The DePuy Synthes 2.7mm VA LCP Clavice Plate System is indicated for fixation of fractures, and nonunions of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

Device Description

The DePuy Synthes 2.7mm VA LCP Clavicle Plate System consists of lateral, shaft and medial plates designed for temporary fixation, correction or stabilization of clavicle bones. The subject plates are available in various sizes in both sterile and non-sterile configurations and are available in stainless steel and titanium alloy. The system also consists of non-implantable templates that correspond to the implants. Templates are intended for implant size selection and are available in non-sterile.

AI/ML Overview

This submission describes a medical device, the DePuy Synthes 2.7mm VA LCP Clavicle Plate System, and its substantial equivalence to predicate devices, rather than a study evaluating the performance of an AI-powered diagnostic device against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and performance metrics for an AI system is not applicable to this document.

However, I can extract and structure the relevant information regarding the device acceptance and the studies conducted to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria	Reported Device Performance
Mechanical Performance	Mechanical performance of the subject devices (DePuy Synthes 2.7mm VA LCP Clavicle Plates) is at least equivalent to that of the predicate devices (DePuy Synthes 3.5mm LCP Reconstruction Plates).	Static and cyclic mechanical testing of constructs has been performed to compare the subject DePuy Synthes 2.7mm VA LCP Clavicle Plates to the predicate DePuy Synthes 3.5mm LCP Reconstruction Plates. This information supports that the mechanical performance of the subject devices is at least equivalent to that of the predicate devices.
Magnetic Resonance (MR) Compatibility	Establish MR Conditional parameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle Plates.	Magnetic Resonance compatibility testing has been performed to establish MR Conditional parameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle Plates.
Endotoxin Level	Sterile subject DePuy Synthes 2.7mm VA LCP Clavicle Plates meet the specified endotoxin requirement of 20 EU/device.	Endotoxin testing has been performed using to the LAL test method to establish that the sterile subject DePuy Synthes 2.7mm VA LCP Clavicle Plates meet the specified endotoxin requirement of 20EU/device.
Biocompatibility	The subject DePuy Synthes 2.7mm VA LCP Clavicle Plates are biologically safe when used as intended.	Biocompatibility evaluation and testing has been performed in accordance with ISO 10993-1 and it is concluded that the subject DePuy Synthes 2.7mm VA LCP Clavicle Plates are biologically safe when used as intended.
Substantial Equivalence	The subject device is substantially equivalent to legally marketed predicate devices, with no new issues of safety and effectiveness identified compared to the predicate devices.	The non-clinical performance data as well as the comparison of indications and design features included in this premarket notification demonstrate that any differences in technological characteristics of the subject devices compared to the predicate devices do not raise any new questions of safety and effectiveness. It is concluded that the information provided herein supports substantial equivalence of the subject devices. (This is the overarching conclusion required for 510(k) clearance).

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

Test Set Sample Size: Not specified for any of the non-clinical tests. For mechanical testing, samples of constructs (presumably plate-bone models) would have been used, but the specific number is not stated. Same for MR compatibility, endotoxin, and biocompatibility - "testing has been performed" implies a sample set was used, but the size is absent from this summary.
Data Provenance: The studies are described as "non-clinical performance data." This strongly suggests laboratory-based testing rather than patient data. No country of origin is specified for the data itself, but the manufacturer is Synthes GMBH, Switzerland, and the sponsor (DePuy Synthes) also has a US address (West Chester, PA). The testing appears to be retrospective, as it was conducted to support a premarket notification for an existing device design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This document describes non-clinical testing of a medical implant, not an AI diagnostic device where expert ground truth is typically assessed. The "ground truth" for these tests would be the measured physical, chemical, or biological properties conforming to established standards and predicate device performance.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI diagnostic study involving human interpretation of results against a gold standard, no adjudication method is relevant.

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. This is not an AI-powered diagnostic device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not Applicable. This is a physical medical device (clavicle plate system), not an algorithm or AI system.

7. The Type of Ground Truth Used

For Mechanical Performance: The "ground truth" is the established mechanical properties of the predicate device (DePuy Synthes 3.5mm LCP Reconstruction Plate) and relevant engineering standards for bone fixation devices. The subject device's performance is compared against these benchmarks.
For MR Compatibility: The "ground truth" is the established MR conditional parameters based on standardized testing procedures.
For Endotoxin: The "ground truth" is the regulatory specified endotoxin limit (20 EU/device) for sterile devices. The LAL test method is a standard to determine this.
For Biocompatibility: The "ground truth" is established biological safety criteria as defined by ISO 10993-1, which guides biocompatibility evaluation and testing.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device that requires a training set. The device is a physical implant.

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

Not Applicable. No training set for an algorithm is involved.

