The new A.L.P.S calcaneal plating system is a series of bone plates and screws intended to stabilize calcaneal fractures. The plates come in a left and right specific MIS configuration with five size options and left and right MESH configuration that is offered in three sizes. The plates are manufactured from titanium (ASTM F136) and will utilize the legally marketed and predicate A.L.P.S screw system.

AI/ML Overview

Here's an analysis of the provided text regarding the A.L.P.S Calcaneal Plating System.

Note: This submission pertains to a medical device (bone fixation plates) and not an AI/software device. Therefore, many of the requested elements that are typical for AI/software device studies (like expert adjudication, MRMC studies, ground truth for training sets, etc.) are not applicable or addressable from the provided text. The evaluation criteria for such a device are primarily focused on mechanical performance and material equivalence.

Acceptance Criteria and Device Performance Study for the A.L.P.S Calcaneal Plating System

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied for medical devices of this type)	Reported Device Performance
Mechanical Strength & Stability: Device must demonstrate adequate strength and stability for its intended use in calcaneal fracture fixation, fusion, and osteotomies.	"Preclinical performance tests/rationales were provided to address the subject construct's strength. Results indicate that the subject construct is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness." (K132898, page 1, Section "PERFORMANCE DATA SUMMARY OF NON-CLINICAL TESTS...") Acceptance has been met as per the FDA's substantial equivalence determination for safety and effectiveness.
Material Equivalence: Device materials must be safe and compatible with the human body, similar to predicate devices.	"The technological characteristics of the A.L.P.S calcaneal plating system are similar to the predicate devices including design, dimensions and material." (K132898, page 1, Section "Summary of the Technologies")"The A.L.P.S Calcaneal Plating System components have the same basic technological and material characteristics as the predicate devices except for slight modifications to the general design..." (K132898, page 1, Section "PERFORMANCE DATA SUMMARY OF NON-CLINICAL TESTS...") The plates are manufactured from titanium (ASTM F136). (K132898, page 1, Section "Device description") Acceptance has been met as per the FDA's substantial equivalence determination.
Design Equivalence (functional): The device's design must achieve a similar function to legally marketed predicate devices.	"The technological characteristics of the A.L.P.S calcaneal plating system are similar to the predicate devices including design, dimensions and material." (K132898, page 1, Section "Summary of the Technologies")"The A.L.P.S Calcaneal Plating System components have the same basic technological and material characteristics as the predicate devices except for slight modifications to the general design..." (K132898, page 1, Section "PERFORMANCE DATA SUMMARY OF NON-CLINICAL TESTS...") Acceptance has been met as per the FDA's substantial equivalence determination.
Safety and Effectiveness: Overall, the device must be demonstrated to be safe and effective for its stated indications for use.	"Results indicate that the subject construct is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness." (K132898, page 1, Section "PERFORMANCE DATA SUMMARY OF NON-CLINICAL TESTS...")"No new issues of safety or efficacy have been raised." (K132898, page 1, Section "CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA") The FDA has determined the device is substantially equivalent, implying it meets safety and effectiveness criteria.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the provided text. The studies were "preclinical performance tests/rationales" and engineering rationales. For medical device mechanical testing, sample sizes are typically determined by statistical power analysis for a given test (e.g., fatigue, static strength), but the specific numbers are not disclosed here.
Data Provenance: The studies are described as "preclinical performance tests" and "engineering rationales". This implies laboratory-based mechanical testing and engineering analysis. No country of origin is specified for the data itself, but the submitter is Biomet Manufacturing Corp. in Warsaw, IN, USA. The tests are retrospective in the sense that they are performed on manufactured components separate from a patient population, but the results are for substantiating a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a mechanical device, not an image analysis or diagnostic AI device. "Ground truth" in this context refers to the physical properties and performance of the device under testing conditions, measured by instruments, not by expert human interpretation.

4. Adjudication method for the test set:

Not Applicable. As a mechanical device, adjudication in the sense of reconciling expert opinions is not relevant. Mechanical test results are objective measurements.

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 and therefore an MRMC study is not relevant.

