The MILAGRO ADVANCE 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 will be indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Device Description

The MILAGRO ADVANCE 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 MILAGRO ADVANCE Interference Screw is provided sterile and is for single patient use only.

AI/ML Overview

Here's an analysis of the provided text regarding the MILAGRO ADVANCE Interference Screw, focusing on acceptance criteria and the study conducted.

It's important to note that the provided documents are a 510(k) summary and FDA clearance letter, which typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria in the way one might see for a novel drug or a high-risk device. Therefore, some of the requested information, particularly regarding detailed statistical analysis, specific sample sizes for clinical trials, and multi-reader studies, might not be explicitly present or applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functional Equivalence	Screw fixation strength (at time zero and throughout the healing period in in vitro testing) must be similar to predicate screws or meet established acceptance criteria.	"Results of the testing have demonstrated that the proposed screws are suitable for the intended use." (Implies similarity to predicate or meeting criteria, but specific numerical results or direct comparisons are not provided in this summary document.)
Mechanical Integrity	Screw torque testing must confirm no issue for screw insertion into the bone.	"Results of the testing have demonstrated that the proposed screws are suitable for the intended use." (Implies successful torque testing, but specific numerical results or direct comparisons are not provided in this summary document.)
Substantial Equivalence	Based on indications for use, technological characteristics, and comparison to predicate devices (K060830: MILAGRO Interference Screw; K032717: Biocryl Rapide Interference Screw), the proposed device must be shown to be substantially equivalent under the Federal Food, Drug, and Cosmetic Act.	The FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
Biocompatibility	The device, being made from an absorbable composite of Poly(lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP), is expected to be biocompatible, though specific acceptance criteria for biocompatibility testing are not detailed in this summary. (This would typically involve ISO biocompatibility standards.)	Not explicitly stated in the provided text, but implied by regulatory approval as biocompatibility is a standard requirement for implantable devices. The use of established polymers and TCP would usually leverage prior knowledge of these materials' biocompatibility.
Sterility	The device must be provided sterile and for single patient use only.	"The MILAGRO ADVANCE Interference Screw is provided sterile and is for single patient use only." (This describes the product's state rather than a performance test result, but implicitly confirms it meets sterility requirements.)

Study Details

Due to the nature of a 510(k) summary for a device demonstrating substantial equivalence, the "study" described is primarily non-clinical performance testing rather than a full-scale clinical trial.

Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated. The document mentions "screw fixation strength testing" and "screw torque testing," which are typically benchtop mechanical tests performed on a specific number of devices. The exact number of screws or test conditions used is not detailed in this summary.
- Data provenance: Non-clinical (benchtop/laboratory) testing. No information on country of origin for this specific testing is provided, but it would typically be conducted by the manufacturer or a contract research organization. The study is described as "non-clinical testing," which implies it is prospective in nature for the purpose of this submission. There is no mention of human clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. "Ground truth" established by experts (e.g., radiologists, pathologists) is relevant for diagnostic devices or those involving image interpretation. For a mechanical orthopedic implant, "ground truth" is established by engineering specifications, material properties, and mechanical testing standards. The "experts" involved would be engineers, material scientists, and quality assurance personnel.
Adjudication method for the test set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are used when interpreting subjective data (e.g., radiology scans) where multiple readers disagree. For objective mechanical tests like strength and torque, data is quantitative and ideally directly measurable against a defined specification.
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:
- No. This type of study (MRMC, AI assistance) is for diagnostic or AI-enabled devices, which the MILAGRO ADVANCE Interference Screw is not. This device is a mechanical implant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This question pertains to AI algorithms. The device is a mechanical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing described, the "ground truth" would be based on engineering specifications, established biomechanical performance standards, and comparison to the predicate device's known performance characteristics. This is primarily mechanical property data and performance specifications.
The sample size for the training set:
- Not applicable. This question typically refers to machine learning algorithms. For mechanical devices, there isn't a "training set" in the computational sense. Development might involve iterative design and testing, but it's not analogous to an AI training set.
How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" in the AI sense for this device. The design and validation are based on engineering principles, material science, and established biomechanical testing methods.

