This 510(k) submission (K081497) for the Opus Magnum X Knotless Fixation Device is a notification of a proposed modification to an existing product, the Opus Magnum2 Knotless Fixation Device (K042914). The submission primarily relies on the concept of substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not applicable or available within the provided documentation. The FDA's clearance is based on the new device having the "same intended use and technical characteristics as the predicate device," or "the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device."

Here's a breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Implied by Substantial Equivalence)
Same intended use as predicate device (K042914)	"Indicated for use in fixation of soft tissue to bone for rotator cuff repair." (Matches predicate)
Safe and effective as predicate device (K042914)	"The proposed device, as designed, is as safe and effective as predicate devices."
No new questions raised regarding safety and effectiveness due to modifications	"The differences between the Opus Magnum X and the predicate device do not raise any questions regarding the safety and effectiveness of the implant."
Materials are well characterized and used in similar predicate devices	"Furthermore, the materials are well characterized and have been used in predicate devices with similar indications."
Specific quantitative performance metrics (e.g., tensile strength, pull-out force, etc.) are not explicitly detailed in this summary for the new device, but would have been assessed in comparison to the predicate device.	Specific quantitative performance metrics are not detailed in this summary.

Study That Proves the Device Meets Acceptance Criteria:

The "study" in this context is a substantial equivalence comparison to the predicate device (Opus Magnum2 Knotless Fixation Device, K042914). The documentation asserts substantial equivalence based on a comparison of intended use, technological characteristics, and safety/effectiveness profile. It explicitly states: "The Opus Magnum X design and technology is substantially equivalent to the existing Opus Magnum2 Knotless Fixation Device cleared by the Food & Drug Administration [K042914]."

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. This submission is based on substantial equivalence to a predicate device, not on a new clinical study with a distinct "test set" of patient data as might be found in a de novo premarket submission or a PMA. The "test" for substantial equivalence is a comparison of design, materials, and intended use against the predicate.
Data Provenance: Not applicable. No new patient data (e.g., from a specific country or retrospective/prospective study) is presented for the Opus Magnum X device itself in this summary. The "data" relevant here would be the design specifications, material properties, and performance data used to establish the safety and effectiveness of the predicate device, which are not detailed here.

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

Number of Experts: Not applicable. No "ground truth" derived from expert consensus on a test set of data is described in this substantial equivalence summary. Clinical outcomes with the predicate device would have informed its clearance, but this isn't a new clinical study.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No "test set" requiring adjudication by experts is described for this substantial equivalence submission.

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

MRMC Study Done: No. This type of study is not mentioned or required for this substantial equivalence submission. An MRMC study is typically used to assess the effectiveness of an AI system's performance in a diagnostic context, often comparing human readers with and without AI assistance. This device is a surgical fixation device.
Effect Size: Not applicable.

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

Standalone Study Done: No. This refers to the performance of an AI algorithm on its own. This device is a medical implant, not an AI algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable in the context of a new clinical study for this device. The "ground truth" for the predicate device's safety and effectiveness would have been established through a combination of design validation, bench testing, potentially animal studies, and/or clinical experience, but these details are not provided for the predicate in this summary. For the Opus Magnum X, the "ground truth" is its equivalence to the already cleared predicate.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no AI model or training set described for this device.

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

How Ground Truth Was Established: Not applicable, as there is no AI model or training set.

Summary

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K081497 # 1/2

510(K) SUMMARY

ARTHROCARE CORPORATION OPUS MAGNUM X KNOTLESS FIXATION DEVICE

General Information

JUL 2 8 2008

Submitter Name/Address:	ArthroCare Corporation680 Vaqueros AvenueSunnyvale, CA 94085-3523
Establishment Registration No.:	2951580
Contact Person:	Laura N. KasperowiczSr. Manager, Regulatory Affairs
Date Prepared:	May 28, 2008
Device Description
Trade Name:	Opus Magnum® Knotless Fixation Device
Device Model Name:	Opus Magnum® X Knotless Fixation Device
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: MBL)
Predicate Devices	Opus Magnum2K042914 (Cleared 11/12/2004)

Product Description

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

Indications For Use

The Opus Magnum X device is a bone anchor system with inserter that is indicated for use in fixation of soft tissue to bone for rotator cuff repair

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K08149) # 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 Magnum X design and technology is substantially equivalent to the existing Opus Magnum2 Knotless Fixation Device cleared by the Food & Drug Administration [K042914]. The differences between the Opus Magnum X 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 proposed 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 proposed modification to an existing product. The proposed device, the Opus Magnum X Knotless Fixation Device is substantially equivalent to the Opus Magnum2 Knotless Fixation Device originally cleared under K042914.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2008

Arthrocare Corp. % Ms. Laura N. Kasperowicz 15285 Alton Parkway, #200 Irvine, CA 92618

Re: K081497

Trade/Device Name: Opus Magnum X Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fastener Regulatory Class: Class II Product Code: MBI Dated: June 26, 2006 Received: June 30, 2008

Dear Ms. Kasperwicz:

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 (OS) 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 - Laura N. Kasperwicz

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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

ко 81497 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number: Device Name: Opus Magnum X Knotless Fixation Device Indications for Use: The Opus Magnum X bone anchor with inserter is indicated for use in fixation of soft tissue to bone for rotator cuff repair. NO Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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-Oil) (Division of General, Restorative, and Neurological Devices

510(k) Number L041994

Regulation Number and Section

N/A