The ORTHOFIX CHIMAERA Hip Fracture System – trochanteric nailing system is intended for insertion into the medullary canal of a femur for the alignment, stabilization of various types of fractures or deformities.

The ORTHOFIX CHIMAERA Hip Fracture System - trochanteric nailing system is indicated for treatment of stable and unstable pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximal to the intercondylar notch. These includes traumatic fractures, refractures, non-union, reconstruction, malalignment, pathological fractures and impending pathological fractures.

Device Description

The ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System consists of implantable components (nails, end caps and screws) and instrumentation. The proximal part of the nail features a threaded bore to connect the nail to the targeting handle by means of a cannulated bolt. The insertion of the nail into the femur medullary canal is typically performed by some instruments, including: guide wire, awl, reamer and impactor elements.

AI/ML Overview

This document describes the ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric Nailing System, an intramedullary fixation rod. The information provided is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific acceptance criteria for a novel device.

Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes for test sets, and ground truth establishment for AI-based devices is not applicable to this submission, as it describes a traditional medical device (hardware) rather than a software or AI-driven diagnostic tool.

The "study" that proves the device meets acceptance criteria primarily refers to mechanical testing to demonstrate the structural integrity and performance of the hardware components.

Here's a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
Withstand expected loads without failure	"All testing met or exceeded the requirements, as established by the test protocols and applicable standard." "A review of the mechanical data indicates that the components of the Subject device continues to be capable of withstanding expected loads without failure."
Compliance with ASTM F1264-16 Standard	"The following standard has been followed to perform mechanical test on the System configuration: ASTM F1264 -16 Standard Specifications and Test Methods for Intramedullary Fixation Devices."
Material Biocompatibility:	Implied similar to predicate (not explicitly detailed, but generally a requirement for implantable devices).
Sterility:	Implied similar to predicate (not explicitly detailed, but generally a requirement for implantable devices).
Intended Use:	"Has the mechanical properties to perform its indications safely."

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

Sample Size for Test Set: This is not applicable in the context of device hardware mechanical testing. The "test set" here refers to the number of physical device components or constructs subjected to mechanical evaluation. The document does not specify the exact number of implants tested, but rather refers to "components" and "System configuration" being tested according to a standard.
Data Provenance: The testing is laboratory-based mechanical testing, not clinical data provenance. The device manufacturer is Orthofix Srl, based in Italy.

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):

This is not applicable. For hardware mechanical testing, the "ground truth" is established by the specified mechanical properties and failure limits defined in the ASTM standard (ASTM F1264-16) and internal test protocols, not by expert human interpretation of data.

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

This is not applicable. Mechanical testing results are typically objectively measured and compared against defined thresholds from standards or specifications, not subject to human adjudication in the way medical image interpretation is.

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:

No, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for AI-powered diagnostic devices or software that assist human readers. The ORTHOFIX CHIMAERA Hip Fracture System is a physical implant (hardware). The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the Subject Device."

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

No, this is not applicable. The device is a physical implant, not an algorithm.

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

The "ground truth" for this device's performance is based on mechanical engineering principles and established industry standards (specifically ASTM F1264-16). This standard defines the acceptable mechanical properties and failure modes for intramedullary fixation devices. The device's performance is compared against these objective, quantifiable criteria.

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing processes are refined through engineering principles and testing, not machine learning.

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

This is not applicable. As there is no training set for an AI model, there is no ground truth established in this context.

