The provided text is a 510(k) summary for the DePuy Sterile DVR Anatomic Plating System. This document focuses on establishing substantial equivalence to a predicate device, primarily through bench testing, rather than presenting a clinical study with detailed acceptance criteria for an AI/device performance.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable or available in this specific document.

However, I can extract the following information:

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

Since this is a submission for a bone fixation device, the "acceptance criteria" are not reported as statistical performance metrics of an AI or diagnostic device. Instead, the acceptance criterion for substantial equivalence is met through bench testing, demonstrating that the device performs comparably to the predicate device.

Acceptance Criteria / Performance Metric (Implicit)	Reported Device Performance (Summary)
Substantial Equivalence to Predicate Device	Equivalence confirmed through bench testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable/Not provided. This document refers to "bench testing," which typically involves mechanical or physical tests on the device hardware, not a "test set" of patient data in the context of an AI or diagnostic study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not provided. The ground truth for bench testing is typically based on engineering specifications and physical measurements, not expert consensus on medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation of data, which is not described for this submission.

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:

No. An MRMC study was not done, as this is a physical medical device (bone plating system), not an AI-assisted diagnostic tool.

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

Not applicable/No. This is a physical medical device, not an algorithm.

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

Not explicitly stated, but implied from "bench testing": For a medical device like a bone plate, ground truth would relate to the mechanical properties, material composition, and functional performance (e.g., strength, fatigue resistance, fixation stability) derived from engineering standards and test protocols.

8. The sample size for the training set:

Not applicable/Not provided. This document describes a physical medical device, not a machine learning model.

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

Not applicable/Not provided. This document describes a physical medical device, not a machine learning model.

Summary

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MAR 1 1 2009

K090374

510(k) Summary

Submitted by:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581Phone: (305) 269-6386Fax: (305) 269-6441
Contact Person:	Suzana Otaño, Project Manager, Regulatory Affairs
Date Prepared:	February 16, 2009
GeneralProvisions	The name of the device is:
	Proprietary Name	Common or Usual Name
	DVR Anatomic Plating System	Plate, Fixation, Bone
Name ofPredicateDevices	The device is substantially equivalent to the currently marketed DePuyDVR Anatomic Plating System, K050932.
Classification	Class II, 21 CFR 888.3030
PerformanceStandards	Performance standards have not been established by the FDA undersection 514 of the Food, Drug and Cosmetic Act for these devices.
Indications forUse	The Sterile DVR Anatomic Plating System is intended for fixation offractures and osteotomies of the distal radius.
DeviceDescription	The Sterile DVR Anatomic Plating System offers the DVR plating systemof plates and screws in a sterile configuration.
Biocompatibility	The Sterile DVR Anatomic Plating System does not requirebiocompatibility testing.
Summary ofSubstantialEquivalence	The Sterile DVR Anatomic Plating System is substantially equivalent tothe predicate device. Equivalence was confirmed through bench testing.

ﺴﮧ

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Image /page/1/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2009

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

Re: K090374

Trade/Device Names: DePuy Sterile DVR Anatomic Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT

Dated: February 16, 2009 Received: February 17, 2009

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 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 Otaño

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,

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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510(k) Number:

K090374

DePuy Sterile DVR Anatomic Plating System Device Name:

Indications For Use:

The DePuy Sterile DVR Anatomic Plating System is intended for fixation of fractures and osteotomies of the distal radius.

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

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510(k) Number_

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.