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 SpeedScrew Knotless Fixation Device is an implant that facilitates the attachment of tissue to bone. The SpeedScrew implant is a knotless fixation device, in other words surgical knots are not necessary for fixation of suture to tissue. The Opus SpeedScrew System consists of a 5.5 mm implant and a 6.5 mm implant, and associated instruments for installation of the implant that is designed for specific indications in arthroscopic and orthopedic procedures.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Opus SpeedScrew System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed reported device performance values. Instead, it refers to "side by side bench testing" against predicate devices and a general claim that the device is "as safe and effective as the predicate system."

However, we can infer the implied acceptance criteria based on the type of testing mentioned:

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Static Testing Performance: Must perform comparably or better than the predicate devices (K081893 and K100457) in static pull-out strength/fixation.	"The in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing." "The Opus SpeedScrew System design and technology is substantially equivalent to the existing Opus SpeedScrew System cleared by the Food and Drug Administration (K081893 and K100457)." No specific numerical data is provided in this document.
Cyclic Fatigue Testing Performance: Must perform comparably or better than the predicate devices (K081893 and K100457) in resisting fatigue failure over repeated stress cycles.	"The in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing." "The Opus SpeedScrew System design and technology is substantially equivalent to the existing Opus SpeedScrew System cleared by the Food and Drug Administration (K081893 and K100457)." No specific numerical data is provided in this document.
Material Biocompatibility: Materials must be well-characterized and have a history of safe use in similar predicate devices.	"Furthermore, the materials are well characterized and have been used in predicate devices with similar indications."
Safety and Effectiveness: Differences from the predicate device must not raise new questions of safety and effectiveness.	"The differences between the Opus SpeedScrew System and the predicate system do not raise 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 system, as designed, is as safe and effective as the predicate system."

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

Sample Size for Test Set: Not specified in the provided document. The document only mentions "side by side bench testing" and "in vitro testing."
Data Provenance: The testing was "in vitro testing" using "a simulated human bone substrate." The country of origin for the data is not specified, but given the submitter's address is in Sunnyvale, California, USA, and the FDA submission, it's likely U.S.-based. The testing is prospective as it was conducted for the purpose of this 510(k) submission.

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

This information is not applicable/not provided for this type of device submission. Bench testing of medical implants like bone anchors does not typically involve expert review for "ground truth" in the way clinical studies or diagnostic imaging might. The "ground truth" for mechanical performance is established by the standardized test methods themselves and the physical measurements obtained.

4. Adjudication Method for the Test Set

This is not applicable/not provided. Adjudication methods are relevant for clinical trials or studies where subjective assessments (e.g., by experts) need to be reconciled. For bench testing, the results are typically quantitative measurements.

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

No, an MRMC comparative effectiveness study was not performed as this is a mechanical implant device, not a diagnostic or imaging device requiring human reader interpretation. Therefore, there's no "effect size of how much human readers improve with AI vs without AI assistance."

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

Not applicable. This is a mechanical implant device; there is no "algorithm" in the sense of AI or software processing data that would have a standalone performance. The "device" itself is the implant.

7. Type of Ground Truth Used

The ground truth for the bench testing was established by physical measurements and mechanical properties derived from standardized in vitro tests (static and cyclic fatigue testing) on a simulated human bone substrate. The ground truth is the measured mechanical performance of the device and its predicate devices under controlled conditions.

8. Sample Size for the Training Set

There is no concept of a "training set" in this context. This is a medical device clearance based on substantial equivalence established through bench testing, not a machine learning model.

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

As there is no training set for a machine learning model, this question is not applicable.

Summary

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K101448

510(K) SUMMARY

ARTHROCARE CORPORATION

OPUS SPEEDSCREW SYSTEM

General Information

JUN 2 1 2010

ﻟﺘﻘ

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 11, 2010
Device Description
Trade Name:Device Model Name:Generic/Common Name:Classification Name:	Opus SpeedScrew SystemOpus 6.5 SpeedScrew Knotless Fixation DeviceBone AnchorScrew, Fixation, Bone(Class II per 21 CFR 888.3040, Product code: HWC)
Predicate DevicesOpus Magnum SpeedScrewKnotless Fixation Device	K081893 (Cleared October 1, 2008)

K100457 (Cleared March 19, 2010 Opus SpeedScrew System (Opus 5.5 SpeedScrew Knotless Fixation Device and ancillary instruments)

Product Description

Indications For Use

The SpeedScrew 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

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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 SpeedScrew System design and technology is substantially equivalent to the existing Opus SpeedScrew System cleared by the Food and Drug Administration (K081893 and K100457). Side by side bench testing was performed on the proposed and predicate devices per the US FDA Guidance Document for Testing Bone Anchors. The in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing. The differences between the Opus SpeedScrew System and the predicate system do not raise 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 system, as designed, is as safe and effective as the predicate system.

Summary and Reason for 510k Notification

For the purpose of this premarket notification [510(k)], ArthroCare proposes an additional size implant (Opus 6.5 mm SpeedScrew Knotless Fixation Device) and additional ancillary instrumentation (6.5 mm Punch/Tap) to be used in conjunction with the existing system cleared under the trade name, Opus SpeedScrew System.

page 2 of 2

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle-like symbol with three stylized wing shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

JUN 2 1 2010

Re: K101448

Trade/Device Name: Opus SpeedScrew System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: May 11, 2010 Received: May 24, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 practice requirements as set

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Page 2 - Ms. Laura N. Kasperowicz

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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Qaulau buelup

1ark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

K j01448

Opus SpeedScrew System

Indications for Use:

The SpeedScrew 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) NO

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

Sanita for mxn
Division Sign, Inc.

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

510(k) Number K101448

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.