The Titan Ti Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy;
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction;
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
Hip: Capsular Repair, Acetabular Labral Repair

Device Description

The ArthroCare Titan Ti Suture Anchor is a fully-threaded, self-tapping, titanium corkscrew shape anchor available in 5.5mm and 6.5mm diameter sizes. The suture anchor comes preconfigured with Magnum Wire® sutures and is mounted on a disposable delivery driver. The device is supplied sterile and is available with or without needles. The optional Titan instruments are used to facilitate implantation and removal of the Titan Ti Suture Anchor.

AI/ML Overview

The provided text describes a 510(k) summary for the ArthroCare Corporation Titan™ Ti Suture Anchor System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a clinical or algorithmic study with a test set.

Therefore, many of the requested sections about acceptance criteria, test set details, expert ground truthing, and AI-specific studies are not applicable or cannot be extracted from this type of regulatory submission.

Here's the information that can be extracted, along with explanations for the missing details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Applicable	Efficacy shown in cadaver shoulder bone (as evidence of substantial equivalence to predicate)
Not Applicable	Proposed system is safe and effective as the predicate device (as a general statement of equivalence)

Explanation: In a 510(k) submission like this, the primary "acceptance criterion" is often substantial equivalence to a predicate device. This means the new device performs as intended and is as safe and effective as a device already on the market. Specific quantitative performance acceptance criteria (e.g., "Device must achieve X N/mm of pull-out strength with no more than Y% failure rate") are not typically stated or summarized in this part of the document, as the focus is on comparative safety and effectiveness. The "efficacy in cadaver shoulder bone" is presented as support for this equivalence, not as a direct measurement against a pre-defined numerical performance threshold.

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

Sample Size: Not explicitly stated as a "test set" in the context of an algorithm or human reader study. The study mentioned is "cadaver shoulder bone" for efficacy.
Data Provenance: Cadaver shoulder bone (unspecified country of origin or number of cadavers).
Retrospective or Prospective: Unspecified, but implied to be a laboratory study rather than a clinical one.

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

Number of Experts: Not applicable. The study involved biomechanical testing on cadaver bone, not clinical interpretation requiring expert consensus.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no clinical imagery or diagnostic interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. This document describes a medical device (suture anchor), not an AI algorithm for diagnostic imaging or a system for interpreting data. Therefore, an MRMC study is not relevant.
Effect Size of Human Readers with/without AI: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Study: Not applicable. This device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used

Ground Truth: For the "efficacy in cadaver shoulder bone" mention, the "ground truth" would be the biomechanical performance metrics (e.g., pull-out strength, failure mode) measured directly from the cadaveric specimens under controlled laboratory conditions. This is a form of direct experimental measurement rather than expert consensus or pathology in a clinical sense.

8. Sample Size for the Training Set

Sample Size: Not applicable. This device does not involve a "training set" like an AI algorithm would.

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

Ground Truth Establishment: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The key "study" referenced in the 510(k) for the Titan™ Ti Suture Anchor System is a demonstration of efficacy in cadaver shoulder bone. This testing was conducted to support the claim that the device is substantially equivalent to the predicate device (ArthroCare Titan Ti Suture Anchor, K092133). The document explicitly states: "The Titan Ti Suture Anchor design and technology is identical to the existing Titan Ti Suture Anchor devices cleared in K092133. The addition of ancillary instruments does not raise new questions regarding the safety and effectiveness of the Titan Ti Suture Anchor system. Efficacy of the device was shown in cadaver shoulder bone. The proposed system is safe and effective as the predicate device."

This statement implies that biomechanical testing was performed on cadaveric shoulder bone to assess the performance of the suture anchor, likely focusing on properties like pull-out strength or fixation stability. The results of this testing were deemed sufficient to demonstrate that the device performs comparably to the predicate device and meets its intended purpose. The acceptance criteria in this context are implicitly that the device performs at least as well as the predicate device in relevant biomechanical tests to establish substantial equivalence for regulatory clearance.

Summary

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K101/84.

510(k) Summary

ArthroCare Corporation Titan™ Ti Suture Anchor System

MAY 1 8 2010

General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Establishment Registration Number:

Contact Person:

2951580

April 27, 2010

Valerie Defiesta-Ng Director, Regulatory Affairs

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

5.5/6.5mm Titan Ti Suture Anchor Titan Bone Punch Titan Removal Tool Driver Titan Removal Tool Capture Sleeve

Smooth or Threaded Metallic Bone Fixation Fastener (21 CFR 888.3040)

Class II, 21 CFR 888.3040 Product Code MBI and HWC

Predicate Devices

Arthrocare Titan Ti Suture Anchor

K092133 (November 5, 2009)

Product Description

Intended Uses/Indications for Use

The Titan Ti Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:

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Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps . Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, . Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy;
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, 트 Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament ■ Reconstruction, Radial Collateral Ligament Reconstruction;
트 Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
트 Hip: Capsular Repair, Acetabular Labral Repair

Substantial Equivalence

The Titan Ti Suture Anchor design and technology is identical to the existing Titan Ti Suture Anchor devices cleared in K092133. The addition of ancillary instruments does not raise new questions regarding the safety and effectiveness of the Titan Ti Suture Anchor system. Efficacy of the device was shown in cadaver shoulder bone. The proposed system is safe and effective as the predicate device.

Summary of Safetv and Effectiveness

The proposed modifications to the Titan Ti Suture Anchor System are not substantial changes, and do not significantly affect the safety or efficacy of the predicate device.

p. 2-ot 2

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. Inside the circle is a stylized eagle-like symbol with three curved lines forming its body and wings. The symbol is black and the background is white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

ArthroCare Corporation % Ms. Valerie Defiesta-Ng Regulatory Affairs Director 680 Vaqueros Avenue Sunnyvale, California 94085-3523

MAY 1 8 2010

Re: K101184

Trade/Device Name: ArthroCare® Titan™ Ti Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: April 27, 2010 Received: April 28, 2010

Dear Ms. Defiesta-Ng:

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

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Page 2 - Ms. Valerie Defiesta ~No

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/ReportalProblem/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.

cerely yours.

Barbara Briemd

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

K WIT 84 510(k) Number:

ArthroCare® Titan™ Ti Suture Anchor System Device Name:

Indications for Use:

The Titan Ti Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy;
l Knee: Anterior Cruciate Ligament Repair. Medial Collateral Ligament Repair. Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
I Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction;
포 Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair. Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
Hip: Capsular Repair, Acetabular Labral Repair

Prescription Use Over-the-Counter Use X AND/OR (Part 21 CFR 801 (21 CFR 807 Subpart Subpart D) C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Qutta for mxn

(Division Sign Off) Division of Surgical Orthopedic, and Restorative Devices

510(k) Number K101184

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.