The Biomet Proximal Humerus Plating System is indicated for fixation of fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.

Device Description

The Biomet Proximal Humeral Plating System offers two plating families (Low and High) with both left and right configurations in various lengths. Both plating families in the Biomet Proximal Humerus Plating System incorporate the same spatial subchondral support as the Biomet S3 proximal humerus plates (K060290) in the head of the plates. The plates and screws will be manufactured from Titanium Alloy (ASTM F136) and are either type II or color anodized. The system will also include multidirectional screws that are manufactured from Cobalt Chromium (ASTM F1537). The plates are anatomically designed to match the anatomy of the proximal humerus. The system will also include instrumentation to aid the user in alignment and stabilization of fractures to the skeletal system.

AI/ML Overview

The provided text describes the Biomet Proximal Humerus Plating System, a metallic bone fixation device, and states that substantial equivalence was determined based on non-clinical tests. However, it does not provide specific acceptance criteria or details of a study that proves the device meets such criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc., which are typical for AI/diagnostic devices).

The document is a 510(k) summary for a medical device that appears to be a physical implant, not a software or AI-driven diagnostic device. Therefore, the concepts of "acceptance criteria" and "performance" in the context of AI/diagnostic tools (e.g., sensitivity, specificity, MRMC studies, ground truth establishment) are not applicable here. Instead, the "performance" discussed relates to the mechanical and material characteristics of the implant and its substantial equivalence to predicate devices.

Here's an attempt to answer the questions based on the provided text, while noting the difference in device type:

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

Since this is a physical implant and not a diagnostic/AI device, the "acceptance criteria" are not presented in terms of typical performance metrics like sensitivity or specificity. Instead, the criteria are focused on demonstrating substantial equivalence to existing predicate devices in terms of intended use, indications for use, materials, design features, and sterilization. The reported "performance" relates to the results of non-clinical tests that support this substantial equivalence.

Acceptance Criteria Category (implied for substantial equivalence)	Reported Device "Performance" / Evidence of Equivalence
Intended Use Equivalence	The Intended Use of the Biomet Proximal Humerus Plating System is the same as the intended uses cleared in K955472 and K060290 and similar to K101421 (predicate devices).
Indications for Use Equivalence	The indications for the Biomet Proximal Humerus Plating System are similar to and based on the Indications for Use cleared in K955472, K060290, and K101421.
Materials Equivalence	Plates: Type II anodized Titanium Alloy (Ti-6Al-4V ELI). Locking and non-locking screws: Titanium Alloy (Ti-6Al-4V ELI ASTM F-136), either type II anodized or color anodized. Multi-directional screws: Cobalt Chromium (ASTM F1537). These are "commonly used materials in orthopedic implants and are used in predicate devices cleared via K955472 and K101421." Patient contact instrumentation: Stainless steel (ASTM F-899).
Design Features Equivalence	Design features are similar to currently marketed devices K955472, K060290, and K101421. "The design differences have not identified any issues that would impact the safety and effectiveness of the devices." The system incorporates the same spatial subchondral support as the Biomet S3 proximal humerus plates (K060290).
Sterilization Equivalence	Implants are offered sterile (gamma irradiation) or non-sterile (steam sterilized by user). "These sterilization configurations are the same as the predicate devices currently marketed and cleared via K060290 and K101421."
Mechanical/Physical Performance	Non-clinical performance testing included: • Axial load construct testing • Engineering evaluations • Galvanic corrosion assessment Results indicate that the subject plating system is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness. (No specific numerical results or acceptance thresholds are provided in this summary document.)

Regarding the specific questions tailored for AI/diagnostic devices:

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 implant, not an AI/diagnostic device that uses a "test set" of data in the common sense for AI. The "tests" were non-clinical mechanical/material tests. The document does not specify a "sample size" for these physical tests in a way that would be relevant to data analysis.

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" in the context of this device being an implant. The "ground truth" for substantial equivalence is based on engineering principles, materials science, and regulatory comparisons to predicate devices.

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

Not Applicable: No adjudication method is described or relevant for this type of device and its non-clinical 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: No MRMC study was conducted or is relevant for this implant device. The concept of "human readers" or "AI assistance" does not apply.

