Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biccps 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; patcllar ligament and tendon avulsions

Device Description

The Opus" SpeedScrew™ device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

AI/ML Overview

This 510(k) summary describes a new medical device, the Opus Magnum SpeedScrew Knotless Fixation Device, and seeks to demonstrate its substantial equivalence to previously cleared predicate devices. Since this is a submission for a new product seeking substantial equivalence to existing predicate devices, the provided document does not contain acceptance criteria in the traditional sense of performance targets that the device must meet in a new study. Instead, the "study" demonstrating that the device meets criteria is the argument for substantial equivalence, which primarily relies on comparing its design, technology, and materials to already cleared devices.

Therefore, for many of your requested points, the answer will be "Not applicable" or "No specific study outlined" because the FDA clearance process for devices seeking substantial equivalence often relies on demonstrating similarity to already approved devices rather than requiring new, extensive performance studies with specific numerical acceptance criteria.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicit in filing. The device aims to demonstrate "substantial equivalence" to predicate devices, meaning it has the same intended use and technical characteristics, or the same intended use and different technological characteristics but is demonstrated to be as safe and effective.	The device's design, technology, and materials are stated to be "substantially equivalent" to the predicate devices (Arthrex PEEK SwiveLock and Opus Magnum PI Knotless Fixation Device). The differences are stated not to "raise any questions regarding the safety and effectiveness of the implant."
Indication for use: fixation of soft tissue to bone (as detailed in the "Indications For Use" section).	The Opus® SpeedScrew™ device is indicated for use in fixation of soft tissue to bone, with specific examples provided for shoulder, ankle, foot, elbow, and knee procedures. This matches the intended use of the predicate devices.

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

Sample Size: Not applicable. No specific test set in the context of human data or a statistically powered performance study is described for this 510(k) submission. The evaluation is based on design and material comparison.
Data Provenance: Not applicable. This submission relies on a comparison to existing devices rather than new human data.

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

Number of Experts: Not applicable. Ground truth establishment by experts for a test set is not described for this type of submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set requiring expert adjudication is described.

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

MRMC Study Done: No. This type of study is not mentioned as part of the submission to demonstrate substantial equivalence for this device.

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

Standalone Study Done: No. This device is a physical bone anchor, not an algorithm or AI system, so "standalone performance" in that context is not applicable. The assessment is of the physical device's characteristics and materials.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable. For this 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relies on the established safety and effectiveness of the predicate devices. The new device argues it is similar enough to those established devices that it does not pose new safety or effectiveness concerns.

8. Sample Size for the Training Set

Sample Size: Not applicable. This is not an AI/ML device requiring a training set.

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

Ground Truth Establishment: Not applicable. This is not an AI/ML device requiring a training set.

Summary of the "Study" and How It Meets "Acceptance Criteria"

The "study" in this context is the substantiation of equivalence to predicate devices. The "acceptance criteria" are implied by the FDA's requirements for substantial equivalence:

Same intended use: The Opus Magnum SpeedScrew has the same intended use (fixation of soft tissue to bone) as the predicate devices.
Same technological characteristics, OR different technological characteristics but demonstrated to be as safe and effective: The submission states that the "Opus Magnum SpeedScrew design and technology is substantially equivalent" to the predicates, and that "The differences...do not raise any questions regarding the safety and effectiveness of the implant." It also notes that "the materials are well characterized and have been used in predicate devices with similar indications."

The FDA's decision to clear the device (as indicated in the letter from Mark N. Melkerson) confirms that the submitter successfully demonstrated that these "acceptance criteria" for substantial equivalence were met based on the information provided in the 510(k) notification.

Summary

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K08189}

510(K) SUMMARY

ARTHROCARE CORPORATION OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE

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:

July 2, 2008

Device Description

Trade Name:

Opus Magnum SpecdScrcw™ Knotless Fixation Device

Generic/Common Name:

Classification Name:

Fixation Point

Bonc Anchor

Screw, Fixation, Bone (Class II per 21 CFR 888.3040, Product code: HWC)

Predicate Devices K070227 (Cleared 04/16/07) Opus Magnum PI Arthrex PEEK SwiveLock K061863 (Clcared 10/19/06)

Product Description

The Opus" SpeedScrew™ device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

Indications For Use

The Opus® SpeedScrew™ device is a bonc anchor system with inserter that is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: 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

Kitee: 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

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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 offective as the predicate devices. The Opus Magnum SpeedScrew design and technology is substantially equivalent to the existing Arthrex PEEK SwiveLock and Opus Magnum PI Knotless Fixation Device cleared by the Food & Drug Administration [K061863 and K.070227 respectively]. The differences between the Opus Magnum SpeedScrew and the predicate devices do not raisc any questions regarding the safety and effectiveness of the implant. Furthermore, the materials arc 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 Magnum SpeedScrew Knotless Fixation Device. This new product is substantially equivalent to the Arthrex PEEK SwiveLock originally cleared under K061863, and the Opus Magnum PI Knotless Fixation Device originally cleared under K070227.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrocare Corporation % Ms. Laura Kasperowicz Senior Manager, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085

OCT 0 1 2008

Re: K081893 Trade/Device Name: Opus® Magnum SpeedScrew™ Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: HWC Dated: July 2, 2008 Received: July 3, 2008

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 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 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.

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Page 2 - Ms. Laura Kasperowicz.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number:

K 081893

Device Name:

Opus® Magnum SpeedScrew™ Knotless Fixation Device

Indications for Use:

The Opus Magnum SpeedScrew bone anchor 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

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)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

<081893

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.