Subject of this premarket notification is an extension of the EVOS Large Fragment Plating System, the Peri-Prosthetic Plates, Blunt Tip Screws and Cable Accessories. The proposed devices incorporate design features similar to those currently incorporated on previously cleared Smith & Nephew bone plate and screw systems. Like their previously cleared counterparts. the proposed plates feature a screw-to-plate locking feature that permits their use with the previously cleared and compatibility designed locking and non-locking screws described in this premarket notification. EVOS Large Fragment Per-Prosthetic Plates are available in a variety of plate designs for specific anatomical areas. These plate designs have a combination of 3.5mm and 4.5mm holes. Plate designs may include threaded holes, non-threaded holes, and variable-angle locking holes. Blunt Tip Screws are available in 4.5mm diameter and are identical to the EVOS 4.5mm Cortex Locking Screws described in K201918 with the exception of the blunt tip. Cable Accessories include 3.5mm and 4.5mm cable saddles and 3.5mm cable post.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "EVOS Large Fragment Plating System Peri-Prosthetic" by Smith & Nephew, Inc. This submission focuses on establishing substantial equivalence to previously cleared predicate devices, primarily through engineering and mechanical testing. As such, the information typically found in clinical studies involving acceptance criteria for device performance in terms of clinical outcomes, human reader improvement, or stand-alone AI performance is not applicable or present.

Here's the breakdown of the information requested, based on the provided document:

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

Since this is a 510(k) for a metallic bone fixation system, "acceptance criteria" and "device performance" are primarily evaluated through mechanical and pre-clinical testing, ensuring the new device performs similarly or superiorly to predicate devices. Clinical performance metrics like sensitivity, specificity, or accuracy (common for AI/diagnostic devices) are not relevant here.

Acceptance Criteria (General)	Reported Device Performance
Mechanical Strength & Durability: Maintain structural integrity and function under simulated physiological loads, demonstrating equivalence or superiority to predicate devices in fatigue.	Fatigue Performance: "Results of the testing determined that the subject plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions."
Material Biocompatibility: Materials used must be biocompatible.	Biocompatibility Testing: "EVOS Large Fragment Fracture Plating System Biocompatibility Testing" (Completed, implies met criteria)
Sterility: Device must be sterile and maintain sterility until use.	Bacterial Endotoxin Testing: "Completed and met the acceptable endotoxin limits as stated in the FDA Guidance..."
MRI Safety & Compatibility: Device must not pose a safety risk or significantly interfere with MRI procedures.	MRI Compatibility Testing: "Conducted as per the FDA's guidance 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment', December 11, 2014." (Completed, implies met criteria)
Packaging Integrity: Packaging must protect the device and maintain sterility during transport and storage.	Packaging Verification Testing: "Conducted for the proposed packaging configurations and the results of this testing demonstrated that the product will not be damaged during shipment and will adequately maintain sterility post shipment."
Design Equivalence/Similarity: Design features (screw-to-plate locking, hole types, screw dimensions) should be similar to predicate devices.	Technological Characteristics: "The proposed devices are substantially equivalent to legally marketed predicates with respect to intended use, indications, and performance characteristics." "The holes are identical to those used in the EVOS Large Fragment Plates cleared via K201918. The subject screws feature a hex drive and are identical to existing Smith & Nephew predicate screws with respect to threadform and major and minor diameter."

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

The document primarily discusses pre-clinical and mechanical testing. For mechanical fatigue testing, "worst case plate designs identified through FEA" were used. The sample sizes for these tests (e.g., number of plates or constructs tested) are not specified in the provided text. Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of 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)

This is not applicable to the type of device and submission described. Ground truth established by medical experts (like radiologists for imaging devices) is not relevant for a substantial equivalence claim based on mechanical performance of bone plates.

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

Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions, which isn't the focus of this pre-clinical mechanical evaluation.

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. An MRMC study is relevant for diagnostic imaging devices, especially those involving AI assistance, to assess the impact of AI on human reader performance. This device is a surgical implant.

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

Not applicable. "Standalone performance" refers to the performance of an AI algorithm without human intervention, again, relevant for diagnostic AI devices, not surgical implants.

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

For the mechanical testing, the "ground truth" would be established by engineering standards and validated testing methodologies. For example:

Mechanical Strength: Defined by industry standards (e.g., ASTM, ISO) for bone plates, or by direct comparison to the mechanical properties of predicate devices under equivalent loading conditions. The "ground truth" is that the device must meet or exceed these established engineering performance benchmarks.
Biocompatibility: Established by adherence to ISO 10993 series standards.
Sterility: Established by microbiology standards and endotoxin limits.

8. The sample size for the training set

Not applicable. "Training set" refers to data used to train an AI algorithm. This device is a metallic bone fixation system, not an AI/software device requiring a training set.

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

Not applicable, as there is no AI training set for this device.

Summary

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January 27, 2021

Smith & Nephew, Inc. Thomas Fearnley Senior Regulatory Affairs Specialist 1450 E Brooks Road Memphis, Tennessee 38116

Re: K203405

Trade/Device Name: EVOS Large 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: November 17, 2020 Received: November 19, 2020

Dear Thomas Fearnley:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203405

Device Name EVOS Large Fragment Plating System

Indications for Use (Describe)

The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.

Type of Use (Select one or both, as applicable)
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|X 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:	November 17, 2020
Name of Device:	EVOS Large Fragment Plating System Peri-Prosthetic
Common Name:	Bone Plates
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

Predicates

Product Code:

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	Smith & Nephew Locking BonePlate System (PERI-LOC) PrimaryPredicate	K033669	December 10,2003
Smith & Nephew, Inc.	Smith & Nephew OrthopaedicCabling System (ACCORD)	K031162	May 1, 2003
Smith & Nephew, Inc.	EVOS Small Fragment PlatingSystem Straight Plates and Screws	K162078	November 18, 2016
Smith & Nephew, Inc.	PERI-LOC Proximal Femur LockingBone Plates, Bone Screws andCable Accessories	K072818	November 19, 2007
Smith & Nephew, Inc.	PERI-LOC Periarticular LockedPlating System for Lower & UpperExtremity	K092015	July 30, 2009
Smith & Nephew, Inc.	EVOS Large Fragment PlatingSystem	K201918	November 16,2020

HRS, HWC

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Device Description

Indications for Use

The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.

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 plates with both locking and non-locking holes. Locking holes in the plates can either be threaded holes or variable angle holes and non-locking holes are not threaded. The holes are identical to those used in the EVOS Large Fragment Plates cleared via K201918. The subject screws feature a hex drive and are identical 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 for further mechanical testing. Plates were separated into groups for evaluation based upon similar designs or anatomical application.
Fatigue performance was evaluated through four point bending fatigue or construct fatigue testing for the worst case plate designs identified through FEA. Results of the testing determined that the subject plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions.
Magnetic resonance imaging (MRI) compatibility testing was conducted as per the FDA's ● guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014.
. Packaging verification testing was conducted for the proposed packaging configurations and the results of this testing demonstrated 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.
EVOS Large Fragment Fracture Plating System Biocompatibility Testing .

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Conclusion

This Traditional 510(k) premarket notification is being submitted to request clearance for the EVOS Large Fracture Plating System Peri-Prosthetic. Based on similarities to the predicate plating systems 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.