The HEALIX ADVANCE KNOTLESS BR Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchor is offered in three sizes, 4.75 mm, 5.5 mm and 6.5mm. The HEALIX ADVANCE KNOTLESS BR Anchors are molded from Biocryl Rapide® (BR) material. The HEALIX ADVANCE KNOTLESS BR Anchor is provided sterile and is for single use only.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the HEALIX ADVANCE™ KNOTLESS BR Anchor. It is a clearance letter and a summary of the device, not a study report or clinical trial. Therefore, it does not contain the specific information required to answer the prompt regarding acceptance criteria and performance data for an AI/ML medical device.

The prompt is asking for details typically found in a clinical study report for an AI/ML-driven device, such as:

A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, AUC).
Sample size, data provenance, and retro/prospective nature of the test set.
Number and qualifications of experts for ground truth.
Adjudication method for golden standard.
MRMC study details and effect size.
Standalone algorithm performance.
Type of ground truth used (e.g., pathology, clinical outcome).
Training set sample size.
Method for establishing training set ground truth.

This 510(k) summary focuses on the substantial equivalence of a physical medical device (suture anchor) to predicate devices, based on material, design, and mechanical performance (fixation strength, insertion torque). It does not involve any AI/ML components or related performance metrics that would require the establishment of ground truth by multiple experts, MRMC studies, or analysis of sensitivity/specificity for diagnostic tasks.

Therefore, I cannot fulfill the request using the provided document. The document describes a physical medical device and its premarket clearance, not an AI/ML device with associated performance studies.

Summary

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Medos International SARL % Ashley Goncalo Senior Regulatory Affairs Specialist DePuv Synthes Mitek Sports Medicine. a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

May 10, 2018

Re: K180101

Trade/Device Name: HEALIX ADVANCE™ KNOTLESS BR Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: April 9, 2018 Received: April 10, 2018

Dear Ms. Goncalo:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K180101

Device Name HEALIX ADVANCE™ KNOTLESS BR Anchor

Indications for Use (Describe)

The HEALIX ADVANCE KNOTLESS BR Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder: Rotator Cuff, Biceps Tenodesis, Deltoid Repair

Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), Iliotibial (IT) Band Tenodesis

Foot/Ankle: Achilles Tendon Repair

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY HEALIX ADVANCE™ KNOTLESS BR Anchor

Date Prepared: 1/12/2018

Submitter'sName andAddress	DePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767On behalf of:Medos International SARLChemin-Blanc 38, Le Locle NeuchatelCH 2400, Switzerland
Contact Person	Ashley GoncaloSr. Regulatory Affairs SpecialistDePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767	Telephone: 508-977-3907Email: agoncalo@its.jnj.com
Name of MedicalDevice	Proprietary Name: HEALIX ADVANCE KNOTLESS BR AnchorClassification Name: Single/multiple component metallic bone fixationappliances and accessoriesCommon Name: Suture Anchor
SubstantialEquivalence	The HEALIX ADVANCE KNOTLESS BR Anchor is substantiallyequivalent to:K171114, K130917, K131974, K130539, K131683 HEALIXADVANCE KNOTLESS Anchor K101679, K082810, K071177, K061863, K051219 ArthrexPushLock Anchors
DeviceClassification	HEALIX ADVANCE KNOTLESS BR Anchor is classified as:Single/multiple component metallic bone fixation appliances andaccessories, classified as Class II, product code MAI, regulated under21 CFR 888.3030.
DeviceDescription	The HEALIX ADVANCE KNOTLESS BR Anchor is a one pieceimplantable cannulated, threaded anchor designed to secure soft tissueto bone. The anchor is provided loaded on a disposable inserter driverdevice. The proposed anchor is offered in three sizes, 4.75 mm, 5.5 mmand 6.5mm. The HEALIX ADVANCE KNOTLESS BR Anchors aremolded from Biocryl Rapide® (BR) material. The HEALIXADVANCE KNOTLESS BR Anchor is provided sterile and is forsingle use only.
TechnologicalCharacteristics	The suture anchor design, anchor and suture materials, and finishedgood assembly design remain the same when compared to the predicateHEALIX ADVANCE KNOTLESS Anchors (K171114, K130917,K131974, K130539, K131683).
Indications forUse	The HEALIX ADVANCE KNOTLESS BR Anchors are indicated foruse in the following procedures for reattachment of soft tissue to bone:Shoulder: Rotator Cuff Repair, Biceps Tenodesis, Deltoid RepairKnee: Posterior Oblique, Medial Collateral Ligament (MCL),Lateral Collateral Ligament (LCL), Iliotibial (IT) BandTenodesisFoot/Ankle: Achilles Tendon Repair
Non-clinicalTesting	Verification activities were performed on the proposed device and / orits predicates. Performance testing included evaluation of fixationstrength and insertion torque at time zero as well as in-vitro testing.The proposed device has been determined to be non-pyrogenic per therequirements set forth in ANSI/AAMI ST-72:2011, United StatesPharmacopeia (USP), and European Pharmacopeia (EP) using thebacterial endotoxin testing (BET) method.
Safety andPerformance	Results of performance testing have demonstrated that the proposeddevices are suitable for their intended use.Based on similarities in the indications for use, technologicalcharacteristics, and performance in comparison to the predicate devices,the proposed HEALIX ADVANCE KNOTLESS BR Anchor has shown

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to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.