The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation with post-operative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction , Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

Device Description

The HEALIX ADVANCETM Anchor with PERMATAPETM Suture consists of a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of one strand of #2 PERMACORDTM suture and one strand of PERMATAPETM suture to bone. HEALIX ADVANCETM Anchors with PERMATAPETM are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX ADVANCETM Anchor with PERMATAPETM Suture is provided sterile and is for single use only.

AI/ML Overview

The provided text is a 510(k) Summary for the HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture device. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove the device meets those criteria from scratch.

Therefore, the information I can extract regarding acceptance criteria and a definitive "study that proves the device meets the acceptance criteria" is limited to the comparative testing performed to show substantial equivalence. The document doesn't outline a set of predefined acceptance criteria in the same way a de novo clearance or a clinical trial for an AI device might, nor does it conduct a standalone multi-reader multi-case (MRMC) study or a comprehensive standalone algorithm performance study.

However, I can extract the relevant performance testing and safety assessments that were performed to support substantial equivalence.

Here's a breakdown of the information based on your request:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Since this is a substantial equivalence submission for a mechanical device, the "acceptance criteria" are implied by the performance of the predicate devices and general standards for such implants. The reported device performance is based on comparative testing against these predicates.

Acceptance Criteria (Implied/Comparative)	Reported Device Performance (Comparative to Predicates)
Functional Equivalence: Device performs its intended function (soft tissue to bone fixation) adequately.	The device is similar to predicate devices in its intended use, anchor design and materials, and principle of operation.
Mechanical Strength/Integrity: Sufficient pull-out strength, insertion, and failure torque to securely fix soft tissue to bone.	Pull-out testing, insertion and failure torque, and in-vitro testing were performed. The results "demonstrated that the proposed devices are suitable for their intended use." (Specific quantitative values are not provided in this summary but would be in the full submission).
Biocompatibility/Safety: Materials are safe for implantation and do not pose a biological risk (e.g., endotoxin levels).	Bacterial endotoxin testing was completed, and results "demonstrated that the proposed devices meet the endotoxin limits."
Sterility: Device is sterile and maintains sterility for its shelf life.	The device is provided sterile. Implied, through similarity to predicates, that the sterilization method is validated and effective. (Specific validation results are not in this summary, but would be in the submission). The shelf life is also stated as similar to predicates.

Study Proving Acceptance Criteria (Substantial Equivalence Study):

The "study" to prove the device meets acceptance criteria in this context is the non-clinical performance testing conducted to support substantial equivalence to predicate devices. This is NOT a study in the sense of a clinical trial or an AI performance study with a test set, experts, and ground truth in the way you might expect for an imaging AI device.

Study Name: Non-clinical (bench) testing and comparisons to predicate devices.
Objective: To demonstrate that the HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture is substantially equivalent to legally marketed predicate devices, specifically the K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture and K100012, K073412 Gryphon™ BR Anchor with Orthocord® Suture.

Detailed Responses to Your Specific Questions:

A table of acceptance criteria and the reported device performance: Refer to the table above.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated in the summary. For bench testing of mechanical properties (pull-out, torque), standard engineering practices would involve a certain number of samples per test condition (e.g., 5-10 units).
- Data Provenance: The testing is "non-clinical testing" and "in-vitro testing," meaning it was conducted in a lab environment (bench testing) rather than on patients or patient data. Therefore, country of origin of data or retrospective/prospective status is not applicable in the human data sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. This is a mechanical device, and ground truth is established by physical measurement tools and engineering standards, not by expert interpretation of medical images or patient outcomes.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as this is bench testing of a mechanical implant, not an AI diagnostic device requiring expert adjudication.
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: Not applicable. This device is a surgical implant, not an AI diagnostic tool, so an MRMC study is not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from physical measurements (e.g., force in Newtons for pull-out, torque in N·cm) and material properties testing against established engineering and regulatory standards for mechanical implants, and comparison to the performance of predicate devices.
The sample size for the training set: Not applicable. This device does not use a training set as it is not an AI/machine learning product.
How the ground truth for the training set was established: Not applicable.

Summary of the Device's Approach to Meeting Criteria:

The HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture demonstrates that it meets the necessary safety and performance criteria by establishing substantial equivalence to existing, legally marketed predicate devices. This is done through:

Design and Material Similarity: Showing that its intended use, anchor design, materials (absorbable BR and non-absorbable PEEK), suture (PERMATAPE™) which is also similar to a reference device (PERMACORD™), device assembly, sterilization method, and shelf life are comparable to predicates.
Non-Clinical Performance Testing: Conducting bench-top tests like pull-out testing, insertion and failure torque, and in-vitro testing. The results of these tests indicated the device is "suitable for its intended use" when compared to the performance characteristics expected for such devices and demonstrated by its predicates.
Safety Testing: Completing bacterial endotoxin testing to ensure biocompatibility and safety regarding endotoxin levels.

