Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and fragments and as non-load bearing stabilization and fixation of bone fragments.

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 non-load 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 EVOS Mini-Fragment Plating System is a modification to a subset of the devices previously cleared Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (K132886). It is an internal fixation plating system comprised of assorted implantable, small utility "flat" locking bone plates and compatible locking and non-locking bone screws and washers to be used on various small bones and fragments. Plates consist of groups of devices with a flat cross-section where the number of holes in plates will range from 4 through 20. All described implant devices are manufactured from implant-grade 316L Stainless Steel material and will be available in a sterile or non-sterile packaged condition.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "EVOS Mini-Fragment Plating System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials or extensive performance studies typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Therefore, the study design and acceptance criteria outlined in the original request—which are highly specific to AI/SaMD performance evaluation (e.g., AUC, sensitivity, specificity, human reader improvement with AI assistance, ground truth establishment by experts, adjudication methods, training/test set sizes)—are not applicable to this traditional hardware medical device submission.

This submission focuses on mechanical bench testing to demonstrate that the new device (EVOS Mini-Fragment Plating System) performs comparably to its predicate devices in terms of physical properties and strength.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document, reimagined to fit the context of this specific product:

Acceptance Criteria and Device Performance for the EVOS Mini-Fragment Plating System

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Non-Inferiority)	Reported Device Performance
Four-point bend fatigue testing (Plates)	Number of log cycles to failure must be non-inferior to the number of log cycles to failure achieved by the predicate devices when tested at the same bending moment.	Results concluded that, when compared to predicates tested at the same bending moment, the number of log cycles to failure met the acceptance criteria in that they were found to be non-inferior to the number of log cycles to failure achieved by the predicates.
Four-point bend fatigue testing (Screws)	Number of log cycles to failure must be non-inferior to the number of log cycles to failure achieved by the predicate devices when tested at the same bending moment.	Results of the testing concluded that, compared to the predicates and when tested at the same bending moment, the proposed bone screws met the acceptance criteria in that they were found to be non-inferior to the number of log cycles to failure achieved by the predicates. (Specifically for 2.0mm, 2.4mm, and 2.7mm bone screws).
Torque-to-failure testing (Screws)	Average values for torsional strength must be non-inferior to the predicates and non-inferior to the minimum values cited in ASTM F543.	Results concluded that the average values for torsional strength of the proposed devices met the acceptance criteria in that they were non-inferior to the predicates and non-inferior to the minimum values cited in ASTM F543. (Specifically for 2.0mm, 2.4mm, and 2.7mm cortex screws & 4.0mm osteopenia screws).

Note: The "acceptance criteria" here are based on "non-inferiority" to the predicate devices and relevant industry standards (ASTM F543).

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

Sample Size: The document does not specify the exact number of physical samples (plates, screws) tested for each category (e.g., "worst-case bone plates," "2.0mm, 2.4mm, and 2.7mm bone screws"). However, it implies testing was conducted on sufficient samples to draw conclusions about non-inferiority.
Data Provenance: The testing was "non-clinical bench (mechanical) testing" conducted by or for Smith & Nephew. The provenance is internal corporate testing to support a regulatory submission, not patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a hardware device performance study focusing on mechanical properties, not an AI/SaMD study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is objective physical measurements and established engineering standards.

4. Adjudication Method for the Test Set

Not Applicable. As this is mechanical testing, there is no human interpretation or adjudication process in the sense of consensus on diagnostic findings. The results are quantitative measurements against predefined criteria.

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

No. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. It is not applicable to the mechanical testing of bone plates and screws.

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

Yes, in the context of device performance. The "standalone" performance here refers to the intrinsic mechanical performance of the plates and screws themselves, without human surgical interaction being part of the evaluation criteria for regulatory clearance. The tests demonstrate the device's physical properties independent of user variability in a real-world surgical setting.

