The DePuy ACE® Universal and Troch Entry Femoral Nail System is intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric/intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware.

In addition to the above indications, the Universal Nail, when used in the retrograde mode, is also indicated for treatment of femoral shaft fractures in obese or multiple trauma patients and supracondylar fractures, including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologic fractures, and those proximal to total knee prosthesis.

Device Description

The DePuy ACE® Universal Nail is a revision of the ACE® AIM Femoral Nail (K871539). The Universal Nail is a slightly bowed intramedullary nail with proximal holes and distal lateral / medial holes and anterior/ posterior holes. The nail is "universal" in design, as it requires no right or left device configurations. It is designed to be inserted in either an antegrade or retrograde approach. The nail sizes include 8mm through 15mm diameters and lengths of 280mm through 500mm.

The Troch Entry Nail (TEN) is similar in design to the ACE® Trochanteric Nail System (K010780) and the ACE® Long Trochanteric Nail System (K013563). The Troch Entry Nail is a slightly bowed femoral intramedullary nail with proximal and distal holes. It is intended for antegrade insertion only. This nail includes a small proximal bend for insertion just lateral to the tip of the greater trochanter. Due to this bend, the nail designs require a right and left anatomic version. This nail system includes 9mm, 11mm and 13mm diameters in lengths of 280mm through 500mm in right and left versions.

The Nail System includes intramedullary nails, screws, and end caps. All components are manufactured from ASTM F-136 Ti 6A1-4V alloy with titanium type II anodise (TiMaxTM).

AI/ML Overview

The medical device being described is the DePuy ACE® Universal and Troch Entry Femoral Nail System, an intramedullary rod used for bone fixation. Based on the provided text, the submission is a 510(k) premarket notification, which establishes substantial equivalence to legally marketed predicate devices, rather than proving a device meets specific performance acceptance criteria through clinical studies.

Therefore, the document does not contain information related to specific acceptance criteria or a study designed to prove the device meets such criteria.

Here’s why and what information is available:

Substantial Equivalence (510(k) pathway): The FDA’s letter clearly states: "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..." This means the device's safety and effectiveness are established by demonstrating it is as safe and effective as a legally marketed predicate device, not by meeting new, specific performance acceptance criteria through a dedicated study for that purpose.
Lack of Performance Study Details: The document does not describe any clinical or non-clinical study that would generate "reported device performance" against predefined "acceptance criteria." There are no sections detailing sample sizes, data provenance, expert panels, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

Therefore, the full table and subsequent detailed questions about a performance study cannot be answered from the provided text.

Here is the information that can be extracted or inferred from the provided text, related to the nature of the submission:

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

Acceptance Criteria	Reported Device Performance
Not specified	Not specified
(The approval is based on substantial equivalence to predicate devices, not on meeting new specific acceptance criteria through a performance study described here.)	(The document does not provide details of a specific device performance study or its results.)

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

Sample size: Not applicable/Not provided. No test set for a performance study is described.
Data provenance: Not applicable/Not provided.

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

Not applicable/Not provided. No ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable/Not provided.

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/Not provided. This device is an intramedullary rod, not an AI-assisted diagnostic tool for human readers.

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

Not applicable/Not provided. This device is an intramedullary rod, not an algorithm.

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

Not applicable/Not provided.

8. The sample size for the training set

Not applicable/Not provided. This device is an intramedullary rod, not an AI/algorithm product requiring a training set.

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

Not applicable/Not provided.

In summary: The provided document is a 510(k) premarket notification for an intramedullary rod system, where FDA approval is granted based on substantial equivalence to existing predicate devices. It does not contain the details of a performance study with acceptance criteria, sample sizes, expert ground truth, or other elements typically found in submissions for novel diagnostic algorithms or devices requiring de novo performance evaluation.

Summary

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

K033329

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy ACE®P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46581-0988
510(k) CONTACT:	Rhonda MyerRegulatory Affairs
TRADE NAME:	DePuy ACE® Universal and Troch EntryFemoral Nail Systems
COMMON NAME:	Intramedullary Rod
CLASSIFICATION:	888.3030: Single/multiple component metallicbone fixation appliances and accessories; ClassII
DEVICE PRODUCT CODE:	87 HSB
SUBSTANTIALLY EQUIVALENTDEVICES:	DePuy ACE® AIM Femoral Nail (K871539)DePuy ACE® Trochanteric Nail System(K010780)DePuy ACE® Long Trochanteric Nail System

DEVICE DESCRIPTION:

(K013563)

The Nail System includes intramedullary nails, screws, and end caps. All components are manufactured from ASTM F-136 Ti 6A1-4V alloy with titanium type II anodise (TiMaxTM).

$$\text{און } \mathsf{L} \text{ é איז } \mathsf{L}$$

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

Ko33329

INTENDED USE AND INDICATIONS:

The DePuy ACE® Universal and Troch Entry Femoral Nail System is intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware.

page 2 of 2

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

Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes coiled around it, topped with a pair of wings.

Public Health Service

NOV 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rhonda Myer Regulatory Affairs DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K033329

Trade/Device Name: DePuy ACE® Universal and Troch Entry Femoral Nail Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: II Product Code: HSB Dated: October 14, 2003 Received: October 16, 2003

Dear Ms. Myer:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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

Page 2 - Ms. Rhonda Myer

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark M. Millenn

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

Enclosure

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

Image /page/4/Picture/0 description: The image shows the logo for DePuy ACE, a Johnson & Johnson company. The logo features a black circle followed by the words "DePuy ACE" in a bold, sans-serif font. Underneath the company name is the text "a Johnson-Johnson company" in a smaller, cursive font.

DePuy ACE

PO Box 988 700 Orthopaedic Drive Warsaw. Indiana 46581-0988 ાં નિર્મ Tel. +1 :574) 267 8143 Fax. + 1 (574) 267 7098

510(k) Number (if known): _ K033329

Device Name: DePuy ACE® Universal and Troch Entry Femoral Nail System

Intended Use and Indications:

The DePuy ACE® Universal and Troch Entry Femoral Nail System is intended to treat proximal. middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric/intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware.

Image /page/4/Picture/8 description: The image contains a signature and some text. The signature appears to be "Mark N Millam". The text below the signature includes the words "Men-Off", "General, Restorative", and "Neurological Devices". The text seems to be related to medical devices.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

page 1 of 1

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.