The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

Device Description

The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System consists of the plate types Long, Short and Button which can be used to treat simple and complex clavicle fractures including malunions, non-unions and isolated ligamentous injuries of the AC joint. The subject plates are available in three hook depths, in left- and right-side versions, in both sterile and non-sterile configurations and are available in stainless steel and titanium. The system also consists of non-implantable templates that correspond to the implants. Templates are intended for implant size selection and are available non-sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove acceptance criteria for a novel AI/software device.

Therefore, many of the requested elements for describing an AI-driven device's acceptance criteria and studies (like sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this document. The document describes a traditional medical device (metallic bone fixation appliance).

Here's a breakdown based on the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of acceptance criteria in the way it would for an AI device. Instead, it focuses on demonstrating that the performance of the new device is at least equivalent to the predicate device.

Criteria/Test	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance	Mechanical performance is at least equivalent to the predicate device (Synthes 3.5mm LCP Clavicle Hook Plates, K061753).	"Mechanical performance testing of constructs has been performed to compare the subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates to the predicate DePuy Synthes 3.5mm LCP Clavicle Hook Plates. This data supports that the mechanical performance of the subject devices is at least equivalent to that of the predicate devices."
MR Compatibility	Established MR Conditional parameters.	"A magnetic resonance compatibility assessment has been performed to establish MR Conditional parameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates."
Endotoxin Content	Meets specified endotoxin requirement of 20EU/device.	"Endotoxin testing has been performed according to the LAL test method to establish that the sterile subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates meet the specified endotoxin requirement of 20EU/device."
Biocompatibility	Biologically safe when used as intended, in accordance with ISO 10993-1.	"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 Hook Plates are biologically safe when used as intended."
Substantial Equivalence	No new issues of safety and effectiveness compared to the predicate device.	"The non-clinical performance data as well as the comparison of 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 issues of safety and effectiveness."

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

Not applicable. This document describes mechanical, material, and biological testing, not a clinical study on patient data to evaluate algorithmic performance. The "test set" would refer to physical devices or materials used in the non-clinical performance tests. Specific sample sizes for these tests are not provided in this summary but would be detailed in the full submission. Data provenance is implied to be from laboratory testing.

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

Not applicable. Ground truth in the context of an AI device typically refers to expert labels on a dataset. For this medical device, "ground truth" would be established by validated engineering tests and established biological safety standards.

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

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/software ground truth. This is not a study involving expert review of images or data.

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 study is not mentioned as this is not an AI-assisted device. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

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

No. This is not an algorithm or AI device.

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

For mechanical performance: Ground truth is established by engineering standards and comparison to a known predicate device's performance.
For MR Compatibility: Ground truth is established by specific testing protocols and standards (e.g., ASTM F2503).
For Endotoxin Testing: Ground truth is established by established laboratory methods (LAL test) and regulatory limits (20 EU/device).
For Biocompatibility: Ground truth is established by international standards (ISO 10993-1) and biological safety evaluations.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary

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September 11, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K201959

Trade/Device Name: DePuy Synthes 2.7mm VA LCP Clavicle Hook 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: July 7, 2020 Received: July 14, 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.

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

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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 (QS) 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,

for - 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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K201959

Device Name DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System

Indications for Use (Describe)

The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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5 510(k) Summary