Summary

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K123362 (page 1 of 2)

SECTION 2 - 510(k) SUMMARY

MILAGRO ADVANCE Interference Screw

Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Yayoi FujimakiRegulatory Affairs Senior AssociateDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3541Facsimile: 508-977-6911e-mail: yfujimal@its.jnj.com
Name ofMedical Device	MILAGRO ADVANCE Interference ScrewProprietary Name:Classification Name: Smooth or threaded metallic bone fixation fastenerCommon Name: fastener, fixation, biodegradable, soft tissue
SubstantialEquivalenceFacility	The MILAGRO ADVANCE Interference Screw is substantially equivalent to:K060830: MILAGRO Interference ScrewK032717: Biocryl Rapide Interference Screw
DeviceClassification	HWC - Smooth or threaded metallic bone fixation fastener, classified as Class II,regulated under 21 CFR 888.3040MAI - Single/multiple component metallic bone fixation appliances and accessories,classified as Class II, regulated under 21 CFR 888.3030.

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K123362 (Page 2 of 2)

DeviceDescription	The MILAGRO ADVANCE Interference Screw is an absorbable, tapered, cannulated,threaded fastener for use in interference fixation of soft tissue grafts or bone-tendongrafts. The Interference Screw is made from a composite made of absorbable Poly(lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP).The MILAGRO ADVANCE Interference Screw is provided sterile and is for singlepatient use only.
Indications forUse	The MILAGRO ADVANCE Interference Screw is intended for attachment of softtissue 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 of the knee, proximal bicep tenodesis in the shoulderand distal bicep tenodesis in the elbow.
Safety andPerformance	Non-clinical TestingScrew fixation strength testing (at time zero and in vitro testing throughout healing.period) was performed to confirm that the proposed screws perform similarly to thepredicate screws or meet the acceptance criteria. Screw torque testing was performedto confirm that there is no issue for screw insertion into the bone. Results of the testinghave demonstrated that the proposed screws are suitable for the intended use.Based on the indications for use, technological characteristics, and comparison to thepredicate devices, the proposed MILAGRO ADVANCE Interference Screw has beenshown to be substantially equivalent to the predicate device under the Federal Food,Drug and Cosmetic Act.

DeviceDescription

The MILAGRO ADVANCE Interference Screw is an absorbable, tapered, cannulated,threaded fastener for use in interference fixation of soft tissue grafts or bone-tendongrafts. The Interference Screw is made from a composite made of absorbable Poly(lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP).The MILAGRO ADVANCE Interference Screw is provided sterile and is for singlepatient use only.

Indications forUse

The MILAGRO ADVANCE Interference Screw is intended for attachment of softtissue 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 of the knee, proximal bicep tenodesis in the shoulderand distal bicep tenodesis in the elbow.

Safety andPerformance

Non-clinical TestingScrew fixation strength testing (at time zero and in vitro testing throughout healing.period) was performed to confirm that the proposed screws perform similarly to thepredicate screws or meet the acceptance criteria. Screw torque testing was performedto confirm that there is no issue for screw insertion into the bone. Results of the testinghave demonstrated that the proposed screws are suitable for the intended use.Based on the indications for use, technological characteristics, and comparison to thepredicate devices, the proposed MILAGRO ADVANCE Interference Screw has beenshown to be substantially equivalent to the predicate device under the Federal Food,Drug and Cosmetic Act.

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.

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, a Johnson and Johnson Company % Yayoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, Massachusetts 02767

Letter dated: February 1, 2013

Re: K123362

Trade/Device Name: MILAGRO ADVANCE Interference Screw . Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MAI Dated: January 8, 2013 Received: January 11, 2013 ·

Dear Yayoi Fujimaki:

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 – Yayoi Fujimaki

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/CDRH0ffices/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 yours.

Mark N. Melkerson

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): K123362

Device Name: MILAGRO ADVANCE Interference Screw

Indications for Use:

The MILAGRO ADVANCE 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 will be indicated for: medial and lateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices 2013.02.01 14:22:01 -05'00'

Page 1 of 1

Premarket Notification: Traditional MILAGRO ADVANC Interference Screw

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.