The Milagro® BR interference screws are designed to attach soft tissues to bone in orthopedic surgical procedures. The screws may be used for interference fixation of soft tissues (such as ligaments or tendons) to bone, when the implant sizes offered are patient appropriate. The implant operates, in conjunction with the appropriate postoperative immobilization, throughout the healing period.

Device Description

The DePuy Mitek Milagro® Interference Screws are absorbable, tapered, cannulated, threaded fasteners 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).

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (Milagro® Interference Screws) seeking substantial equivalence to predicate devices. It focuses on demonstrating that the new device shares similar technological characteristics and performance to already legally marketed devices. As such, it does not involve the typical assessment of a new diagnostic algorithm or AI system, which would require the specific details outlined in your request.

Therefore, many of the requested items (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance of an algorithm, ground truth methods for AI training) are not applicable to this type of submission.

However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its performance relative to its predicates.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly state "acceptance criteria" in the same way a diagnostic algorithm's F1 score or AUC would be presented. Instead, its acceptance is based on demonstrating "substantial equivalence" through nonclinical testing. The "acceptance criteria" can be inferred as meeting the performance levels demonstrated by the predicate devices or demonstrating acceptable mechanical performance for the intended use.

Acceptance Criteria (Inferred from "Substantial Equivalence")	Reported Device Performance
Comparable Insertion Torque to predicate devices.	Performed. Results "demonstrated that the proposed device is substantially equivalent to the predicate devices." (Specific torque values are not disclosed in this summary but would have been part of the full 510(k) submission).
Comparable Anchor Pullout (at T=0, 3, 6, and 12 weeks in-vitro physiological aging) to predicate devices.	Performed. Results "demonstrated that the proposed device is substantially equivalent to the predicate devices." (Specific pullout resistance values over time are not disclosed but would have been part of the full 510(k) submission).
Comparable Torque to Failure to predicate devices.	Performed. Results "demonstrated that the proposed device is substantially equivalent to the predicate devices." (Specific torque to failure values are not disclosed but would have been part of the full 510(k) submission).
Similar Technological Characteristics (design construct, packaging, indications, material).	"Technological characteristics including design construct, packaging and indications are similar to the predicate devices and use similar or identical material and packaging as the predicates." The new devices are absorbable, tapered, cannulated, threaded fasteners made from Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP).
Safe and Effective for Indications for Use.	"Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate devices." The device is designed to attach soft tissues (ligaments or tendons) to bone in orthopedic surgical procedures through interference fixation.

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

Sample Size: Not specified in the provided summary. Nonclinical testing typically involves a set number of physical samples (e.g., screws) tested under laboratory conditions.
Data Provenance: Not applicable in terms of human patient data. The tests are "in-vitro physiological aging" and mechanical tests on the physical devices. This is not retrospective or prospective human clinical data.

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

Not Applicable. This document describes the mechanical testing of a medical device, not a diagnostic algorithm that requires expert-established ground truth.

4. Adjudication Method for the Test Set

Not Applicable. No human-based adjudication is mentioned for these nonclinical, mechanical tests.

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

No. This type of study is relevant for diagnostic imaging or interpretation systems with human readers, not for the mechanical performance of a physical interference screw.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not Applicable. For mechanical tests, the "ground truth" is typically the measured physical properties based on standardized testing methods, comparing against established benchmarks or predicate device performance. It doesn't involve expert consensus, pathology, or outcomes data in the way a diagnostic study would.

8. The Sample Size for the Training Set

Not Applicable. As this is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.

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

Not Applicable. Same as above.

In summary:

This 510(k) summary is designed to demonstrate "substantial equivalence" of a new version of an interference screw to existing, legally marketed devices. The "study" involves nonclinical, mechanical, and material characteristic tests to show that the new device performs similarly and is as safe and effective as its predicates. It does not involve human subjects, imaging interpretation, or AI algorithms, which are the contexts where most of your specific questions would apply.

Summary

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APR 24 2012 K (20589(1/2)

Image /page/0/Picture/1 description: The image shows the DePuy Synthes logo. The logo consists of a black circle with the word "DePuy" in bold, black letters next to it. Below the word "DePuy" are the words "Synthes" in smaller, black letters. The tagline "never stop moving" is to the right of the logo.

MILAGRO INTERFERENCE SCREWS SUBMISSION DATE: FEBRUARY 27™, 2012 SUBMISSION TYPE: TRADITIONAL STORIO BOOK BIA

ATTACHMENT 1

5 I 0(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
Senior Regulatory Affairs Specialist
TELEPHONE	508-977-3998
FACSIMILE	508-977-6911
E-MAILDATE PREPARED	dpal3@its.jnj.com02/17/2012

NAME OF MEDICAL DEVICE

CLASSIFICATION NAME	Comments of the contraction of contribution of contribution and consistence and controllation and consistence and controllation and more consection of contribution of the con
Fastener, Fixation, Biodegradable, Soft Tissue

of the controller of the program and any and a province of the comments of COMMON/USUAL NAME

Bone Anchor

PROPRIETARY NAME

DePuy Mitek Milagro® Interference Screws

SUBSTANTIAL EQUIVALENCE

The proposed DePuy Mitek Milagro® Interference Screws are substantially equivalent to the following devices.

· K103831, K060830, K032717: Milagro Interference Screws
· K051726, K041356, K020043: Arthrex Tenodesis Screws
· K102410: Linvatec's Matryx Screws

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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Image /page/1/Figure/1 description: The image shows the DePuy Synthes logo. The logo includes the company name, "DePuy," in a bold, sans-serif font, with a black circle to the left of the name. Below the name, there is the text "Mitek Inc." and a tagline that reads "never stop moving." The logo is positioned in the upper-left corner of the image.

MILAGRO INTERFERENCE SCREWS ISSION DATE: FEBRUARY 27 MISSION TYPE: TRADITIONA

ATTACHMENT 1

Continues ...

5 I 0(k) SUMMRY - DEPUY MITEK MILAGRO® INTERFERENCE SCREWS

DEVICE DESCRIPTION

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERSTICS

The design specifications of the proposed DePuy Mitek Millagro® Interference Screws are substantially equivalent to the existing DePuy Mitek Milagro® Interference Screws cleared under 510(k) K103831, K060830 and K032717. Technological characteristics including design construct, packaging and indications are similar to the predicate devices 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, 3, 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in black. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

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

APR 2 4 2012

Re: K120589

Trade/Device Name: 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: February 27, 2012 Received: February 28, 2012

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, 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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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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ely yours,

For Dothm

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/4/Picture/1 description: The image shows the DePuy Synthes logo. The logo features the company name in bold, black letters, with a black circle to the left of the name. Below the name is the tagline "never stop moving" in a smaller, italicized font.

PRODUCT: -MILAGRO INTERFERENCE SCREWS SUBMISSION DATE: FEBRUARY 27™, 2012 SUBMISSION TYPE: TRADITIONAL

ATTACHMENT 2

INDICATIONS FOR USE

510(k) Number (if known):

Device Names: Milagro® Interference Screws

Indications for Use: The Milagro® BR interference screws are designed to attach soft tissues to bone in orthopedic surgical procedures. The screws may be used for interference fixation of soft tissues (such as ligaments or tendons) to bone, when the implant sizes offered are patient appropriate. The implant operates, in conjunction with the appropriate postoperative immobilization, throughout the healing period.

Over-The-Counter Use AND/OR Prescription Use V (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

(Division Sig Division of Surgical. Orthopedic. and Restorative Devices

510(k) Number K120589

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.