7. The Type of Ground Truth Used

Objective Mechanical Measurements and Engineering Standards:
- "Ground truth" for plate and screw fatigue: The number of log cycles to failure under specific bending moments, assessed against the performance of predicate devices.
- "Ground truth" for screw torsional strength: The average torsional strength values, assessed against predicate devices and the minimum values specified in ASTM F543 (Standard Specification for Metallic Medical Bone Screws).
- Finite Element Analysis (FEA): Used to predict the "worst-case" plate, which then guides the selection of samples for physical testing. This acts as a computational "ground truth" to identify critical designs for physical validation.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning model where a "training set" of data is used to build an algorithm. The "training" in this context would be the design and engineering process, with the "test set" being the physical devices manufactured and tested.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. See point 8. The "ground truth" for the design of the device would be principles of biomechanical engineering, material science, and prior knowledge from predicate devices. The "validation" of this design comes from the bench testing.

In summary: The EVOS Mini-Fragment Plating System is a traditional medical device demonstrating substantial equivalence through non-clinical bench (mechanical) testing. Its "acceptance criteria" are based on showing non-inferiority in mechanical performance (fatigue life, torsional strength) compared to already cleared predicate devices and relevant ASTM standards. The study design and terminology requested in the prompt are tailored for AI/SaMD, which is a fundamentally different type of regulatory submission and performance evaluation.

Summary

{0}------------------------------------------------

> We are smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	May 2, 2014
Contact Person and Address:	Samantha StaubachRegulatory Affairs Specialist IT 901-399-6132F 901-566-7596
Name of Device:	EVOS Mini-Fragment Plating System
Common Name:	Bone Plates, Screws and Washers
Device Classification Name andReference:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessoriesClass II21 CFR 888.3040 Smooth or threaded metallic bone fixationfastenerClass II
Panel Code:	Orthopedics/87
Product Code:	HRS/HTN/HWC

Device Description

Intended Use

Indications for Use

{1}------------------------------------------------

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.

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

Technological Characteristics

Device comparisons described in this premarket notification demonstrate that the proposed bone plates and bone screws are substantially equivalent to the legally marketed predicate devices (listed below in Toble 1) with regard to intended use, indications for use, and performance characteristics.

Substantial Equivalence Information

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

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	Variable-Angle Locking Mini-Fragment Plating System	K132886	02-04-2014
Smith & Nephew, Inc.	Plate and Screw Instruments	K123055	01-25-2013
Smith & Nephew, Inc.	VLP FOOT Plating, ScrewSystem and Accessories	K090675	06-04-2009

Table 1: Substantially Equivalent Predicates to the EVOS Mini-Fragment Plating System

Summary of Pre-Clinical Testing

To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was conducted to support the proposed bone plates and bone screws. Test results demonstrated that the proposed devices are substantially equivalent to one or more of the previously cleared predicate devices described above. The specific types of non-clinical testing conducted are listed below.

. Finite Element Analysis (FEA) was conducted on all proposed bone plates to predict the worst-case plate to be used in subsequent non-clinical bench (mechanical) testing.
Four-point bend fatigue testing was conducted on the worst-case bone plates . identified through FEA. Results of testing concluded that, when compared to

{2}------------------------------------------------

predicates tested at the same bending moment, the number of log cycles to failure met the acceptance criteria in that they were found to be non-inferior to the number of log cycles to failure achieved by the predicates.

Four-point bend fatigue testing was also performed on the proposed 2.0mm, 2.4mm, . and 2.7mm bone screws. Results of the testing concluded that, compared to the predicates and when tested at the same bending moment, the proposed bone screws met the acceptance criteria in that they were found to be non-inferior to the number of log cycles to failure achieved by the predicates.
Torque-to-failure testing of the proposed 2.0mm, 2.4mm, and 2.7mm cortex screws . and 4.0mm osteopenia screws was conducted. Results concluded that the average values for torsional strength of the proposed devices met the acceptance criteria in that they were non-inferior to the predicates and non-inferior to the minimum values cited in ASTM F543.

Conclusion

As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the EVOS Mini-Fragment Plating System. 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 above in Table 1.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, a traditional symbol of medicine, with three wavy lines.

Public Health Service

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

May 7, 2014

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

Re: K140814

Trade/Device Name: EVOS 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, HTN, HWC Dated: April 10, 2014 Received: April 11, 2014

Dear Ms. 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

{4}------------------------------------------------

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/ResourcesforYou/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,

Lori A. Wiggins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Premarket Notification Indications for Use Statement

K140814 510(k) Number (if known): _

Device Name: EVOS Mini-Fragment Plating System

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)

IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Casey Hanley -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140814

Page 1 of 1

4-1

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.