K Number

Device Name

Manufacturer

ARTHROCARE CORPORATION

Date Cleared

2013-02-14

(121 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

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

Hip capsule repair
Acetabular labrum reattachment

Device Description

The SpeedLock HIP Knotless Fixation Implant (SpeedLock HIP) 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 suture to tissue.

The SpeedLock HIP 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 by ethylene oxide. Both the anchor and inserter are designed for single use only.

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

The design modification that is the subject of this Premarket Notification relates to the internal detachment feature of the SpeedLock HIP anchor. The modification does not alter the overall device characteristics or the manner in which the device is used, and there are no changes to the device's cleared indications for use.

AI/ML Overview

The provided document is a 510(k) summary for the ArthroCare® Corporation SpeedLock® HIP Knotless Fixation Implant. It describes a modification to an already cleared device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing. It does not involve studies to establish clinical acceptance criteria or assess AI/human reader performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, ground truth, expert opinions, and AI studies is not applicable to this document. The document explicitly states: "No clinical or animal data are included in this submission."

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states that "Design Verification testing to demonstrate conformance with device specifications" was performed. This included:

Functional testing of all aspects of device performance.
Use of the device with ancillary devices.
Anchor deployment, bone lock, and suture lock in a foam bone model.
Insertion testing in a simulated hard bone substrate.
Side-by-side comparative testing of the modified and predicate devices, including static and cyclic suture and anchor pull testing, as well as elements of standard verification testing.

Acceptance Criteria and Reported Performance (Based on provided text)

Acceptance Criteria Domain	Reported Device Performance/Conclusion
Device Specifications	"conformance with device specifications"
Functional Performance	"functional testing of all aspects of device performance" (met)
Ancillary Device Compatibility	"use of the device with ancillary devices" (met)
Anchor Deployment	Demonstrated in foam bone model (met)
Bone Lock	Demonstrated in foam bone model (met)
Suture Lock	Demonstrated in foam bone model (met)
Insertion Performance	Successfully performed in simulated hard bone substrate (met)
Static Suture/Anchor Pull Test	"side-by-side comparative testing" demonstrated substantial equivalence to predicate
Cyclic Suture/Anchor Pull Test	"side-by-side comparative testing" demonstrated substantial equivalence to predicate
Design/Performance/Safety	"meets its design, performance, and safety specifications"
Substantial Equivalence	"performs substantially equivalently to the predicate SpeedLock HIP Knotless Fixation Implant."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "testing" (e.g., functional testing, insertion testing, side-by-side comparative testing) but does not provide specific sample sizes (e.g., number of anchors tested, number of cycles).
Data Provenance: The testing appears to be primarily laboratory-based mechanical and functional testing, not data from human or animal subjects. No country of origin is mentioned for the "data," but the submitter is based in Austin, TX, USA.
Retrospective or Prospective: Not applicable as it's non-clinical, mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This submission focuses on engineering and mechanical testing, not clinical performance or diagnostic accuracy. Ground truth in the traditional sense for medical imaging or clinical diagnosis is not relevant here. The "truth" would be the measured mechanical properties and functional performance against predefined engineering specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving interpretation (e.g., by human readers). This document describes non-clinical, objective mechanical testing.

5. 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

Not applicable. No MRMC study was performed. The device is a surgical implant, not a diagnostic tool utilizing AI. The document explicitly states: "No clinical or animal data are included in this submission."

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

Not applicable. This device is a mechanical surgical implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" would be defined by engineering specifications, material properties, and established test standards for mechanical performance (e.g., force required for pull-out, number of cycles before failure, successful deployment of anchor).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set."

Summary

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Image /page/0/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, circular graphic on the left and the word "ArthroCare" on the right. The graphic is made up of several curved lines that create a sense of motion or rotation. The text "ArthroCare" is in a bold, sans-serif font, with a small trademark symbol next to the word.

K123240

510(k) Summary

ArthroCare® Corporation SpeedLock® HIP Knotless Fixation Implant FEB 1 4 2013

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
Contact Person:	Cheryl FrederickDirector, Regulatory AffairsPhone: 512-391-5751Fax: 512-895-1489
Date Prepared:	January 31, 2013

Device Name

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

Predicate Device

This 510(k) relates to a modification to the SpeedLock HIP Knotless Fixation Implant cleared under K 120943 (September 21, 2012).

Description

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

Page 1/2

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K123240

Intended Use/Indications For Use

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

0 Hip capsule repair
- Acetabular labrum reattachment

Non-Clinical Data

The following testing was submitted in support of a determination of substantial equivalence between the predicate and modified devices:

Design Verification testing to demonstrate conformance with device specifications. This testing included functional testing of all aspects of device performance, use of the device with ancillary devices, and anchor deployment, bone lock and suture lock in a foam bone model.
. Insertion testing in a simulated hard bone substrate.
트 Side-by-side comparative testing of the modified and predicate devices, including static and cyclic suture and anchor pull testing, as well as elements of standard verification testing.

The test results demonstrate that the modified SpeedLock HIP Knotless Fixation Implant meets its design, performance, and safety specifications and that it performs substantially equivalently to the predicate SpeedLock HIP Knotless Fixation Implant.

Clinical Data

No clinical or animal data are included in this submission.

Summary

All testing demonstrates that the modified SpeedLock HIP Knotless Fixation Implant performs as intended and has acceptable mechanical properties 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 HIP Knotless Fixation Implant raises any new questions of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird-like figure with its wings spread, suggesting protection and care.

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

February 14, 2013

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

Re: K123240

Trade/Device Name: SpeedLock® HIP Knotless Fixation Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: January 21, 2013 Received: January 22, 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, 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

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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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin DKeith

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

Enclosure

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K123240

Indications for Use

510(k) Number (if known): Not yet assigned

Device Name: SpeedLock® HIP Knotless Fixation Implant

Indications for Use:

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

· · Hip capsule repair
- I Acetabular labrum reattachment

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)

Anton E. Dmitriev, PhD 2013.02.12 13:48:09 -05'00' Division of Orthopedic Devices

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Regulation Number and Section

N/A