The system is intended for use in adult and pediation: transitional adolescent B (18 years to <21 years) 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 included of the humerus, thia, and femur, particularly in osteopenic bone.

Device Description

The G3TM Active Plate® Large Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plates and screws are intended to be used for long bone fracture fixation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and silicone elastomer in the subject device. The screws are 5.0 mm diameter and come in lengths ranging from 14 to 145 mm. The plates range in size from 6 holes to 14 holes. 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 document is a 510(k) summary for the G3™ Active Plate® Large Fragment System, which is a bone fixation device. It is a submission to the FDA for market clearance, not a study evaluating device performance against pre-defined acceptance criteria in the way one would for a diagnostic or AI-driven device.

Therefore, the information typically found in acceptance criteria and study designs for such devices (like accuracy, sensitivity, specificity, sample size, ground truth establishment, expert qualifications, etc.) is not applicable to this submission.

This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, the G3™ Active Plate Large Fragment System (K142938). The primary argument for substantial equivalence rests on the fact that the subject device is "identical in every way except for the process by which the sliding element is manufactured."

Instead of a typical performance study, the submission references mechanical testing that was previously performed on the predicate device. The underlying assumption is that since the only change is a manufacturing process for a sub-component, and the form, fit, and intended function remain the same, the previous mechanical testing results are still valid and applicable.

Here's a breakdown of what can be extracted, even though it doesn't align with the requested format for a diagnostic/AI device:

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

Acceptance Criteria: While not explicitly stated as "acceptance criteria" in the context of a new performance study, the underlying criteria for substantial equivalence are that the subject device performs at least as well as the predicate device in terms of mechanical properties and safety.

Reported Device Performance:

Performance Tests Performed (on predicate device): Stiffness, fatigue, pullout, torsion, torque, construct fatigue, and wear.
Standards Referenced: ASTM F543 and ASTM F382.
Conclusion: The submission asserts that "Since the subject and predicate are identical in every way except for the process by which the sliding element is manufactured, this testing also applies to the subject device and thus the subject device is substantially equivalent to the predicate."

Table (Re-interpreted for this context):

Performance Metric (Tested on Predicate)	Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Performance (Inferred for Subject Device)
Stiffness	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.
Fatigue	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.
Pullout	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.
Torsion	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.
Torque	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.
Construct Fatigue	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.
Wear	Meets ASTM F543/F382 standards and performs equivalently to predicate.	Deemed equivalent to predicate, meeting standards.

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

This information is not provided. The performance data discussed refers to mechanical testing of physical device components, not a clinical test set of patient data.

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)

Not applicable. Ground truth in this context would refer to material properties and mechanical performance, which are established through standardized engineering tests, not expert human review.

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

Not applicable for mechanical testing.

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 is not an AI-driven device or diagnostic tool.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for the mechanical testing would be defined by the specifications and measurement results obtained from applying the ASTM F543 and ASTM F382 standards to the physical devices.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model.

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

Not applicable.

Summary

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Image /page/0/Picture/1 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 an abstract symbol that resembles a stylized caduceus or a representation of the human form. The symbol is composed of three wavy lines that converge to form a head-like shape.

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

April 30, 2015

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

Re: K150649 Trade/Device Name: G3TM Active Plate® Large 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 9, 2015 Received: March 12, 2015

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 Part 801); medical device reporting (reporting of medical device

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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.

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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K150649

Device Name

G3TM Active Plate® Large 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)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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510(k) Summary

G3™ Active Plate® Large Fragment System March 9, 2015

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 TM Active Plate ® Large 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

Device Description: The G3TM Active Plate® Large Fragment System is a straight plate and locking
screw system comprised of a variety of sizes to accommodate various patient
anatomy and pathology. The plates and screws are intended to be used for long
bone fracture fixation. All implantable components are manufactured from
medical grade titanium alloy (Ti6Al4V-ELI) and silicone elastomer in the subject
device. The screws are 5.0 mm diameter and come in lengths ranging from 14
to 145 mm. The plates range in size from 6 holes to 14 holes. 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

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locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.

Indications for Use: The system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to <21 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, and femur, particularly in osteopenic bone.

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

G3™ Active Plate Large Fragment System (K142938, S.E. 11/26/2014)

The subject G3™ Active Plate® Large Fragment System is identical to and thus substantially equivalent in terms of intended use, material, and geometry. The only difference between the subject and predicate devices is a change in the manufacturing of the sliding element. The silicone will no longer be molded within the plate. The silicone will now be overmolded on the sliding element prior to assembly within the plate.

	Subject of Present 510(k):	Predicate Device
	G3™ Active Plate®	G3™ Active Plate®
Intended Use/ Indicationsfor Use	The G3™ Active Plate® LargeFragment System isintended for use in adult andpediatric cases requiringstabilizations od mal-unions,non-unions, andosteotomies of long bones,as well as repair of closedand open fractures, Thesystem is indicated for thefixation of long bonefractures including, but notlimited to, fractures of thehumerus, tibia, and femur,particularly in osteopenicbone.	Identical

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Primary Material	Titanium	Identical
Geometry and Dimensions	Plates: 6 - 14 holes; Lengths:145 mm - 305 mm	Identical
	Locking Screws: Diameter:5.0 mm
	Lengths: 14 mm - 145 mm
Active feature (ifapplicable)	Sliding elements	Identical
Manufacturing Process forActive Feature	Molded within plate	Overmolded on slidingelement prior to assemblywithin plate

Performance Testing: Mechanical testing, including stiffness, fatigue, pullout, torsion, torque, construct fatigue and wear was previously performed per ASTM F543 and ASTM F382 on the predicate G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system. Since the subject and predicate are identical in every way except for the process by which the sliding element is manufactured, this testing also applies to the subject device and thus the subject device is substantially equivalent to the predicate.

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.