Intended for use in reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 1st metatarsal-2nd metatarsal (IM) angle.

Device Description

The KISSloc™ Suture System is a non-resorbable system consisting of a small Suture Plate, UHMWPE Suture Assembly and Arrow Plate for security. The suture is hooked around the Arrow Plate and passes through the two holes in the plate to form the entire assembly. This implant construct is intended to be used for realignment and stabilization of an underlying skeletal deformity. Ancillary instruments required to aid in insertion of the KISSloc™ Suture System will be provided separately in a sterile disposable package. All implant components will also be provided in a sterile package.

AI/ML Overview

The provided document describes Arthrosurface Inc.'s KISSloc™ Suture System and its 510(k) premarket notification for substantial equivalence, focusing on engineering tests rather than clinical studies with explicit acceptance criteria for device performance.

Therefore, many of the requested fields regarding clinical study details, such as sample sizes, expert qualifications, and detailed ground truth establishment, are not applicable based on the information provided. The submission focuses on demonstrating substantial equivalence through non-clinical mechanical tests against predicate devices.

Here's an attempt to fill in the table and provide the requested information based on the available text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Metric)	Target Performance (Acceptance Threshold)	Reported Device Performance (KISSloc™ Suture System)
Peak load to failure (N)	Equivalent or superior to predicate	Equivalent or outperformed predicate
Number of cycles completed prior to failure	Equivalent or superior to predicate	Equivalent or outperformed predicate
Displacement slippage per cycle interval	Equivalent or superior to predicate	Equivalent or outperformed predicate

Study Proving Device Meets Acceptance Criteria:

A non-clinical mechanical testing and engineering evaluation study was conducted to demonstrate the substantial equivalence of the KISSloc™ Suture System to its predicate devices.

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of devices/tests) used for the non-clinical mechanical tests.
- Data Provenance: The data was generated through laboratory mechanical testing and Finite Element Analysis (FEA). The country of origin for the data is not explicitly stated, but the company is based in Franklin, MA, USA, suggesting the testing likely occurred in the USA or through contracted labs. This was a retrospective comparison against established predicate device performance or specifications, as no new clinical data was provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a mechanical engineering study, not a clinical study involving expert assessment of medical images or patient outcomes. The "ground truth" for these tests would be the measured mechanical properties according to standard test methods.
Adjudication method for the test set:
- Not applicable. Mechanical testing involves quantitative measurements, not subjective adjudication methods like those used in clinical image review.
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 MRMC comparative effectiveness study was done. This device is a surgical implant, not an AI-powered diagnostic tool. The submission explicitly states, "No clinical data was provided in support of this substantial equivalency."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical implant, not an algorithm or AI system. Its performance is intrinsic to its mechanical properties, not a standalone algorithmic output.
The type of ground truth used:
- For the mechanical tests, the ground truth was the measured physical and mechanical properties (e.g., peak load, number of cycles, displacement slippage) determined through standardized laboratory testing protocols, compared against performance or specifications of the predicate devices. The Finite Element Analysis (FEA) provided simulated engineering data.
The sample size for the training set:
- Not applicable. There was no "training set" in the context of machine learning or AI, as this was a physical device undergoing mechanical testing.
How the ground truth for the training set was established:
- Not applicable for the same reasons as above.

Summary

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JUL 0 3 2014

Section 5 510(k) Summary
510(k) Owner:	Arthrosurface, Inc.28 Forge ParkwayFranklin, MA 02038Tel: 508.520.3003Fax: 508.528.4604
Contact:	Dawn WilsonVP, Quality & Regulatory
Date of Preparation:	November 27, 2013
Trade Name:	KISSloc™ Suture System
Common Name:	Plate & Suture System
Device:	Single/multiple component metallic bone fixationappliances and accessories
Classification Regulation:Device Class:Review Panel:Product Code:	Regulation Number 888.3030Class IIOrthopedicHTN

Device Intended Use

Intended for use in reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 1st metatarsal-2nd metatarsal (IM) angle.

Device Description

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Substantial Equivalency:

The intended use, materials, and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed devices:

· Arthrex Mini TightRope	K090107
· Arthrex Mini TightRope Repair Kit	K061925

The fundamental scientific technology of the proposed device has not changed relative to the predicate devices:

Intended for treatment of Hallux Valgus deformity. .
. Similar device designs
Same Titanium and UHMWPE implant materials .

In support of this submission, non-clinical mechanical tests and engineering evaluations were performed on the subject device and comparable predicate:

. Peak load to failure (N)
Number of cycles completed prior to failure .
Displacement slippage per cycle interval .
Finite Element Analysis .
Clinical Evaluations .

The test reports demonstrate the Arthrosurface KISSloc™ device was equivalent or outperformed the Arthrex predicate device for the non-clincial mechanical tests conducted.

No clinical data was provided in support of this substantial equivalency.

The results have demonstrated the safety and effectiveness of the KISSloc™ Suture System along with substantial equivalence to the predicate devices. Minor differences in device design and technique were determined not to be critical to the intended use of the device when used as labeled.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 10903 New Hampshire Avenue Dacument Control Center - WO66-G609 Silver Spring, MI) 20993-0002

Arthrosurface. Incorporated Ms. Dawn Wilson Vice President, Quality and Regulatory 28 Forge Parkway Franklin. Massachusetts 02038

Re: K133835

Trade/Device Name: KISSLocTM Suture System 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: May 30, 2014 Received: June 2, 2014

July 3, 2014

Dear Dawn Wilson:

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

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Page 2 - Ms. Dawn Wilson

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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" (21CFR 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 yours,

Mark N. Melkerson -S

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

Enclosure

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Section 4 Indications for Use Statement

510(k) Number (if known): K133835

Device Name: KISSloc™ Suture System

Indications for Use:

Intended for use in reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 186 metatarsal-2nd metatarsal (IM) angle.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

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.