Summary

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December 7, 2017

Orthofix Srl % Cheryl Wagoner Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 28408

Re: K173458

Trade/Device Name: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: November 6, 2017 Received: November 7, 2017

Dear Cheryl Wagoner:

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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 mediation-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 -5 for 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) K173458

Device Name

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Special 510(k) Premarket Notification ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

510(k) Summary

(as required by 21 CFR 807.92)

Submitter	Orthofix Srl
	Via delle Nazioni, 9
	37012 Bussolengo (VR) - Italy
Telephone	+ 39 045 6719.000
Fax	+ 39 045 6719.380
Contact Person	Gianluca Ricadona
	Sr. Quality & Regulatory Affairs Manager
Address		Via delle Nazioni, 9
	37012 Bussolengo (VR) - Italy
Telephone	+ 39 045 6719.000
Fax	+ 39 045 6719.380
email	GianlucaRicadona@orthofix.it

Submission date	11/06/2017

Trade Name	ORTHOFIXCHIMAERAHipFractureSystem
	Trochanteric Nailing System
Common Name	Rod, fixation, intramedullary and accessories
Panel Code	87 / Orthopaedic
Classification Name	Intramedullary fixation rod.
Class	Class II
Regulation Number	21 CFR 888.3020
Product Code	HSB

Name of Predicate Device	510(k) #	Manufacturer
ORTHOFIX CHIMAERA Hip	K161466	Orthofix Srl

Fracture System - Trochanteric
Nailing System

Description		The ORTHOFIX CHIMAERA Hip Fracture System -
		Trochanteric Nailing System consists of implantable
	components	(nails, end caps and screws)and
		instrumentation. The proximal part of the nail features a
		threaded bore to connect the nail to the targeting handle
		by means of a cannulated bolt. The insertion of the nail
		into the femur medullary canal is typically performed by
		some instruments, including: guide wire, awl, reamer
	and impactor elements.
Intended Use		The ORTHOFIX CHIMAERA Hip Fracture System -
Indications for use		Trochanteric Nailing System is intended for insertion into
		the medullary canal of a femur for the alignment,
		stabilization and fixation of various types of fractures or
	deformities.
		The ORTHOFIX CHIMAERA Hip Fracture System -
		Trochanteric Nailing System is indicated for treatment of
		stable and unstable pertrochanteric, intertrochanteric
		and subtrochanteric fractures of the femur alone or when
		these fractures occur in combination with shaft fractures,
		or when these fractures occur in combination with shaftfractures extending distally to a point approximately 10

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Special 510(k) Premarket Notification

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

	These includes traumatic fractures, re-fractures, non-reconstruction,malunion,malalignment.union.fractures and impendingpathologicalpathologicalfractures.
Technological Characteristics and	Documentation provideddemonstratesthatthe

Substantial Equivalence	ORTHOFIX CHIMAERA Hip FractureSystem
	Trochanteric Nailing System is substantially equivalent
	to the legally marketed predicate.
	The components and instruments included in the Subject
	System and the predicate are all internal fracture fixation
	systems, as defined in 21 CFR 888.3020.
	The ORTHOFIX CHIMAERA Hip Fracture System -

	Trochanteric Nailing System is substantially equivalent
	to the predicate device in: intended use and Indications
	for use, site of application, patient population, condition
	of use, basic design, technology, materials, implantable
	components and mechanical performances.
Performance Data	potential hazards have been evaluatedTheand
	controlled through a Risk Management Plan.
	All testing met or exceeded the requirements, as
	established by the test protocols and applicable
	standard.

	A review of the mechanical data indicates that the
	components of the Subject device continues to be
	capable of withstanding expected loads without failure.
	Subject device was therefore found to beThe
	substantially equivalent to the Predicate device and has
	the mechanical properties to perform its indications
	safely.
	Clinical data was not needed to support the safety and
	effectiveness of the Subject Device.

	The following standard has been followed to perform
	mechanical test on the System configuration:
	· ASTM F1264 -16 Standard Specifications and Test
	Methods for Intramedullary Fixation Devices.
Conclusion	Based upon similarities in: intended use and Indications
	for use, site of application, patient population, condition
	of use, basic design, technology, materials, implantable
	components and mechanical performances, the Subject
	System has been shown to be substantially equivalent to

	the legally marketed predicate device and to be safe and
	effective for its intended use.

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.