The Small Size DePuy Mitek Milagro® Interference Screws are indicated as follows: Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. Knee: Medial and lateral collateral ligament repair Shoulder: Proximal bicep tenodesis Elbow: Distal bicep tenodesis

Device Description

The Small Size DePuy Mitek Milagro® Interference Screw is an absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP). The proposed Small Size DePuy Mitek Milagro® Interference Screws are offered in diameters of 5mm and 6mm and lengths of 23mm and 30mm.

AI/ML Overview

The provided text is a 510(k) summary for the DePuy Mitek Milagro® Interference Screws and does not contain information about studies related to software performance, AI, or diagnostic algorithm acceptance criteria. Instead, it describes a medical device, its intended use, and its substantial equivalence to previously cleared predicate devices based on non-clinical (mechanical) testing.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance related to a diagnostic algorithm.
Sample sizes for test sets, data provenance, or expert ground truth establishment.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Ground truth types for diagnostic algorithms.
Training set sample sizes or ground truth establishment for training sets.

The document explicitly states:

"Product Design Verification activities, such as, Insertion Torque, Anchor Pullout (at T=0, 6 and 12 week in-vitro physiological aging), and Torque to Failure were performed on the implant." (Page 2)

"Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate devices." (Page 2)

This indicates that the "study" proving the device meets acceptance criteria was a series of non-clinical mechanical tests to demonstrate substantial equivalence to previously cleared devices, not a study evaluating a diagnostic algorithm or AI performance.

The acceptance criteria for this device are implied to be the successful demonstration of comparable mechanical properties (Insertion Torque, Anchor Pullout, Torque to Failure) to the predicate devices, thereby ensuring comparable safety and effectiveness. The reported "device performance" is that these tests showed substantial equivalence to the predicate devices.

Summary

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103831

Image /page/0/Picture/1 description: The image shows the logo for DePuy Mitek Inc., a Johnson & Johnson company. The logo features the DePuy name in bold, black letters, with a small graphic to the left. Below the name is the text "Mitek Inc. a Johnson & Johnson company" in a smaller font. To the right of the logo is the tagline "never stop moving" in a cursive font.

milagro interference screw PRODUCT: SUBMISSION DATE: 12/29/2010 SUBMISSION TYPE: TRADITIONAL

JUL 2 1 2011 5 I O(k) SUMMARY - DEPUY MITEK MILAGRO® INTERFERENCE SOREWS

SUBMITTER'S NAME AND ADDRESS

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

CONTACT PERSON

Deep Pal Regulatory Affairs Specialist II TELEPHONE 508-828-3359 FACSIMILE 508-977-6911 dpal3@its.jnj.com E-MAIL DATE PREPARED 12/29/2010

NAME OF MEDICAL DEVICE

CLASSIFICATION NAME Fastener, Fixation, Nondegradable, Soft Tissue

COMMON/USUAL NAME

Bone Anchor

PROPRIETARY NAME

DePuy Mitek Milagro® Interference Screws

SUBSTANTIAL EQUIVALENCE

Small Size DePuy Mitek Milagro® Interference Screws are substantially equivalent to the following devices.

K060830 Milagro® Interference Screws
Milagro® Interference Screw/previously known as Biocryl Rapide Interference Screw . K032717
. K051726, K041356, K020043 Arthrex Tenodesis Screw Family

FDA PRODUCT CODE

MAI, HWC

DEVICE CLASSIFICATION

This type of fixation screw was 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.

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|<10383|

DePuy	never stop moving
Mitek Inc.
a Johnson Johnson company

5 I O(k) SUMMRY - DEPUY MITEK MILAGRO® INTERFERENCE SOREWS

DEVICE DESCRIPTION

The proposed Small Size DePuy Mitek Milagro® Interference Screws are offered in diameters of 5mm and 6mm and lengths of 23mm and 30mm.

