The Titan Ti Suture 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 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 MagnumWire® sutures and is mounted on a disposable delivery driver. The device is supplied sterile and is available with or without needles.

AI/ML Overview

The provided text describes a 510(k) summary for the ArthroCare® Corporation Titan™ Ti Suture Anchor. This document details the device's substantial equivalence to predicate devices, focusing on physical and mechanical performance testing rather than clinical study data involving human or expert-derived diagnoses.

Therefore, many of the requested fields regarding acceptance criteria, study design, and ground truth in the context of diagnostic or AI performance are not applicable to this type of device submission. The submission relies on establishing substantial equivalence through engineering and material performance comparison and does not involve AI or diagnostic interpretation.

However, I can extract the information relevant to the types of studies mentioned and present it in the requested format.

Acceptance Criteria and Device Performance for ArthroCare® Corporation Titan™ Ti Suture Anchor

The provided 510(k) summary for the Titan™ Ti Suture Anchor does not detail acceptance criteria and device performance in the context of diagnostic accuracy or AI performance. Instead, it focuses on establishing substantial equivalence to predicate devices through performance testing that demonstrates the physical and mechanical properties of the suture anchor are comparable.

The "performance testing" referred to in the document would typically involve mechanical tests to assess properties like pull-out strength, fatigue, and material biocompatibility, rather than diagnostic accuracy metrics like sensitivity or specificity. The acceptance criteria would be defined as meeting or exceeding the performance characteristics of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., minimum pull-out strength in Newtons) and corresponding device performance values are not explicitly stated in the provided text, a detailed table cannot be populated. The document only generically states:
"Additionally, performance testing has been completed to demonstrate the substantial equivalence of the Titan Ti Suture Anchor to the predicate device."
"The differences in performance specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device."

Therefore, the principle acceptance criterion is:

Acceptance Criterion: The Titan Ti Suture Anchor's performance specifications (likely mechanical and material properties) must be substantially equivalent to those of the predicate devices.
Reported Device Performance: Performance testing demonstrated substantial equivalence to predicate devices.

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

Sample Size: Not specified in the provided text. The "performance testing" likely involved a set of physical devices subjected to mechanical tests.
Data Provenance: Not specified. This would refer to laboratory testing data, not clinical patient data.

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

Not Applicable. For this type of medical device (suture anchor), "ground truth" is established through engineering and material science testing standards, not through expert human interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or clinical outcomes where discrepancies need resolution. This is not the case for mechanical performance testing of a suture anchor.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Performed/Not Applicable. The device is a physical implant, not a diagnostic tool or AI-assisted system for interpretation. MRMC studies analyze human reader performance, usually in radiology or pathology, which is irrelevant to this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Performed/Not Applicable. This device is a physical medical implant, not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant.

7. Type of Ground Truth Used

Engineering and Material Science Standards: The "ground truth" for this device's performance would be defined by industry standards for mechanical properties (e.g., ASTM standards for pull-out strength, fatigue) and biocompatibility, as measured by laboratory testing. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of AI or machine learning for this physical medical device. The "training" in manufacturing involves process validation and quality control, not data-driven model training.

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

Not Applicable. As there is no training set as understood in AI/ML, there's no ground truth established for it.

Summary

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K092133 p.1 of 2 .

510(k) Summary

NOV - 5 2009

ArthroCare® Corporation Titan™ Ti Suture Anchor

General Information Submitter Name/Address:

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Description Trade Name:

Generic/Common Name:

Tissue

Classification Name:

Device Classification:

680 Vaqueros Avenue Sunnyvale, CA 94085-3523

ArthroCare Corporation

2951580

Valerie Defiesta-Ng Director, Regulatory Affairs

July 13, 2009

Titan Ti Suture Suture Anchor

Screw, Fixation, Bone; Fastener, Fixation, Nondegradable, Soft

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

Class II, 21 CFR 888.3040 Product Code MBI and HWC

Predicate Devices

Arthrex Corkscrew FT Suture Anchor Arthrex Corkscrew FT Suture Anchor Arthrex Corkscrew FT III Suture Anchor Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio Corkscrew FT Suture Anchor(s)

K050358 cleared 04/15/05) K061665 (cleared 07/25/06) K062679 (cleared 09/27/06) K061863 (cleared 10/19/06)

Product Description

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Intended Uses/Indications for Use

The Titan Ti Suture 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 미 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 해 Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
1 Hip: Capsular Repair, Acetabular Labral Repair

Substantial Equivalence

In establishing substantial equivalence to the predicate devices. ArthroCare compared the indications for use, dimensional specifications, and performance specifications of the subject device and the predicate device. Additionally, performance testing has been completed to demonstrate the substantial equivalence of the Titan Ti Suture Anchor to the predicate device. The performance testing and device comparison demonstrate that the subject devices are substantially equivalent to the predicate devices, and is safe and effective for its intended use.

Summary of Safety and Effectiveness

The Titan Ti Suture Anchor, as described in this premarket notification 510(k), is substantially equivalent to the predicate devices. The differences in performance specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is positioned above a wavy line, possibly symbolizing water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

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

NOV - 5 2009

Re: K092133

Trade/Device Name: Titan™ Ti Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: October 20, 2009 Received: October 21, 2009

· 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Valerie Defiesta-Ng

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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark McMilleon

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

Titan™ Ti Suture Anchor Device Name

KOGZI33 510(k) Number:

Indications for Use:

The Titan Ti Suture 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; '
비 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 트 Reconstruction, Radial Collateral Ligament Reconstruction;
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial 트 Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
Hip: Capsular Repair, Acetabular Labral Repair .

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

Prescription Use X (Per 21 CFR 801.109)

Over-the-Counter Use

Onetta for mxn

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

510(k) Number KD92133

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.