The proposed Healix Advance Knotless 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 anchors will be offered in a 6.5 mm size. The proposed 6.5 mm Healix Advance Knotless BR Anchor is manufactured from "biocryl rapide" material.

AI/ML Overview

The provided document does not describe the acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML device.

Instead, this document is a 510(k) summary for a medical device called the "HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5mm)". It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the performance of an AI/ML algorithm against predefined acceptance criteria.

The device in question is a physical bone anchor for soft tissue reattachment, not an AI/ML diagnostic or treatment planning system. Therefore, most of the requested information (like sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this type of medical device submission.

Here's the relevant information that can be extracted, framed within the context of a traditional medical device submission for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are tied to demonstrating that the new device (6.5mm anchor) performs similarly from a safety and effectiveness perspective to the predicate devices (4.75mm and 5.5mm anchors). The "reported device performance" are the results of non-clinical bench testing.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Device performance is comparable to predicate devices in terms of mechanical properties	Product Design Verification and Design Validation activities, such as: - Insertion Torque tests - Torque to Failure tests - Anchor Pullout tests Results demonstrated that the proposed device is substantially equivalent to the predicate devices regarding performance and safety. (Specific numerical values or thresholds are not provided in this summary but would be in the full submission).
No new technological characteristics are introduced that would raise new safety/effectiveness concerns.	The proposed 6.5mm anchor has the same design principles and is manufactured from the same "biocryl rapide" material as the predicate 4.75mm and 5.5mm anchors. The only change is size.

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

Test Set Sample Size: Not explicitly stated as this is non-clinical bench testing. The "test set" would refer to the number of anchors or test specimens used for the mechanical tests (Insertion Torque, Torque to Failure, Anchor Pullout).
Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" comes from laboratory bench testing.

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

Not applicable. Ground truth in this context is determined by validated engineering test methods and measurements, not expert clinical interpretation.

4. Adjudication method for the test set

Not applicable. This is not a clinical study involving human readers.

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

Not applicable. This device is not an AI/ML system.

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

Not applicable. This device is not an AI/ML system.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by validated engineering standards and measurement equipment for mechanical properties (e.g., torque, force).

8. The sample size for the training set

Not applicable. This device is not an AI/ML system.

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

Not applicable. This device is not an AI/ML system.

Summary

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K131974 (1/2)

	never stop moving •
Mitek Inca Johnson&Johnson company

PRODUCT: HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5mm) SUBMISSION DATE: June 27, 2013 SUBMISSION TYPE: SPECIAL

510(k) SUMMARY

JUL 2 5 2013

Submitter:	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Kristine ChristoManager, Regulatory AffairsDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3359Facsimile: 508-977-6911e-mail: kchristo@its.jnj.com
Date Prepared	June 27, 2013
Name of MedicalDevice	Proprietary Name: HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5mm)Classification Name: Fastener, Fixation, Biodegradable, Soft tissueCommon Name: Bone Anchor
SubstantialEquivalence	The HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5mm) is substantially equivalent to:• K130917 Mitek Healix Advance Knotless BR Anchor (4.75 and 5.5mm)
DeviceClassification	Single/multiple component metallic bone fixation appliances and accessories, classified as a ClassII device, regulated under 21 CFR 888.3030, product code MAI.
DeviceDescription	The proposed Healix Advance Knotless Anchor is a one piece implantable cannulated, threadedanchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposableinserter driver device. The proposed anchors will be offered in a 6.5 mm size. The proposed 6.5mm Healix Advance Knotless BR Anchor is manufactured from "biocryl rapide" material.
Indications forUse	The Healix Advance Knotless Anchors are indicated for use in the following procedures forreattachment of soft tissue to bone:Shoulder• Rotator Cuff• Biceps Tenodesis

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K131974 (2/2)

DePuyMitek Inc.never stop moving	PRODUCT: HEALIX ADVANCE KNOTLESSBR ANCHOR (6.5mm)SUBMISSION DATE: June 27, 2013SUBMISSION TYPE: SPECIAL
------------------------------------------	---------------------------------------------------------------------------------------------------------------------

Comparison ofTechnologicalCharacteristics	The proposed Healix Advance Knotless BR Anchors will have the same design as compared to thepredicate devices (4.75mm and 5.5mm) but will be larger in size (6.5mm). Both the proposedand predicate Healix Advance Knotless BR Anchors are molded from the same BR "biocrylrapide" material. No new technological characteristics were introduces as a result of the proposedchanges.
Safety andPerformance	Non-clinical TestingProduct Design Verification and Design Validation activities, such as, Insertion Torque, Torque toFailure and Anchor Pullout were performed on the proposed implant device. Results ofperformance and safety testing have demonstrated that the proposed device is substantiallyequivalent to the predicate devices.Based on the indications for use, technological characteristics, and comparison to predicatedevices, the proposed 6.5mm Healix Advance Knotless Anchors have been shown to besubstantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

Comparison ofTechnologicalCharacteristics

The proposed Healix Advance Knotless BR Anchors will have the same design as compared to thepredicate devices (4.75mm and 5.5mm) but will be larger in size (6.5mm). Both the proposedand predicate Healix Advance Knotless BR Anchors are molded from the same BR "biocrylrapide" material. No new technological characteristics were introduces as a result of the proposedchanges.

Safety andPerformance

Non-clinical TestingProduct Design Verification and Design Validation activities, such as, Insertion Torque, Torque toFailure and Anchor Pullout were performed on the proposed implant device. Results ofperformance and safety testing have demonstrated that the proposed device is substantiallyequivalent to the predicate devices.Based on the indications for use, technological characteristics, and comparison to predicatedevices, the proposed 6.5mm Healix Advance Knotless Anchors have been shown to besubstantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

DePuy Mitek, Incorporated % Ms. Kristine Christo Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767 July 25, 2013

Re: K131974

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: June 27, 2013 Received: June 28, 2013

Dear Ms. Christo:

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

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Page 2 - Ms. Kristine Christo

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Salcty/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): K131974

Device Names: Healix Advance Knotless BR Anchor

Indications for Use: The Healix Advance Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder

. Rotator Cuff
Biceps Tenodesis .

ಳ Prescription Use

AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

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.