Summary

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DePuy Synthes % Georgina Mueller Regulatory Affairs Specialist II Synthes GMBH Luzernstrasse 21 Zuchwil. SO 4528 Switzerland

Re: K201321

Trade/Device Name: DePuv Synthes 2.7mm VA LCP Clavicle Plate 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 Dated: May 13, 2020 Received: May 18, 2020

Dear Georgina Mueller:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K201321

Device Name

DePuy Synthes 2.7mm VA LCP Clavicle Plate System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Sponsor	DePuy SynthesGeorgina Mueller1301 Goshen ParkwayWest Chester, PA 19380Phone: +41 61 965 63 14
Date Prepared	July 21, 2020
ProprietaryName	DePuy Synthes 2.7mm VA LCP Clavicle Plate System
ClassificationName	Single/multiple component metallic bone fixation appliances and accessories
Classification	Class IIRegulation Number: 21 CFR 888.3030Product Code: HRS
Primarypredicate device	Synthes LCP Reconstruction Plate 3.5 (K000684)
Secondarypredicate device	Synthes 3.5mm LCP Clavicle Plate System (K111540)
DeviceDescription	The DePuy Synthes 2.7mm VA LCP Clavicle Plate System consists of lateral, shaft andmedial plates designed for temporary fixation, correction or stabilization of clavicle bones.The subject plates are available in various sizes in both sterile and non-sterile configurationsand are available in stainless steel and titanium alloy. The system also consists of non-implantable templates that correspond to the implants. Templates are intended for implantsize selection and are available in non-sterile.
Indications foruse	Fixation of fractures, osteotomies, and non-unions of the clavicle in adults, and in bothadolescents (12-18 years) and transitional adolescents (18-21 years), in which the claviculargrowth plates have fused or in which the growth plates will not be crossed by the plate system.
TechnologicalCharacteristics	The design, features, and specifications of the subject and predicate devices are compared below.The range of lengths and widths of the subject devices are similar to those offered in the predicate devices. The subject plates are slightly thinner than the predicate plates. The materials of both the subject and predicate devices are the same for plates offered in stainless steel (i.e. 316L). The materials of the subject and primary predicate plates are similar; i.e. titanium alloy (TAN) and commercially pure Titanium, respectively. The materials for the subject and secondary predicate plates are the same, i.e. TAN. Subject and predicate plates feature Locking and Compression Technology (LCP) and subject plates additionally feature Variable Angle (VA) technology to allow insertion of screws up to 15° angulation in addition to nominal angulation, whereas the predicate plates feature Locking Technology (LCP) only at nominal angulation. The subject and predicate plates have varying screw holes; in number, type and diameter. The subject plates have Variable Angle locking and Combi holes whereas the predicate plates have Locking holes and Combi holes. The subject plate screw holes are 2.7mm diameter whereas the predicate plate screw holes are 3.5mm diameter. All plates are compatible with Cortex Screws to ensure axial and plate-to-bone compression and with screws using locking technology to ensure angular stable fixation. Additional compatible screw types vary for subject (VA Locking, Metaphyseal) and
	predicate (Locking, Cancellous) plates, as do the screw diameters for subject plates(2.7mm) and predicate plates (3.5mm, 2.7mm, 2.4mm and 4.0mm).
	• Subject (Lateral and Shaft) and secondary predicate plates (Superior) feature K-wireholes for temporary fixation, whereas subject (Medial) and primary predicate plates donot feature suture or K-wire holes. Subject plates (Lateral) feature suture holes, which arenot featured in either of the predicate plates.• Subject and secondary predicate plates are pre-contoured to accommodate for anatomicaldifferences and available as mirrored plates dedicated for the left and right clavicle.Primary predicate plates are straight and can be used for left and right clavicle. All platescan be contoured intra-operatively and notches are featured to facilitate plate bending.• Subject plates and secondary predicate plates have a low-profile design to help avoidpotential for soft tissue irritation and feature tapered tips (edges) to facilitate plateinsertion. Primary predicate plates do not feature low-profile design or tapered tips(edges).
Non-clinicalPerformanceData	Static and cyclic mechanical testing of constructs has been performed to compare the subjectDePuy Synthes 2.7mm VA LCP Clavicle Plates to the predicate DePuy Synthes 3.5mm LCPReconstruction Plates. This information supports that the mechanical performance of thesubject devices is at least equivalent to that of the predicate devices.
	Magnetic Resonance compatibility testing has been performed to establish MR Conditionalparameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle Plates.
	Endotoxin testing has been performed using to the LAL test method to establish that the sterilesubject DePuy Synthes 2.7mm VA LCP Clavicle Plates meet the specified endotoxinrequirement of 20EU/device.
	Biocompatibility evaluation and testing has been performed in accordance with ISO 10993-1and it is concluded that the subject DePuy Synthes 2.7mm VA LCP Clavicle Plates arebiologically safe when used as intended.
ClinicalPerformanceData	Clinical testing was not necessary for the determination of substantial equivalence.
SubstantialEquivalence	Both the subject and the predicate devices are intended for the use in temporary fixation,correction or stabilization of clavicle bones during open reduction internal fixation (ORIF)performed by surgeons within a health care facility. Plates are available sterile and non-sterile. Sterile plates are sterilized by gamma irradiation.
	The subject devices have similar indications to the primary predicate and fully align withthe indications of the secondary predicate: fixation of fractures, osteotomies, and non-unionsof the clavicle. The subject devices' patient target population includes both adolescence andadults consistent with the secondary predicate devices. No new issues of safety andeffectiveness for the subject devices have been identified compared to the predicate devices.
	The non-clinical performance data as well as the comparison of indications and designfeatures included in this premarket notification demonstrate that any differences intechnological characteristics of the subject devices compared to the predicate devices do notraise any new questions of safety and effectiveness.
	It is concluded that the information provided herein supports substantial equivalence of thesubject devices.

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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.