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

Device Description

The Anatomic Locked Plating System Long Plate Line Extension offers various longer length anatomically contoured plates for use with nonlocking, locking and variable angle screws. With conventional non-locking 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.

AI/ML Overview

The supplied text describes a 510(k) premarket notification for a medical device called the "DePuy Anatomic Locked Plating System Long Plate Line Extension." However, it does not contain the specific details required to complete all sections of your request concerning acceptance criteria and a study that proves the device meets them in the context of an AI/human reader study.

Based on the provided text, here's what can be extracted:

Device Type: This is a physical bone fixation device (plate, fixation, bone long plate line extension), not a software or AI-driven diagnostic tool. Therefore, many of the questions related to AI performance, human readers, ground truth for algorithms, etc., are not applicable to this particular submission.
Study Type: The device's equivalency was established through bench testing.

Here's a breakdown of the information that can be answered and what cannot be answered from the provided text, along with explanations:

Acceptance Criteria and Device Performance Study for DePuy Anatomic Locked Plating System Long Plate Line Extension

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate devices)	Reported Device Performance (bench testing)
Not explicitly detailed in the document. The text states "pre-determined acceptance criteria" (implicitly based on predicate device performance).	"Load and bend testing demonstrated that the Long Plate Line Extension performed equivalently to the predicate devices, successfully meeting the pre-determined acceptance criteria."

Explanation: The document states that the device successfully met "pre-determined acceptance criteria" through "load and bend testing." However, the specific numerical or qualitative criteria (e.g., maximum deflection, ultimate load, fatigue cycles) are not detailed in this summary. These would typically be specified in the full test protocols and reports, which are not included here.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. This typically refers to the number of physical plates tested in bench studies.
Data Provenance: Not applicable in the conventional sense (e.g., country of origin for clinical data). The data comes from bench testing performed by the manufacturer, DePuy Orthopaedics, Inc., at their facilities (indicated by the submission address in Warsaw, IN).
Retrospective/Prospective: Not applicable as it's not a clinical study. It's a laboratory-based, prospective testing of new device samples.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a hardware device tested via physical bench testing, not an AI or diagnostic device that requires expert review for ground truth establishment.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-AI studies or clinical trials, not for bench testing of mechanical properties. The "ground truth" here is the physical performance measured against engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not done. This type of study is relevant for diagnostic devices (e.g., imaging software) where human readers interpret medical images or data, and an AI's impact on their performance is evaluated. This device is a bone fixation plate.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not Applicable. This question pertains to AI algorithms. The DePuy Anatomic Locked Plating System is a physical implant.

7. Type of Ground Truth Used

Engineering Specifications / Predicate Device Performance. For mechanical devices, the "ground truth" in performance testing is typically defined by established engineering standards (e.g., ASTM, ISO) or, in the case of 510(k) submissions, by demonstrating equivalence to the performance of legally marketed predicate devices. The document implies that the acceptance criteria were derived from the performance of the predicate devices (K082300 and K072083).

8. Sample Size for the Training Set

Not Applicable. This device uses physical bench testing for performance demonstration, not a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As above, no training set in the machine learning sense was used. The product's design and manufacturing processes are likely informed by engineering principles, material science, and clinical needs, but not data-driven "ground truth" for a training set.

In summary, the provided document is a 510(k) summary for a mechanical medical device (bone plate). Many of your questions are tailored towards AI/software medical devices or clinical studies, which are not applicable to this submission. The performance demonstration was entirely based on bench testing to show equivalence to predicate devices in terms of mechanical properties.

Summary

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K101421 (1/2)

510(k) Summary JUN 1 6 2010 Submitted by: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581 Phone: (305) 269-6386 Fax: (305) 269-6441 Contact Person: Suzana Otaño, Project Manager, Regulatory Affairs Date Prepared: May 19, 2010 General The name of the device is: Provisions Proprietary Name Common or Usual Name Anatomic Locked Plating System Plate, Fixation, Bone Long Plate Line Extension Name of The device is substantially equivalent to the currently marketed DePuy Anatomic Locked Plating System Long Plate Line Extension System. Predicate Devices K082300 and DePuy's Small Fragment Locking Plating System K072083. Classification Class II, 21 CFR 888.3030 Performance Performance standards have not been established by the FDA under Standards section 514 of the Food, Drug and Cosmetic Act for these devices. Device The Anatomic Locked Plating System Long Plate Line Extension offers Description various longer length anatomically contoured plates for use with nonlocking, locking and variable angle screws. With conventional non-locking 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. Indications for The Anatomic Locked Plating System Long Plate Line Extension is Use intended for fixation of fractures, fusions, osteotomies and non-unions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone. Technological The technological characteristics of the Anatomic Locked Plating System Characteristics Long Plate Line Extension are similar to the predicate devices in both design and material. The systems are manufactured from titanium allov. Dimensional characteristics are similar among the systems including thickness, width and length.

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Summary of Substantial Equivalence The Anatomic Locked Plating System Long Plate Line Extension is substantially equivalent to the predicate devices as confirmed through bench testing. Load and bend testing demonstrated that the Long Plate Line Extension performed equivalently to the predicate devices, successfully meeting the pre-determined acceptance criteria.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure, with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

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

JUN 1 6 2010

DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Regulatory Affairs Project Manager 700 Orthopaedic Drive Warsaw, Indiana 16581

Re: K101421

Trade/Device Name: DePuy Anatomic Locked Plating System Long Plate Line Extension Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC, HTN Dated: May 19, 2010 Received: May 20, 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 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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/ucm115809.htm 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" (21CFR Part 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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vou

Barbara Kuchno

Mark N. Melk 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:

K101421

DePuy Anatomic Locked Plating System Long Device Name: 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)

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(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101421

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DePuy Anatomic Locked Plating System Long Plate Line Extension Special 510(k)

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.