The DePuy Synthes TOMOFIX Osteotomy System is intended for osteotomies, treatment of bone and joint deformities, fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.

Specifically.

The TOMOFIX Medial Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial proximal tibia
The TOMOFIX Lateral Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease. such as osteoarthritis, of the lateral proximal tibia
The TOMOFIX Lateral Distal Femur Plates are indicated for open-and closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the lateral distal femur
The TOMOFIX Medial Distal Femur Plates are indicated for closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the medial distal femur

Device Description

The DePuy Synthes TOMOFIX Osteotomy System consists of five different titanium plate families with locking and combination locking/compression holes. This system features plates designed to provide stable fixation of osteotomies of the distal femur and proximal tibia.

The DePuy Synthes TOMOFIX Medial Distal Femur Plates are part of the DePuy Synthes TOMOFIX Osteotomy System used for closed wedge femoral osteotomies. The subject plates are anatomically contoured to fit the medial distal femur, are available in right and left versions, as well as sterile and non-sterile.

AI/ML Overview

The provided document is a 510(k) premarket notification for the DePuy Synthes TOMOFIX Osteotomy System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data.

However, the document does not contain acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML device. This document pertains to traditional medical hardware (bone fixation plates) and the "performance data" refers to mechanical testing for durability and strength, not algorithmic performance.

Therefore, most of the requested information regarding AI/ML device performance and related studies (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this document.

I will provide the information that is available in the document regarding the device and its testing.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria	Reported Device Performance
Mechanical Performance	Comparable to predicate devices	Results demonstrate substantial equivalence through:
Axial Testing (Osteotomized Sawbone Femur)	Comparable stiffness and fatigue strength to predicate devices	Conducted by mounting plates on an osteotomized sawbone femur model and subjecting to axial load. Results demonstrate substantial equivalence.
Torsion Testing (Osteotomized Sawbone Femur)	Comparable stiffness and fatigue strength to predicate devices	Conducted by mounting plates on an osteotomized sawbone femur model and subjecting to torsional load. Results demonstrate substantial equivalence.
Bending Stiffness (Critical Cross-Section)	Comparable stiffness and fatigue strength to predicate devices	ProEngineer CAD software used to calculate and compare stiffness properties. Results demonstrate substantial equivalence.
Dynamic (Fatigue) Testing (Plate-Screw Constructs)	Comparable stiffness and fatigue strength to predicate devices	Conducted by mounting plate-screw constructs on POM-C test blocks with milled surface, introducing cyclical axial force. Results demonstrate substantial equivalence.

Explanation of "Acceptance Criteria" for this Device:
For this type of device (bone fixation plates), the "acceptance criteria" for performance are established through showing equivalence to legally marketed predicate devices. This involves demonstrating similar mechanical properties (stiffness, fatigue strength) under relevant testing conditions. The document states that the testing was "designed to assess the stiffness and fatigue strength of the subject devices" and that the "results... demonstrate substantial equivalence." This implies that the observed performance was found to be statistically and clinically comparable to the predicate devices.

Regarding AI/ML specific criteria (which are not in this document):

Sample size used for the test set and the data provenance: Not applicable (not an AI/ML device). The mechanical tests were performed on "osteotomized sawbone femur model[s]" and "POM-C test blocks." The specific number of samples for each mechanical test is not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (not an AI/ML device). Ground truth for mechanical testing is based on physical measurements and engineering principles.
Adjudication method for the test set: Not applicable (not an AI/ML device).
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 (not an AI/ML device). This is a hardware device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable (not an AI/ML device).
The type of ground truth used: For mechanical testing, the ground truth is derived from engineering principles and physical measurement of forces, displacement, and cycles to failure, often compared against established standards or predicate device performance.
The sample size for the training set: Not applicable (not an AI/ML device).
How the ground truth for the training set was established: Not applicable (not an AI/ML device).

Summary

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

August 29, 2014

Synthes (USA) Products LLC Ms. Kara A. R. Elkin Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K141796

Trade/Device Name: DePuy Synthes TOMOFIX Osteotomy System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: August 1, 2014 Received: August 4, 2014

Dear Ms. Elkin:

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

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Page 2 – Ms. Kara A.R. Elkin

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" (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.

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,

Lori A. Wiggins -S

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

Enclosure

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See PRA Statement below.

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

Indications for Use

510(k) Number (if known)

K141796

Device Name

DePuy Synthes TOMOFIX Osteotomy System

Indications for Use (Describe)

Specifically.

