Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Device Description

The ALPS 2.5mm Inline Fusion Plate consists of a 2.5mm Titanium alloy fusion plate offered to be used with non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures, fusions, revisions and reconstructive surgeries.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the ALPS 2.5mm Inline Fusion Plate. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document describes a bone fixation plate, which is a physical implant, not an AI or software-based medical device. Therefore, the questions related to AI/algorithm performance, ground truth, expert opinions, and reader studies are not applicable to this submission.

The acceptance criteria and supporting "study" relate to the physical and mechanical properties of the plate compared to existing devices.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device (bone plate), the "acceptance criteria" are related to its mechanical performance and biocompatibility. The summary states:

Criterion	Reported Device Performance
Substantial Equivalence	"The ALPS 2.5mm Inline Fusion Plate is substantially equivalent to currently marketed devices..."
Pre-clinical Data	"...demonstrated with pre-clinical data including axial load construct testing and evaluation of galvanic corrosion potential."
Safety and Efficacy Concerns	"No new issues of safety or efficacy have been raised."
Technological Characteristics	"The technological characteristics of the ALPS 2.5mm Inline Fusion Plate are similar to the predicate devices including design, dimensions and material."

Study Proving Acceptance Criteria:

The study referenced is "pre-clinical data" that includes:

Axial load construct testing: This is a mechanical test to assess the device's ability to withstand forces along its axis, simulating how it would hold bones together.
Evaluation of galvanic corrosion potential: This test assesses the likelihood of corrosion when different metals are in contact within a biological environment.

This "study" (series of tests) demonstrated that the ALPS 2.5mm Inline Fusion Plate performed similarly to its predicate devices concerning these crucial mechanical and material properties, confirming substantial equivalence.

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. This is a physical device submission. "Sample size" in this context would refer to the number of plates tested in mechanical and material evaluations, which is not specified in the summary. Data provenance is also not relevant for these types of engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no "ground truth" to be established by medical experts in this context. The "truth" is determined by established engineering standards and test methods for mechanical and material properties of implants.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for human interpretation or clinical studies, not for mechanical device testing.

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. This is not an AI/software device.

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

Not applicable. This is not an AI/software device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. For a physical device, the "ground truth" relates to compliance with engineering specifications, material properties, and performance in standardized mechanical tests, rather than a clinical "ground truth."

8. The sample size for the training set

Not applicable. This is not an AI/software device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/software device.

Summary

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Section 5 — 510(k) Summary

Submitted by:	Biomet Trauma56 East Bell DrivePO Box 587Warsaw, IN 46581Phone: (305) 269-6386Fax: (305) 269-6400OCT 2 9 2013
Contact Person:	Suzana Otaño, Global Project Manager, Regulatory Affairs
Date Prepared:	June 17, 2013
Proprietary Name:	ALPS 2.5mm Inline Fusion Plate
Common Name:	Plate, Fixation, Bone
Classification Name:	Single/multiple component metallic bone fixation appliances andaccessories (21 CFR § 888.3030)
Predicate Devices:	The ALPS 2.5mm Inline Fusion Plate is substantially equivalent tocurrently marketed Fracture and Fusion Plating System (K093474)and the Mini Fragment Plating System (K061748).
Device Description:	The ALPS 2.5mm Inline Fusion Plate consists of a 2.5mm Titaniumalloy fusion plate offered to be used with non-locking, locking andvariable angle screws manufactured from Titanium alloy and CoCrfor bone fixation and the management of fractures, fusions,revisions and reconstructive surgeries.
Indications for Use:	The system is intended for use in stabilization and fixation offractures, revision procedures, fusions, reconstructions (osteotomy)and non-unions of the bones of the hand, foot, wrist, ankle, finger,toe, humerus, olecranon, clavicle, scapula and pelvis, particularly inosteopenic bone. The system can be used in both adult andpediatric patients (adolescents [>12 - 21 years of age]), where theimplant would not cross open epiphyseal plates in skeletallyimmature patients.
TechnologicalCharacteristics:	The technological characteristics of the ALPS 2.5mm Inline FusionPlate are similar to the predicate devices including design,dimensions and material.

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K131867 page 1 of 2

Summary of Substantial Equivalence:

The ALPS 2.5mm Inline Fusion Plate is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data including axial load construct testing and evaluation of galvanic corrosion potential. No new issues of safety or efficacy have been raised.

ALPS 2.5mm Inline Fusion Plate - Traditional 510(k) - Amended Biomet Trauma

Page 47 of 232

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol to the right, consisting of three curved lines that resemble a human form. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the symbol.

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

October 29, 2013

Biomet, Inc. Ms. Suzana Otaño Global Project Manager, Regulatory Affairs 56 East Bell Drive P.O. Box 587 Warsaw. Indiana 46581

Re: K131867

Trade/Device Name: ALPS 2.5mm Inline Fusion Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Date: September 30, 2013 Received: October 1. 2013

Dear Ms. Otaño:

We have reviewed vour 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

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Page 2 - Ms. Suzana Otaño

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 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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/ReportalProblem/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.

Ering Meith

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number:	K131867
Device Name:	ALPS 2.5mm Inline Fusion Plate

Indications For Use:

× Prescription Use_ (Per 21 CFR 801 Subpart D)

AND/OR Over-the-Counter_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Division of Orthopedic Devices

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Regulation Number and Section

N/A