testing (such as acceptance criteria for AI performance metrics, sample sizes for test/training sets for AI, expert adjudication of AI ground truth, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this submission.

The document focuses on the mechanical and biological performance of the physical medical device.

However, I will extract information related to "acceptance criteria" and "proof of meeting criteria" as broadly as possible within the context of this specific, non-AI medical device.

Acceptance Criteria and Study for the INVISIKNOT Ankle Syndesmosis Repair Kit (Non-AI Device)

The "acceptance criteria" and "study proving the device meets criteria" in this 510(k) submission refer to the mechanical performance, material composition, and biological safety of the INVISIKNOT Ankle Syndesmosis Repair Kit, not the performance of an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the exact sample sizes (e.g., number of devices or test repetitions) for the mechanical or endotoxin testing. This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The studies were conducted by Smith & Nephew, Inc. (Andover, Massachusetts, USA). The studies are "premarket" submissions, so they are inherently prospective in the sense that the testing was performed specifically to support this regulatory submission. Country of origin for data collection is implied as USA, given the submitting company's location.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This question is not applicable as this is a mechanical and biological testing of a physical device, not an AI/ML device relying on human expert interpretation of medical images or data to establish a "ground truth." The "ground truth" for mechanical testing is based on engineered specifications and test methods (e.g., pass/fail for breakage, displacement measurements). For endotoxin testing, it's based on laboratory standards and quantitative measurements.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "adjudication" in the sense of multiple human readers or experts resolving disagreements for a test set of medical data, as this is not an AI/ML device study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical surgical implant kit, not an algorithm.

7. The Type of Ground Truth Used:

• For mechanical performance: The "ground truth" is based on the physical and mechanical properties of the materials and device design, evaluated against engineering specifications and expected physiological loads. This is determined via standardized test methods, material science principles, and comparison to predicate devices' known performance.
• For biocompatibility: The "ground truth" for endotoxin testing is established by validated laboratory assays (LAL Kinetic Chromogenic method) against regulatory limits (<20 EU/device).

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set" of data.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant.

In summary, the provided document details the regulatory clearance process for a traditional medical device. The "acceptance criteria" and "proof" relate to the physical and biological integrity and performance of the surgical implant, confirmed through mechanical testing and biological assays, and a claim of substantial equivalence to already approved predicate devices. It does not contain any information relevant to the testing and validation of an AI/ML device.

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