The EVOS Small Fragment Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.

Device Description

Subject of this premarket notification is an extension to the EVOS family of plates and screws, the EVOS Small Fragment Plating System. This system features similarities to existing Smith & Nephew small fragment plates (TC-100 Small Bone Plating System, PERI-LOC Plating System) and also shares some instruments and implants from the existing EVOS MINI Plating System. It is comprised of a variety of locking and non-locking 2.7mm and 3.5mm straight plates as well as 3.5mm locking and non-locking screws and 4.7mm non-locking osteopenia screws.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (EVOS Small Fragment Plating System), not a study analyzing AI performance. Therefore, I cannot extract information related to AI acceptance criteria, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance.

However, I can extract the acceptance criteria and study descriptions for the mechanical performance of the physical EVOS Small Fragment Plating System, as detailed in the document.

Here's the information based on the provided text, focusing on the mechanical testing of the device itself:

1. A table of acceptance criteria and the reported device performance

Test Type	Acceptance Criteria	Reported Device Performance
Finite Element Analysis (FEA)	The subject bone plates exhibited similar or superior structural strength compared to the existing 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.	The acceptance criteria were met.
Four-point Bend Fatigue Testing	The bending fatigue performance achieved by the proposed bone plates met the acceptance criteria in that they were found to be similar to the bending fatigue performance of a previously cleared predicate.	The acceptance criterion was met.
Torque to Failure Testing (Bone Screws)	The static torsional performance of the EVOS screws was found to be similar to the static torsional performance of a previously cleared predicate device.	The acceptance criterion was met.
Axial Pull-out Testing (Osteopenia Screws)	The subject screws that were tested showed similar or superior (higher) pull-out strength compared to the predicates.	The acceptance criterion was met.
Static Cantilever Bending Performance (Locking Mechanism)	The results met the acceptance criteria in that they were similar or superior (higher) than the predicates. (Evaluated through threaded locking mechanism and variable angle locking holes for 3.5mm and 2.7mm screws).	The acceptance criteria were met.
Packaging Testing	The product will not be damaged during shipment and will adequately maintain sterility post shipment.	The results of this testing showed that the product will not be damaged during shipment and will adequately maintain sterility post shipment.
Bacterial Endotoxin Testing	Met acceptable endotoxin limits as stated in FDA Guidance documents ("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).	Completed and met the acceptable endotoxin limits.

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

Sample Size: Not explicitly stated for each mechanical test. The document mentions "worst-case designs" for FEA and fatigue testing, and specific sizes of screws (3.5mm, 4.7mm) for others. Typically, mechanical testing involves a limited number of samples (e.g., 5-10 per test condition) to satisfy a statistical confidence level or regulatory requirement, but the exact numbers are not provided here.
Data Provenance: Not applicable as these are pre-clinical (benchtop) tests of the device's physical properties, not clinical data from patients. The testing was conducted by Smith & Nephew, Inc.

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. These are engineering and mechanical tests, not analyses requiring expert human interpretation or ground truth establishment in a clinical sense. The "ground truth" is defined by the objective measurement of mechanical properties against predetermined performance standards, often based on existing predicate devices or industry standards like ASTM.

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

Not applicable. This is not a study involving human interpretation or adjudication. The results are quantitative measurements against objective criteria.

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 document describes the mechanical testing of a medical implant, not an AI or diagnostic imaging device.

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

Not applicable. This document describes the mechanical testing of a medical implant, not an AI algorithm.

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

The "ground truth" for the mechanical testing is based on:

Performance of legally marketed predicate devices. The acceptance criteria consistently refer to being "similar or superior" to predicates.
Adherence to industry standards (e.g., ASTM F543 for screw testing).
Compliance with FDA Guidance documents for sterility and endotoxin testing.

8. The sample size for the training set

Not applicable. This is not an AI study requiring a training set.

