The HEALIX ADVANCE SP PEEK Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
• Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair
• Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral collateral ligament reconstruction, iliotibial (IT) band tenodesis
• Foot/Ankle: Achilles tendon repair

Device Description

The HEALIX ADVANCE SP PEEK Anchor is a two-piece “self-punching” design consisting of a cannulated, threaded anchor and dilator which are permanently implanted into the body. The anchor-dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). During implantation the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The proposed HEALIX ADVANCE SP PEEK Anchor is offered in two sizes, 4.9 mm and 5.5 mm and is molded from Polyetheretherketone (PEEK) material. The HEALIX ADVANCE SP PEEK Anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the HEALIX ADVANCE™ SP PEEK Anchor, focusing on acceptance criteria and supporting studies.

Based on the provided FDA 510(k) summary for the HEALIX ADVANCE™ SP PEEK Anchor, the device is a medical implant, and the approval process primarily focuses on engineering and biocompatibility performance testing rather than AI/machine learning performance. Therefore, many of the requested categories related to AI/ML studies (such as MRMC, standalone algorithm performance, number of experts for ground truth, sample size for training set, etc.) are not applicable to this specific device and submission.

The acceptance criteria here concern the mechanical integrity, sterility, and biocompatibility of the anchor.

Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Fixation Strength	Verification activities were performed on the proposed device and/or its predicates. Performance testing included evaluation of fixation strength. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. (Specific values or thresholds for "fixation strength" are not provided in this summary but would have been part of the full submission).
Insertion Torque	Verification activities were performed on the proposed device and/or its predicates. Performance testing included evaluation of insertion torque. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. (Specific values or thresholds for "insertion torque" are not provided).
Torque to Failure	Verification activities were performed on the proposed device and/or its predicates. Performance testing included evaluation of torque to failure. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. (Specific values or thresholds for "torque to failure" are not provided).
Cyclic Migration at Time Zero	Verification activities were performed on the proposed device and/or its predicates. Performance testing included evaluation of cyclic migration at time zero. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. (Specific values or thresholds for "cyclic migration" are not provided).
Sterilization (EO)	Validated according to ANSI/AAMI/ISO 11135: 2014 to a Sterility Assurance Level (SAL) of 1 x 10^-6.
EO Residuals	Tested per AAMI/ANSI/ISO 10993-7:2008. (Specific results confirming compliance are not provided but implied by stating successful testing).
Non-pyrogenic	Determined to be non-pyrogenic per the requirements set forth in ANSI/AAMI ST-72:2011, United States Pharmacopeia (USP), and European Pharmacopeia (EP) using the bacterial endotoxin testing (BET) method. (Specific results confirming compliance are not provided but implied by stating successful testing).
Biocompatibility (Material)	The PEEK material is identical to that present in the reference device- HEALIX ADVANCE™ KNOTLESS PEEK Anchor (K171114). The Suture Anchor design, anchor materials, principle of operation and indications for use are similar when compared to the predicate Arthrex PushLock Suture Anchors (K101679, K082810, K071177, K061863, K051219). Implied acceptable biocompatibility based on substantial equivalence to previously cleared devices with similar materials.

Details Regarding the Study/Testing:

Sample size used for the test set and the data provenance:
- The 510(k) summary does not specify the exact number of samples (e.g., how many anchors were tested for fixation strength, how many were subjected to cyclic migration). This information would typically be detailed in the full test reports submitted to the FDA, but is summarized here.
- Data Provenance: The device is manufactured by Medos International SARL in Switzerland (CH 2400, Switzerland), though the submitter is DePuy Synthes Mitek in Massachusetts, USA. The testing would have been conducted by the manufacturer or a contracted lab. The studies are non-clinical (benchtop and lab-based), not human subject data. Therefore, concepts like country of origin for data (in a clinical sense) or retrospective/prospective are not directly applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this type of medical device (suture anchor), "ground truth" is established by engineering standards, material specifications, and validated test methods, not by expert interpretation of clinical data in the way one would for an AI diagnostic algorithm. The "experts" involved would be engineers, materials scientists, and quality assurance specialists.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where subjective interpretation is involved. For engineering performance testing, the results are quantitative and objective, based on validated test protocols and measuring equipment.
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 mechanical implant, not an AI diagnostic tool. MRMC studies are used to evaluate diagnostic imaging devices or AI algorithms that assist human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a mechanical implant with no AI component, so there is no algorithm to test in a standalone manner.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical performance tests (fixation strength, torque, migration): The "ground truth" is determined by engineering specifications and validated biomechanical test methods that simulate physiological loads. The objective is to demonstrate that the device meets predefined mechanical thresholds and performance characteristics.
- For sterilization and biocompatibility: The "ground truth" is established by international standards (ISO, AAMI) and regulatory guidelines (USP, EP), which define acceptable levels for sterility, endotoxin, and material safety.
The sample size for the training set:
- Not Applicable. This device does not use machine learning or AI, so there is no "training set."
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

