The DePuy ALPS Small Bone Locked Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Device Description

The DePuy ALPS Small Bone Locked Plating System consists of a series of plates and screws manufactured from Titanium alloy and CoCr used in bone fixation and the management of fractures and reconstructive surgeries.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the DePuy ALPS Small Bone Locked Plating System:

Based on the provided text, the device is a DePuy ALPS Small Bone Locked Plating System, which is a metallic bone fixation appliance. The documentation is a 510(k) summary, aiming to demonstrate substantial equivalence to legally marketed predicate devices rather than fulfilling specific performance acceptance criteria for a novel device.

Therefore, the "acceptance criteria" here are not performance metrics (like sensitivity or specificity) but rather the demonstration of substantial equivalence to predicate devices. The "study" proving this is a pre-clinical engineering comparison and testing report, not a clinical study involving human or even animal subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Summary of Pre-clinical Data)
Technological Characteristics Similarity: Device's material and design are similar to predicate devices.	The technological characteristics of the DePuy ALPS Small Bone Locked Plating System are similar to the predicate devices including design and material.
Mechanical Performance Equivalence: Device meets mechanical performance standards comparable to predicate devices.	Testing included construct static bending.
Biocompatibility/Corrosion Resistance Equivalence: Device demonstrates similar corrosion resistance to predicate devices.	Testing included galvanic corrosion testing.
Indications for Use Comparison: Device's intended use aligns with predicate devices.	Comparison of indications for use.
Device Geometry and Design Comparison: Device's physical attributes are comparable to predicate devices.	Comparison of device geometry and design.

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

Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The "test set" here refers to the physical samples of the device and predicate devices used for pre-clinical engineering tests. The exact number of samples tested for static bending and galvanic corrosion is not specified, but it would have been a limited number of physical prototypes or manufactured units of the device and its predicates.
Data Provenance: Not explicitly stated. Given that DePuy Orthopaedics, Inc. is based in Warsaw, Indiana, USA, it's highly probable the testing was conducted either internally in the US or outsourced to testing facilities, possibly in the US or Europe, but this is not confirmed by the document. The data is retrospective in the sense that it's a comparison to existing, already marketed predicate devices.

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. "Ground truth" in this context would generally refer to clinical outcomes or expert diagnoses, which are not part of a pre-clinical 510(k) submission for mechanical equivalence. The "truth" here is established by engineering standards and comparison data from predicate devices, likely interpreted by engineers and regulatory specialists.

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

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data (e.g., medical image interpretation). For pre-clinical mechanical testing and substantial equivalence, the "adjudication" is typically a regulatory review process by the FDA based on the provided engineering test reports and comparisons.

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 diagnostic devices, particularly those involving interpretation by human readers (e.g., radiology AI). The DePuy ALPS Small Bone Locked Plating System is a surgical implant, not a diagnostic tool requiring human interpretation comparison in this manner.

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

No, an algorithm-only standalone performance study was not done. This device is a physical surgical implant, not an algorithm or AI system.

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

For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily based on:
- Engineering Standards and Measurements: Objective measurements from static bending and galvanic corrosion tests.
- Predicate Device Data: Existing, legally marketed predicate device materials, design specifications, and performance data.
- Regulatory Definitions: Compliance with regulatory definitions of "substantial equivalence" based on comparison of indications for use, materials, device geometry, and design.

8. The sample size for the training set

Not applicable. This device is not an AI or machine learning model that requires a "training set."

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

Not applicable for the same reason as above.

Summary

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Section 5 — 510(k) Summary

Submitted by:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581Phone: (305) 269-6386Fax: (305) 269-6441
	JUL 2 3 2010
Contact Person:	Suzana Otaño, Project Manager, Regulatory Affairs
Date Prepared:	April 29, 2010
Proprietary Name:	DePuy ALPS Small Bone Locked Plating System
Common Name:	Plate, Fixation, Bone
Classification Name:	Single/multiple component metallic bone fixation appliances andaccessories (21 CFR § 888.3030)
Predicate Devices:	The DePuy ALPS Small Bone Locked Plating System is substantiallyequivalent to currently marketed devices including DePuy's LCL &Fusion Plating System (K091294) and Mini Fragment Plating System(K061748).
Device Description:	The DePuy ALPS Small Bone Locked Plating System consists of aseries of plates and screws manufactured from Titanium alloy andCoCr used in bone fixation and the management of fractures andreconstructive surgeries.
Indications for Use:	The DePuy ALPS Small Bone Locked Plating System is intended foruse in stabilization and fixation of fractures, revision procedures,fusions, reconstructions (osteotomy) and non-unions of the bones ofthe hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle,scapula and pelvis, particularly in osteopenic bone. The system canbe used in both adult and pediatric patients (adolescents [>12 - 21years of age]), where the implant would not cross open epiphysealplates in skeletally immature patients.
TechnologicalCharacteristics:	The technological characteristics of the DePuy ALPS Small BoneLocked Plating System are similar to the predicate devices includingdesign and material.
Summary ofSubstantialEquivalence:	The DePuy ALPS Small Bone Locked Plating System is substantiallyequivalent to currently marketed devices as demonstrated with pre-clinical data. Testing included construct static bending and galvaniccorrosion testing, in addition to a comparison of indications for use,materials, device geometry and design forming a basis for adetermination of substantial equivalence to legally marketedpredicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract human figure or a caduceus, with three curved lines representing the body and a base that looks like intertwined snakes or roots.

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

JUL 2 3 2010

DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K101240

Trade/Device Name: DePuy ALPS Small Bone Locked Plating System Regulation Number: 21 CFP. 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 29, 2010 Received: May 4, 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. 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.

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

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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 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 yours,

Mark M. Millman

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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SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number:

DePuy ALPS Small Bone Locked Device Name: Plating System

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)

Quta for nxm
Division Sign off

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

510(k) Number K101240

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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.