The Opus TwinLock 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

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® TwinLock™ device is a bone anchor system 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 TwinLock Knotless Fixation Device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics.

The 510(k) process for medical devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with predefined acceptance criteria in the same way a drug or a novel, high-risk device might.

Therefore, I cannot populate the requested table and answer the questions based on the provided text.

Here's why and what's missing:

Acceptance Criteria & Reported Performance (Table and Q1): The document does not define any specific performance metrics (e.g., tensile strength, pull-out force, dissolution rates, clinical success rates, accuracy, sensitivity, specificity, etc.) that the device must meet, nor does it report any experimental results against such criteria. The "study" mentioned here is the comparison to the predicate device, not a performance study against acceptance criteria.
Sample Size, Data Provenance, Experts, Adjudication (Q2-4): These questions are relevant for studies involving human data or expert review (e.g., diagnostic device performance, clinical outcomes). Since this is a submission for a bone anchor device demonstrating substantial equivalence via material and design comparison, these elements are not present. There is no "test set" in the context of diagnostic performance here.
MRMC Comparative Effectiveness (Q5): This is specific to diagnostic imaging devices where human readers interpret images with and without AI assistance. It's not applicable to a knotless fixation device.
Standalone Performance (Q6): "Standalone" performance usually refers to an algorithm's performance without human intervention. This device is a physical implant, not an algorithm.
Type of Ground Truth (Q7): "Ground truth" is typically used in the context of diagnostic accuracy studies (e.g., pathology confirmation for a cancer detection algorithm). For an orthopedic implant, the "ground truth" would be related to its mechanical properties and biocompatibility, which are usually assessed through engineering tests and material characterization, not expert consensus or pathology on a "test set" in the same vein.
Training Set Sample Size & Ground Truth (Q8-9): These are concepts related to machine learning models. This document is about a medical device, not an AI/ML product.

In summary, the provided 510(k) document is not a study report demonstrating compliance with specific acceptance criteria in the manner requested by your questions. It's a regulatory submission affirming equivalence to an existing device.

Summary

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K. 071374 page 174

510(K) SUMMARY

ARTHROCARE CORPORATION

OPUS TWINLOCK KNOTLESS FIXATION DEVICE

AUG - 2 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:	May 15, 2007
Device Description
Trade Name:	Opus® TwinLock™ 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: MBI)
Predicate Devices	Opus MiniMagnumK042584 (Cleared 12/14/04)

Product Description

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

Indications For Use

The Opus® TwinLock™ device is a bone 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

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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 effective as the predicate device. The Opus TwinLock design and technology is substantially equivalent to the existing Opus MiniMagnum Knotless Fixation Device cleared by the Food & Drug Administration [K042584]. The differences between the Opus TwinLock 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 TwinLock Knotless Fixation Device. This new product is substantially equivalent to the Opus MiniMagnum Knotless Fixation Device originally cleared under K042584.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG - 2 2007

Re: K071374

Trade/Device Name: Opus® TwinLock™ 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, JDR Dated: May 15, 2007 Received: May 16, 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) rrarer et notification. The FDA finding of substantial equivalence of your device to a legally premated 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). 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.

Sincerely yours,

Mark A. Millhiser

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 071374

Device Name:

Opus® TwinLock™ Knotless Fixation Device

Indications for Use:

The Opus TwinLock 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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR x

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)

Mark A. Millerson

al. Restorative,

510(k) Number

Regulation Number and Section

N/A