The proposed DePuy Mitek's Healix Knotless™ PEEK 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 one size. The proposed DePuy Mitek's Healix Knotless™ Anchor is molded with PEEK (Polyetheretherketone) material.
The proposed DePuy Mitek's Healix Knotless™ PEEK Anchor will be provided in one size with outer diameter of 4.75mm.

AI/ML Overview

The provided text is a 510(k) summary for the DePuy Mitek's Healix Knotless™ PEEK Anchor. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials with detailed performance criteria.

Therefore, much of the requested information (such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) is not applicable or not provided in this type of regulatory submission.

The document emphasizes nonclinical testing to demonstrate that the proposed device performs comparably to its predicate devices in terms of mechanical properties.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the sense of predefined thresholds for clinical or diagnostic performance metrics. Instead, "performance" is assessed through a comparison to predicate devices, indicating that the new device should function at least as well as the established devices in key mechanical properties.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Insertion Torque	Comparable to predicate devices	Performed during "Product Design Verification and Design Validation activities." Results "demonstrated that the proposed device is substantially equivalent to the predicate devices."
Anchor Pullout (at T=0)	Comparable to predicate devices	Performed during "Product Design Verification and Design Validation activities." Results "demonstrated that the proposed device is substantially equivalent to the predicate devices."
Torque to Failure	Comparable to predicate devices	Performed during "Product Design Verification and Design Validation activities." Results "demonstrated that the proposed device is substantially equivalent to the predicate devices."

Note: The phrase "substantially equivalent" is the primary acceptance criterion in this context, meaning the new device performs as safely and effectively as a legally marketed predicate device.

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

Sample Size for Test Set: Not specified. The nonclinical testing performed (Insertion Torque, Anchor Pullout, Torque to Failure) would typically involve a certain number of device samples, but the exact count is not detailed in this summary.
Data Provenance: Not applicable in the context of clinical data. The nonclinical tests are laboratory-based mechanical tests performed on the device itself.

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

Number of Experts: Not applicable. These are mechanical tests, not assessments requiring expert interpretation of clinical data.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This is not a study requiring human adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices involving human readers, which is not relevant for a surgical anchor.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (surgical anchor), not an algorithm or AI system.

7. The Type of Ground Truth Used

Ground Truth: For nonclinical testing, the "ground truth" would be the directly measured physical properties (e.g., torque values, force required for pullout) of the device and its predicate counterparts, assessed against engineering specifications. There is no biological "ground truth" in this context.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

Summary

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HEALIX KNOTLESS™ PEEK ANCHOR PRODUCT: SUBMISSION DATE: NOVEMBER 28", 2011 SUBMISSION LABE: SPECIAL

ATTACHMENT 1

Continues ...

5 I O(k) SUMMARY - Healix KnotlerJ™ Anchor

DEVICE DESCRIPTION

The proposed DePuy Mitek's Healix Knotless™ PEEK Anchor will be provided in one size with outer diameter of 4.75mm.

INDICATIONS FOR USE

The Healix Knotless™ Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder

. Rotator Cuff
Biceps Tenodesis ●

TECHNOLOGICAL CHARACTERSTICS

The technological characteristics in terms of product design and performance specification; the . proposed DePuy Mitek's Healix Knotless™ PEEK Anchor is substantially equivalent to the predicate DePuy Mitek's Healix Knotless™ BR Anchor, DePuy Mitek's Gryphon PEEK Anchor (K103712) and Arthrex PushLock Anchor (K061863).
The technological characteristics as it relate to the product design, material specifications, . packaging, indications for use and sterilization method; the proposed Healix Knotless™ Anchor is substantially equivalent to the predicate devices.

The PEEK material utilized in the construct of the proposed device is identical utilized in manufacturing of currently marketed DePuy Mitek's Gryphon PEEK Anchors (K103712).

NONCLINICAL TESTING

Product Design Verification and Design Validation activities, such as, Insertion Torque, Anchor Pullout (at T=0), and Torque to Failure were performed on the proposed implant device.

SAFETY AND PERFORMANCE

Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate devices.

Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed DePuy Mitek's Healix Knotless™ PEEK Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Image /page/1/Picture/1 description: The image shows the DePuy Mitek Inc. logo with the tagline "never stop moving". The logo is black and white and features the DePuy name in a bold, sans-serif font. Below the name is the text "Mitek Inc." and "a Johnson & Johnson company" in a smaller font. The tagline is in a cursive font and is located to the right of the logo.

PRODUCT: HEALIX KNOTLESS™ PEEK ANCHOR SUBMISSION DATE: NOVEMBER 28™, 2011 SUBMISSION TYPE: SPECIAL ---------

ATTACHMENT 1

5 I O(k) SUMMARY - Healix Knotlers™ Anchor

SUBMITTER'S NAME AND ADDRESS

DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767

CONTACT PERSON

Deep Pal Senior Regulatory Affairs Specialist TELEPHONE 508-828-3359

	508-628-5555
FACSIMILE	508-977-6911
E-MAIL	dpal3@its.jnj.com
DATE PREPARED	November 10th, 2011

NAME OF MEDICAL DEVICE

COMMON/USUAL NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Suture Anchor

TRADE NAME/PROPRIETARY NAME - NAME - NAME - NAME - SE MA Healix Knotless™ PEEK Anchor

SUBSTANTIAL EQUIVALENCE

The proposed Healix Knotless™ Anchor is substantially equivalent to the following devices.

· K112249 DePuy Mitek's Healix Knotless™ BR Anchor
· K103712 DePuy Mitek's Gryphon PEEK Anchor
· KO61863 Arthrex PushLock Anchors

FDA PRODUCT CODE

MAI, HWC

DEVICE CLASSIFICATION

These types of Anchor devices were originally classified as a Class II medical device by the Orthopedic Review Panel; regulated as 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener.

FDA PRODUCT CODE: MAI, HWC

COMMON CLASSIFICATION NAME: Screw, Fixation, Bone

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Image /page/2/Picture/1 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 an abstract image of an eagle or bird-like figure, with stylized lines representing its wings and body.

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

DePuy Mitek, Incorporated a Johnson & Johnson Company % Deep Pal Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767

DEC 2 0 2011

Re: K113534

Trade/Device Name: Healix Knotless™ PEEK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MAI, HWC Dated: November 28, 2011 Received: November 30, 2011

Dear Deep Pal:

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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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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 vours.

Erine Keith

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

Enclosure

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K113534 (111)

PRODUCT:	HEALIX KNOTLESS PEEK ANCHOR
SUBMISSION DATE:	NOVEMBER 28 TH , 2011
SUBMISSION TYPE:	SPECIAL

ATTACHMENT 2

INDICATIONS FOR USE

510(k) Number (if known):	K113534
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Device Names: Healix Knotless
TM PEEK Anchor

Indications for Use: The Healix Knotless
TM Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder

Rotator Cuff
Biceps Tenodesis

Prescription Use		AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____

for Mark Melkerson

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number	K113534
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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.