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 Opus SpeedLock Knotless Fixation Device is a bone anchor with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

AI/ML Overview

The provided text is a 510(k) summary for the Opus SpeedLock Knotless Fixation Device. It asserts substantial equivalence to a predicate device (Opus LabraLock P Knotless Fixation Device, K061349). However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, the submission focuses on:

Description of the new device and its intended use.
Identification of an existing predicate device the new device is substantially equivalent to.
A statement of substantial equivalence, asserting that the differences do not raise new questions of safety or effectiveness.
Regulatory information such as classification, product code, and contact details.

Therefore, I cannot populate the table or answer most of your detailed questions because the necessary information about performance studies, acceptance criteria, sample sizes, ground truth, or expert involvement is not present in the provided document. The 510(k) process for this type of device typically relies on demonstrating equivalence to a legally marketed predicate, rather than extensive de novo clinical studies with specific performance metrics.

Here's what I can extract based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

2. Sample size used for the test set and the data provenance:

Sample size: Not specified.
Data provenance: Not specified. The submission relies on substantial equivalence to a predicate device, implying that the safety and effectiveness are inferred from the predicate's known performance, rather than new performance data specific to the Opus SpeedLock device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new test set or ground truth establishment is described in this 510(k) summary.

4. Adjudication method for the test set:

Not applicable. No new test set or adjudication process is described.

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 bone anchor, not an AI-assisted diagnostic tool or imaging device that would involve human readers or AI.

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

Not applicable. This device is a bone anchor, not an algorithm.

7. The type of ground truth used:

Not applicable. No new ground truth is described. The basis for clearance is substantial equivalence to a predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI device, and no training set is mentioned.

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

Not applicable.

Summary

{0}------------------------------------------------

K090615 + 1/2.

510(K) SUMMARY

ARTHROCARE CORPORATION OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE JUN - 3 2009

General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

Sr. Manager, Regulatory Affairs

Laura N. Kasperowicz

March 5, 2009

Establishment Registration No .: 2951580

Contact Person:

Date Prepared:

Device Description

Trade Name:

Opus® SpeedLock™ Knotless Fixation Device

Generic/Common Name:

Bone Anchor, Fastener, Fixation, Soft Tissue

Fastener, Fixation, Nondegradeable, Soft Tissue (Class II per 21 CFR 888.3040, Product code: MBI)

Classification Name:

Predicate Devices

Opus LabraLock™ P Knotless Fixation Device

K061349 (Cleared July 14, 2006)

Product Description

The Opus SpeedLock Knotless Fixation Device is a bone anchor with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

Indications For Use

The Opus SpeedLock Knotless Fixation Device 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

{1}------------------------------------------------

K090615 #2/2

510(K) SUMMARY

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 Opus SpeedLock Knotless Fixation Device is substantially equivalent to the existing Opus LabraLock P Knotless Fixation Device cleared by the Food & Drug Administration (K061349, cleared July 14, 2006). The differences between the Opus SpeedLock 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 device, as designed, is as safe and effective as predicate devices.

Summary and Reason for 510k Notification

The purpose of this 510k is to notify the Food and Drug Administration of a new product, the Opus SpeedLock Knotless Fixation Device. This new product is substantially equivalent to the Opus LabraLock P Knotless Fixation Device originally cleared under K061349 (July 14, 2006).

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ArthroCare Corporation % Ms. Laura N. Kasperowicz Senior Manager, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523

JUN - 3 2009

Re: K090615

Trade/Device Name: Opus® SpeedLock™ Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: March 5, 2009 Received: March 9, 2009

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, 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 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

{3}------------------------------------------------

Page 2- Ms. Laura N. Kasperowicz

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/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Brenn

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

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number:

K 090615

Device Name:

Opus® SpeedLock™ Knotless Fixation Device

Indications for Use:

The Opus SpeedLock Knotless Fixation Device 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

Prescription Use (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)

Onsta
Division Si

(Devision Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090615

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.