Agile Nail by Orthofix Srl | FDA 510(k) Summary

The Agile Nail is intended for insertion in the medullary canal of a femur for the alignment and the stabilization of fractures, and for the correction of deformities.
It is indicated for the treatment of subtrochanteric fractures and of femoral shaft fractures, with the exception of newborns and infants, and in adult patients with an appropriate medullary canal.
The indications include:
prophylactic nailing of impending pathologic fractures;
fixation of femurs that have been surgically prepared (osteotomy);
nonunions and malunions;
reconstruction following tumor resection and grafting and bone lengthening and shortening.

Device Description

The Agile Nail consists of ante grade intramedullary nails, end caps and screws, and related instrumentation for insertion and extraction of the implantable components.
The System is designed to address femoral fractures and deformity corrections procedures.

AI/ML Overview

The provided document describes the Orthofix Agile Nail, an intramedullary fixation rod, and its 510(k) submission for FDA clearance. The submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting a de novo clinical study with specific performance acceptance criteria for an AI/device algorithm.

Therefore, many of the requested details about acceptance criteria, study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance), and training data for an AI-powered medical device are not applicable to this submission. This is a traditional medical device (implantable hardware) clearance, not an AI software as a medical device (SaMD) clearance.

However, based on the information provided, I can construct an answer that reflects the type of "acceptance criteria" and "proof" used for this mechanical device.

Acceptance Criteria and Device Performance for Orthofix Agile Nail

This device, the Orthofix Agile Nail, is a mechanical intramedullary fixation rod, not an AI-powered medical device. As such, the "acceptance criteria" and "study proving the device meets the acceptance criteria" differ significantly from those for an AI algorithm. The clearance for this device was based on substantial equivalence to predicate devices, primarily demonstrated through mechanical performance testing and biocompatibility.

Here's how the requested information applies to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For a mechanical device like the Agile Nail, the "acceptance criteria" are tied to established engineering standards and comparative performance against predicate devices, rather than a diagnostic accuracy metric.

Area of Performance	Acceptance Criteria (Implicit from 510(k) Process)	Reported Device Performance (as stated in document)
Mechanical Performance	Device capable of withstanding expected loads without failure, and equivalent/better mechanical properties compared to predicate devices, as per recognized standards (e.g., ASTM F1264, ASTM F543).	"All testing met or exceeded the requirements as established by the test protocols and applicable standards.""A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure.""The Agile Nail was therefore found to be substantially equivalent to the predicate involved in the performance.""Mechanical testing demonstrate how the mechanical properties of the Subject Device are equivalent / better than the predicate involved."
Biocompatibility	Device materials must be non-pyrogenic and biocompatible, meeting established international and FDA standards (e.g., USP, ANSI/AAMI ST72).	"In order to establish the Subject device non-pyrogenicity, some tests were performed on an equivalent System implants, according to the following international standard:• USP 38: 2014 < 85 > "Bacterial endotoxin test (LAL)".• USP 38: 2014 < 161 > "Medical devices – bacterial endotoxin and pyrogen tests".• ANSI / AAMI ST72: 2011 "Bacterial endotoxins – Test methodologies, routine monitoring and alternative batch testing".• FDA 2012 Q&A "Guidance for Industry Pyrogen and Endotoxins Testing: Question and Answers"."Multiple test reports are referenced.
Intended Use & Indications for Use	Intended use and indications for use must be substantially equivalent to predicate devices.	The Agile Nail has identical indications for use as stated for the predicate devices (Synthes Adolescent Lateral Entry Femoral Nail System K070843 and Orthopediatrics PediNal Intramedullary Nailing System K083726), addressing femoral fractures and deformity corrections.
Technological Characteristics	Operating principles, materials, and overall design must be substantially equivalent to predicate devices.	"The Agile Nail is substantially equivalent to the predicate devices in: intended use, site of application, patient population, conditions of use, mechanical performances, operating principles and materials."

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

Sample Size: Not applicable in the context of patient data for an AI algorithm. For mechanical testing, the "sample size" refers to the number of physical devices or components tested. The document does not specify the exact number of devices tested but indicates that "All testing met or exceeded the requirements."
Data Provenance: The "data" for this submission consists of engineering test results and biocompatibility test results, not patient data in the typical sense of a clinical study for an AI device. These tests are conducted in laboratories (e.g., in Italy, given the manufacturer's location). The testing is prospective (performed specifically for the submission).

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

Not applicable. For a mechanical device, ground truth is established by engineering standards (e.g., ASTM standards define how tests are to be performed and what constitutes passing criteria) and comparator device specifications, not by human expert interpretation of images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or "adjudication" in the sense of an expert consensus on a diagnostic outcome for this type of device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance for diagnostic tasks (e.g., radiologists reading images). This device is an implantable orthopedic rod, not a diagnostic imaging AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm. The "performance" is the mechanical integrity and biocompatibility of the physical implant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

Established engineering standards (e.g., ASTM F1264 for intramedullary fixation devices, ASTM F543 for bone screws) which specify test methods and performance requirements.
Biocompatibility standards (e.g., USP, ANSI/AAMI ST72) which provide methods and criteria for assessing pyrogenicity and other biological responses.
The performance characteristics of legally marketed predicate devices, against which the Agile Nail's performance is directly compared to demonstrate equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. There is no training set for this mechanical device.

