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.

Device Description

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.

AI/ML Overview

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 <20 EU/device)	"Bacterial endotoxin testing" using the LAL Kinetic Chromogenic method was conducted. The devices "have been found to meet the acceptable endotoxin limit of <20 EU/device."
Substantial Equivalence	Similarities in indications for use, design, operating principles, materials.	The device "is substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate device (Biomet ToggleLoc (K083070)) and raises no new issues of safety and efficacy."

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.

Summary

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June 8, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. Gregory Neal Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

Re: K162996

Trade/Device Name: INVISIKNOT Ankle Syndesmosis Repair Kit Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: April 28, 2017 Received: May 5, 2017

Dear Mr. Gregory Neal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K162996

Device Name INVISIKNOT Ankle Syndesmosis Repair Kit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K162996 Page 1 of 2

Endoscopy Smith & Nephew 150 Minuteman Road Andover, MA 01810

978 749 1000 978 749 1443 Fax www.smith-nephew.com

Image /page/3/Picture/3 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange, matching the color of the flower symbol.

510(k) Summary

SUBMITTER INFORMATION	CONTACT INFORMATION
Smith & Nephew, Inc.	Gregory Neal
150 Minuteman Road	Senior Regulatory Affairs Specialist
Andover, MA 01810	Phone: (508) 337-4120
	Fax: (978) 749-1443

DEVICE NAME (UNMODIFIED)
Trade or proprietary name	INVISIKNOT Ankle Syndesmosis Repair Kit
Common or usual name	Soft Tissue Fixation Device
Classification name	21 CFR §888.3030
Device Class	Class II
Product Code	HTN

LEGALLY MARKETED PREDICATE DEVICE

The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution:

Predicate Device	510(k) Number	Clearance Date	Predicate Type
Biomet Sport Medicine ToggleLoc System	K083070	12/16/2008	Primary
Smith & Nephew ULTRATAPE	K132357	10/30/2013	Reference

DEVICE DESCRIPTION

INTENDED USE

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

INDICATIONS FOR USE

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TECHNOLOGICAL CHARACTERISTICS

Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate device (Biomet ToggleLoc (K083070)) and raises no new issues of safety and efficacy. The predicate device shares operating principles - two buttons connected by a flexible material that can be used to reduce a syndesmotic trauma.

SUMMARY OF PERFORMANCE DATA

Mechanical testing to evaluate whether the performance of Smith and Nephew INVISINKOT Ankle Syndesmosis Repair constructs can withstand the expected loading conditions during the healing period following an ankle syndesmosis trauma occurred. Whether the 3.5mm drill tip passing pin required to deploy the implant can withstand use without breaking was also evaluated. Data for after-fatigue displacement and passage of the device from the medial to lateral side demonstrate the INVISIKNOT Ankle Syndesmosis Repair Kit is substantially equivalent to the currently marketed predicate devices.

Bacterial endotoxin testing has been conducted for the subject devices using the LAL Kinetic Chromogenic method. The subject devices have been found to meet the acceptable endotoxin limit of <20 EU/ device.

SUBSTANTIAL EQUIVALENCE INFORMATION

The substantial equivalence of the INVISIKNOT Ankle Syndesmosis Repair Kit is based on similarities in indications for use, design features, operational principles, material composition, and performance to the predicate devices listed above. Based on the similarities to the predicates, the INVISIKNOT Ankle Syndesmosis Repair Kit is substantially equivalent to its predicates.

Regulation Number and Section

§ 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.