(224 days)
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:
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Stated) | Reported Device Performance and Proof |
|---|---|---|
| Mechanical Performance | Ability to withstand expected loading conditions during healing period. | "Mechanical testing" was conducted to evaluate if the constructs can withstand expected loading conditions. |
| "Data for after-fatigue displacement and passage of the device from the medial to lateral side" demonstrate substantial equivalence to predicate devices. | ||
| Drill Tip Passing Pin | Ability to withstand use without breaking. | Evaluated, and the device was found to "withstand use without breaking." (Implicitly, the testing confirmed this). |
| Biocompatibility/Safety | Acceptable endotoxin limit for implantable devices. (Typically |
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.