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 SpeedFix Suture Implant is a bone anchor that facilitates the attachment of tissue to bone. The SpeedFix Suture System consists of an implant and associated instruments for installation of the implant that is designed for specific indications in arthroscopic and orthopedic procedures.

The following device-specific instrumentation is part of this submission:

SpeedLock Drill, Bone Drill
Bone Hole Locator
SpeedLock Drill Guide, Drill Guide

AI/ML Overview

Here's an analysis of the provided text regarding the SpeedFix Suture System (K101437), focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a substantial equivalence determination, not a study setting specific numeric acceptance criteria for performance such as accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are based on demonstrating that the SpeedFix Suture System is as safe and effective as the predicate device (Opus® SpeedLock® Knotless Fixation Device K090615).

Acceptance Criteria Category	Specific Criteria (Implied by Substantial Equivalence and Testing)	Reported Device Performance (as described in the document)
Intended Use	Same intended use as the predicate device.	"The SpeedFix Suture Implant is indicated for use in fixation of soft tissue to bone." This matches the general intended use described for the predicate by virtue of substantial equivalence. Specific examples of procedures are listed for both.
Technical Characteristics/Safety & Effectiveness	Either the same technical characteristics, or different characteristics that are demonstrated to be as safe and effective.	"The SpeedFix Suture Implant design and technology is substantially equivalent to the existing SpeedLock Knotless Fixation Device [K090615]."
Biocompatibility	Materials are well characterized and have been used in predicate devices with similar indications.	"Furthermore, the materials are well characterized and have been used in predicate devices with similar indications."
Mechanical Performance	Performance in in vitro testing (static and cyclic fatigue) is comparable to the predicate device.	"Side by side comparison bench testing was performed on the proposed and predicate device per the US FDA Guidance Document for Testing Bone Anchors. The in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing." The document states that "The differences between the SpeedFix and the predicate device do not raise any questions regarding the safety and effectiveness of the implant." This implies comparable performance.

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

Sample Size: The document does not specify a numerical sample size (e.g., number of anchors, number of tests). It only states "in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing."
Data Provenance: The testing was "in vitro," meaning it was conducted in a laboratory setting, not with human or animal subjects. The data is thus retrospective in the sense that it evaluates the device's characteristics, but it's not clinical data. The country of origin for the data is not specified, but the manufacturer is ArthroCare Corporation in Sunnyvale, CA, USA, so it's likely U.S.-based or from a facility associated with the U.S. company.

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

Not applicable. This was a bench test (in vitro mechanical testing) comparing a new device to a predicate device based on FDA guidance for bone anchors. It did not involve expert review or establishment of "ground truth" in the diagnostic context.

4. Adjudication Method for the Test Set

Not applicable. There was no expert review or adjudication process, as the "test set" was mechanical testing of the device itself.

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. This device is a surgical implant (suture system/bone anchor), not a diagnostic or AI-assisted device. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (implantable hardware), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the in vitro bench testing, the "ground truth" can be considered the objective mechanical properties and performance characteristics (e.g., pull-out strength, fatigue resistance) measured according to established engineering and material science standards outlined in the "US FDA Guidance Document for Testing Bone Anchors." The "truth" is whether the new device's performance falls within an acceptable range compared to that of the predicate device, demonstrating equivalent safety and effectiveness based on these measurable physical properties.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this device does not involve a training set.

Summary

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K101437

OCT 2 9 2010

510(K) SUMMARY ARTHROCARE CORPORATION SPEEDFIX SUTURE SYSTEM

General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

Establishment Registration No.: 2951580

Contact Person:

Laura N. Kasperowicz Sr. Manager, Regulatory Affairs

Date Prepared:

May 19, 2010

Device Description

Model Name: Generic/Common Name: Classification Name: Device Classification:

SpeedFix Suture System Bone Anchor, Fastener, Fixation, Soft Tissue Fastener, Fixation, Nondegradeable, Soft Tissue Class II per 21 CFR 888.3040, Product code: MBI

The following device-specific instrumentation is part of this submission:

Model Name:Generic/Common Name:	SpeedLock DrillBone Drill

Generic/Common Name:	Bone Hole Locator
Model Name:	SpeedLock Drill Guide
Generic/Common Name:	Drill Guide
Predicate Devices
t	A AA10

Opus® SpeedLock® Knotless Fixation Device K090615 (June 3, 2010)

Product Description

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K101437

510(K) SUMMARY

Indications For Use

The SpeedFix Suture Implant with inserter 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

Substantial Equivalence

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The SpeedFix Suture Implant design and technology is substantially equivalent to the existing SpeedLock Knotless Fixation Device [K090615]. Side by side comparison bench testing was performed on the proposed and predicate device per the US FDA Guidance Document for Testing Bone Anchors. The in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing. The differences between the SpeedFix and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed device, as designed, is as safe and effective as predicate devices.

Summary and Reason for 510k Notification

For the purpose of this premarket notification [510(k)], ArthroCare proposes a modification to an existing product. The proposed device, the SpeedFix Suture Implant, is substantially equivalent to the SpeedLock Knotless Fixation Device originally cleared under K090615.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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

ArthroCare Corporation % Ms. Laura Kasperowicz 680 Vaqueros Avenue Sunnyvale. California 94085-3523

OCT 2 9 2010

Re: K101437 Trade/Device Name: Speedfix Suture System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: September 30, 2010 Received: October 1, 2010

Dear Ms. Kasperowicz:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Laura Kasperowicz

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Milburn

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

Enclosure

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INDICATIONS FOR USE STATEMENT

OCT 2 9 2010

510(k) Number:

Device Name:

SpeedFix™ Suture System

K 101437

Indications for Use:

The SpeedFix Suture 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 (Part 21 CFR 801 Subpart D) X

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)

Oputta for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101437

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.