The core of this 510(k) submission is to show that the new device does not raise new questions of safety and effectiveness compared to devices already on the market, thereby implying it meets the accepted performance and safety "criteria."

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

May 18, 2017

Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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

Medos International SARL % Ms. Julie Vafides Project Lead, Regulatory Affairs Depuv Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K170639

Trade/Device Name: HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: February 28, 2017 Received: March 2, 2017

Dear Ms. Vafides:

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

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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 devicerelated adverse events) (21 CFR 803); 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.

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 Biometrics/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,

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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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)

K170639

Device Name

HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture

Indications for Use (Describe)

The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation with post-operative immobilization as follows:

Shoulder:	Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular SeparationRepair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle:	Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee:	Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair,Iliotibial Band Tenodesis
Elbow:	Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction , Radial Collateral Ligament Reconstruction
Hip:	Capsular Repair, Acetabular Labral Repair

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)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) SUMMARY

HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture

Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Date Prepared: February 28, 2017
Contact Person	Julie VafidesProject Lead, Regulatory AffairsDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-977-6645e-mail: jvafides@its.jnj.com
Name ofMedical Device	Proprietary Name: a) HEALIX ADVANCE™ BR Anchor with PERMATAPE™Sutureb) HEALIX ADVANCE™ PEEK Anchor withPERMATAPE™ SutureClassification Name: a) Single/multiple component metallic bone fixationappliances and accessoriesb) Smooth or threaded metallic bone fixation fastenersCommon Name: Suture Anchor
SubstantialEquivalence	The HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture is substantiallyequivalent to:■ K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture■ K100012, K073412 Gryphon™ BR Anchor with Orthocord® SutureReference devices:■ K162247 PERMATAPE™ Suture■ K120449 HEALIX ADVANCE™ PEEK Anchor
DeviceClassification	> HEALIX ADVANCE™ BR Anchor with PERMATAPE™ Suture is classified as:Single/multiple component metallic bone fixation appliances and accessories,classified as Class II, product code MAI, regulated under 21 CFR 888.3030.> HEALIX ADVANCE™ PEEK Anchor with PERMATAPE™ Suture is classifiedas:Smooth or threaded metallic bone fixation fasteners, classified as Class II, productcode MBI, regulated under 21 CFR 888.3040.
DeviceDescription	The HEALIX ADVANCETM Anchor with PERMATAPETM Suture consists of athreaded suture anchor preloaded on a disposable inserter assembly intended forfixation of one strand of #2 PERMACORDTM suture and one strand ofPERMATAPETM suture to bone. HEALIX ADVANCETM Anchors withPERMATAPETM are available in absorbable BR and non-absorbable PEEK materials.Devices with needles will be offered to facilitate suture passage through tissue. TheHEALIX ADVANCETM Anchor with PERMATAPETM Suture is provided sterile andis for single use only.
TechnologicalCharacteristics	The proposed HEALIX ADVANCETM Anchors with PERMATAPETM Suture aresimilar to the predicate HEALIX ADVANCETM Anchors with PERMACORDTMSuture (K133794) in that they share the same intended use, anchor design andmaterials, PERMACORD suture design and materials, device assembly, sterilizationmethod, and shelf life. The proposed devices are similar to the predicate Gryphon™BR Anchor with Orthocord® Suture in that they share the same indications for use,same anchor materials, similar anchor / device assembly design and principle ofoperation. The proposed devices are similar to the reference device, PERMACORDTMSuture (K162247), in that they share the same suture design and material. Theproposed devices are similar to the reference device, HEALIX ADVANCETM PEEKAnchor (K120449), in that both are offered with or without needles to facilitate suturepassage through tissue.
Indications forUse	The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation inassociation with post-operative immobilization as follows:
	Shoulder:Foot/Ankle:Knee:Elbow:Hip:	Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,Capsular Shift or Capsulolabral ReconstructionLateral Stabilization, Medial Stabilization, Achilles Tendon RepairMedial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Posterior Oblique Ligament Repair, Iliotibial Band TenodesisBiceps Tendon Reattachment, Ulnar Collateral LigamentReconstruction , Radial Collateral Ligament ReconstructionCapsular Repair, Acetabular Labral Repair
Non clinicalTesting	Verification activities were performed on the proposed device and / or its predicates.Testing assessments include pull out testing, insertion and failure torque and in-vitrotesting.
Safety andPerformance	Results of performance testing have demonstrated that the proposed devices aresuitable for their intended use.Bacterial endotoxin testing has been completed and results have demonstrated that theproposed devices meet the endotoxin limits.Based on similarities in the indications for use, technological characteristics, andperformance in comparison to the predicate devices, the proposed HEALIXADVANCETM Anchor with PERMATAPETM Suture has shown to be substantially

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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.