The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:

Open reduction and internal fixation of fractures, mal-unions, and non-unions
Following excision of benign bone tumors
Replantations and reconstructions
Arthrodeses of joints involving small bones
Osteotomies, including deformity correction such as rotation, lengthening, shortening
Pathological fractures, including impending pathologic fractures

Device Description

The DePuy Synthes Variable Angle Locking Hand System consists of metallic plates and screws that offer screw-to-plate locking designed for various fracture modes of the hand. Generally, the system consists of plates, screws, and instruments which feature variable angle locking technology. The plates contained in the DePuy Synthes Variable Angle Locking Hand System are offered in a range of configurations to accommodate patient anatomy and surgical need. The plates are designed to accept existing 1.5mm cortex screws (K090047), previously cleared 1.5mm Locking Screws at the nominal angle only (K090047), and new 1.5mm VA Locking Screws. The new 1.5mm VA Locking Screws feature existing variable angle locking technology (K100776, K120689, K110354), and are designed to fit in the 1.5mm holes of the subject plates.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (DePuy Synthes Variable Angle Locking Hand System). This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance as would be seen in a PMA or De Novo submission.

Therefore, the document does not contain information typically found in acceptance criteria and study reports for software/AI devices (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details).

However, it does describe the non-clinical testing performed to demonstrate the substantial equivalence of the mechanical aspects of the device.

Here's an analysis of what information is available in the provided text, structured to address your request as much as possible given the limitations of the document:

Acceptance Criteria and Study to Prove Device Performance

This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing rather than clinical performance metrics with specific acceptance criteria typically associated with software or AI devices. The information below reflects the mechanical performance testing mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the non-clinical tests in the format of a table, nor does it provide the quantitative results of these tests. Instead, it lists the types of tests performed to support the device's performance and substantial equivalence to predicates.

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied by testing)
Mechanical Strength & Durability	Dynamic Fatigue Testing: Performed on representative constructs to assess long-term durability and resistance to cyclic loading.
Screw Torsional Properties	Torsional properties of 1.5mm VA Locking Screws per ASTM F543: Demonstrates the screw's resistance to twisting forces during insertion or under load.
Screw Pullout Strength	Pullout strength of 1.5mm VA Locking Screws per ASTM F543: Assesses the strength of the screw's fixation in bone.
Screw Insertion Torque	Insertion Torque of 1.5mm VA Locking Screws per ASTM F543: Evaluates the force required to insert the screws.
Structural Integrity & Stress Distribution	Finite Element Analysis (FEA): Used to determine worst-case constructs and analyze stress distribution within the device and its interaction with simulated bone.
Material Biocompatibility	Not explicitly mentioned in the "Substantial Equivalence" section but implied for all implantable devices.

2. Sample Size and Data Provenance

Sample Size for Test Set: Not specified for the mechanical tests. For non-clinical mechanical testing, sample sizes are typically determined by relevant ASTM standards or internal validation protocols, often involving a small number of representative samples.
Data Provenance: The tests are non-clinical (laboratory-based) and conducted by the manufacturer (DePuy Synthes). Country of origin is implied to be within the manufacturer's operational locations (e.g., USA, as the submitting entity is Synthes USA). The data is by nature "prospective" in the sense that the tests were designed and executed to evaluate this specific device configuration.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a mechanical implant, not an AI/software device requiring expert interpretation for ground truth establishment. The "ground truth" for mechanical testing is established by the physical properties of the materials and designs under standardized test conditions.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for clinical image interpretation or diagnostic decisions, not for mechanical testing of orthopedic implants.

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

Not applicable. This is a mechanical orthopedic implant, not an imaging device or AI diagnostic tool that would typically involve human readers.

6. Standalone Performance

The "standalone performance" in this context refers to the device's mechanical performance in laboratory settings, independent of human interaction during the test itself. The non-clinical tests (Dynamic Fatigue, Torsional, Pullout, Insertion Torque, FEA) evaluate the device in this standalone capacity.

