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, acctabulum, metacarpals, metatarsals, and clavicle.

Device Description

The subject of this special premarket notification is a modification in the manufacturing process for select EVOS Small Fragment Straight Plates that were previously cleared via K162078. Also subject to this special premarket notification is the addition of EVOS 3.5mm Locking Hole Inserts and EVOS 3.5mm Washers and Double Washers. The subject devices are intended to be used with existing Smith & Nephew implants and instruments that have been previously cleared for market for use with the EVOS Small Fragment Plating System.

AI/ML Overview

This document is a 510(k) premarket notification for the EVOS Small Fragment Plating System. The focus of the changes discussed in this submission is on manufacturing process modifications and the addition of new components (locking hole inserts and washers), rather than providing a detailed study that proves the device meets specific performance acceptance criteria in a clinical setting.

Therefore, the requested information cannot be fully provided as the document does not contain details about:

A specific clinical study proving device performance against acceptance criteria.
Sample sizes for test sets, data provenance, number of experts, adjudication methods, or MRMC studies.
Standalone algorithm performance.
Specific ground truth types or training set details.

However, based on the provided text, here is what can be inferred about the pre-clinical engineering testing and its acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance (Pre-clinical Engineering Testing)

Acceptance Criteria	Reported Device Performance
Plates (Manufacturing Process Change)
Bending fatigue performance to be similar to EVOS sculpture milled plates (cleared via K162078) and additional predicate plating systems.	"The bending fatigue performance achieved by the proposed bone plates manufactured from extruded material met the acceptance criteria in that they were found to be similar to the bending fatigue performance of the EVOS sculpture milled plates cleared via K162078 and additional predicate plating systems."
Locking Hole Inserts (Addition of New Component)
EVOS Locking plates with locking hole inserts expected to have similar or superior (higher) bending performance compared to EVOS Locking plates without locking hole inserts.	"Based on the results of the testing, the EVOS Locking Plates with locking hole inserts are expected to have a similar or superior (higher) bending performance as the Locking Plates without locking hole inserts."
Bacterial Endotoxin Levels
Endotoxin levels to be under 20 EU/device.	"Bacterial endotoxin levels were evaluated using the LAL method and were shown to be under 20 EU/device."

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for each test, but referred to as "worst-case designs" for plate fatigue testing.
Data Provenance: This is pre-clinical engineering testing, not clinical data from patients or a specific country. It's a lab-based study to assess mechanical properties and biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as this is pre-clinical mechanical and biological testing, not a study involving human expert interpretation of data like images.

4. Adjudication method for the test set

Not applicable for pre-clinical mechanical and biological testing.

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 is not an AI/imaging device.

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

Not applicable. This is not an AI/imaging device.

7. The type of ground truth used

For the plate and locking hole insert bending fatigue tests, the "ground truth" would be established by the physical testing methods themselves (e.g., measuring force, displacement, cycles to failure) against predefined engineering specifications derived from predicate devices and industry standards.
For bacterial endotoxin levels, the ground truth is established by the LAL (Limulus Amebocyte Lysate) method, which is a standard assay for endotoxin detection.

8. The sample size for the training set

Not applicable. This is pre-clinical testing, not a machine learning model.

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

Not applicable. This is pre-clinical testing, not a machine learning model.

In summary: The provided document is a 510(k) submission focusing on demonstrating substantial equivalence through engineering rationales and pre-clinical mechanical and biological testing. It does not include information about clinical studies with human subjects or AI performance, which are the typical contexts for many of the questions asked. The "acceptance criteria" here refer to engineering performance benchmarks.

Summary

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

April 24, 2017

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

Re: K170887

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, HTN Dated: March 24, 2017 Received: March 27, 2017

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

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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 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" (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) K170887

Device Name EVOS Small Fragment Plating System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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FORM FDA 3881 (8/14)

PSC Publishing Services (301) 443-6740

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Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	April 11, 2017
	Samantha StaubachRegulatory Affairs SpecialistT 901-399-6132F 901-566-7596
Name of Device:	EVOS Small Fragment Plating System
Common Name:	Bone Plates, Screws, Washers
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/HTN

Predicates

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	Smith & Nephew, Inc. EVOSSmall Fragment Plating System(primary predicate)	K162078	November 18,2016
Smith & Nephew, Inc.	Smith & Nephew Bone PlateSystem (now branded as TC-100)	K993106	December 9, 1999
Smith & Nephew, Inc.	PERI-LOC Periarticular LockedPlating System for UpperExtremity	K061352	June 8, 2006
Smith & Nephew, Inc.	PERI-LOC Locking Hole Insertsand Cable Accessories	K100325	May 4, 2010
Smith & Nephew, Inc.	EVOS Mini-Fragment PlatingSystem (Reference Predicate)	K140814	May 7, 2014
Synthes (USA)	Synthes Small FragmentDynamic Compression LockingSystem	K000684	April 28, 2000

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Device Description

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

The subject devices are very similar to existing Smith & Nephew Plating System implants. Compared to the Reconstruction and Compression Plates cleared via K162078, the modified plates have minor dimensional changes and are manufactured using a slightly different manufacturing process (Plates will be manufactured from extruded stock instead of being manufactured using a sculpture milled process.) No other changes were made to the subject modified plates. The 3.5mm Washers and Double Washers and Locking Hole Inserts are designed for use with the EVOS Small Plating Fragment System. These implant accessories are similar to washers and locking hole inserts provided with other Smith & Nephew Plating Systems. 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.

Summary of Pre-Clinical Testing

Engineering rationales were leveraged for minor design modifications to the plates to . ensure that the modifications would not have a significant influence on plate strength.
Four point bend fatigue testing was conducted on the worst-case designs of the o proposed bone plates, as previously identified through FEA. Results of the testing concluded that the bending fatigue performance achieved by the proposed bone plates manufactured from extruded material met the acceptance criteria in that they were found to be similar to the bending fatigue performance of the EVOS sculpture milled plates cleared via K162078 and additional predicate plating systems.
. Four point bend fatigue testing was conducted for an EVOS Locking plate with locking hole inserts compared to an EVOS Locking plate without locking hole inserts. Based on the results of the testing, the EVOS Locking Plates with locking hole inserts are expected to have a similar or superior (higher) bending performance as the Locking Plates without locking hole inserts.
Bacterial endotoxin levels were evaluated using the LAL method and were shown to ● be under 20 EU/device

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Conclusion

This Special 510(k) premarket notification is being submitted to request clearance for the EVOS Small Fragment Plating System Straight Plates and implant accessories. 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.