The purpose of this submission is to request clearance for the new A.L.P.S Clavicle Plating System. The A.L.P.S Clavicle Plating System implants are designed to address fractures of the clavicle. The system is comprised of plates and instruments to facilitate the installation of the implants. The plates are manufactured from Titanium Alloy per ASTM F136. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

AI/ML Overview

This document is an FDA 510(k) summary for the A.L.P.S. Clavicle Plating System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the manner requested for AI/ML devices. Therefore, a direct answer to the prompt's structured questions is not possible from the provided text.

However, I can extract information related to the device's performance justification from a regulatory perspective:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance in the context of an AI/ML algorithm. Instead, it relies on demonstrating substantial equivalence to a predicate device based on common characteristics and non-clinical testing.

Acceptance Criteria (from a regulatory standpoint for substantial equivalence)	Reported Device Performance
Intended Use: Similar to predicate device (K083843)	Met: The intended use of the A.L.P.S. Clavicle Plating System is "similar to the intended use cleared in K083843."
Indications for Use: Similar to predicate device (K083843)	Met: The indications for use are "similar to the indications for use cleared in K083843." Indicated for "fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone."
Materials: Manufactured from a commonly used implant grade titanium alloy (ASTM F136)	Met: Plates are manufactured from Titanium Alloy (per ASTM F136).
Design Features: Similar to currently marketed devices (K083843), with no identified issues impacting safety/effectiveness.	Met: "Design features for new A.L.P.S. Clavicle Plating System is similar to those in currently marketed devices cleared in K083843." "The design differences have not identified any issues that would impact the safety and effectiveness of the device."
Sterilization: Offered non-sterile, requiring steam sterilization by the user, similar to predicate device.	Met: Implants and instruments are offered in non-sterile configuration, similar to predicate devices currently marketed and cleared via K083843.
Non-Clinical Performance: Demonstrate safety and effectiveness through mechanical testing.	Met: "Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised." Specifically, the following tests were conducted: - Construct Static Testing - Galvanic Corrosion Evaluation

Regarding the other requested information:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The document relies on engineering non-clinical tests and comparison to a predicate device, not a test set of data like an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided, as this is not an AI/ML study involving expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
5. 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
- Not applicable/No MRMC study was done, as this is a physical medical device (plating system), not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/No algorithm is involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is defined by established engineering standards and specifications, for example, the performance criteria for Construct Static Testing and Galvanic Corrosion Evaluation.
8. The sample size for the training set
- Not applicable/No training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable/No training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the U.S. Department of Health & Human Services, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to it.

April 6, 2018

Biomet Inc. Dhaval Saraiya Regulatory Affairs Sr. Specialist 56 East Bell Drive Warsaw, Indiana 46582

Re: K173767

Trade/Device Name: A. L. P. S. Clavicle Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: March 22, 2018 Received: March 23, 2018

Dear Dhaval Saraiya:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K173767

Device Name A.L.P.S. Clavicle Plating System

Indications for Use (Describe)

The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and non-unions of the clavice including osteopenic bone.

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

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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K173767

PAGE 1 OF 3

510(k) Summary

In accordance with 21 CFR $807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the A.L.P.S. Clavicle Plating System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact Person:	Dhaval SaraiyaRegulatory Affairs Sr. SpecialistTelephone: (305-269-6386)Fax: (305-269-6400)
Date:	March 22nd, 2018
Subject Device:	Trade Name: A.L.P.S. Clavicle Plating SystemCommon Name: Plate, Fixation, Bone
	Classification Name:• HRS - Single/multiple component metallic bonefixation appliances and accessories (21 CFR 888.3030)
Predicate Device(s):	K083843	Locking Anatomic& CompositePlating System	DepuyOrthopaedics*
* The predicate device is included in Biomet's current productportfolio. Biomet acquired DePuy Trauma and as a result of theacquisition of DePuy Trauma, Biomet is now the owner of thepredicate device 510(k).
Purpose and DeviceDescription:	The purpose of this submission is to request clearance forthe new A.L.P.S Clavicle Plating System. The A.L.P.SClavicle Plating System implants are designed to addressfractures of the clavicle. The system is comprised of platesand instruments to facilitate the installation of theimplants. The plates are manufactured from TitaniumAlloy per ASTM F136. Implants and instruments will be

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provided in non-sterile configuration and will require steam sterilization prior to use.

Intended Use and Indications for Use:

Summary of Technological Characteristics:

The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: The intended use is similar to the ● intended use cleared in K083843.
Indications for Use: The indications for use are ● similar to the indications for use cleared in K083843.
Materials: The new A.L.P. S. Clavicle Plating System ● plates are manufactured from Titanium Alloy (per ASTM F136). Implant grade titanium alloys are commonly used materials in orthopedic implants.
Design Features: The design features for new ● A.L.P. S. Clavicle Plating System is similar to those in currently marketed devices cleared in K083843. The design differences have not identified any issues that would impact the safety and effectiveness of the device.
Sterilization: The implants and instruments are offered to the user in the non-sterile configuration. The non-sterile implants and instruments will be required to be steam sterilized by the user prior to use. The nonsterile packaging configuration is similar to the predicate devices currently marketed and cleared via K083843.

Summary of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Tests: ●

Construct Static Testing o
Galvanic Corrosion Evaluation O
Clinical Tests:
- o N/A

Substantial Equivalence

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Conclusion

The A.L.P.S. Clavicle Plating System has shown to be substantially equivalent to the predicate device. Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.

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.