Sponsor	DePuy SynthesGeorgina Mueller1301 Goshen ParkwayWest Chester, PA 19380Phone: +41 61 965 63 14
Date Prepared	September 3, 2020
Proprietary Name	DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
Classification Name	Single/multiple component metallic bone fixation appliances and accessories
Classification	Class IIRegulation Number: 21 CFR 888.3030Product Code: HRS
Predicate device	Synthes 3.5mm LCP Clavicle Hook Plates (Synthes USA Clavicle Hook Plate;K061753)
Device Description	The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System consists of the platetypes Long, Short and Button which can be used to treat simple and complex claviclefractures including malunions, non-unions and isolated ligamentous injuries of the ACjoint. The subject plates are available in three hook depths, in left- and right-side versions,in both sterile and non-sterile configurations and are available in stainless steel andtitanium. The system also consists of non-implantable templates that correspond to theimplants. Templates are intended for implant size selection and are available non-sterile.
Indications for use	The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixationof lateral clavicle fractures and dislocations of the acromioclavicular joint.
TechnologicalCharacteristics	The design, features, and specifications of the subject and predicate devices are comparedbelow.The range of plate lengths, thickness and hook depths of the subject devices aresimilar to those offered in the predicate devices. The subject plate hooks areangulated, whereas the predicate plate hooks are not. The materials of both the subject and predicate devices are the same with platesoffered in stainless steel and titanium (i.e. 316L and commercially pure titanium). The subject and predicate plates have varying screw holes; in number, type anddiameter. Subject and predicate plates feature Locking and Compression Technology(LCP) and subject plates additionally feature Variable Angle (VA) technology toallow insertion of screws up to 15° angulation in addition to nominal angulation,whereas the predicate plates feature Locking Technology (LCP) only at nominalangulation. The subject plates have Variable Angle locking and Combi holes whereas thepredicate plates have Locking holes and Combi holes. The subject plate screwholes are 2.7mm diameter whereas the predicate plate screw holes are 3.5mmdiameter. All plates are compatible with Cortex Screws to ensure axial and plate-to-bonecompression and with screws using locking technology to ensure angular stablefixation. Additional compatible screw types vary for subject (VA Locking,Metaphyseal) and predicate (Locking, Cancellous) plates, as do the screwdiameters for subject plates (2.7mm) and predicate plates (3.5mm and 4.0mm).
		Subject plates feature Suture / K-wire holes, whereas these are not featured in the•predicate plates.
		Both subject and predicate plates are pre-contoured to accommodate for anatomicaldifferences, are available as mirrored plates dedicated for the left and right clavicleand are designed to allow intra-operative contouring.
		Plates have a rounded shaft-profile to reduce prominence and feature tapered tips•(edges) to facilitate plate insertion. Subject plates (long version only) feature notchesto facilitate plate bending, whereas the predicate plates do not feature notches.
Non-clinicalPerformance Data		Mechanical performance testing of constructs has been performed to compare the subjectDePuy Synthes 2.7mm VA LCP Clavicle Hook Plates to the predicate DePuy Synthes3.5mm LCP Clavicle Hook Plates. This data supports that the mechanical performance ofthe subject devices is at least equivalent to that of the predicate devices.
		A magnetic resonance compatibility assessment has been performed to establish MRConditional parameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle HookPlates.
		Endotoxin testing has been performed according to the LAL test method to establish thatthe sterile subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates meet the specifiedendotoxin requirement of 20EU/device.
		Biocompatibility evaluation and testing has been performed in accordance with ISO10993-1 and it is concluded that the subject DePuy Synthes 2.7mm VA LCP ClavicleHook Plates are biologically safe when used as intended.
ClinicalPerformance Data		Clinical testing was not necessary for the determination of substantial equivalence.
SubstantialEquivalence		Both the subject and the predicate devices are intended for use in fixation of the clavicleand the acromioclavicular joint during open reduction internal fixation (ORIF)performed by surgeons within a health care facility. Subject plates are available sterileand nonsterile, whereas the predicate plates are available sterile only. Sterile plates forboth subject and predicate are sterilized by gamma irradiation.
		The subject devices have the same indications as the predicate 3.5mm LCP ClavicleHook Plates (K061753).
		The non-clinical performance data as well as the comparison of design features includedin this premarket notification demonstrate that any differences in technologicalcharacteristics of the subject devices compared to the predicate devices do not raise anynew issues of safety and effectiveness.
		It is concluded that the information provided herein supports substantial equivalence ofthe subject 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.