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 small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

Device Description

The subject Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is an internal fixation plating system comprised of assorted small. implantable utility locking bone plates and compatible locking and non-locking bone screws and washers to be used on various small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones. Plates consist of groups of devices with a flat cross-section and others with a radiused cross-section where of holes in plates will range from 4 through 20. All described implant devices are manufactured from implant-grade titanium alloy material and will be available in a sterile packaged condition.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System, based on the provided 510(k) summary:

This device is a physical medical device (bone plates, screws, and washers), not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical acceptance criteria and study components associated with AI/SaMD (like ground truth, expert consensus, MRMC studies, training sets, etc.) are not applicable in this context. The evaluation focuses on physical performance and substantial equivalence to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit for physical devices)	Reported Device Performance
Mechanical Performance	Demonstrated equivalent or superior mechanical properties to predicate devices.	- Finite Element Analysis (FEA): Used to predict worst-case plates.- Four-point bend fatigue testing: Performed on bone plates and screws.- Torque-to-failure testing: Performed on bone screws.- Axial pull-out testing: Performed on bone screws.
Material Composition	Made from implant-grade materials suitable for long-term implantation.	Manufactured from implant-grade titanium alloy material.
Biocompatibility	Materials are biocompatible and safe for implantation.	Implied by use of implant-grade titanium alloy, which is a well-established biocompatible material, and substantial equivalence to predicate devices.
Sterility	Provided in a sterile condition.	Will be available in a sterile packaged condition.
Intended Use Fit	Suitable for internal fixation of small bone fragments and non-load bearing stabilization/reduction in long bones.	Bench testing results "demonstrated that the proposed devices are substantially equivalent to one or more of the previously cleared predicate devices described above" for the stated intended use.
Substantial Equivalence	Demonstrates similar intended use, indications for use, materials, and performance characteristics to predicate devices.	Substantial equivalence is the primary acceptance criterion, explicitly stated and supported by the non-clinical testing.

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

Sample Size: Not explicitly stated in terms of a specific number of devices. The non-clinical testing involved various tests (FEA, fatigue, torque, pull-out) which would have used multiple samples of plates and screws to generate statistically relevant data.
Data Provenance: The testing was "non-clinical bench (mechanical) testing" conducted by the manufacturer, Smith & Nephew, Inc. This is laboratory-based testing on manufactured devices, not patient data. Therefore, concepts like country of origin or retrospective/prospective do not apply.

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

Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus as described for AI/SaMD (e.g., radiologists interpreting images) is not relevant. The "ground truth" for mechanical testing is established by engineering standards, test methodologies, and material science. The experts involved would be mechanical engineers, material scientists, and quality assurance professionals within Smith & Nephew, as well as external notified bodies or testing laboratories that might be accredited for such tests. Their qualifications would be in these engineering and scientific disciplines.

4. Adjudication Method for the Test Set

Not Applicable. As this is mechanical testing of physical devices, there's no "adjudication method" in the sense of reconciling divergent expert interpretations. Results are typically quantitative measurements, and acceptance is determined by comparing these measurements against predetermined specifications and predicate device performance. Any discrepancies would be addressed through repeat testing, calibration checks, or investigation into methodology.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This type of study (MRMC) is used for evaluating human performance, typically in diagnostic tasks, and is therefore not applicable to a physical bone plating system.
Effect Size: Not applicable.

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

No. This concept is only applicable to AI/software. The "device" itself is a physical implant.

7. The Type of Ground Truth Used

Not Applicable / Engineering Standards and Predicate Device Performance. For mechanical testing, the "ground truth" is typically defined by:
- Applicable international and national consensus standards (e.g., ASTM, ISO standards for implants).
- Performance data from the legally marketed predicate devices, against which the new device is compared for substantial equivalence.
- Engineering calculations and material properties.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of a physical device. Training sets are relevant for machine learning algorithms.

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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K132886

510(k) Summary of Safety and Effectiveness FEB - 4 2014

Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System

Submitted By:	Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date Prepared:	December 27, 2013
Contact Person:	David Henley, Regulatory Affairs Project ManagerTel: (901) 399-6487 Fax: (901) 566-7079
Proprietary Name:	Smith & Nephew Variable-Angle LockingMini-Fragment Plating System
Common Name:	Bone Plates, Bone Screws and Washers
Classification Name and Reference:	21 CFR 888.3030, Single/multiple component metallicbone fixation appliances and accessories - Class 2
	21 CFR 888.3040, Smooth or threaded metallic bonefixation fastener - Class 2
Device Product Code and Panel Code:	HRS / HWC / HTN Orthopedics / 87

Device Description:

Intended Use:

Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are intended for use in internal fixation of small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

Indications for Use:

Page 1 of 2

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

Technological Characteristics:

Device comparisons described in this premarket notification demonstrated that the proposed bone plates, bone screws and washers are substantially equivalent to the legally marketed predicate devices (listed below) with regard to intended use, indications for use, materials and performance characteristics.

Substantial Equivalence Information:

When compared to the predicate devices listed below, substantial equivalence is based similar intended use, indications for use, raw materials, operating principles and design/performance characteristics.

Smith & Nephew Bone Plate System (TC-100 Plating and Screw System) K993106 .
VLP Foot Plating and Screw System K090675 .
PERI-LOC (Titanium) Bone Plating and Screw System K083032 .
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws K060736 .
PERI-LOC B-Plate Locking Bone Plates and Screws K062216 .
Synthes Modular Mini Fragment LCP System K063049 .
Medartis APTUS Titanium System K051567 ♥
DePuy ALPS Small Bone Locked Plating System K101240 .
Hand Innovations LLC, Mini Fragment Plates K061748 .

Non-clinical Testing:

To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was conducted on bone plates and screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System. Test results demonstrated that the proposed devices are substantially equivalent to one or more of the previously cleared predicate devices described above. The specific type of non-clinical testing conducted is described as:

. Finite element analysis (FEA) of bone plates to predict the worst-case plate for subsequent nonclinical bench (mechanical) testing
Four-point bend fatigue testing of bone plates and bone screws .
Torque-to-failure testing of bone screws .
Axial pull-out testing of bone screws .

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5-2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

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

February 4, 2014

Smith & Nephew, Incorporated Mr. David Henley Regulatory Affairs Project Manager 1450 Brooks Road Memphis, Tennessee 38116

Re: K132886

Trade/Device Name: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating 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, HTN Dated: December 27, 2013 Received: December 30, 2013

Dear Mr. Henley:

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 ffor 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. Iisting 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 '

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Page 2 – Mr. David Henley

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.

Vincent到Devlin -S

for 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

K132886

510(k) Number (if known):

Device Name: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System

Indications for Use: .

Components in the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.

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

Over-the-Counter Use (Part 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)

Elizabet铜砂砾rank -S

Division of Orthopedic 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.