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

Not Applicable: This is not an algorithm or AI device; therefore, no standalone performance study in that sense was conducted.

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

Not Applicable: As mentioned, ground truth in the context of an AI/diagnostic device is irrelevant here. The basis for safety and effectiveness is established through comparison to predicate devices, material standards (ASTM), and non-clinical mechanical testing, rather than a clinical ground truth.

8. The sample size for the training set

Not Applicable: There is no training set for this physical implant device.

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

Not Applicable: There is no training set or ground truth in the context of AI for this device.

Summary

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

March 30, 2015

Biomet Manufacturing Ms. Julie Largent Regulatory Affairs Specialist P.O. Box 587 56 East Bell Drive Warsaw, Indiana 46582

Re: K143697

Trade/Device Name: Biomet Proximal Humerus 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: February 18, 2015 Received: February 19, 2015

Dear Ms. Largent:

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

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Page 2 - Ms. Julie Largent

(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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 -S

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)

K143697 (paqe 1/1)

Device Name

Biomet Proximal Humerus Plating System

Indications for Use (Describe)

The Biomet Proximal Humerus Plating System is indicated for fixation of fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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 Biomet Proximal Humerus 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:	Julie LargentRegulatory Affairs Specialist305-269-6391
Date:	March 12, 2015
Subject Device:	Trade Name: Biomet Proximal Humerus Plating SystemCommon Name: Plate, Fixation, BoneClassification Name:• HRS - Single/multiple component metallic bone fixation

appliances and accessories (21 CFR 888.3030)

Legally marketed devices to which substantial equivalence is claimed:

ACE Proximal Humerus Plates K955472 ●
S Shoulder Plating System K060290
Anatomic Locked Plating System Long Plate Line Extension K101421

Device Description

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Intended Use and Indications for Use

The Intended Use of the Biomet Proximal Humerus Plating System is for internal fixation of humeral fractures. The indications for the Proximal Humerus Plating System are as follows: The Biomet Proximal Humerus Plating System is indicated for fixation of fractures and fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.

Summary of Technological Characteristics

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

Intended Use: The Intended Use of the Biomet Proximal Humerus Plating System is the same as to the intended uses cleared in K955472 and K060290 and similar to K101421.
Indications for Use: The indications for the Biomet Proximal Humerus Plating System is similar to and based on the Indications for Use cleared in K955472, K060290, and K101421.
Materials: The Biomet Proximal Humerus Plating System plates are manufactured from Type II anodized Titanium Alloy (Ti-6Al-4V ELI). The locking and non-locking screws included in the system are also manufactured from Titanium Alloy (Ti-6Al-4V ELI ASTM F-136) and are either type II anodized or color anodized. The system also contains multi-directional screws that are manufactured from Cobalt Chromium (ASTM F1537). Titanium alloys as well as implant grade cobalt chromium are commonly used materials in orthopedic implants and are used in predicate devices cleared via K955472 and K101421. The patient contact instrumentation is comprised of stainless steel that meets ASTM F-899.
. Design Features: The design features for the Biomet Proximal Humerus Plating System are similar to currently marketed devices K955472, K060290 and K101421. The design differences have not identified any issues that would impact the safety and effectiveness of the devices.
. Sterilization: The implants are offered to the user either in the sterile or non-sterile configuration. The non-sterile devices will be required to be steam sterilized by the user prior to use while the sterile implants will be terminally sterilized by gamma irradiation. These sterilization configurations are the same as the predicate devices currently marketed and cleared via K060290 and K101421.

Summary of Performance Data (Nonclinical and/or Clinical)

. Non-Clinical Tests
- Non-clinical performance testing included axial load construct testing, o engineering evaluations and galvanic corrosion assessment to determine substantial equivalence of the Biomet Proximal Humerus Plating System. Results indicate that the subject plating system is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
Clinical Tests
- o No clinical tests are provided for basis of substantial equivalence.

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Substantial Equivalence Conclusion

The Biomet Proximal Humerus Plating System has shown to be substantially equivalent to the predicate devices. Results of non-clinical tests/engineering justification and the similarities with legally marketed predicated devices indicate 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.