The Synthes 4.5mm VA-LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.

The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant. The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.

Device Description

The Synthes 4.5mm VA-LCP Curved Condylar Plate System consists of anatomically-contoured, stainless steel and titanium plates and screws featuring variable angle locking and combi-holes designed to provide stable fixation of the distal femur and system-specific instrumentation. The current 510(k) introduces OPTILINK™ Technology stainless steel screws, positioning pins for cerclage cable, and system-specific instrumentation as a line extension to the currently cleared Synthes 4.5mm VA-LCP Curved Condylar Plate System.

AI/ML Overview

The provided text is a 510(k) summary for the "Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins". This document is a premarket notification for a medical device seeking substantial equivalence to existing devices. It focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the way one might for a novel AI device or a device requiring a PMA.

Therefore, the information typically requested in your prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable to this type of regulatory submission. This submission primarily relies on non-clinical performance data and material characterization to demonstrate substantial equivalence to predicate devices, and explicitly states that "Clinical data was not needed to demonstrate the safety and effectiveness of the proposed devices."

Since this is a Class II device and a line extension, the focus is on mechanical and material testing to ensure it performs comparably to the predicate.

Here's an attempt to answer your questions based only on the information available in the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" in this context:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance (Summary)
Mechanical Performance	Dynamic Fatigue Construct Testing	Subject OPTILINK™ screws met performance requirements.
	Connection Strength Testing	Subject OPTILINK™ screws met performance requirements.
	Torque-through and screw recess torsion tests	Subject OPTILINK™ screws met performance requirements.
	ASTM-543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws (Torsional Properties, Insertion/Removal Torque, Pull-out Strength)	Subject OPTILINK™ screws met performance requirements.
Biocompatibility	Endotoxin Requirement (LAL test method)	Devices met the specified endotoxin requirement of 20EU/device.
Material Characterization	Metallurgical Corrosion Behavior (anodic polarization, galvanic and fretting corrosion assessments)	Demonstrated substantial equivalence to the predicate device using both stainless steel and titanium plates.

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

Test Set Sample Size: Not provided. The document refers to "testing" and "evaluations" but does not specify the number of samples or specimens used in these mechanical or material tests.
Data Provenance: Not specified, but generally refers to laboratory testing. Not applicable for retrospective/prospective human data.

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

Not applicable. Ground truth as typically understood for AI/clinical studies (e.g., expert consensus on image interpretation) is not relevant for mechanical and material testing of an orthopedic implant. Performance is evaluated against engineering standards and specifications.

4. Adjudication method for the test set

Not applicable. Performance is measured against predetermined test specifications and standards for mechanical and material properties. There is no "adjudication" in the clinical sense.

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

Not applicable. This is not an AI device or an imaging device requiring human-in-the-loop performance evaluation.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" equivalent in this context would be the established engineering standards and material specifications (e.g., ASTM standards, specified endotoxin limits) that the device must meet, and the performance characteristics of the predicate device for comparison.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

Summary based on the document:

The device (Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins) demonstrates its performance and safety through non-clinical testing, material characterization, and comparison to a legally marketed predicate device (Synthes 4.5mm VA LCP Curved Condylar Plate System (K110354)) to establish "substantial equivalence." The evaluations included various mechanical tests (Dynamic Fatigue, Connection Strength, Torque, Torsional Properties, Insertion/Removal Torque, Pull-out Strength) and material tests including endotoxin and corrosion assessments. All performed tests indicated that the device met the required specifications and demonstrated substantial equivalence to the predicate device. No clinical data or human reader studies were deemed necessary for this 510(k) submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.

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

March 29, 2017

DePuy Synthes Christopher J. Medberry, PhD, RAC Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K162124 Trade/Device Name: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDP, HWC, JDQ, HRS Dated: March 1, 2017 Received: March 2, 2017

Dear Dr. Medberry:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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" (21 CFR 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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Indications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K162124
Device Name	Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension
Indications for Use (Describe)	The Synthes 4.5mm VA LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

PSC Publishing Services (301) 443-6740

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K162124
Device Name	Variable Angle Positioning Pins
Indications for Use (Describe)	The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant.The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW:

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

PSC Polishing Services (901) 443-6740

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Date Prepared: March 28, 2017
DePuy Synthes Sponsor:
Primary Contact: Christopher J. Medberry. PhD. RAC Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6806 Email: cmedberr@its.jnj.com
Secondary Contact: Stacey Bonnell, MBA, RAC Associate Director Regulatory Affairs 1301 Goshen Parkway West Chester, PA 19380 (610) 719-5895 Email: sbonnell@its.jnj.com

Bundled Submission/Device Names:

1. Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension
1. Variable Angle Positioning Pins
Requlation: Screws: §888.3030; Condylar Plate Fixation Implant - Single/multiple component metallic bone fixation appliances and accessories §888.3040; Screw, Fixation, Bone - Smooth or threaded metallic bone fixation fastener. Positioning Pins: §888.3010; Cerclage, Fixation - Bone fixation cerclage. System-specific Instruments: §888.3030; Condylar Plate Fixation Implant - Single/multiple component metallic bone fixation appliances and accessories; Classification/ Product Code: Screws: Class II / JDP, HWC Positioning Pins: Class II /JDQ System-specific Instruments: Class II / JDP, HRS, HWC Synthes 4.5mm VA LCP Curved Condylar Plate System (K110354) Predicate Devices: 3.5 mm VA Locking Positioning Pin (K120689) Reference Devices: Synthes 4.5 mm LCP Plate (K041911) Synthes 4.5 mm Broad LCP Plate (K000682) Synthes Cortical Screws (K112583) LCP Condylar Plate (K000066) Device Description: The Synthes 4.5mm VA-LCP Curved Condylar Plate System consists of anatomically-contoured, stainless steel and titanium plates and screws featuring variable angle locking and combi-holes designed to provide stable fixation of the distal femur and system-specific instrumentation. The current 510(k) introduces OPTILINK™ Technology stainless steel

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screws, positioning pins for cerclage cable, and system-specific instrumentation as a line extension to the currently cleared Synthes 4.5mm VA-LCP Curved Condylar Plate System.

Intended Use/ Indications for Use:

Bundled Device #1 IFU: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension The Synthes 4.5mm VA-LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supracondylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions. Bundled Device #2 IFU: Variable Angle Positioning Pins The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant. The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws. Non-clinical Information presented supports substantial equivalence of the Synthes Performance Data: 4.5mm VA-LCP Curved Condylar Plate System Line extension parts and variable angle positioning pins compared to and compatible to the predicate Synthes 4.5mm VA-LCP Curved Condylar Plate System. The subject OPTILINK™ screws and Variable Angle Positioning Pins have the same indications for use, are similar in design, material, and fundamental technology as the predicates. The mechanical performance of the subject OPTILINK™ screws have been evaluated via Dynamic Fatigue Construct testing, Connection Strength testing, Torque-through and screw recess torsion tests, ASTM-543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws testing, which evaluated Torsional Properties, Insertion/Removal Torque, and Pull-out Strength. The devices also meet the specified endotoxin requirement of 20EU/device using the LAL test method.

Clinical Performance Data:

Clinical data was not needed to demonstrate the safety and effectiveness of the proposed devices.

Material Characterization

The proposed OPTILINK™ technology screws have been evaluated to Evidence: determine the metallurgical corrosion behavior via anodic polarization,

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galvanic and fretting corrosion assessments using both stainless steel and titanium plates. Conclusions drawn from these evaluations demonstrate substantial equivalence to the predicate device.

Conclusion: The subject devices demonstrate substantial equivalence to the predicate devices.

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.