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. The device's "performance" is its mechanical integrity and function as a standalone implant. The preclinical tests evaluated the device in isolation, in a lab setting, independent of human interaction during the test itself.

7. The type of ground truth used:

Objective Mechanical Measurements and Engineering Analysis: The "ground truth" for this device's performance is derived from standardized mechanical testing (e.g., fatigue testing, static load testing, material property verification) to ASTM or ISO standards, as well as engineering rationales and comparisons against predicate device performance under similar conditions. This would involve quantifiable measurements of force, displacement, cycles to failure, and material properties.

8. The sample size for the training set:

Not Applicable. This is not an AI/software device and does not have a "training set" in that context. The device's design and manufacturing processes are developed through engineering principles, rather than machine learning on a dataset.

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

Not Applicable. As there is no "training set" as understood in AI/software, this question does not apply. The "ground truth" for the device's design and manufacturing is established through engineering specifications, material standards (e.g., ASTM F136 for titanium), and quality control processes.

Summary

{0}------------------------------------------------

K132898 page 1 of 2

Section 5 - 510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

Submitter Information
Name	Biomet Manufacturing Corp.
Address	56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0857
Phone number	(574) 372-1941
Fax number	(574) 371-1027
EstablishmentRegistration Number	1825034
Name of contactperson	Jared CooperRegulatory Affairs Specialist
Date prepared	09/06/13
Name of device
Trade or proprietaryname	A.L.P.S Calcaneal Plating System
Common or usualname	Bone Fixation Plate
Classification name	Single/multiple component metallic bone fixation appliances andaccessories (21 CFR § 888.3030)
Classification panel	Orthopedics
Regulation	21 CFR § 888.3030
Product Code(s)	HRS - Plate, Fixation, Bone: Single/multiplecomponent metallic bone fixation appliances andaccessories
Legally marketed device(s) towhich equivalence is claimed	DePuy Fracture and Fusion Plating System (K093474),DePuy Calcaneal Plate (K993465),Tornier Calcaneal Fracture Plate System (K090582)
Reason for 510(k) submission	New Device Construct
Device description	The new A.L.P.S calcaneal plating system is a series of bone platesand screws intended to stabilize calcaneal fractures. The platescome in a left and right specific MIS configuration with five sizeoptions and left and right MESH configuration that is offered inthree sizes. The plates are manufactured from titanium (ASTMF136) and will utilize the legally marketed and predicate A.L.P.Sscrew system.
Indications for use	The Biomet A.L.P.S Calcaneal Plating System is intended for fixationof fractures, fusions, and osteotomies of the calcaneus.
Summary of the Technologies

The technological characteristics of the A.L.P.S calcaneal plating system are similar to the predicate devices including design, dimensions and material.

{1}------------------------------------------------

PERFORMANCE DATA SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

Performance Test Summary-New Device

ッシュ・

The A.L.P.S Calcaneal Plating System components have the same basic technological and material characteristics as the predicate devices except for slight modifications to the general design as described in this 510(k) notification. Preclinical performance tests/rationales were provided to address the subject construct's strength. Results indicate that the subject construct is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

Clinical Performance Data/Information: None provided as a basis for substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The results of preclinical tests/engineering rationales and the similarities with legally marketed devices indicate ALPS calcaneal plating System is substantially equivalent to currently marketed devices. No new issues of safety or efficacy have been raised.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Public Health Service

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

November 19, 2013

Biomet Manufacturing Corporation Mr. Jared Cooper Regulatory Affairs Specialist P.O. Box 587 56 East Bell Drive Warsaw, Indiana 46581-0857

Re: K132898

Trade/Device Name: A.L.P.S Calcaneal 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: October 1, 2013 Received: October 2, 2013

Dear Mr. Cooper:

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. Ilsting 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

{3}------------------------------------------------

Page 2 - Mr. Jared Cooper

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/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.

Lori A: Wiggins

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

Enclosure

{4}------------------------------------------------

Section 4 - Indications for Use Statement

510(k) Number: K132898

A.L.P.S Calcaneal Plating System Device Name:

Indications For Use:

The Biomet A.L.P.S Calcaneal Plating System is intended for fixation of fractures, fusions, and osteotomies of the calcaneus.

× 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

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.