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 Magnum™ PI 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 ArthroCare Corporation Opus Magnum PI Knotless Fixation Device. It's a regulatory document for premarket notification of a medical device, not a study report or clinical trial. Therefore, it does not contain the detailed information typically found in a study describing acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Here's what can be inferred and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., tensile strength thresholds, pull-out force, success rates). The acceptance criterion implicitly is that the device is "as safe and effective" as the predicate devices, despite the change in material.

Reported Device Performance: No specific performance metrics or data (e.g., experimental results, clinical outcomes) are reported. The document states: "The differences between the Opus® Magnum™ PI and the predicate devices 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." This is a declarative statement of equivalence, not a presentation of performance data.

Acceptance Criteria (Implied)	Reported Device Performance
As safe and effective as predicate devices	Declared "as safe and effective as predicate devices" based on substantial equivalence to existing devices (Opus® Magnum™ Knotless Fixation Device and Opus® LabraLock™ P Knotless Fixation Device) with well-characterized materials. No specific performance metrics or test results are provided.

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

Sample Size for the Test Set: Not applicable/Not provided. This document does not describe a clinical or performance test with a "test set" in the traditional sense of a study. The demonstration of equivalence is based on comparing the new device's characteristics to already-cleared predicate devices.
Data Provenance: Not applicable. No new data (clinical or experimental) is described in this summary to have specific provenance. The basis for safety and effectiveness relies on the prior clearance of predicate devices and the known characteristics of the PEEK material.

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

Not applicable/Not provided. Ground truth establishment for a test set is not part of this 510(k) summary. The regulatory process for substantial equivalence to predicate devices typically involves a review of scientific data and rationales by FDA experts, but this is distinct from establishing ground truth for a study's test set.

4. Adjudication Method for the Test Set

Not applicable/Not provided. There is no described "test set" or adjudication method.

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 is a medical device for bone/soft tissue fixation, not an image analysis or AI-driven diagnostic device. Therefore, an MRMC study or AI-assisted performance evaluation is not relevant to this submission.

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

Not applicable. As noted above, this device is not an algorithm or AI system.

7. The Type of Ground Truth Used

Not applicable/Not provided. The concept of "ground truth" for experimental or clinical data is not directly relevant to this submission, which relies on substantial equivalence. The "truth" in this context is that the predicate devices are considered safe and effective by the FDA.

8. The Sample Size for the Training Set

Not applicable/Not provided. Training sets are typically associated with machine learning models and are not relevant to this type of mechanical medical device submission.

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

Not applicable/Not provided. As above, training sets and their ground truth are not relevant to this submission.

Summary

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Ko70227 pge 'f²

510(K) SUMMARY

ARTHROCARE CORPORATION OPUS MAGNUM PI KNOTLESS FIXATION DEVICE

APR 16 2007

General Information

Submitter Name/Address:	ArthroCare Corporation680 Vaqueros AvenueSunnyvale, CA 94085-3523
Establishment Registration No.:	2951580
Contact Person:	Laura N. KasperowiczSr. Manager, Regulatory Affairs
Date Prepared:	January 23, 2007
Device Description
Trade Name:	Opus® Magnum™ PI
Generic/Common Name:	Bone Anchor, Fastener, Fixation, Soft Tissue
Classification Name:	Fastener, Fixation, Nondegradeable, Soft Tissue(Class II per 21 CFR 888.3040, Product code: MB)
Predicate Devices
Opus Magnum	K012125 (Cleared 09/17/01)
Opus LabraLock P	K061349 (Cleared 07/14/06)

Product Description

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

Indications For Use

The Opus® Magnum™ PI 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

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pge yf2

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® Magnum™ PI design and technology is substantially equivalent to the existing Opus® Magnum™ Knotless Fixation Device cleared by the Food & Drug Administration [K012125, and subsequently amended by K020172, K031083 and K042914]. The Opus" Magnum™ PI material is substantially equivalent to the existing Opus" LabraLock™ P Knotless Fixation Device cleared by the Food & Drug Administration [K061349]. The differences between the Opus® Magnum™ PI and the predicate devices 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 Magnum™ PI Knotless Fixation Device. This new product is substantially equivalent to the Opus® Magnum™ Knotless Fixation Device originally cleared under K012125 [and subsequently amended by K020172. K031083 and K042914], but is manufactured from PEEK (polyether-etherketone) as opposed to stainless steel.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Re:

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

APR 1 6 2007

K070227 Trade/Device Name: Opus® Magnum™ PI 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, HWC Dated: January 23, 2007 Received: January 24, 2007

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 N. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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,

Darbar Bonchum

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

Enclosure

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page 1 of 1

INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

Opus™ Magnum™ PI Knotless Fixation Device

Indications for Use:

The Opus® Magnum™ PI bone anchor with inserter 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

KO 7022

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) NO

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

Barbara Buchus

Division of Ger neral, Restorative. and Neurological Devices

510(k) Number K070227

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.