The DePuy Anatomic Locked Plating System Extra Long Plate Line Extension is intended for fixation of fractures, fusions, osteotomies and nonunions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone.

Device Description

The Anatomic Locked Plating System Extra Long Plate Line Extension offers various longer length anatomically contoured plates for use with non-locking, locking and variable angle screws. With conventional nonlocking plating, compression of the plate to the bone is a necessary mode of action. However, with locking plating technology, the plate does not need to contact bone or load against the periosteum for construct strength. The locking plate/screw construct provides stability even in osteopenic bone where screw purchase can be more difficult. These posterior lateral plates will be available in 210mm and 250mm lengths.

AI/ML Overview

The provided document is a 510(k) summary for the DePuy Anatomic Locked Plating System Extra Long Plate Line Extension. It outlines the device's characteristics, its substantial equivalence to predicate devices, and its intended use.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Predetermined Acceptance Criteria (specific criteria are not detailed in this summary, but are implied)	Performed equivalently to the predicate devices. This implies that the device successfully met all defined criteria for mechanical properties like load and bend strength, and functional performance in a biological model.
Achieve "Substantial Equivalence" to predicate devices (K082300 and K072423)	Confirmed through bench testing and validation in cadaveric models.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated. The document mentions "bench testing" and "validation in cadaveric models" but does not provide specific numbers for the plates tested or the number of cadavers used.
Data Provenance: The testing was likely conducted in a controlled laboratory environment by the manufacturer (DePuy Orthopaedics, Inc. in Warsaw, IN). The data is prospective in the sense that it was generated specifically for this submission to demonstrate equivalence. The country of origin for the data is implicitly the USA given the address of the submitting company.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For a medical device like a bone plate, "ground truth" typically refers to established biomechanical standards and measurements, and potentially expert evaluation of surgical construct stability in cadaveric models. The document doesn't detail who performed these evaluations or their qualifications.

4. Adjudication method for the test set

This information is not provided. Given the nature of bench testing and cadaveric validation for a bone plate, it's less likely to involve a human adjudication process in the same way an imaging AI might. Instead, performance is measured against established engineering and biomechanical specifications.

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 comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is involved. This device is a mechanical implant (bone plate), and its effectiveness is determined through mechanical testing and biological modeling, not human reader performance.

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

This question is not applicable to the device described. This device is a bone plate, not an algorithm or a system that operates with or without human-in-the-loop performance. Its performance is entirely "standalone" in the sense that its mechanical properties are inherent to the device itself.

7. The type of ground truth used

The ground truth for this device's performance relies on established biomechanical engineering standards and specifications. This includes:
- Mechanical Load and Bend Testing: Measuring the plate's resistance to deformation and failure under various forces, simulating physiological loads.
- Cadaveric Model Validation: Assessing the plate's performance and stability when implanted in human cadaveric bone, simulating surgical application. This type of "ground truth" in this context is based on in vitro and ex vivo experimental data, comparing its performance directly to the legally marketed predicate devices.

8. The sample size for the training set

This question is not applicable to the device described. There is no mention of "training set" as this is a physical medical device, not an AI or machine learning model that requires a training set.

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

This question is not applicable for the reasons stated above (no training set for a physical implantable device).

In summary, the substantial equivalence of the DePuy Anatomic Locked Plating System Extra Long Plate Line Extension was established through direct comparison to predicate devices using bench testing (load and bend testing) and cadaveric validation. The acceptance criteria, while not explicitly detailed in quantitative terms in this summary, were met by demonstrating equivalent performance to the predicate devices in these tests.

Summary

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K103408
pg 1/2

DEC 1 6 2010

510(k) Summary

DePuy Orthopaedics, Inc. Submitted by: 700 Orthopaedic Drive Warsaw, IN 46581 Phone: (305) 269-6386 Fax: (305) 269-6441 Contact Person: Suzana Otaño, Project Manager, Regulatory Affairs Date Prepared: November 17, 2010 General The name of the device is: Provisions Proprietary Name Common or Usual Name Anatomic Locked Plating System Plate, Fixation, Bone Extra Long Plate Line Extension The device is substantially equivalent to the currently marketed DePuy Name of Predicate Anatomic Locked Plating System Extra Long Plate Line Extension System. K082300 and DePuy's Large Fragment Locking Plating System Devices K072423. Class II, 21 CFR 888.3030 Classification Performance Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act for these devices. Standards The Anatomic Locked Plating System Extra Long Plate Line Extension Device Description offers various longer length anatomically contoured plates for use with non-locking, locking and variable angle screws. With conventional nonlocking plating, compression of the plate to the bone is a necessary mode of action. However, with locking plating technology, the plate does not need to contact bone or load against the periosteum for construct strength. The locking plate/screw construct provides stability even in osteopenic bone where screw purchase can be more difficult. These posterior lateral plates will be available in 210mm and 250mm lengths. The Anatomic Locked Plating System Extra Long Plate Line Extension is Indications for intended for fixation of fractures, fusions, osteotomies and non-unions of Use the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone.

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K103408
Pg2/2

Technological Characteristics

The technological characteristics of the Anatomic Locked Plating System Extra Long Plate Line Extension are similar to the predicate devices in both design and material. The systems are manufactured from titanium alloy. Dimensional characteristics are similar among the systems including thickness, width and length.

Summary of Substantial Equivalence

The Anatomic Locked Plating System Extra Long Plate Line Extension is substantially equivalent to the predicate devices as confirmed through bench testing. Load and bend testing, as well as validation in cadaveric models, demonstrated that the Extra Long Plate Line Extension performed equivalently to the predicate devices, successfully meeting the predetermined acceptance criteria.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

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

DEC 16 2019

Re: K103408

Trade/Device Name: DePuy Anatomic Locked Plating System Extra Long Plate Line Extension Regulation Number: 21 CFP. 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: November 17, 2010 Received: November 19, 2010

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 noi 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Susan Otaño

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 liusting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of modical device-related adverse events) (21 CFR 803); 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 100-0-1050,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1118001.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CF) Plat 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffer no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

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510(k) Number:

K103408

DEC 1 6 2010

DePuy Anatomic Locked Plating System Extra Device Name: Long Plate Line Extension

Indications For Use:

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)

Ar M. Melkorm

(Division $)gn-Off)
Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K103408

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.