The TOMOFIX Medial Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial proximal tibia
The TOMOFIX Lateral Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease. such as osteoarthritis, of the lateral proximal tibia
The TOMOFIX Lateral Distal Femur Plates are indicated for open-and closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the lateral distal femur
The TOMOFIX Medial Distal Femur Plates are indicated for closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the medial distal femur

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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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5.0	510(k) Summary	Page 1 of 3
Sponsor:	DePuy Synthes1301 Goshen ParkwayWest Chester, PA 19380
	Phone: (610) 719-1239Fax: (484) 356-9682
	Contact Person: Kara A. R. ElkinDate Prepared: August 1, 2014
Device Name:	DePuy Synthes TOMOFIX Osteotomy System
Classification:	Product Code - HRS, Plate, Fixation, Bone, Class II, §888.3030 –Single / multiple component metallic bone fixation appliance andaccessories.
Predicate Devices:	Synthes TOMOFIX Medial Distal Femur Plates (K081353)
	Synthes TOMOFIX Osteotomy System (K023941)
	Synthes Large Fragment Dynamic Compression Locking System(K000682)
Device Description:	The DePuy Synthes TOMOFIX Osteotomy System consists of fivedifferent titanium plate families with locking and combinationlocking/compression holes. This system features plates designed toprovide stable fixation of osteotomies of the distal femur andproximal tibia.
	The DePuy Synthes TOMOFIX Medial Distal Femur Plates are partof the DePuy Synthes TOMOFIX Osteotomy System used for closedwedge femoral osteotomies. The subject plates are anatomicallycontoured to fit the medial distal femur, are available in right and leftversions, as well as sterile and non-sterile.
Intended Use:	The DePuy Synthes TOMOFIX Osteotomy System is intended forosteotomies, treatment of bone and joint deformities, fixation offractures, and malalignment caused by injury or disease, such asosteoarthritis, of the distal femur and proximal tibia.
	Specifically,– The TOMOFIX Medial Proximal Tibia Plates are indicatedfor open- and closed-wedge osteotomies fixation of fractures,and malalignment caused by injury or disease, such asosteoarthritis, of the medial proximal tibia– The TOMOFIX Lateral Proximal Tibia Plates are indicatedfor open- and closed-wedge osteotomies fixation of fractures,

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and malalignment caused by injury or disease, such as osteoarthritis, of the lateral proximal tibia

The TOMOFIX Lateral Distal Femur Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the lateral distal femur
The TOMOFIX Medial Distal Femur Plates are indicated for closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial distal femur

Substantial The intent of this submission is to update the indications for use Equivalence: statement of the DePuy Synthes TOMOFIX Osteotomy System (cleared under K023941) by specifying osteotomy type (open or closed) and specific anatomical region indicated for each plate family in the system. Information has been provided to support the use of the DePuy Synthes TOMOFIX Osteotomy System for the proposed indications to support a substantially equivalent decision in comparison to the predicate Synthes TOMOFIX Osteotomy System as cleared under K023941.

It is also the intent of this submission to modify the design of the DePuy Synthes TOMOFIX Medial Distal Femur Plate. Information presented supports substantial equivalence of the DePuy Synthes TOMOFIX Medial Distal Femur Plate to the predicate devices, Synthes TOMOFIX Medial Distal Femur Plates (K081353), Synthes TOMOFIX Osteotomy System (K023941) and Synthes Large Fragment Dynamic Compression Locking System (K000682). The proposed plates have similar indications for use, design characteristics, materials, and incorporate the same fundamental technology.

Performance Data

Static and dynamic construct testing was completed for the plates included in the DePuy Synthes TOMOFIX Osteotomy System in order to demonstrate comparable mechanical performance to the predicates. The mechanical testing was designed to assess the stiffness and fatigue strength of the subject devices. The following tests and analyses were performed:

Axial Testing conducted by mounting the plates on an ● osteotomized sawbone femur model and subjecting the plates to an axial load
Torsion Testing - conducted by mounting the plates on an osteotomized sawbone femur model and subjecting the plates to a torsional load
Bending Stiffness - ProEngineer CAD software was used to calculate and compare stiffness properties in the critical cross section of the plates

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. Dynamic (Fatigue) Testing – conducted by mounting the plate-screw constructs on POM-C test blocks with a milled surface to match the bottom of the plate and introducing a cyclical axial force
The results of the mechanical testing and engineering analyses demonstrate substantial equivalence.

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.