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.

Device Description

Subject of this premarket notification is an extension of the EVOS Small Fragment Plating System, the EVOS Small Fragment Upper Extremity Plates. The subject plates feature similarities to existing Smith & Nephew small fragment plating systems (TC-100 Small Bone Plating System, PERI-LOC/PERI-LOC VLP Plating Systems) and also share some instruments and compatible implants from the existing EVOS MINI Plating System and EVOS Small Fragment Plating System. When compared against EVOS Small Fragment Plates already cleared for market, the subject plates use the same hole features and are designed to work with the same bone screws. The EVOS Small Fragment Upper Extremity Plates are available in a variety of plate designs for specific anatomical areas. These plate designs include plates with 2.7mm holes or 3.5mm holes only, or with a combination of 2.7mm and 3.5mm holes. Plate designs may include threaded holes, non-threaded holes, and variable-angle locking holes.

AI/ML Overview

The context provided is for a 510(k) premarket notification for a medical device called the "EVOS Small Fragment Upper Extremity Plates." This document describes the device, its indications for use, and a summary of pre-clinical testing conducted to demonstrate its substantial equivalence to predicate devices. It is not a study demonstrating device performance against specific acceptance criteria for an AI or diagnostic device.

Therefore, many of the requested sections regarding AI/algorithm performance, ground truth, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes cannot be answered from the provided text.

However, I can extract information related to the device's pre-clinical testing and the general concept of acceptance criteria in the context of mechanical performance and sterility.

Here's an attempt to answer based on the provided text, indicating when information is not available:

Acceptance Criteria and Study Details (Based on K173293 Summary)

This document describes the pre-market notification (K173293) for the EVOS Small Fragment Upper Extremity Plates, a Class II medical device (metallic bone fixation appliances and accessories) manufactured by Smith & Nephew, Inc. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove performance against specific AI-related acceptance criteria.

The "studies" described are pre-clinical tests to assess the mechanical robustness and packaging integrity of the bone plates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Metric (Implicit)	Reported Device Performance
Mechanical Performance (Bending Fatigue/Structural Strength)	Equivalent or superior structural strength and fatigue performance to predicate devices under similar conditions. (Implied: Resist fracture, maintain structural integrity)	- Finite Element Analysis (FEA): Conducted to identify worst-case plates for mechanical testing. - Bending Fatigue Testing: Worst-case plates were tested. Results showed "the subject EVOS plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions." - Engineering Rationales: Leveraged for some plates based on previous FEA, mechanical testing, and hand calculations.
Packaging Integrity	Product not damaged during shipment; sterility maintained post-shipment.	"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 Limits	Meet acceptable endotoxin limits as per FDA Guidance and ANSI/AAMI ST72.	"Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance..."

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

Mechanical Testing (FEA & Fatigue): The text mentions "worst case plates" were identified through FEA for further mechanical testing. It does not specify the exact number of plates or samples tested in the bending fatigue analysis.
Data Provenance: The tests are pre-clinical, conducted by the manufacturer, Smith & Nephew, Inc. The data is prospective, generated specifically for this submission. The country of origin for the data generation is not explicitly stated but is implicitly tied to Smith & Nephew's testing facilities (likely in the US based on the company's address).
Packaging and Endotoxin Testing: No specific sample sizes are mentioned for these tests, only that they were conducted and met criteria.

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

Not Applicable. This is a medical device (bone plate) pre-market notification, not an AI or diagnostic device. There is no concept of "ground truth" established by experts in the context of these mechanical and sterility tests. The "truth" is determined by objective physical and chemical measurements.

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

Not Applicable. No adjudication method is described as there is no subjective interpretation of results by experts involved in establishing a "ground truth" for these pre-clinical tests.

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 device is a bone plate, not an AI-assisted diagnostic tool. No MRMC studies were conducted or are relevant to this submission.

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

Not Applicable. This is a physical medical device. No algorithm or standalone performance study was conducted.

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

Not Applicable (in the context of AI/diagnostic "ground truth"). For the mechanical tests, the "ground truth" corresponds to the objective physical properties and performance measured against established engineering standards and predicate device performance. For packaging and endotoxin tests, it's objective adherence to recognized standards and guidance.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" in manufacturing refers to process validation and quality control, not a data set for model development.

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

Not Applicable. No training set or associated ground truth.

Summary

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January 8, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K173293

Trade/Device Name: EVOS Small Fragment Upper Extremity Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: December 19, 2017 Received: December 20, 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -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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>< smith&nephew

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: 06/30/2020See PRA Statement below.

Indications for Use

510(k) Number (if known)	K173293
Device Name	EVOS Small Fragment Upper Extremity Plates
Indications for Use (Describe)	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.

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)

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>< We are smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	October 12, 2017
Name of Device:	Samantha StaubachRegulatory Affairs Specialist IIT 901-399-6132F 901-566-7596EVOS Small Fragment Upper Extremity Plates
Common Name:	Bone Plates

Device Classification Name andReference:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	HRS

Predicates

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	Smith & Nephew Bone PlateSystem (primary predicate,now branded as TC-100)	K993106	December 9,1999
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 (nowbranded as PERI-LOC VLP)	K062216	September 15,2006
Smith & Nephew, Inc.	PERI-LOC Periarticular LockedPlating System -VLP LockingBone Plates and Screws	K071563	August 8, 2007
Smith & Nephew, Inc.	EVOS Small Fragment PlatingSystem Straight Plates andScrews	K162078	November 18,2016
Smith & Nephew, Inc.	EVOS Small Fragment LowerExtremity Plates	K170457	June 14, 2017
Smith & Nephew, Inc.	EVOS Small Fragment PlatingSystem	K170887	April 24, 2017

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Device Description

Indications for Use

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 designs with a variety of hole features, which are available on EVOS Small Fragment Plates previously cleared for market. The subject plates differ from the EVOS Small Fragment Plates previously cleared in that the plate shapes are more anatomically specific for upper extremity fractures.

Summary of Pre-Clinical Testing

. Finite element analysis (FEA) was conducted on the proposed plate designs to determine the worst case plates based upon structural strength for further mechanical testing. Plates were separated into groups for evaluation based upon similar designs or anatomical application.
. Bending fatigue performance or construct fatigue performance was evaluated for the worst case plate designs identified through FEA. Results of the testing determined that the subject EVOS plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions.
Engineering rationales were leveraged to justify the bending strength of some EVOS . plates based on previously conducted FEA, previously conducted mechanical testing, and hand calculations.

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. 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.

Conclusion

This Traditional 510(k) premarket notification is being submitted to request clearance for the EVOS Small Fragment Plating System Upper Extremity Plates. 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.