The DePuy Ace™ VersaNail Tibial Nail is indicated for the internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.

The Tibial Nail is intended for bone fixation in the management of fractures and reconstructive surgeries.

Non-weight bearing bone fixation is indicated in the following conditions:

Transverse, oblique, spiral, segmental and comminuted fractures;
Fractures with bone loss and bone transport;
Open fractures, pathologic fractures;
Corrective osteotomies;
Pseudarthrosis of the tibial shaft;
Nonunions, malunions, metaphyseal and epiphyseal fractures.

Device Description

The DePuy Ace™ VersaNail Tibial Nail is a cannulated intramedullary nail available in diameters of 8mm, 9mm, 11mm, 12mm and 13mm, and lengths of 24.0cm to 43.5cm. There are two holes on the proximal end and three holes on the distal end of the nail that allow for cortical bone screw locking. Screw hole diameters are 5.97mm at the proximal and distal ends respectively. The proximal end of the nail also features a 13mm medial/lateral (M/L) slot for dynamization, and an 8-degree bend with a bend radius of approximately 2.25mm. The distal end also has a bend radius of approximately 2.25mm and has a bullet tip. The DePuy Ace™ VersaNail Tibial Nail is intended for intramedullary fixation of tibial fractures.

AI/ML Overview

This document does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text is a 510(k) summary for a medical device (DePuy Ace™ VersaNail Tibial Nail) seeking clearance based on substantial equivalence to a predicate device.

Here's what the document does provide, and why it doesn't answer your specific questions:

Device Description and Intended Use: It details the physical characteristics of the tibial nail and lists the types of tibial fractures it's intended to fix.
Basis of Substantial Equivalence: It explicitly states that the device is substantially equivalent to a previously cleared device (DePuy Ace™ Bio Win Tibial Nail, K013430) and highlights the minor design differences between them.
Regulatory Information: It includes the 510(k) contact, trade name, common name, classification, product code, and the FDA's clearance letter.

Why the requested information is absent:

Acceptance Criteria and Device Performance Table: This type of table is typically found in a clinical study report or a detailed design verification/validation report, which are not usually included in the public 510(k) summary. For devices cleared via the 510(k) pathway, particularly those with a predicate device, the primary "proof" is demonstrating substantial equivalence, often through design comparisons, material testing, and sometimes bench testing, rather than a full-scale clinical trial with pre-defined acceptance criteria for performance metrics like sensitivity, specificity, etc.
Sample Size, Data Provenance, Experts, Adjudication, MRMC Study, Standalone Study, Ground Truth: These are all elements of clinical performance studies or specific testing methodologies (like evaluating AI/algorithm performance) that are not required for a typical orthopedic implant 510(k) submission, especially one where the design changes are minor and the predicate device has established safety and effectiveness. The focus here is on mechanical properties and biocompatibility, not diagnostic accuracy or human-AI interaction.
Training Set Information: This is relevant for machine learning algorithms, which are not applicable to the DePuy Ace™ VersaNail Tibial Nail as described.

In summary, the provided text is a regulatory clearance document based on substantial equivalence, not a study report demonstrating specific performance against acceptance criteria for an AI or diagnostic device. Therefore, I cannot extract the requested information from this document.

Summary

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AUG - 8 2003

K 032097
page 1 of 1

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy Ace™ Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46581-0988
510(k) CONTACT:	Tiffani RogersClinical Research Specialist, Clinical/RegulatoryAffairs
TRADE NAME:	DePuy Ace™ Versa Nail Tibial Nail
COMMON NAME:	Intramedullary Rod
CLASSIFICATION:	888.3020: Rod, Fixation, Intramedullary andAccessories; Class II
DEVICE PRODUCT CODE:	87 HSB
SUBSTANTIALLY EQUIVALENTDEVICE:	DePuy Ace™ Bio Win Tibial Nail, K013430

DEVICE DESCRIPTION:

INTENDED USE AND INDICATIONS:

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Ace™ VersaNail Tibial Nail has the same indications and contraindications as the DePuy Ace™ Bio Win Tibial Nail cleared in K013430 with a similar design. The sole differences between the two designs are: modification of the proximal hole pattern; increase in cannulation; modification of the distal hole pattern; the removal of the optional bioresorbable window available with the DePuy Ace™ Bio Win nail and a smaller size, 24.0cm, will be available for smaller stature adults. The proximal and distal ends of the nail were modified to accommodate the use of a new jig bolt instrument and a ball nose guide wire instead of the exchange tube and nail driving wire used with the DePuy Ace™ Bio Win nail.

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Image /page/1/Picture/1 description: The image shows a circular seal or logo. The seal features a stylized design of three curved lines, possibly representing wings or waves, on the right side. The text curves around the top and bottom of the circle, but the text is not legible due to the image quality. The overall impression is that of an official emblem or symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2003

Ms. Tiffani D. Rogers Clinical Research Specialist Clinical/Regulatory Affairs Depuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K032097

Trade/Device Name: DePuy Ace™ VersaNail Tibial Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 1, 2003 Received: July 16, 2003

Dear Ms. Rogers:

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

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Page 2 - Ms. Tiffani D. Rogers

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. 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) 594-4639. 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 may be obtained 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,

Miriam C. Provost

o 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

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510(k) Number (if known) Ko

Device Name DePuy Ace™ VersaNail Tibial Nail

Inter.ded Use and Indications:

The Tibial Nail is intended for bone fixation in the management of fractures and reconstructive surgeries.

Non-weight bearing bone fixation is indicated in the following conditions:

Transverse, oblique, spiral, segmental and comminuted fractures; ●
Fractures with bone loss and bone transport; ●
Open fractures, pathologic fractures;
Corrective osteotomies;
Pseudarthrosis of the tibial shaft; ●
Nonunions, malunions, metaphyseal and epiphyseal fractures.

#서비스========================================================================================================================================================================= Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use A o

Miriam C. Provost

eneral. Restorative and Neurological De

510(k) Number K032697

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.