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 System (MultiFIX S) is a laser marked PEEK implantable 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 laser marked PEEK implantable bone anchor and an 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.

AI/ML Overview

This document is a 510(k) summary for the ArthroCare® Corporation MultiFIX® S Knotless Fixation System. It describes the device, its intended use, and demonstrates substantial equivalence to a predicate device, K132590.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria	Reported Device Performance
Toxicological Testing (Gas and Liquid Chromatography Mass Spectrometry, FTIR)	Material is non-cytotoxic and equivalent to predicate.	"All toxicological... testing passed, demonstrating that the material is non-cytotoxic and equivalent to the predicate."
Biocompatibility Testing (Cytotoxicity)	Material is non-cytotoxic and equivalent to predicate.	"All... biocompatibility testing passed, demonstrating that the material is non-cytotoxic and equivalent to the predicate."
Bench Testing (Anchor Pound-in)	Anchor implant strength is not impacted by laser marking; implant screw body is successfully delivered sub-cortical.	"Bench testing in bone foam analog confirmed that the laser marking has no impact on implant strength as the implant screw body was able to be successfully delivered sub-cortical at the end of deployment. The test results demonstrate that the proposed MultiFIX S meets its design, performance, and safety specifications."
Mechanical Properties	Acceptable mechanical properties, substantially equivalent to predicate.	"Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling."

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

Test Set Sample Size: The document does not explicitly state the specific sample sizes for the toxicological, biocompatibility, and bench tests. It refers to "testing" in plural, implying multiple units were tested, but no numbers are provided.
Data Provenance: The data is from non-clinical testing (toxicological, biocompatibility, and bench testing) performed by ArthroCare Corporation. There is no information about the country of origin of the data beyond the company's location in Austin, TX, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate the performance of the new device with laser marking.

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

This device is a physical medical implant, not a diagnostic or AI-driven decision support system. Therefore, the concept of "ground truth" as established by human experts for a "test set" (like image data) does not directly apply in the same way.
The "ground truth" for the non-clinical tests would be the objective measurements and pass/fail criteria for each test (e.g., cytotoxicity levels, force required for pound-in without impact on strength). The expertise involved would be in designing these tests and interpreting the results according to established scientific and regulatory standards for medical device evaluation. The document does not specify the number or qualifications of these testing personnel beyond the company's regulatory affairs contact.

4. Adjudication Method for the Test Set

Again, as this is a physical implant evaluated through non-clinical laboratory tests, an "adjudication method" like 2+1 or 3+1 (common in expert review of medical images) is not applicable. The results of the non-clinical tests (e.g., chemical analysis, mechanical force measurements) are objective and are interpreted against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical or animal data are included in this submission." The evaluation relies entirely on non-clinical (bench) testing and comparison of technological characteristics to a predicate device to establish substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This report is for a physical medical device (bone anchor), not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on objective scientific and engineering measurements and established regulatory standards for material biocompatibility and mechanical performance of implantable devices. This includes:
- Chemical analysis results (Gas and Liquid Chromatography Mass Spectrometry, FTIR).
- Biocompatibility assay results (Cytotoxicity).
- Mechanical test results (anchor pound-in force, successful sub-cortical delivery).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. Machine learning or AI models, which typically require training sets, are not involved.

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

Not applicable. As there is no training set, there is no ground truth for it.

Summary

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MAY 1 4 2014

510(k) Summary

ArthroCare® Corporation MultiFIX® S Knotless Fixation System

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:	Laura KasperowiczSr. Manager, Regulatory AffairsPhone: 949-585-2406Fax: 949-585-2401
Date Prepared:	March 7, 2014

Device Name

Proprietary Name:	MultiFIX® S Knotless Fixation System
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 Device

MultiFIX® S Knotless Fixation System: K 132590 (cleared September 17, 2013)

Description

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

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Non-Clinical Data

Toxicological testing (Gas and Liquid Chromatography Mass Spectrometry and FTIR), biocompatibility testing (Cytoxicity) and bench testing (anchor pound-in) were performed. All toxicological and biocompatibility testing passed, demonstrating that the material is non-cytotoxic and equivalent to the predicate. Bench testing in bone foam analog confirmed that the laser marking has no impact on implant strength as the implant screw body was able to be successfully delivered sub-cortical at the end of deployment. The test results demonstrate that the proposed 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 device when used in accordance with labeling.

Clinical Data

No clinical or animal data are included in this submission.

Summary

All testing demonstrates that the proposed 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 device, the proposed MultiFIX S Knotless Fixation System is substantially equivalent. The minor differences between the proposed MultiFIX S and predicate device do not raise any new questions of safety or effectiveness.

Comparison of Technological Characteristics
Characteristics	Predicate DeviceMultiFIX S(K132590)	Proposed DeviceMultiFIX S
Intended Use	Fixation of soft tissue to bone	Same
Delivery Method	Arthroscopic and Limited Access	Same
How Supplied	Sterile	Same
Suture Material	No. 2 UHMWPE Suture	Same
Anchor Material	Invibio PEEK Optima®	Invibio PEEK Optima®with lasermarking to enhance anchorvisualization during delivery
Design Technology	Pound in Anchor with screw	Same
Bone LockingMechanism	Interference Fit(threaded screw)	Same
Suture LockingMechanism	Plug/Cylinder Compression	Same
# of Suture Legs	2, 3 or 4	Same

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Comparison of Technological Characteristics
Characteristics	Predicate DeviceMultiFIX S(K132590)	Proposed DeviceMultiFIX S
Diameter of CorticalLock	5.5 mm & 6.5 mm	Same
Anchor DeployedLength	20 to 23 mm	Same
Device Length	291mm	Same
Sterilization Method	Irradiation	Same
Packaging	Sterile / Thermoform Tray withTyvek Lid	Same

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol that resembles a human figure embracing or supporting three horizontal lines, which may represent the department's mission to protect and promote the health of all Americans.

Public Health Service

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

May 14, 2014

ArthroCare® Corporation Mr. Mitchell Dhority Vice President, Regulatory Affairs 7000 West William Cannon Drive, Building One Austin, Texas 78735

Re: K140604

Trade/Device Name: MultiFIX® S Knotless Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 18, 2014 Received: April 21, 2014

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 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 - 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 Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Biometries/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.

Ronald P. Jean -S for

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140604

Device Name

MultiFIX® S Knotless Fixation System

Indications for Use (Describe)

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-clavioular separation, rotator cuff repair, capsule shift/capsule-labrai 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

Knec: 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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
------------------------------------------------------------------------------	--

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Page 1 of 1

FORM FDA 3881 (1/14)

PSC Pablubing Services (201) 445-6740 PP

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.