The G3™ Acive Plate® Small Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to <21 years)) cases requiring stabilizations of mal-unions, and osteotomies of long bones, as well as repair of closed and open fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, fibula, and radius.

Device Description

The G3TM Active Plate® Small Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plate and screw are intended to be used for fracture fixation. All implantable components are manufactured from medical grade stainless steel and silicone elastomer the same as the subject device. The screws are 3.5 mm diameter and come in lengths ranging from 10 to 90 mm. The plates range in size from 6 hole to 18 hole. The plates incorporate sliding elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to the sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.

AI/ML Overview

The provided text is a summary of a 510(k) premarket notification for a medical device called the G3™ Active Plate® Small Fragment System. It details the device's intended use, classification, and claims of substantial equivalence to previously cleared devices based on various performance tests. However, it does not include information about acceptance criteria for a study proving the device meets those criteria, specifically in the context of an AI/algorithm-driven device for diagnostic or prognostic purposes, which seems to be the focus of the request.

The request asks for information related to the acceptance criteria and a study that proves a device meets acceptance criteria, particularly for a device that seems to involve AI or algorithmic performance (given the questions about sample size for test/training sets, ground truth, experts, MRMC studies, and standalone performance). The provided document describes a metallic bone fixation appliance, not an AI-driven device.

Therefore, I cannot fulfill the request as it is posed because the provided document does not contain the type of information required for an AI/algorithm performance study.

Here's why the provided text doesn't contain the requested information:

Type of Device: The G3™ Active Plate® Small Fragment System is a physical implant for fracture fixation, not a digital diagnostic or prognostic tool.
"Acceptance Criteria" in this context: For this implant, "acceptance criteria" generally refer to design specifications, material properties, biocompatibility, and mechanical performance (stiffness, fatigue, pullout, torsion, torque) of the physical product, as demonstrated through bench testing (e.g., ASTM F543, ASTM F382). It does not involve diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for AI devices.
"Study" Information: The document refers to "Performance Testing" which included mechanical tests (stiffness, fatigue, pullout, torsion, torque, and construct fatigue). These are bench tests on the physical device components, not clinical studies involving human readers, ground truth established by experts, or AI algorithm performance.
Missing Information Categories: All categories in your request (Table of acceptance criteria/performance, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set) are entirely irrelevant to the type of device and testing described in the provided document.

To summarize, the document details the regulatory clearance of a surgical implant based on its physical properties and mechanical performance, demonstrating substantial equivalence to predicate devices through bench testing. It does not describe an AI/algorithmic device or a study involving human readers, clinical data interpretation, or ground truth establishment relevant to AI performance.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image 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

April 22, 2016

Genesis Fracture Care, Incorporated % Ms. Christine Scifert Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Bartlett, Tennessee 38133

Re: K160633

Trade/Device Name: G3™ Active Plate® Small Fragment 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: March 4, 2016 Received: March 7, 2016

Dear Ms. Scifert:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (21CFR 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 yours,

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)

K160633

Device Name

G3TM Active Plate® Small Fragment System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

G3™ Active Plate® Small Fragment System March 11, 2016

Company:	Genesis Fracture Care, Inc.13568 SE 97th AveSuite 202Clackamas, OR 97015503-528-4048503-413-5216 (fax)
Primary Contact:	Christine Scifert
Company Contact:	Michael Bottlang
Trade Name:	G3 ™ Active Plate ® Small Fragment System
Common Name:	Plate, Fixation, BoneScrew, Fixation, Bone
Classification:	II
Regulation Number:	888.3030 - Single/multiple component metallic bone fixation appliancesand accessories888.3040 - Smooth or threaded metallic bone fixation fastener
Panel:	87-Orthopedic
Product Code(s):	HRS, HWC

The G3TM Active Plate® Small Fragment System is a straight plate and locking Device Description: screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plate and screw are intended to be used for fracture fixation. All implantable components are manufactured from medical grade stainless steel and silicone elastomer the same as the subject device. The screws are 3.5 mm diameter and come in lengths ranging from 10 to 90 mm. The plates range in size from 6 hole to 18 hole. The plates incorporate sliding elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to the sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.

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Indications for Use: The G3™ Active Plate® Large Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years)) cases requiring stabilizations of mal-unions, non-unions, and osteotomies of long bones, as well as repair of closed and open fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, fibula, and radius.

Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following plate and screw systems previously cleared by the FDA:

Zimmer® Universal Locking System (K060710; S.E.4/26/2006)
Zimmer® MotionLoc™ Screw for Periarticular Locking Plate System (K130810; S.E. 9/19/2013)
Smith & Nephew Locking Bone Plate System (K033669; S.E. 12/10/2003 and K083032, S.E. ● 01/07/2009)
Genesis Fracture Care G3™ Active Plate® Large Fragment System (K152242; S.E. 11/24/2015)
Genesis Fracture Care G3™ Active Plate® Large Fragment System (K142938; S.E. 11/26/2014)

In addition to being substantially equivalent in terms of intended use, materials, geometry, and active feature, the subject G3™ Active Plate® Small Fragment System has also demonstrated to be substantially equivalent in terms of construct stiffness performance when compared to the previously cleared titanium G3™ Active Plate Large Fragment System (K152242, S.E. 11/24/2015). The subject G3™ Locking Screws have also demonstrated to be substantially equivalent to those in the previously cleared Zimmer Universal Locking System (K060710; S.E. 04/26/2006) in terms of performance. Finally, the G3™ Active Plate® Small Fragment System has demonstrated to be substantially equivalent to the 3.5mm Zimmer® MotionLoc ™ Universal Plating System (Stainless Steel – K060710; S.E. 04/26/2006) in fatigue and Smith & Nephew PERI-LOC Bone Plating and Screw System (K033669, S.E. 12/10/2003 and K083032, S.E. 01/07/2009) and 3.5mm Zimmer® MotionLoc ™ Universal Plating System (Stainless Steel – K060710; S.E. 04/26/2006) in construct fatigue testing.

	Subject of Present 510(k):	Predicate Devices
	G3™ Active Plate™
Intended Use/ Indicationsfor Use	The G3™ Active Plate® Small Fragmentsystem is intended for use in adult andpediatric (subpopulation: transitionaladolescent B (18 years to <21 years)cases requiring stabilizations of mal-unions, non-unions, and osteotomiesof long bones, as well as repair ofclosed and open fractures. Thesystem is indicated for the fixation oflong bone fractures including but not	Inclusive

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	limited to fractures of the humerus,tibia, fibula, and radius.

Primary Material	Stainless Steel	Identical
Geometry and Dimensions	Plates: 6 - 18 holes; Lengths: 145 mm -305 mmLocking Screws: Diameter: 3.5 mmLengths: 10 mm - 90 mm	Inclusive

Performance Testing: Mechanical testing, including stiffness, fatigue, pullout, torsion, torque, and construct fatigue have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Small Fragment System, as well as the G3™ locking screws used within the system, have shown them to be substantially equivalent to the predicate plate and screw systems.

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.