The VLP Wrist Fracture System is a radial plating system comprised of plates, screws, and device specific instrumentation. Plates, screws, and locking pegs are provided in sterile packaging. Volar plate design options are offered in 3 hole, 5 hole, and 10 hole plate configurations, with both standard and wide sizes available for all sizes except the 10 hole plate. The 10 hole plate is available in standard size only. All plate designs are available in left and right configurations. 1.8mm Locking Pegs are available in lengths ranging from 10mm to 30 mm and 3.5mm Cortex and Locking Screws are available in lengths ranging from 10mm to 30mm. The system uses existing Smith & Nephew 2.4mm locking and cortex screws.

AI/ML Overview

This document is a 510(k) premarket notification for the "VLP Wrist Fracture System". It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving device performance against acceptance criteria in the sense of a clinical trial or algorithm validation study. Therefore, most of the requested information regarding acceptance criteria and study details for an AI/device performance study (like sample sizes, ground truth, expert qualifications, adjudication, or MRMC studies) is not applicable to this type of regulatory submission because it relates to a surgical implant, not an AI system.

However, based on the document, I can extract the following relevant information regarding the pre-clinical mechanical testing conducted to support the substantial equivalence claim:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Method	Acceptance Criteria	Reported Device Performance
Finite Element Analysis (FEA)	Proposed designs do not represent a new worst-case compared to existing worst-case.	Results determined that the proposed line addition plates did not represent a new worst-case when compared against the existing designs.
Four-Point Bend Fatigue	Not explicitly stated, but leveraging existing data implies meeting prior established criteria.	Existing mechanical testing for a 4 Hole Wide Plate design (K132296) was leveraged, indicating the new design is considered equivalent.
Torque-to-Failure (3.5mm locking screws)	Ultimate torsional strength greater than the minimum value outlined in ASTM F543.	The screws met the acceptance criteria by achieving an ultimate torsional strength greater than the minimum value outlined in ASTM F543.
Pullout Testing (3.5mm screws)	Not explicitly stated for performance, but the rationale was based on dimensional equivalence.	An engineering rationale was leveraged; critical dimensions for pullout behavior were identical to existing predicate screws. No new testing was deemed necessary.
Bacterial Endotoxin Testing	Acceptable endotoxin limits as stated in FDA Guidance and ANSI/AAMI ST72.	Met the acceptable endotoxin limits as stated in relevant FDA Guidance and ANSI/AAMI ST72.

Regarding the other points, they are generally not applicable to this type of 510(k) submission for a metallic bone fixation device:

Sample sized used for the test set and the data provenance: Not applicable. For mechanical bench testing, "sample size" refers to the number of devices tested, which is typically described in the full test reports (not provided here). Data provenance would be from internal lab testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on ASTM standards or industry-accepted engineering principles, not expert medical consensus.
Adjudication method: Not applicable to mechanical testing.
Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted diagnostic devices.
Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable. This is for AI systems.
The type of ground truth used: For mechanical testing, the "ground truth" is defined by the physical behavior of the materials and device components under specified test conditions, measured against established engineering standards (e.g., ASTM F543 for torsional strength). For sterility, it's defined by microbiological assay results against established endotoxin limits.
The sample size for the training set: Not applicable. This is for AI/machine learning. FEA involves computational modeling, not a "training set" in the AI sense.
How the ground truth for the training set was established: Not applicable.

In summary, this document describes the regulatory submission for a physical medical device (bone fracture system) and the pre-clinical mechanical and biological testing conducted to support its safety and effectiveness by demonstrating substantial equivalence to predicate devices, not an AI or diagnostic device that would require human reader studies or extensive ground truth establishment by medical experts.

Summary

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

November 15, 2016

Smith & Nephew, Inc. Samantha Staubach Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116

Re: K161665

Trade/Device Name: VLP Wrist Fracture 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: October 28, 2016 Received: October 31, 2016

Dear Samantha Staubach:

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 SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K161665

Device Name VLP Wrist Fracture System

Indications for Use (Describe)

The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius.

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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Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	October 28, 2016
Contact Person and Address:	Samantha StaubachRegulatory Affairs SpecialistT 901-399-6132F 901-566-7596
Name of Device:	VLP Wrist Fracture System
Common Name:	Bones Plates and Screws
Device Classification Name andReference:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories
	21 CFR 888.3040 Smooth or threaded metallic bone fixationfastener
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	HRS/HWC

Predicates

Table 1: Substantially Equivalent Predicates to the VLP Wrist Fracture System

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	Smith & Nephew, Inc. D-RADSMARTPACK (primary predicate)	K132296	January 7, 2014
Smith & Nephew, Inc.	Smith & Nephew Bone Plate System	K993106	December 9, 1999
Synthes (USA)	Synthes 3.5mm Cortex Screws	K043185	February 3, 2005
Smith & Nephew, Inc.	PERI-LOC Periarticular LockedPlating System Hexalobular BoneScrews	K082516	September 17, 2008
Smith & Nephew, Inc.	PERI-LOC Bone Plating and Screw System	K083032	January 7, 2009
Biomet Trauma	Modified Distal Radius Plating System	K133939	April 1, 2014

Device Description

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30 mm and 3.5mm Cortex and Locking Screws are available in lengths ranging from 10mm to 30mm. The system uses existing Smith & Nephew 2.4mm locking and cortex screws.

Indications for Use

The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius.

Technological Characteristics

The proposed radial plates are similar to the predicates described in Table 1. Device comparisons described in this premarket notification demonstrated that the proposed bone plates and bone screws are substantially equivalent to the legally marketed predicate devices listed in Table 1 with regard to intended use, indications for use, materials, and performance characteristics. The subject plates feature similarities in design to the primary predicate, with the major difference being the increased product offering. To accommodate for the size differences in the screws compared to the primary predicate, mechanical testing was conducted on the subject screw and an engineering rationale was leveraged based on similar design features to existing Smith & Nephew screw designs.

Summary of Pre-Clinical Testing

· Finite element analysis (FEA) was conducted on the proposed line addition plate designs to evaluate the proposed designs against the existing worst case plate design from K132296. Results of the testing determined that the proposed line addition plates did not represent a new worst-case when compared against the existing designs.
Existing mechanical testing for four-point bend fatigue was leveraged based on the . fact that the 4 Hole Wide Plate design previously cleared via K132296 is also being offered in the subject system with minor modifications. As described above, FEA did not result in a new worst-case plate design compared against the existing worstcase, the 4 Hole Wide Plate cleared via K132296.
Torque-to-failure testing was conducted on the subject 3.5mm locking screws. The . screws met the acceptance criteria by achieving an ultimate torsional strength greater than the minimum value outlined in ASTM F543.
. An engineering rationale was leveraged in lieu of pullout testing for the proposed 3.5mm screws. The dimensions critical to screw behavior during pullout testing were compared between the subject screws and an existing Smith & Nephew predicate screw and the dimensions were identical. As such, it was determined that completion of pullout testing was not necessary.
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits . as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.

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Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the VLP Wrist Fracture System. Based on the similarities to the predicate devices and a review of the mechanical testing performed and leveraged, the devices are substantially equivalent to the plating systems described in Table 1

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.