7. Type of Ground Truth Used

For the mechanical tests, the "ground truth" is defined by:

Standard ASTM methodologies: (e.g., ASTM F543 for screw properties).
Engineering principles and material properties: Used in Finite Element Analysis.
Physical measurements under controlled laboratory conditions.

This differs significantly from a "ground truth" for a diagnostic medical device which would involve expert consensus, pathology, or outcomes data.

8. Sample Size for Training Set

Not applicable. This is a mechanical device, not an AI/machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm involved in the primary function or evaluation of this mechanical device.

Summary

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

March 30, 2015

Synthes USA Mr. Nicholas Fountoulakis Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K141527

Trade/Device Name: DePuy Synthes Variable Angle Locking Hand System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: February 18, 2015 Received: February 19, 2015

Dear Mr. Fountoulakis:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Nicholas Fountoulakis

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (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 -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

DePuySynthes Variable Angle Locking Hand System

Indications for Use (Describe)

System indications include the following:

· Open reduction and internal fixation of fractures, mal-unions, and non-unions
· Following excision of benign bone tumors
· Replantations and reconstructions
· Arthrodeses of joints involving small bones
· Osteotomies, including deformity correction such as rotation, lengthening, shortening
· Pathological fractures, including impending pathologic fractures

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Date Prepared: March 16, 2015

Date Prepared:	March 16, 2015
Sponsor:	DePuy SynthesNicholas Fountoulakis1301 Goshen ParkwayWest Chester, PA 19380Office: (610) 719-6553Fax: (484)-356-9682
ProprietaryName:	DePuy Synthes Variable Angle Locking Hand System
Classification:	Classification: §888.3030, §888.3040Product Code: HRS, HWC
PredicateDevice:	Synthes 1.5mm LCP Mini-Fragment System (K090047)Synthes Locking Hand Plates (K092247)Synthes Stainless Steel Modular Hand System (K030310)Synthes VA Locking Screws (K100776, K120689, K110354)
DeviceDescription:	The DePuy Synthes Variable Angle Locking Hand System consists of metallic platesand screws that offer screw-to-plate locking designed for various fracture modes ofthe hand. Generally, the system consists of plates, screws, and instruments whichfeature variable angle locking technology. The plates contained in the DePuy SynthesVariable Angle Locking Hand System are offered in a range of configurations toaccommodate patient anatomy and surgical need. The plates are designed to acceptexisting 1.5mm cortex screws (K090047), previously cleared 1.5mm Locking Screwsat the nominal angle only (K090047), and new 1.5mm VA Locking Screws. The new1.5mm VA Locking Screws feature existing variable angle locking technology(K100776, K120689, K110354), and are designed to fit in the 1.5mm holes of thesubject plates.
Indications forUse:	The DePuy Synthes Variable Angle Locking Hand System is intended for fracturefixation of the hand and other small bones and small bone fragments, in adults andadolescents (12-21) particularly in osteopenic bone.System indications include the following:Open reduction and internal fixation of fractures, mal-unions, and non-●unionsFollowing excision of benign bone tumors●Replantations and reconstructions●Arthrodeses of joints involving small bones●Osteotomies, including deformity correction such as rotation,●lengthening, shorteningPathological fractures, including impending pathologic fractures●
SubstantialEquivalence:	The proposed DePuy Synthes Variable Angle Locking Hand System shares the samefundamental technological characteristics as the predicate systems (K090047,K092247, K100776, K120689, and K110354).Non-Clinical information has been provided in support of the performance of thesubject system as follows:Finite Element Analysis to determine worst case constructs●Dynamic Fatigue Testing on representative constructs●Torsional properties of 1.5mm VA Locking Screws per ASTM F543●Pullout strength of 1.5mm VA Locking Screws per ASTM F543●Insertion Torque of 1.5mm VA Locking Screws per ASTM F543●Literature has been provided to support the revision in indications, including theaddition of the adolescent population.The same technologies are used across the subject and predicate systems throughfeatures such as Combi-holes, limited contact profiles, variable and standard lockingtechnology, anatomic contours, and similar size ranges. Based on the presentedcomparisons and discussions, the subject DePuy Synthes Variable Angle LockingHand System does not raise any new issues of safety and efficacy.

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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.