In summary, the HEALIX ADVANCE™ SP PEEK Anchor is a conventional medical device whose substantial equivalence and safety/effectiveness are demonstrated through non-clinical engineering, material, and sterilization testing, not through AI/ML performance studies or clinical reader studies.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

February 26, 2019

Medos International SARL % Elizabeth Messana Regulatory Affairs Specialist II DePuy Synthes Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K182941

Trade/Device Name: HEALIX ADVANCE™ SP PEEK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 16, 2019 Received: January 17, 2019

Dear Ms. Messana:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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,

Laurence D. Coyne -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: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K182941

Device Name

HEALIX ADVANCE™ SP PEEK Anchor

Indications for Use (Describe)

The HEALIX ADVANCE SP PEEK Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:

· Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair

· Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament reconstruction, iliotibial (IT) band tenodesis

· Foot/Ankle: Achilles tendon 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)

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510(K) SUMMARY HEALIX ADVANCE™ SP PEEK Anchor Date Prepared: 1/9/2019

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	Elizabeth MessanaRegulatory Affairs Specialist IIDePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767	Telephone: 508-828-3150Email: emessan1@its.jnj.com
Name of MedicalDevice	Proprietary Name: HEALIX ADVANCE™ SP PEEK AnchorClassification Name: Smooth or threaded metallic bone fixationfastenerProduct Code: MBICommon Name: Suture Anchor
SubstantialEquivalence	The HEALIX ADVANCE SP PEEK Anchor is substantially equivalent to:K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Suture Anchors Reference Devices: K161638, SPEEDTRAP™ Graft Preparation System K171114, HEALIX ADVANCE™ KNOTLESS PEEK Anchor K120824, K090530, Stryker ReelX STT™ Suture Anchor System
Device Classification	HEALIX ADVANCE SP PEEK Anchor is classified as:Fastener, Fixation, Nondegradable, Soft Tissue, classified as Class II, product code MBI, regulated under 21 CFR 888.3040.
Device Panel	Orthopedic Devices
Device Description	The HEALIX ADVANCE SP PEEK Anchor is a two-piece “self-punching” design consisting of a cannulated, threaded anchor and dilator which are permanently implanted into the body. The anchor-dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). During implantation the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The proposed HEALIX ADVANCE SP PEEK Anchor is offered in two sizes, 4.9 mm and 5.5 mm and is molded from Polyetheretherketone (PEEK) material. The HEALIX ADVANCE SP PEEK Anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.
Technological Characteristics	The suture anchor design, anchor materials, principal of operation and indications for use are similar when compared to the predicate Arthrex PushLock Suture Anchors (K101679, K082810, K071177, K061863, K051219).The suture anchor design, anchor materials, principal of operation and indications for use are similar when compared to the reference device- ReelX STTTM Suture Anchor by Stryker Corp. (K120824, K090530).The stay-suture design and material are identical to the winding suture present in the reference device- SPEEDTRAPTM Graft Preparation System (K161638).The PEEK material is identical to that present in the reference device- HEALIX ADVANCETM KNOTLESS PEEK Anchor (K171114).
Indications forUse	The HEALIX ADVANCE SP PEEK Anchor is indicated for use in thefollowing procedures for reattachment of soft tissue to bone:• Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair• Knee: Posterior oblique repair, medial collateral ligament (MCL)reconstruction, lateral collateral ligament reconstruction, iliotibial(IT) band tenodesis• Foot/Ankle: Achilles tendon repair
Non-clinicalTesting	Verification activities were performed on the proposed device and / orits predicates. Performance testing included evaluation of fixationstrength, insertion torque, torque to failure and cyclic migration at timezero.
	Ethylene Oxide Sterilization was validated according toANSI/AAMI/ISO 11135: 2014 to a SAL of 1 x 10-6.
	EO residuals were tested per AAMI/ANSI/ISO 10993-7:2008
	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 SP PEEK Anchor has shown to besubstantially equivalent to the predicate devices under the Federal Food,Drug and Cosmetic Act.

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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.