The DePuy ACE TiMAX™ Meta Plate has a triangular shaped projection at the end of a shaft portion. The shaft portion has compression slots with a pitch of 13mm which matches the small fragment, active compression plate. The plate thickness is 1.6mm in the shaft region and transitions to a thickness of 1mm in the triangular shaped metaphyseal region. A cut-out in the middle of the metaphyseal region provides an open architecture to facilitate contouring by the surgeon, to accommodate the anatomical topography of the distal tibia as well as other indicated anatomical regions, and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the 3.5mm cortical screw and the 4.0mm cancellous screw. The plate will be offered in two sizes: small (width=30mm) and large (width=38mm) with various lengths.

AI/ML Overview

This document is a 510(k) summary for a medical device (DePuy ACE TiMAX™ Meta Plate), which focuses on establishing substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the manner an AI/software device would. Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable to this type of submission.

Here's a breakdown of what can be extracted and what cannot:

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

Not Applicable. This document is for a traditional medical implant (bone plate), not a software or AI device. The "performance" assessment focuses on the physical and mechanical equivalence to an existing device, not on specific quantitative metrics or a study demonstrating achievement of pre-defined acceptance criteria in the context of an AI/software product. The acceptance criteria for this type of device generally relate to safety, material biocompatibility, mechanical strength (often through bench testing), and similarity in design and intended use to a predicate device. These are assessed through a broader regulatory review, not a single "performance study" as would be done for an AI algorithm.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. There is no "test set" or "data provenance" in the context of an AI/software device for this submission. The "testing" for this bone plate would typically involve bench testing (mechanical and material properties) and potentially cadaver studies, but not a dataset in the way an AI algorithm uses it. The document does not provide details on sample sizes for these types of tests, if they were conducted.

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. No "ground truth" establishment in the context of an AI/software algorithm is described. For a bone plate, medical experts (e.g., orthopedic surgeons) would be involved in defining the intended use and potentially evaluating design, but not in establishing a "ground truth" for a dataset.

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

Not Applicable. No "adjudication method" for a test set is described.

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 a study about human readers or AI assistance.

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

Not Applicable. There is no algorithm discussed.

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

Not Applicable. No "ground truth" in the context of an AI/software algorithm is described. The "ground truth" for a bone plate would be based on established medical and engineering principles, material science, and clinical experience with equivalent devices.

8. The sample size for the training set:

Not Applicable. There is no "training set."

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

Not Applicable. There is no "training set" or ground truth establishment in this context.

Summary of what the document does provide in relation to regulatory acceptance:

Predicate Device: The DePuy ACE TiMAX™ Meta Plate is deemed substantially equivalent to the Synthes Cloverleaf Plate (P/N 240.23), which was a pre-amendment device (marketed prior to May 28, 1976). This substantial equivalence is the primary "acceptance criterion" for 510(k) submissions.
Intended Use: The device is intended for distal intra-articular tibia fractures, proximal tibia fractures, and proximal and distal humerus fractures. This must align with the predicate device's intended use or be demonstrably safe and effective for similar uses.
Device Description: The document describes the plate's physical characteristics (triangular shaped projection, shaft with compression slots, plate thickness, cut-out for contouring, screw hole design compatible with 3.5mm cortical and 4.0mm cancellous screws, two sizes). These features are compared to the predicate device to establish equivalence.
Regulatory Decision: The FDA determined the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This decision is the formal acceptance of the device for market.

Summary

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6 4 8 3 8 5 3

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DEC 2 2 1998

510(k) SUMMARY

NAME OF FIRM:

510(k) CONTACT PERSON:

TRADE NAME:

COMMON NAME:

CLASSIFICATION NAME:

REGULATORY CLASS:

DEVICE CODE:

SUBSTANTIALLY EQUIVALENT DEVICES: DePuy ACE Medical Company 2260 East El Segundo Boulevard El Segundo, CA 90245

Kathleen Dragovich Regulatory Affairs Specialist DePuy ACE Medical Company

DePuy ACE TiMAX™ Meta Plate

Plate, Fixation, Bone

888.3030 Single/multiple component metallic bone fixation appliances and accessories.

Class II

87HRS

Synthes Cloverleaf Plate, P/N 240.23

INTENDED USE:

I Distal intra-articular tibia fractures
트 Proximal tibia fractures
내 Proximal and distal humerus fractures

DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The DePuy ACE TiMAX™ Meta Plate is similar in design and function to the Synthes Cloverleaf plate (pre-amendment device).

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three intertwined lines representing the branches of government and a stylized human figure at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 1998

Mr. Paul Doner Director, Regulatory and Clinical Affairs DePuy ACE Medical Company 2260 East El Segundo Boulevard El Segundo, California 90245-4694

K983853 Re: DePuy ACE TiMAX™ Meta Plate Regulatory Class: II Product Code: HRS Dated: October 27, 1998 Received: October 30, 1998

Dear Mr. Doner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Paul Doner

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

-Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for DePuy ACE. The logo consists of a black circle followed by the text "DePuyACE" in a stylized font. The letters are all capitalized, and the "ACE" portion is slightly smaller than the "DePuy" portion. There is a trademark symbol in the bottom right corner of the logo.

510(k) Number (if known) _ K 983853

DePuy ACE TiMAX™ Meta Plate Device Name:

Indication for User:

Distal intra-articular tibia fractures 買
Proximal tibia fractures 포
Proximal and distal humerus fractures E

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter

locottefa

(Division Sign-Off) Division of General Restorative i 510(k) Number _

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.