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.

The EVOS Partial Articular and Anti-Glide plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classification Type B), and for fracture fixation of the fibula.

Device Description

Subject of this premarket notification is an extension of the EVOS Small Fragment Plating System, the EVOS Small Fragment Lower Extremity Plates. The subject plates feature similarities to existing Smith & Nephew small fragment plates (TC-100 Small Bone Plating System, PERI-LOC and PERI-LOC VLP Plating Systems, EVOS Small Fragment Plating System Straight Plates) and also share some instruments and compatible implants from the existing EVOS MINI Plating System and EVOS Small Fragment Plating System. EVOS Small Fragment Lower 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, nonthreaded holes, and variable-angle locking holes. The subject plates are offered in "thick" and "thin" varieties. The "thin" plates are the partial articular/antiglide plates.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the EVOS Small Fragment Lower Extremity Plates, presented in the requested format:

It's important to note that the provided document is a 510(k) clearance letter and an associated summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria through a clinical study in the way an AI/ML device would. Therefore, much of the requested information for AI/ML device studies (like sample sizes for test/training sets, ground truth establishment, MRMC studies, etc.) is not applicable to this traditional medical device clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a traditional medical device (bone plates) seeking 510(k) clearance by demonstrating substantial equivalence, the "acceptance criteria" are not based on clinical performance metrics like sensitivity/specificity but rather on engineering and material performance compared to predicate devices.

Acceptance Criteria (Performance Objective)	Reported Device Performance (Summary of Findings)
Mechanical Performance: Comparable or superior mechanical integrity to predicate devices under stress.	Finite Element Analysis (FEA): Conducted to identify worst-case plates.Bending Performance (Static/Cantilever Testing): "Results of the testing determined that the subject plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions."
Packaging Integrity: Maintain sterility and prevent damage during shipment.	Packaging Verification Testing: "demonstrated that the product will not be damaged during shipment and will adequately maintain sterility post shipment."
Sterility/Biocompatibility: Meet acceptable endotoxin limits for devices labeled as sterile.	Bacterial Endotoxin Testing: "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." (These are industry standards and FDA guidance, functioning as acceptance criteria).

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

Sample Size for Test Set: Not applicable. For traditional medical device clearances based on substantial equivalence, mechanical and materials testing are typically performed on a subset of product configurations or representative samples, not on a "test set" in the context of clinical data. The document mentions "worst case plates" identified by FEA for mechanical testing. The specific number of plates or trials is not provided within this summary.
Data Provenance: Not applicable in the sense of patient data. The provenance for the testing data would be Smith & Nephew's internal labs or authorized testing facilities performing controlled laboratory experiments.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This device is cleared based on engineering and performance testing, not on interpretation of clinical images or data by experts to establish a "ground truth."

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the sense of data requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device, and thus MRMC studies are not performed for its clearance.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

Not applicable. This is a physical medical device (bone plates), not a software algorithm.

7. Type of Ground Truth Used

Not applicable in the context of clinical "ground truth." The "ground truth" for this device's clearance would be established engineering principles, material science standards (e.g., ASTM standards for mechanical testing), and regulatory guidance regarding sterility and biocompatibility.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device, and therefore no training set or its ground truth establishment is relevant.

Summary Conclusion from the Document:

The EVOS Small Fragment Lower Extremity Plates received 510(k) clearance (K170457) based on demonstrating substantial equivalence to legally marketed predicate devices (Smith & Nephew Bone Plate System K993106, K033669, K062216, K071563, and K162078). This was achieved through:

Technological Characteristics: Showing similarities to predicate devices in design, materials, and hole configurations (locking and non-locking).
Pre-Clinical Testing:
- Finite Element Analysis (FEA) to identify worst-case configurations.
- Mechanical bending tests proving performance "similar or superior" to predicates.
- Packaging verification to ensure sterility and prevent damage.
- Bacterial endotoxin testing meeting established standards.
Intended Use and Indications: The indications for use are consistent with those of predicate devices, covering adult and pediatric patients with osteopenic bone for fixation of various small and long bone fractures, including partial articular and anti-glide plates for specific tibia and fibula fractures.

The regulatory conclusion is that, "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."

Summary

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Image /page/0/Picture/2 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 image of three human profiles facing to the right, with flowing lines beneath them.

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

June 14, 2017

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

Re: K170457

Trade/Device Name: EVOS Small Fragment Lower 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: May 16, 2017 Received: May 17, 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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Indications for Use

510(k) Number (if known) K170457

Device Name EVOS Small Fragment Lower Extremity Plates

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)

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>< We are smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	February 14, 2016
	Samantha Staubach
	Regulatory Affairs Specialist
	T 901-399-6132
	F 901-566-7596
Name of Device:	EVOS Small Fragment Lower 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, reference predicate)	K033669	December 10,2003
Smith & Nephew, Inc.	PERI-LOC Periarticular LockedPlating System – B Plate LockingBone Plates and Screws (nowbranded as PERI-LOC VLP,reference predicate)	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 (reference predicate)	K162078	November 18,2016

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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

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, identical to the holes used in the EVOS Small Fragment Straight Plates cleared via K162078.

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.
Bending performance was evaluated through static or cantilever bend 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.
. 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.

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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 Lower 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.