The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and fragments. This system is also indicated for nonload bearing stabilization and reduction of bone fragments in long bones.

Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.

Device Description

The subject premarket notification describes 1.5mm line additions to the VLP Mini-Mod Small Bone Plating System. The subject internal fixation plating system is comprised of assorted implantable, locking bone plates and compatible locking and non-locking bone screws to be used on various small bones and fragments. The VLP Mini-Mod Small Bone Plating System is a subset of the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System, which was previously cleared via Traditional 510(k) K132886. Subject plates consist of groups of devices with a radiused cross-section where the number of holes in the plates will range from 6 through 24. Specific plate designs include Y-plates, Straight plates, and Column plates. All described implant devices are manufactured from implant-grade titanium alloy material (Ti-6Al-4V) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation. Bone screws will be offered in both locking and non-locking options in a variety of lengths.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws." The information presented is for a medical device (bone plates and screws) and is primarily focused on demonstrating "substantial equivalence" to predicate devices through mechanical testing, not on clinical performance or diagnostic accuracy. Therefore, many of the requested categories for AI/clinical studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Finite Element Analysis (FEA) for Plate Strength	Subject bone plates exhibited similar or superior structural strength compared to existing 1.5mm predicates.	The acceptance criteria was met in that the subject bone plates exhibited similar or superior structural strength compared to the existing 1.5mm predicates. Results of the FEA demonstrated that the plates identified for mechanical testing were the appropriate bone plates because they possessed the highest stress concentrations.
Four-Point Bend Fatigue Testing for Plates	The number of log cycles to failure achieved by the proposed bone plates met the acceptance criteria by being non-inferior to the fatigue log cycles to failure of a previously cleared predicate.	Results of the testing concluded that the number of log cycles to failure achieved by the proposed bone plates met the acceptance criteria in that they were found to be non-inferior to the fatigue log cycles to failure of a previously cleared predicate.
Torque-to-Failure Testing for Screws	All tested 1.5mm screws met the minimum torsional strength requirement dictated by ASTM F543-07.	The acceptance criterion was met in that all tested 1.5mm screws met the minimum torsional strength requirement dictated by ASTM F543-07.
Axial Pull-out Testing for Screws	The maximum pull-out force of the subject screws was non-inferior to the maximum pull-out force of the predicate.	The subject implants met the acceptance criteria in that the maximum pullout force of the subject screws was non-inferior to the maximum pull-out force of the predicate.

Regarding the requested details that are not applicable to this type of device (bone plates and screws) or document (510(k) summary focused on substantial equivalence through mechanical testing):

This document describes a mechanical device (bone fixation system), not a diagnostic AI medical device or a device requiring a clinical study with human subjects to evaluate performance in the way described by the prompts (e.g., diagnostic accuracy, reader improvement, ground truth establishment with experts). The "performance" here refers to mechanical integrity and comparison to existing, cleared devices.

Therefore, the following information is not available or not applicable in this document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable: This refers to mechanical testing of physical device samples, not data sets for an AI model. The sample sizes would be the number of test articles for each mechanical test (e.g., number of plates for fatigue testing, number of screws for torque/pull-out), but these specific numbers are not provided in this summary. Data provenance (country, retrospective/prospective) is irrelevant for mechanical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: There is no "ground truth" in the diagnostic sense for these mechanical tests. Standards (ASTM F543-07) and engineering principles (FEA, mechanical testing protocols) define the acceptance.

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

Not Applicable: This relates to human expert review for establishing ground truth, which is not relevant here.

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: No clinical or AI-assisted diagnostic study was performed. This is a mechanical device.

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

Not Applicable: No algorithm performance in a standalone capacity was assessed. This is a physical device.

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

Not Applicable: As mentioned, ground truth in the diagnostic sense is not relevant. The "ground truth" for mechanical testing is established by recognized engineering standards and the performance of predicate devices.

