The G3™ Active Plate® Miniature System is intended for fracture fixation in patients 18 years of age and older requiring stabilization of mal-unions, osteotomies and repair of closed and open fractures in small bones. The system is indicated for the fixation of small bone fractures including, but not limited to, fractures of the hand, foot, wrist and ankle.

Device Description

The G3™ Active Plate® Miniature System is a straight plate and locking screw system intended to be used for fracture fixation of the hand and foot. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI), medical grade cobalt chrome alloy (Co-28Cr-6Mo) and silicone elastomer in the subject device.

The plate has 8 holes. The plates incorporate link elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to both the link element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. The screws are 1.5 mm diameter and come in lengths ranging from 8 mm to 24 mm.

AI/ML Overview

This document describes a medical device, the G3™ Active Plate® Miniature System, and its substantial equivalence to predicate devices, rather than outlining acceptance criteria and a study to prove a device meets those criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the information requested in the specified format regarding acceptance criteria and performance studies. The provided text is a 510(k) summary for a bone fixation system, which focuses on demonstrating substantial equivalence to previously cleared devices through material, geometric, and mechanical performance comparisons, not a clinical study with an AI algorithm.

Here's why the requested information cannot be extracted from the provided text:

No Acceptance Criteria for an AI Device: The document is about a physical bone fixation plate and screws, not an AI/ML algorithm. Therefore, there are no acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
No Reported Device Performance for an AI Device: Similarly, there is no performance data for an AI algorithm because the device itself is a mechanical implant.
No Test Set/Ground Truth/Experts/Adjudication/MRMC/Standalone Study: These are all concepts relevant to the evaluation of AI/ML diagnostic or prognostic tools. The provided document does not discuss any such studies or evaluations.
No Training Set Information: There is no AI training set because this is not an AI/ML device.

In summary, the provided text does not contain the type of information related to AI/ML device acceptance criteria and performance studies that your questions are designed to extract.

Summary

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Genesis Fracture Care, Inc. % Christine Scifert Managing Partner MRC-X, LLC 6075 Poplar Ave Suite 500 Memphis, Tennessee 38119 October 23, 2017

Re: K171293

Trade/Device Name: G3TM Active Plate® Miniature 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: September 18, 2017 Received: September 21, 2017

Dear Christine 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 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 (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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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 (DICE) 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 (DICE) 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

510(k) Number (if known)

K171293

Device Name

G3TM Active Plate® Miniature 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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K171293 Page 1/3

510(k) Summary G3™ Active Plate® Miniature System September 18, 2017

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® Miniature 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 G3™ Active Plate® Miniature System is a straight plate and locking screw Device Description: system intended to be used for fracture fixation of the hand and foot. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI), medical grade cobalt chrome alloy (Co-28Cr-6Mo) and silicone elastomer in the subject device.

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Indications for Use: The G3™ Active Plate® Miniature System is intended for fracture fixation in patients 18 years of age and older requiring stabilization of mal-unions, osteotomies and repair of closed and open fractures in small bones. The system is indicated for the fixation of small bone fractures including, but not limited to, fractures of the hand, foot, wrist and ankle.

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

Primary Predicate

Hand Innovations (Zimmer Biomet Inc.) Mini Fragment Plates (K061748) ●
Additional Predicates
DePuy Synthes Variable Angle Locking Hand System (K141527) ●
DePuy Synthes - Small Bone Locking Plating System (K083364)
Small Bone Innovations SBI K-Wires (K051605) ●
. Wright Medical - WMT Implantable K-wires (K132895)

Reference Devices

Genesis Fracture Care (Zimmer Biomet Inc.) G3™ Active Plate® Large Fragment . System (K152242)
The subject G3™ Active Plate® Miniature System has demonstrated to be substantially equivalent to the predicates as the products are similar in indications, materials, geometry, and active feature.

	Subject of Present 510(k):G3 TM Active Plate® Miniature Plate	Predicate Devices
Intended Use/ Indicationsfor Use	The G3 TM Active Plate® MiniatureSystem is intended for fracture fixationin patients 18 years of age and olderrequiring stabilization of mal-unions,non-unions, osteotomies and repair ofclosed and open fractures in smallbones. The system is indicated for thefixation of small bone fractures	Inclusive

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	including, but not limited to, fractures of the hand, foot, wrist and ankle.
Materials	Titanium Alloy (Plate)Silicone – NuSil (Plate)Cobalt Chrome (Screws)	Identical
Geometry and Dimensions	Plates: 8 holesLength: 25 mmLocking Screws:Diameter: 1.5mmLengths: 8 mm – 24 mm	Inclusive

Performance Testing: Mechanical testing including axial, torsional and shear stiffness and fourpoint bend per ASTM F382-08 was performed on the subject G3™ Active Plate® Miniature System and the results show the subject plates to be substantially equivalent to the predicate devices. Engineering analysis was used to compare the torsional strength, axial pullout strength and insertion/removal torque of the subject screws to the predicates.

Conclusion

Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predict 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.