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 reattachment

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 MultiFIX S Knotless Fixation Device (MultiFIX S) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.

The MultiFIX S consists of two primary parts: a PEEK bone anchor inserter. which is preloaded with the anchor. The anchor inserter is a disposable tool.

The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by irradiation. Both the anchor and inserter are designed for single use only.

The MultiFIX S Knotless Fixation System consists of the bone anchor and associated instruments for implanting the bone anchor.

AI/ML Overview

The provided document describes the MultiFIX® S Knotless Fixation Device and its 510(k) submission, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this submission.

However, I can extract information regarding the device's acceptance criteria and the study that proves it meets them, based on the document's content.

Acceptance Criteria and Device Performance for MultiFIX® S Knotless Fixation Device

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Metric)	Reported Device Performance (Summary)
Mechanical Properties	Deemed substantially equivalent to predicate devices. Meets design, performance, and safety specifications. Performs as intended.
Design Specifications	Met
Performance Specifications	Met
Safety Specifications	Met
Substantial Equivalence	Demonstrated across intended use, operating principle, materials, and technological characteristics when compared to predicate devices. Minor differences do not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document does not specify a numerical sample size for the mechanical tests. It mentions that "Bench testing was performed on both the proposed and predicate devices," indicating that multiple units of each were tested.
Data Provenance: The testing was "in vitro," using a "simulated human bone substrate." This indicates the data is from a controlled lab environment (bench testing), not from human or animal subjects. The country of origin is not explicitly stated but implies the US, given the submission to the FDA. The testing is prospective as it's part of the premarket submission process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the study involves mechanical bench testing of a device, not an AI/ML algorithm requiring expert ground truth for classification or diagnosis. The "ground truth" here is the physical performance measured against engineering specifications.

4. Adjudication method for the test set

This question is not applicable for the same reasons as above. No expert adjudication method (like 2+1 or 3+1) is relevant for mechanical bench testing.

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

This question is not applicable. This submission is for a medical device (bone anchor), not an AI/ML software. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. This involves a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the mechanical testing was based on pre-defined design, performance, and safety specifications, and comparison to the mechanical properties of legally marketed predicate devices. This is an engineering/design-based ground truth, not clinical or diagnostic.

8. The sample size for the training set

This question is not applicable as there is no AI/ML algorithm involved. The device underwent bench testing, not a training process.

9. How the ground truth for the training set was established

This question is not applicable as there is no AI/ML algorithm involved.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized wave-like graphic on the left, followed by the word "ArthroCare" in a sans-serif font. A small registered trademark symbol is located to the upper right of the word "Care".

510(k) Summary

JUL 2 9 2013

ArthroCare® Corporation MultiFIX® S Knotless Fixation Device

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

Submitter Name:	ArthroCare Corporation
Address	7000 West William Cannon DriveAustin, TX 78735
Contact Person:	Mitchell DhorityVice President, Regulatory and Clinical AffairsPhone: 512-358-5995Fax: 512-895-1489
Date Prepared:	April 26, 2013

Device Name

Proprietary Name:	MultiFIX® S Knotless Fixation Device
Common Name:	Bone Anchor
Classification Name:	Smooth or threaded metallic bone fixation fastener
Device Class:	Class II
Product Code:	MBI
CFR Section:	21 CFR 888.3040

Predicate Devices

ArthroCare MultiFIX® P Knotless Fixation Device: K120096 (cleared March 27, 2012)

ArthroCare 5.5 mm SpeedScrew® Knotless Fixation Device: K081893 (cleared October 1, 2008)

ArthroCare 6.5 mm SpeedScrew® Knotless Fixation Device: K101448 (cleared June 21, 2010)

Description

The MultiFIX S consists of two primary parts: a PEEK bone anchor inserter. which is preloaded with the anchor. The anchor inserter is a disposable tool.

The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by irradiation. Both the anchor and inserter are designed for single use only.

The MultiFIX S Knotless Fixation System consists of the bone anchor and associated instruments for implanting the bone anchor. In accordance with the ArthroCare Product Development Process, testing was performed to demonstrate the proposed device is substantially equivalent to the predicate device. Mechanical testing was performed in accordance with the requirements of the FDA Guidance Document, Testing Bone Anchor Devices, April 1996.

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Intended Use/Indications For Use

The MultiFIX S Knotless Fixation Device 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 reattachment

Non-Clinical Data

Bench testing was performed on both the proposed and predicate devices in accordance with the FDA Guidance Document, Testing Bone Anchors. April 1996. This in vitro testing involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing.

The test results demonstrate that the MultiFIX S meets its design, performance, and safety specifications. Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate devices when used in accordance with labeling.

Clinical Data

No clinical or animal data are included in this submission.

Summary

All testing demonstrates that the MultiFix S performs as intended and has acceptable mechanical properties when used in accordance with its labeling.

As the intended use, operating principle, materials and technological characteristics are comparable to the predicate devices, the MultiFIX S Knotless Fixation System is substantially equivalent. The minor differences between the MultiFix S and predicate devices do not raise any new questions of safety or effectiveness.

	Comparison of Technological Characteristics
Characteristics	Proposed DeviceMultiFIX S	Predicate DeviceMultiFIX P(K120096)	Predicate DeviceSpeedScrew(K081893, K101448)
Intended Use	Fixation of soft tissue tobone	Same	Same
Delivery Method	Arthroscopic and LimitedAccess	Same	Same
How Supplied	Sterile/Irradiation	Same	Same
Suture Material	No. 2 UHMWPE Suture	Same	Same
Anchor Material	Invibio PEEK Optima®	Same	Same

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Comparison of Technological Characteristics
Characteristics	Proposed DeviceMultiFIX S	Predicate DeviceMultiFIX P(K120096)	Predicate DeviceSpeedScrew(K081893, K101448)
Design Technology	Pound in Anchor with screw	Pound in Anchor with radialbarbs	Screw in Anchor
Bone Locking Mechanism	Interference Fit(threaded screw)	Interference Fit(6 barbs)	Interference Fit(threaded screw)
Suture Locking Mechanism	Plug/Cylinder Compression	Same	Same
# of Suture Legs	2. 3 or 4	2. 3 or 4	2
Diameter of Cortical Lock	5.5 mm & 6.5 mm	4.5 mm	5.5 mm & 6.5 mm
Deployed Length	20 to 23 mm	14 to 17 mm	14 to 16 mm
Sterilization Method	Irradiation	Same	Same
Packaging	Sterile / Thermoform Traywith Tyvek Lid	Same	Same

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing, and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle is facing to the right. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the bottom and "USA" at the top.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

ArthroCare Corporation % Mr. Mitchell Dhority Vice President, Regulatory and Clinical Affairs 7000 West William Cannon Drive Austin, Texas 78735

July 29, 2013

Re: K131182

Trade/Device Name: MultiFIX® S 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 Dated: May 9, 2013 Received: May 14, 2013

Dear Mr. Dhority:

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 10 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 vour 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 - Mr. Mitchell Dhority

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 yours.

Mark N. Melkerson - S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K_131182

Device Name: MultiFIX® S Knotless Fixation Device

Indications for Use:

The MultiFIX S 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 reattachment

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

X 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)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Page 1 of _ 1

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.