The Modified Distal Radius Plating System consists of Titanium alloy Extra Narrow and Extra Long family of plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures and reconstructive surgeries.

AI/ML Overview

The provided text describes a 510(k) submission for a Modified Distal Radius Plating System and focuses on demonstrating substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or reader improvement.

Therefore, many of the requested elements for describing an AI/CAD-based study are not applicable to this document. The document primarily outlines pre-clinical mechanical testing to ensure the new device is comparable to existing ones.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated as such, but inferred from testing)	Reported Device Performance
Axial load construct testing performance	Passed (demonstrated substantial equivalence)
4-point bending testing performance	Passed (demonstrated substantial equivalence)
Evaluation of galvanic corrosion potential	Passed (demonstrated substantial equivalence)
Multidirectional screw capability	Passed (demonstrated substantial equivalence)

Note: The document states that "pre-clinical data including axial load construct testing, 4-point bending testing, evaluation of galvanic corrosion potential and multidirectional screw capability" demonstrated substantial equivalence. Specific quantitative acceptance criteria (e.g., minimum load bearing, maximum corrosion rate) and the exact quantitative results are not provided in this summary.

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

Sample Size: Not applicable. The "test set" here refers to the physical devices undergoing mechanical and material testing, not a dataset of medical images or patient records. The number of physical implants/constructs tested is not specified in the provided summary.
Data Provenance: Not applicable in the context of clinical/imaging data. The data provenance relates to laboratory testing of device components.

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

Not applicable. Ground truth in this context would be defined by engineering specifications and physical measurements, not expert consensus on medical images.

4. Adjudication method for the test set

Not applicable. This concept is relevant for expert review of clinical data, not for material and mechanical 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

No, an MRMC comparative effectiveness study was not done. This document pertains to a medical device's physical and material properties, not an AI/CAD system for image interpretation.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance would be derived from engineering specifications, material science standards, and mechanical testing protocols. For example, the load at which a construct fails in axial loading would be the measurable "truth" compared against a specified acceptance load.

8. The sample size for the training set

Not applicable. This product is a physical implant, not an AI model requiring a training set.

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

Not applicable. No training set for an AI model.

Summary

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Section 5 — 510(k) Summary

APR - 1 2014

Submitted by:	Biomet Trauma56 East Bell DrivePO Box 587Warsaw, IN 46581Phone: (305) 269-6386Fax:(305) 269-6400
Contact Person:	Suzana Otaño, Regulatory Affairs Manager
Date Prepared:	December 20, 2013
Proprietary Name:	Modified Distal Radius Plating System
Common Name:	Plate, Fixation, Bone
Classification Name/ Product Code:	Single/multiple component metallic bone fixation appliances andaccessories (21 CFR § 888.3030) / HRS
Predicate Devices:	The Modified Distal Radius Plating System is substantially equivalentto currently marketed Distal Volar Radius Plating System (K112345,K050932, K060864).
Device Description:	The Modified Distal Radius Plating System consists of Titanium alloyExtra Narrow and Extra Long family of plates utilizing non-locking,locking and variable angle screws manufactured from Titanium alloyand CoCr for bone fixation and the management of fractures andreconstructive surgeries.
Indications for Use:	The system is intended for fixation of fractures, malunions andosteotomies involving the distal radius.
TechnologicalCharacteristics:	The technological characteristics of the Modified Distal RadiusPlating System are similar to the predicate devices including design,dimensions and material.
Summary ofSubstantialEquivalence:	The Modified Distal Radius Plating System is substantially equivalentto currently marketed devices as demonstrated with pre-clinicaldata including axial load construct testing, 4-point bending testing,evaluation of galvanic corrosion potential and multidirectional screwcapability. No new issues of safety or efficacy have been raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

Public Health Service

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

April 1, 2014

Biomet Trauma Ms. Suzana Otaño Regulatory Affairs Manager 56 East Bell Drive PO Box 587 Warsaw, Indiana 46581

Re: K133939

Trade/Device Name: Modified Distal Radius 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: January 3, 2014 Received: January 6, 2014

Dear Ms. Otaño:

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. Suzana Otaño

(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 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/McdicalDcvices/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/Resourcesfor You/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

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SECTION 4 - Indications for Use Statement

K133939 510(k) Number:

Modified Distal Radius Plating System Device Name:

Indications For Use:

The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.

Prescription Use_ X (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)

Elizabet愉👍Frank -S

Division of Orthopedic Devices

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Modified Distal Radius Plating System - Traditional 510(k) Biomet Trauma

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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.