The ACE BioWin Tibial Nailing System is indicated in reamed and unreamed applications for 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, pseudoarthrosis of the tibial shaft, nonunions, metaphyseal fractures and epiphyseal fractures.

Device Description

The BioWin Tibial Nailing System consists of an intramedullary nail, cortical screws, end cap, and an optional bioresorbable window. The nails, screws and end cap are all manufactured from Titanium (Ti-6Al-4V ELI) and the optional bioresorbable window is made from a lactide/glycolide copolymer.

AI/ML Overview

The provided text is a 510(k) summary for the "ACE BioWin Tibial Nailing System." This type of document is for regulatory clearance of a medical device, not a typical study report proving device performance against specific acceptance criteria in the manner of an AI/ML device or a diagnostic accuracy study.

Therefore, the information requested in your prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set details) is not applicable to this document.

Explanation:

Acceptance Criteria & Reported Performance: For this type of device (intramedullary nail), acceptance isn't typically based on quantifiable performance metrics from a clinical study in the way a diagnostic algorithm would be. Instead, "acceptance" for 510(k) clearance is determined by demonstrating substantial equivalence to predicate devices already on the market. This means showing that the new device has the same intended use, similar technological characteristics, and does not raise different questions of safety and effectiveness.
Study Design Elements (Sample Size, Experts, Adjudication, MRMC, Standalone, Ground Truth): These concepts apply to studies designed to evaluate diagnostic accuracy, treatment effectiveness, or the performance of a software algorithm. The 510(k) summary is a regulatory filing, not a scientific publication detailing a de novo study to establish performance benchmarks.
Training Set: This is a concept relevant to machine learning/AI development, which is not applicable to a physical bone fixation device.

In summary, the provided document does not contain the specific information requested because it is a regulatory filing for substantial equivalence of a physical medical device, not a performance study for an AI/ML product or diagnostic test.

Summary

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DEC 1 7 2001

K013430

Page 1 of 2

510(k) Summary

Name of Sponsor:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910
510(k) Contact:	Marcia J. ArentzSenior Regulatory AssociatePhone: (219) 371-4944FAX: (219) 371-4987
Trade Name:	ACE BioWin Tibial Nailing System
Common Name:	Bone fixation device
Classification:	Class II Device per 21 CFR 888.3020Intramedullary fixation rodDescription: Rod, Fixation, Intramedullary andAccessories, Metallic and Non-collapsible
Device Product Code:	Code: 87HSBNo performance standards have been establishedunder Section 514 of the Federal Food, Drug,and Cosmetic Act for intramedullary nails orbone fixation fasteners.
Substantially Equivalent Device:	ACE AIM Tibial Nail K972183Synthes AO Nail K914453Biomet LactoSorb ® 5.0mm washer K001581
Device Descriptions:	The BioWin Tibial Nailing System consists of anintramedullary nail, cortical screws, end cap, andan optional bioresorbable window. The nails,screws and end cap are all manufactured fromTitanium (Ti-6Al-4V ELI) and the optionalbioresorbable window is made from alactide/glycolide copolymer.

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page 2 of 2
KOI 3430

510(k) Summary (continued)

Indications for use:

The BioWin Tibial Nailing System is indicated in reamed and unreamed applications for internal fixation of tibial fractures, including transverse fractures, spiral fractures, fractures, oblique comminuted fractures, segmental fractures, fractures with bone loss, bone transport, open corrective o osteotomies, pathologic fractures, fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.

Substantial equivalence:

The BioWin Tibial Nailing System has the same intended use and has the same general design features as the ACE AIM Tibial Nail and the Synthes AO nail and is therefore substantially equivalent to other legally marketed devices.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2001

Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopedic, Inc. 700 Orthopedic Drive P.O. Box 988 Warsaw, Indiana 46581

Re: K013430

Trade/Device Name: Bio™Win Tibial Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 15, 2001 Received: October 16, 2001

Dear Ms. Arentz:

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 may or dayse to and 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 r rease of a rised 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.

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Page 2 - Ms. Marcia J. Arentz

This letter will allow you to begin marketing your device as described in your Section 510(k) This retor wification. The FDA finding of substantial equivalence of your device to a legally premarket notification. The a be 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 11 you dosile bpooms acres 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of 11 Sel-4659. Additionally, for questions on the promotion and advertising of Compinance at (301) 594-1007 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation entitiou, "Whiordialing of esponsibilities under the Act may be obtained from the Oinor general missimalion sturers, 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,

signature

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):

BioWin™ Tibial Nailing System Device Name:

Indications for Use:

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_L_O13 430

Concurrence of CDRH, Office of Device Evaluation

સ > Prescription Use OR (Per 21 CFR/801.109)

Over-The-Counter Use No

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.