INDICATIONS FOR USE

The Small Size DePuy Mitek Milagro® Interference Screws are indicated as follows:

ScrewDiameter x Length, mm	Knee: Attachment of abone-tendon-bone (BTB)graft to the tibia and/orfemur during cruciateligament reconstructionprocedures.	Knee: Attachment of asoft tissue (ST) graft tothe tibia and/or femurduring cruciate ligamentreconstructionprocedures.	Knee: Medial and lateralcollateral ligament repair	Shoulder: Proximal biceptenodesis	Elbow:Distalbiceptenodesis
5x23		V	V	V	V
5x30		V
6x23		V	V	V	V
6x30		V
7x23	V	V	V	V	V
7x30	V	V
8x23	V	V	V	V	V
8x30	V	V
9x23	V	V	V	V	V
9x30	V	V
9x35	V	V
10x23	V	V
10x30	V	V
10x35	V	V
11x30	V	V
11x35	V	V
12x30	V	V
12x35	V	V

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K103831
---------

DePuy Logo
Mitek Inc.

a Johnson & Johnson company
never stop moving
MILAGRO INTERFERENCE SCREW PRODUCT: SUBMISSION DATE: 12/29/2010 SUBMISSION TYPE: TRADITIONAL

5 I O(K) SUMMARY - DEPUY MITEK MILAGRO® INTERFERENCE SOREWS

TECHNOLOGICAL CHARACTERSTICS

The design specifications of the proposed Small Size DePuy Mitek Milagro® Interference Screws is substantially equivalent to the existing DePuy Mitek Milagro® Interference Screws cleared under 510(k) K060830, K032717 except that the proposed Small Size DePuy Mitek Milagro® Interference Screws are smaller is diameter. Technological characteristics including design and indications are the same as the predicate cleared device and use similar or identical material and packaging as the predicates.

NONCLINICAL TESTING

Product Design Verification activities, such as, Insertion Torque, Anchor Pullout (at T=0, 6 and 12 week in-vitro physiological aging), and Torque to Failure were performed on the implant.

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 Small Size DePuy Mitek Milagro® Interference Screws have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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

DePuy Mitek, A Johnson & johnson Company % Mr. Deep Pal Regularatory Affairs Specialist II 325 Paramount Drive Raynham, Massachusetts 02767

JUL 2 1 2011

Re: K103831

Trade/Device Name: DePuy Mitek Milagro® Interference Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MAI, HWC Dated: July 14, 2011 Received: July 15, 2011

Dear Mr. 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. Iisting 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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Page 2 - Mr. Deep Pal

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 go to http://www.fda.gov/AboutFDA/CentersOffices/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.

E. 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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Image /page/5/Picture/0 description: The image shows the DePuy Mitek Inc. logo, which is a Johnson & Johnson company. The logo is black and white and includes the words "DePuy" and "Mitek Inc." The image also includes the phrase "never stop moving-" in a smaller font. The logo is simple and professional.

MILAGRO INTERFERENCE SCREW PRODUCT: SUBMISSION DATE: DECEMBER 29™, 2010 รมหาวิราชิก TYPE: โชคติเมื่อปี

ATTACHMENT 2

INDICATIONS FOR USE

K103831 510(k) Number (if known): ____

Device Names: DePuy Mitek Milagro® Interference Screws

Indications for Use: The Small Size DePuy Mitek Milagro® Interference Screws are indicated as follows:

ScrewDiameter x Length, mm	Knee: Attachment of abone-tendon-bone (BTB)graft to the tibia and/orfemur during cruciateligament reconstructionprocedures.	Knee: Attachment of asoft tissue (ST) graft tothe tibia and/or femurduring cruciate ligamentreconstructionprocedures.	Knee: Medial and lateralcollateral ligament repair	Shoulder: Proximal biceptenodesis	bicep
5x23		V	V	V	V
5x30		V
6x23		V	V	V	V
6x30		V
7x23	V	V	V	V	V
7x30	V	V
8x23	V	V	V	V	V
8x30	V	V
9x23	V	V	V	V	V
9x30	V	V
9x35	V	V
10x23	V	V
10x30	V	V
10x35	V	V
11x30	V	V
11x35	V	V
12x30	V	V
12x35	V	V

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)

Signature

(Division Sign-Off)	Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Surgical, Orthopedic, and Restorative Devices	Page 1 of 1

510(k) Number <103831

54 age

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.