The DePuy Small Locking Plate 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

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AI/ML Overview

The provided text is a 510(k) summary for the DePuy Small Locking Plate System. It describes the device's intended use and claims substantial equivalence to predicate devices based on technological characteristics and pre-clinical data. However, the document does not contain information regarding detailed acceptance criteria, a specific study proving device performance against those criteria, or any of the detailed aspects requested in the prompt (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies, or standalone performance data).

The 510(k) summary states: "The Small Locking Plate 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 indicates that the regulatory approval was based on demonstrating equivalence, not necessarily on a de novo study against defined acceptance criteria, or an AI-driven system.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated:

Information from the Provided Text:

Device Name: Small Locking Plate System
Intended Use: 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.
Basis for Approval: Substantial equivalence to predicate devices based on pre-clinical data.

Missing Information:

The following information, as requested in the prompt, is not present in the provided 510(k) summary:

A table of acceptance criteria and the reported device performance: Not provided. The approval is based on substantial equivalence, not explicit performance metrics against acceptance criteria.
Sample sizes used for the test set and the data provenance: Not provided. No specific "test set" for performance evaluation is mentioned in the context of this 510(k) summary, as it relies on pre-clinical data demonstrating equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such "test set" and ground truth establishment process for performance evaluation are described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 device is a physical medical implant (a bone fixation plate), not an AI-driven diagnostic or assistive system for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no such ground truth establishment for performance evaluation is described. The approval is based on "pre-clinical data" for substantial equivalence.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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SECTION 5 - 510(K) SUMMARY

Submitted by:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581 Phone: (305) 269-6386 Fax: (305) 269-6441

Suzana Otaño, Project Manager, Regulatory Affairs Contact Person:

Date Prepared: February 23, 2009

Proprietary Name: Small Locking Plate System

Common Name: Plate, Fixation, Bone

Classification Single/multiple component metallic bone fixation appliances and accessories (21 CFR § 888.3030) Name:

Predicate Devices:

The Small Locking Plate System is substantially equivalent to currently marketed devices.

Intended Use: The DePuy Small Locking Plate 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.

Technoloqical The technological characteristics of the Small Locking Plate Characteristics: System are the same as the predicate devices including design and material.

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

MAR 3 1 2009

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/13 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Depuy Orthopedics, Inc. % Ms. Suzana Otano Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K090492

Trade/Device Name: Small Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

MAR 3 1 2009

Regulatory Class: II Product Code: HRS Dated: February 23, 2009 Received: February 25, 2009

Dear Ms. Otano:

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.

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Page 2 - Ms. Suzana Otano

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 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 Assistance 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

for
Mark N. Mcllierson

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

Enclosure

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K090492

SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number:

Small Locking Plate System Device Name:

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)
(Division Sign-Off) for MXAT
Division of General, Restorative,
and Neurological Devices
Page 1 of 1

510(k) Number_ 1090497

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

Page 19 of 87

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.