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

Not applicable. This is not an AI study requiring a training set or its associated ground truth establishment.

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

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

November 18, 2016

Smith & Nephew, Inc. Samantha Staubach Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38119

Re: K162078

Trade/Device Name: EVOS Small 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 Dated: October 27, 2016 Received: October 28, 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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K162078 page 1 of 1

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)	K162078
--------------------------	---------

Device Name EVOS Small Fragment Plating System

Indications for Use (Describe)

045

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)	☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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>< We are smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	October 27, 2016
Name of Device:	EVOS Small Fragment Plating System
Common Name:	Bone Plates and Screws
Device Classification Name andReference:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040 Smooth or threaded metallic bone fixationfastener
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	HRS/HWC

Predicates

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	Smith & Nephew Bone PlateSystem (primary predicate,now branded as TC-100)	K993106	December 9,1999
Synthes (USA)	Synthes Small FragmentDynamic Compression LockingSystem	K000684	April 28, 2000
Smith & Nephew, Inc.	Smith & Nephew Locking BonePlate System (now branded asPERI-LOC)	K033669	December 10,2003
Smith & Nephew, Inc.	PERI-LOC Periarticular LockedPlating System – B Plate LockingBone Plates and Screws	K062216	September 15,2006
Smith & Nephew, Inc.	PERI-LOC Periarticular LockedPlating System Hexalobular BoneScrews	K082516	September 17,2008

Device Description

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It is comprised of a variety of locking and non-locking 2.7mm and 3.5mm straight plates as well as 3.5mm locking and non-locking screws and 4.7mm non-locking osteopenia screws.

Indications for Use

The EVOS Small Fragment Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.

Technological Characteristics

Device comparisons described in this premarket notification demonstrated that the proposed devices are substantially equivalent to legally marketed predicates with respect to intended use, indications, and performance characteristics. The subject devices include locking and non-locking plates. Screw holes in the locking plates can either be threaded holes or variable angle holes and the non-locking plates have non-threaded holes. The subject screws feature a hex drive and are similar to existing Smith & Nephew predicate screws with respect to threadform and major and minor diameter.

Summary of Pre-Clinical Testing

Finite element analysis (FEA) was conducted on the proposed plate designs to determine the worst case plates as well as the high stress region of the plate to be used for subsequent mechanical testing. The acceptance criteria were met in that the subject bone plates exhibited similar or superior structural strength compared to the existing 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 was conducted on the worst-case designs of the . proposed bone plates, as identified through FEA. Results of the testing concluded that the bending fatigue performance achieved by the proposed bone plates met the acceptance criteria in that they were found to be similar to the bending fatigue performance of a previously cleared predicate.
. Torque to failure testing for the proposed 3.5mm and 4.7mm bone screws was conducted following the guidelines of ASTM F543. The acceptance criterion was met in that the static torsional performance of the EVOS screws was found to be similar to the static torsional performance of a previously cleared predicate device.
Axial pull-out testing was conducted on the proposed 4.7mm osteopenia screws . following the guidelines of ASTM F543. The acceptance criterion was met in that the subject screws that were tested showed similar or superior (higher) pull-out strength compared to the predicates.
. Static cantilever bending performance of the locking mechanism for the 3.5mm and 2.7mm screws was evaluated at a fixed angle through the threaded locking mechanism and variable angle locking holes and the results met the acceptance criteria in that they were similar or superior (higher) than the predicates.

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. Engineering rationales were leveraged for several proposed devices due to the similarity in design when compared against the predicates.
. Packaging testing was conducted for the larger pouch/carton design and the results of this testing showed that the product will not be damaged during shipment and will adequately maintain sterility post shipment.
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.

Conclusion

This Traditional 510(k) premarket notification is being submitted to request clearance for the EVOS Small Fragment Plating System Straight Plates and Screws. Based on similarities to the predicate components and a review of the mechanical testing performed, the subject devices are substantially equivalent 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.