The DePuy Small Bone Locking Plating System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

Device Description

The Small Bone Locking Plating System is substantially equivalent to currently marketed devices. The technological characteristics of the Small Bone Locking Plating System are the same as the predicate devices including design and material.

AI/ML Overview

The provided text is a 510(k) summary for the DePuy Small Bone Locking Plating System. This type of regulatory submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and conducting a detailed study to prove the device meets these criteria through clinical performance metrics.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details for an AI/device.

Here's why the requested information is absent:

Device Type: This is a physical orthopedic implant (bone plating system), not a software or AI-based diagnostic/interpretive device. Clinical performance for such devices is typically evaluated through pre-clinical testing (e.g., mechanical strength, biocompatibility), and subsequent post-market surveillance.
Regulatory Pathway (510(k) - Substantial Equivalence): The 510(k) pathway demonstrates that a new device is as safe and effective as a legally marketed predicate device. It usually does not require new clinical studies to establish specific performance metrics against pre-defined acceptance criteria in the same way an AI/software device would. Instead, it relies on demonstrating similar design, materials, and intended use as the predicate.
Focus of the Document: The document explicitly states, "The Small Bone Locking Plating System is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data. No new issues of safety or efficacy have been raised." This highlights the nature of the submission.

If this were an AI or software device, the 510(k) summary would typically include a detailed section on clinical performance, including the metrics you've asked for. However, for this type of device, that information is not provided in this regulatory document.

Summary

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KQ81546 (pg111)

Section 5-510(k) Summary

AUG 2 6 2008 Submitted by: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581 (305) 269-6386 Phone: (305) 269-6441 Fax: Contact Person: Suzana Otaño, Project Manager, Regulatory Affairs May 30, 2008 Date Prepared: Small Bone Locking Plating System Proprietary Name: Common Name: Plate, Fixation, Bone Classification Single/multiple component metallic bone fixation appliances and accessories (21 CFR § 888.3030) Name: The Small Bone Locking Plating System is substantially Predicate Devices: equivalent to currently marketed devices. Intended Use: The DePuy Small Bone Locking Plating System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone. The technological characteristics of the Small Bone Locking Technological Characteristics: Plating System are the same as the predicate devices including design and material.

The Small Bone Locking Plating System is substantially Summary of Substantial equivalent to currently marketed devices as demonstrated with Equivalence: pre-clinical data. No new issues of safety or efficacy have been raised.

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Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three intertwined strands instead of snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2008

Depuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K081546

Trade/Device Name: Small Bone Locking Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: May 30, 2008 Received: June 2, 2008

Dear Ms. Otaño:

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. Suzana Otaño

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 10(s) marketed prodicate device results in a classification for your device and thus, permitte 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 Center for Devices and Radiological Health's (CDRH) s) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistances at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4 - INDICATIONS FOR USE STATEMENT

KO8ISTIP (PATI) 510(k) Number:

Small Bone Locking Plating Device Name: System

Indications For Use:

X Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buelln

ision Sion . Off Division of General, Restorative, and Neurological Devices

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510(k) Number K081546

Small Bone Locking Plating System Traditional 510(k) DePuy Orthopaedics, Inc.

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.