In summary, the K172699 submission for the Orthofix Agile Nail exemplifies a traditional 510(k) clearance pathway for a mechanical medical device, where the "acceptance criteria" and "proof" are rooted in engineering specifications, established consensus standards, and direct comparison to predicate devices, rather than clinical studies with human evaluators or AI algorithm performance metrics.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Orthofix Srl % Cheryl Wagoner Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 24408

Re: K172699

Trade/Device Name: Agile Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: March 23, 2018 Received: March 26, 2018

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);

April 23, 2018

{1}------------------------------------------------

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 -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K172699

Device Name Agile Nail

Indications for Use (Describe)

The Agile Nail is intended for insertion in the medullary canal of a femur for the alignment and the stabilization of fractures, and for the correction of deformities.

It is indicated for the treatment of subtrochanteric fractures and of femoral shaft fractures, with the exception of newborns and infants, and in adult patients with an appropriate medullary canal.

The indications include:

prophylactic nailing of impending pathologic fractures;

fixation of femurs that have been surgically prepared (osteotomy);

nonunions and malunions;

reconstruction following tumor resection and grafting and bone lengthening and shortening.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Orthofix logo, which is a blue abstract shape above the word "ORTHOFIX" in black, with a registered trademark symbol. Below the logo is the text "510(k) Summary" in a smaller font size. The text "(as required by 21 CFR 807.92)" is below the summary in an even smaller font size.

Submitter Name	Orthofix Srl
Address	Via delle Nazioni, 9 37012 Bussolengo (VR) - Italy
Telephone	+ 39 045 6719.000
Fax	+ 39 045 6719.380
Contact Person	Gianluca RicadonaSr. Quality & Regulatory Affairs Manager
Address	Via delle Nazioni, 937012 Bussolengo (VR) - Italy
Telephone	+ 39 045 6719 000
Fax	+ 39 045 6719 380
email	GianlucaRicadona@orthofix.it
Date Prepared	August 29, 2017
Trade Name	Agile Nail
Common Name	Rod, fixation, intramedullary and accessories
Panel Code	Orthopedic
Classification Name	Intramedullary fixation rod.
Class	Class II
Regulation Number	21 CFR 888.3020
Product Code	HSB
Predicate Device Name	510(k) Number	Manufacturer
Synthes Adolescent Lateral EntryFemoral Nail System	K070843	Synthes(USA)
Orthopediatrics PediNal IntramedullaryNailing System	K083726	Orthopediatrics, Corp.
Device description	The Agile Nail consists of ante grade intramedullary nails, end caps and screws, and related instrumentation for insertion and extraction of the implantable components.The System is designed to address femoral fractures and deformity corrections procedures.
Indications for use	The Agile Nail is intended for insertion in the medullary canal of a femur for the alignment and the stabilization of fractures, and for the correction of deformities.It is indicated for the treatment of subtrochanteric fractures and of femoral shaft fractures, in pediatric patients, with the exception of newborns and infants, and in adult patients with an appropriate medullary canal.The indications include:prophylactic nailing of impending pathologic fractures;fixation of femurs that have been surgically prepared (osteotomy);nonunions and malunions;reconstruction following tumor resection and grafting and bone lengthening and shortening.

{4}------------------------------------------------

TechnologicalCharacteristics andSubstantialEquivalence	Documentation was provided to demonstrate that the Agile Nailis substantially equivalent to the legally marketed predicates.Components included in the Subject system and the predicatesare all dedicated to internal fracture fixation procedure, asdefined in 21 CFR 888.3020.The Agile Nail is substantially equivalent to the predicatedevices in: intended use, site of application, patient population,conditions of use, mechanical performances, operatingprinciples and materials. Mechanical testing demonstrate howthe mechanical properties of the Subject Device are equivalent /better than the predicate involved.
Performance Data	The potential hazards have been evaluated and controlledthrough a Risk Management Plan.
	All testing met or exceeded the requirements as established bythe test protocols and applicable standards.
	A review of the mechanical data indicates that the componentsof the Subject device are capable of withstanding expectedloads without failure. The Agile Nail was therefore found to besubstantially equivalent to the predicate involved in theperformance.Clinical data were not needed to support the safety andeffectiveness of the Subject Device.
	Mechanical testing were performed according to the followingstandards:
	ASTM F1264-16 "Standard Specification and Test Methods forIntramedullary Fixation Devices".
	ASTM F543-17 "Standard Specification and Test Methods forMetallic Medical Bone Screws."
Biocompatibility data	In order to establish the Subject device non-pyrogenicity, sometests were performed on an equivalent System implants,according to the following international standard:• USP 38: 2014 < 85 > "Bacterial endotoxin test (LAL)".• USP 38: 2014 < 161 > "Medical devices – bacterial endotoxinand pyrogen tests".• ANSI / AAMI ST72: 2011 "Bacterial endotoxins – Testmethodologies, routine monitoring and alternative batch testing".• FDA 2012 Q&A "Guidance for Industry Pyrogen andEndotoxins Testing: Question and Answers".Here below the test reports and test rationale references list:• 166699_rep_fin dated 2016/10/07• 166700_Report_final dated 2016/10/13• 16VA00533 validation report dated 2016/10/13• Cert_2016_7505, Cert_2016_7506, and Cert_2016_7507report dated 2016/10/19• AGILE_QE_RA03_R1
Conclusion	Based upon similarities in: intended use, site of application,conditions of use, operating principles and mechanicalperformances, the Agile Nail has been shown to be substantiallyequivalent to its legally marketed predicate devices.

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.