Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot

reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

Device Description

The SpeedLock Knotless Fixation System is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. With this anchor, surgical knots are not necessary for the fixation of soft tissue to bone.

The SpeedLock consists of two primary parts: a 3.4 mm PEEK bone anchor and a disposable anchor inserter, which is preloaded with the anchor. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized. Both the anchor and inserter are designed for single use only.

The SpeedLock System also includes associated instruments for implanting the anchor into bone.

The design modifications include aligning the shape and size of the windows at the distal end of the anchor and adding a flat surface to the internal crossbar against which the anchor plug may rest once deployed. The modifications do not alter the overall device characteristics or the manner in which the device is used, and there are no changes to the devices cleared indications for use.

AI/ML Overview

The provided text is a 510(k) summary for the ArthroCare® Corporation SpeedLock® Knotless Fixation System. This document outlines a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way one might for a diagnostic AI algorithm.

Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission, as it concerns a physical bone fixation device, not a diagnostic AI or software.

However, I can extract information related to product performance and testing where available.

Acceptance Criteria and Device Performance (ArthroCare® Corporation SpeedLock® Knotless Fixation System)

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance
Functional Performance	Not explicitly stated as numerical criteria in this document. The overarching goal is that modifications "do not alter the device's intended use or performance."	"The test results demonstrate that the modified SpeedLock Knotless Fixation System meets its design, performance, and safety specifications."
Insertion Strength	Not explicitly stated as numerical criteria in this document.	Testing was conducted. Results are not detailed but the summary states the system "performs as intended."
Pull-out Strength	Not explicitly stated as numerical criteria in this document.	Testing was conducted in a simulated bone substrate. Results are not detailed but the summary states the system "performs as intended."
Design, Performance, Safety	Not explicitly stated as numerical criteria in this document.	"The test results demonstrate that the modified SpeedLock Knotless Fixation System meets its design, performance, and safety specifications."
Substantial Equivalence	Demonstrate that the modified device's intended use and technological characteristics are the same as the cleared predicate device and do not raise new questions of safety or effectiveness.	"All testing demonstrates that the modified SpeedLock Knotless Fixation System performs as intended and mechanical properties are substantially equivalent when used in accordance with its labeling."

Study Proving Device Meets Acceptance Criteria:

The study referenced is a Design Verification testing program.

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

Sample Size: Not specified quantitatively in the document. The testing involved "Insertion strength and pull-out strength testing."
Data Provenance: The testing was conducted in a simulated bone substrate. This indicates a bench-top, in-vitro (non-human/animal) lab setting. The country of origin for the data is not specified but implicitly refers to the testing performed by ArthroCare Corporation.
Retrospective/Prospective: Not applicable, as this was laboratory testing of a physical device.

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

Not Applicable. This submission is for a physical medical device (bone anchor) and its performance in mechanical tests, not a diagnostic AI algorithm requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No. This is a hardware device; MRMC studies are relevant for software/AI interpretation where human readers are involved.

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

Not Applicable. This is a hardware device; "standalone performance" generally refers to AI algorithm performance without human intervention. The testing described is of the physical device itself.

7. The type of ground truth used:

For the mechanical tests (insertion strength, pull-out strength), the "ground truth" would be the measured mechanical properties against pre-defined engineering specifications or performance standards. The document refers to "design, performance, and safety specifications."

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not Applicable. This is not an AI/machine learning device.

Summary of the Study:

The study involved Design Verification testing for the modified SpeedLock® Knotless Fixation System. This testing specifically included:

Evaluation to demonstrate that the modifications did not alter the device's intended use or performance.
Insertion strength testing in a simulated bone substrate.
Pull-out strength testing in a simulated bone substrate.

The purpose of these tests was to demonstrate that the modified device continues to meet its pre-established design, performance, and safety specifications and that its mechanical properties remain substantially equivalent to its predicate device. The submission states that "All testing demonstrates that the modified SpeedLock Knotless Fixation System performs as intended and mechanical properties are substantially equivalent when used in accordance with its labeling." No clinical or animal data were included in this submission, indicating reliance solely on non-clinical, bench-top testing.

Summary

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K130196

510(k) Summary

FEB 2 7 2013

ArthroCare® Corporation SpeedLock® Knotless Fixation System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

Submitter Name:	ArthroCare Corporation
Address:	7000 West William Cannon DriveAustin, TX 78735
Telephone:	(512) 391-5751
Fax:	(512) 895-1489
Contact Person:	Cheryl FrederickDirector, Regulatory Affairs
Date Prepared:	January 25, 2013

Device Name

Proprietary:	SpeedLock® Knotless Fixation System
Common:	Bone Anchor, Fastener, Fixation, Soft Tissue
Classification:	Class II
Product Code:	MBI
CFR Section:	21 CFR 888.3040

Predicate Device

This 510(k) relates to a modification to the SpeedLock Knotless Fixation System cleared under K111044 on August 9, 2011.

Description

The SpeedLock System also includes associated instruments for implanting the anchor into bone.

Image /page/0/Picture/15 description: The image shows the text "Page 1/2". This indicates that it is the first page of a two-page document. The text is written in a simple, sans-serif font. The numbers 1 and 2 are separated by a forward slash.

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K130196

Intended Use/Indications For Use

The SpeedLock Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Non-Clinical Data

Design Verification testing was performed to demonstrate that the modifications to the cleared SpeedLock Knotless Fixation System do not alter the device's intended use or performance. Insertion strength and pull-out strength testing in a simulated bone substrate was also conducted.

The test results demonstrate that the modified SpeedLock Knotless Fixation System meets its design, performance, and safety specifications.

Clinical Data

No clinical or animal data are included in this submission.

Summary

All testing demonstrates that the modified SpeedLock Knotless Fixation System performs as intended and mechanical properties are substantially equivalent when used in accordance with its labeling.

Since the modified device's intended use and technological characteristics are the same as those for the previously cleared device, we do not believe that the modification to the SpeedLock Knotless Fixation System raises any new questions of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 27, 2013

ArthroCare Corporation % Ms. Cheryl Frederick Director, Regulatory Affairs 7000 West William Cannon Drive Austin, Texas 78735

Re: K130196

Trade/Device Name: SpeedLock® Knotless Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: January 25, 2013 Received: January 28, 2013

Dear Ms. Frederick:

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. Iisting 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

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Page 2 - Ms. Cheryl Frederick

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Erin Neith

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

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: SpeedLock® Knotless Fixation System

Indications for Use:

The SpeedLock Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs: reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey E. Hanley, Ph.D.
Division of Orthopaedic Devices

Page 1 of 1 _

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.