The MILAGRO® ADVANCE PEEK Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.

Additionally, the 7, 8 and 9 mm x 23 mm screws are indicated for: medial and lateral ligament repar , medial patellofemoral ligament reconstruction) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Device Description

The MILAGRO® ADVANCE PEEK Interference Screw is a non-absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon-bone grafts. The Interference Screw is made from Polyetheretherkeytone (PEEK). The MILAGRO® ADVANCE PEEK Interference Screw is provided sterile and is for single patient use only.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the MILAGRO® ADVANCE PEEK Interference Screw. It establishes substantial equivalence to predicate devices and describes the device's intended use and technological characteristics.

Here's an analysis of the provided text in the context of device acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Verification activities were performed on the implant and / or its predicate. Testing assessments include pull out testing, and insertion / failure torque." and "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." It also states, "The proposed device also met requirement of bacterial endotoxin testing."

However, the specific quantitative acceptance criteria (e.g., minimum pull-out strength, maximum insertion/failure torque) and the exact reported device performance values are not explicitly stated in the provided text. The document broadly states the device "met requirement" and "demonstrated suitability."

Therefore, a table with specific numerical criteria and performance cannot be generated from this text alone.

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

The document mentions "Verification activities were performed on the implant and / or its predicate." There is no information provided regarding:

The specific sample size used for the pull-out, insertion/failure torque, or bacterial endotoxin testing.
The data provenance (e.g., country of origin, retrospective or prospective) of any testing data.

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

This information is not applicable to the type of device and study described. This document pertains to a medical device (an interference screw) and its mechanical and biological performance, not a diagnostic algorithm or imaging study that would require expert-established ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

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 relevant for diagnostic performance of algorithms where human readers' performance is compared and enhanced. This document describes the mechanical and biological performance of an orthopedic implant.

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

No, a standalone study in the context of an algorithm's performance was not done. This is a medical device approval, not an AI/algorithm submission. The device itself is the "standalone" product being evaluated for its physical and biological properties.

7. The Type of Ground Truth Used:

For the tests mentioned (pull-out, insertion/failure torque, bacterial endotoxin):

Pull-out Testing and Insertion/Failure Torque: The "ground truth" would be established by the physical properties and mechanical engineering standards relevant to such implants. This is determined through standardized laboratory testing procedures where forces and torques are measured against predefined engineering specifications for strength and durability.
Bacterial Endotoxin Testing: The "ground truth" is established by biological safety standards and validated laboratory assays that detect and quantify endotoxins. The "met requirement" implies compliance with established safety thresholds.

8. The Sample Size for the Training Set:

This information is not applicable. The device is an orthopedic implant, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reasons as point 8.

In summary, the provided document focuses on establishing substantial equivalence for a medical implant based on its design, materials, and mechanical/biological performance, rather than the performance of a diagnostic algorithm or AI system. Therefore, many of the requested points related to AI/algorithm studies (like expert ground truth, adjudication, MRMC studies, training sets) are not relevant to this specific FDA submission. The document broadly states that performance testing was conducted, and results indicated suitability, but the specific quantitative criteria and results are not detailed.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of a stylized design of three human profiles facing right, with flowing lines beneath them, resembling a bird or abstract form.

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

June 9, 2016

Medos International SARL % Ms. Kristine Christo Director, Regulatory Affairs Depuy Mitek Inc., a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K161001

Trade/Device Name: MILAGRO® ADVANCE PEEK Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: MBI Dated: April 7, 2016 Received: April 11, 2016

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 Parts 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 (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" (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 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 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) K161001

Device Name

MILAGRO® ADVANCE PEEK Interference Screw

Indications for Use (Describe)

The MILAGRO® ADVANCE PEEK Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.

Type of Use (Select one or both, as applicable)

X 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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SECTION 2 - 510(k) SUMMARY

MILAGRO® ADVANCE PEEK Interference Screw

Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Date Prepared: March 25, 2016
Contact Person	Kristine ChristoDirector, Regulatory AffairsDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3359Facsimile: 508-977-6911e-mail: kchristo@its.jnj.com
Name ofMedical Device	Proprietary Name: MILAGRO® ADVANCE PEEK Interference ScrewClassification Name: Smooth or threaded metallic bone fixation fastenersCommon Name: Fastener, fixation, nondegradable, soft tissue
SubstantialEquivalence	The MILAGRO® ADVANCE PEEK Interference Screw is substantially equivalent to:■ K123362, K143660, MILAGRO ADVANCE™ Interference ScrewReference device:■ K130539 Healix Advance™ Knotless PEEK Anchor
DeviceClassification	Smooth or threaded metallic bone fixation fastener, classified as Class II,product code MBI, regulated under 21 CFR 888.3040.
DeviceDescription	The MILAGRO® ADVANCE PEEK Interference Screw is a non-absorbable, tapered,cannulated, threaded fastener for use in interference fixation of soft tissue grafts orbone-tendon-bone grafts. The Interference Screw is made from Polyetheretherkeytone(PEEK). The MILAGRO® ADVANCE PEEK Interference Screw is provided sterileand is for single patient use only.
TechnologicalCharacteristics	The proposed MILAGRO® ADVANCE PEEK Interference Screw is similar to thepredicate MILAGRO ADVANCE™ Interference Screw (K123362, K143660) in thatthey share the same indication for use, screw design, sterilization method, and shelflife. The proposed MILAGRO® ADVANCE PEEK Interference Screw is similar to thereference device, Healix Advance™ Knotless PEEK Anchor (K130539), in that theyshare the same PEEK material.
Indications forUse	The MILAGRO® ADVANCE PEEK Interference Screw is intended for attachment ofsoft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciateligament reconstruction procedures.
	Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for: medial andlateral collateral ligament repair, medial patellofemoral ligament reconstruction (femurfixation) of the knee, proximal bicep tenodesis in the shoulder and distal biceptenodesis in the elbow.
Non clinicalTesting	Verification activities were performed on the implant and / or its predicate. Testingassessments include pull out testing, and insertion / failure torque.
Safety andPerformance	Results of performance testing have demonstrated that the proposed devices aresuitable for their intended use.
	The proposed device also met requirement of bacterial endotoxin testing.
	Based on similarities in the indications for use, technological characteristics, andperformance in comparison to the predicate devices, the proposed MILAGRO®ADVANCE PEEK Interference Screw has shown to be substantially equivalent to thepredicate device 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.