8. The sample size for the training set

Not Applicable: There is no "training set" as this is not an AI/machine learning device.

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

Not Applicable: As there is no training set, this question is not relevant.

Summary

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

December 18, 2014

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

Re: K143050

Trade/Device Name: VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws 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 22, 2014 Received: October 23, 2014

Dear Ms. 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

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Page 2 - Ms. Samantha Staubach

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/Resourcesfor You/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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Premarket Notification Indications for Use Statement

K143050 510(k) Number (if known):

Device Name: VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws

Indications for Use:

Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	October 22, 2014
Contact Person and Address:	Samantha StaubachRegulatory Affairs Specialist IT (901) 399-6132F (901) 566-7596
Name of Device:	Smith & Nephew, Inc. VLP Mini-Mod Small Bone PlatingSystem 1.5mm Plates and Screws
Common Name:	Bone Plates and Screws
Device Classification Name andReference:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessoriesClass II
	21 CFR 888.3040 Smooth or threaded metallic bone fixationfastenerClass II
Panel Code:	Orthopedics/87

Device Description

Intended Use

Bone plates and bone screws from the VLP Mini-Mod Small Bone Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

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Indications for Use

The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction. replantation or reduction of small bones and fragments. This system is also indicated for nonload bearing stabilization and reduction of bone fragments in long bones.

Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.

The indications for use for the subject VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws are identical to those previously cleared for the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System.

Technological Characteristics

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 below with regard to intended use, indications for use, materials and performance characteristics. The subject VLP Mini-Mod 1.5mm Bone Plates and Screws feature characteristics very similar to the VLP Mini-Mod Small Bone Plating System cleared via K132886, with the primary difference being the 1.5mm size offering. To accommodate for the size difference between the 1.5mm subject plates and the 2.0mm and 2.4mm offerings cleared via K132886, mechanical testing was conducted against the secondary predicates.

Substantial Equivalence Information

When compared to the predicate devices listed below, substantial equivalence is based upon similar function, intended use, indications for use and overall design to the devices listed in the table below.

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew, Inc.	Smith & Nephew Variable-Angle LockingMini-Fragment Plating System (PrimaryPredicate)	K132886	2/4/14
Synthes (USA)	Synthes (USA) 1.5mm Mini Fragment LCPSystem	K090047	4/1/09
Smith & Nephew, Inc.	Smith & Nephew Bone Plate System	K993106	12/9/99

Table 1: Substantially Equivalent Predicates to the VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws

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Summary of Pre-Clinical Testing

Finite element analysis (FEA) was conducted on the proposed 1.5mm bone plate o designs to determine the worst case plate as well as the high stress region of the plate to be used for subsequent mechanical testing. The acceptance criteria was met in that the subject bone plates exhibited similar or superior structural strength compared to the existing 1.5mm predicates. Results of the FEA demonstrated that the plates identified for mechanical testing were the appropriate bone plates because they possessed the highest stress concentrations.
o Four-point bend fatigue testing was conducted on worst-case examples of the proposed bone plates, as identified through FEA testing. Results of the testing concluded that the number of log cycles to failure achieved by the proposed bone plates met the acceptance criteria in that they were found to be non-inferior to the fatigue log cycles to failure of a previously cleared predicate.
Torque-to-failure testing for the proposed 1.5mm bone screws was conducted per the o guidelines of ASTM F543-07. The acceptance criterion was met in that all tested 1.5mm screws met the minimum torsional strength requirement dictated by ASTM F543-07.
o Axial pull-out testing was conducted on the subject 1.5mm cortex screws following the guidelines set forth in ASTM F543 with maximum force denoted as pull-out strength. The subject implants met the acceptance criteria in that the maximum pullout force of the subject screws was non-inferior to the maximum pull-out force of the predicate.

Conclusion

This 510(k) premarket notification is being submitted to request clearance for the VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the predicate plating systems listed in Table 1 on page 5-2.

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.