The AOS Antegrade Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures, including those with severe comminution and intra articular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and maluions, fractures resulting from osteoprorosis.

Device Description

The AOS Antegrade Femoral Nail System consists of Titanium Alloy Rods, Screws and End Caps for femur fracture fixation.

AI/ML Overview

This report describes the acceptance criteria and the study conducted to prove that the device, the AOS Antegrade Femoral Nail System, meets these criteria.

Acceptance Criteria and Device Performance

The device is an intramedullary fixation rod for femoral fractures and is deemed substantially equivalent to a predicate device. The acceptance criteria for the AOS Antegrade Femoral Nail System are primarily based on comparative mechanical testing and material equivalence to its predicate device. This is a Class II medical device, and the evaluation focuses on establishing substantial equivalence rather than independent performance metrics defined by specific clinical endpoints in the way some software algorithms might.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	Same indications for use as predicate. Similar shape and design as predicate. Same fundamental technology as predicate. Made of the same material as predicate.	The AOS Antegrade Femoral Nail System has the same indications for use, is similar in shape and design, has the same fundamental technology, and is made of the same material (Titanium Alloy) as the predicate device (AOS Modular Femoral System, K012190).
Mechanical Performance	Mechanical properties (e.g., strength, durability, fatigue resistance) are demonstrably equivalent or superior to the predicate device per relevant standards.	Subjected to comparative mechanical testing per a test based on ASTM F384. In Vitro testing of accessory screws and components was also performed. The results demonstrate that the AOS Antegrade Femoral Nails and accessories are substantially equivalent to the predicates.
Anatomical Compatibility	Demonstrated compatibility with relevant anatomical elements, particularly concerning surgical implantation and placement.	A cadaver study was done to assess various anatomical elements of the system. (Specific performance results from this study are not detailed in the provided text)

Study Details

The study conducted to prove the device meets the acceptance criteria is a preclinical testing program primarily focused on demonstrating substantial equivalence to a legally marketed predicate device. This is typical for a 510(k) submission for this type of device.

Sample size used for the test set and the data provenance:
- Mechanical Testing: The specific sample sizes for the comparative mechanical testing (per tests based on ASTM F384 and In Vitro testing of accessory screws) are not explicitly stated in the provided text.
- Cadaver Study: The number of cadavers used in the cadaver study is not explicitly stated.
- Data Provenance: The studies were conducted by Advanced Orthopaedic Solutions, Inc. and are prospective in nature, as they were performed specifically to support the 510(k) submission for this new device. The country of origin for the data is not explicitly stated but is implicitly the USA, where the company and regulatory body (FDA) are located.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For a traditional medical device like an intramedullary nail, the "ground truth" is established through engineering and biomechanical principles, standardized testing methods (e.g., ASTM F384), and anatomical studies. It is not typically established by human experts in the same way an AI algorithm's diagnostic performance might be.
- The "ground truth" for the mechanical testing would be the established performance characteristics of the predicate device and the specified requirements of the ASTM standard. This would be interpreted by engineers and biomechanical testing professionals.
- For the cadaver study, anatomical "ground truth" would be assessed by medical professionals, likely orthopedic surgeons or anatomists, but the number and qualifications are not specified.
Adjudication method for the test set:
- Adjudication methods like 2+1 or 3+1 are typically used for clinical trials or diagnostic studies involving human interpretation of data. For preclinical mechanical testing, the "adjudication" is inherent in the objective, quantitative nature of the tests and the comparison against a predicate device or industry standard. There is no explicit mention of an adjudication method in the provided text.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed for this device. This type of study is relevant for AI algorithms or diagnostic imaging systems where human readers' performance with and without AI assistance is being evaluated. The AOS Antegrade Femoral Nail System is a physical implant for fracture fixation, not a diagnostic or AI-driven system.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm only) performance evaluation was not performed. This term is only applicable to AI/software as a medical device (SaMD), which this device is not.
The type of ground truth used:
- The ground truth used for this device's evaluation is primarily engineering specifications, biomechanical performance data (from standardized tests), and anatomical compatibility assessments derived from a cadaver study.
- The ultimate ground truth for substantial equivalence is the legally marketed predicate device.
The sample size for the training set:
- This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in the context of its development and evaluation.
How the ground truth for the training set was established:
- As there is no training set for this type of medical device, this question is not applicable.

Summary

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VANCED ORTHOPAEDIC SOLUTIONS

MAY 2 4 2018

5. TRADITIONAL 510(K) SUMMARY

DATE PREPARED:

May 23, 2013

SUBMITTED BY:

Advanced Orthopaedic Solutions. Inc. 386 Beech Avenue, Unit B6 Torrance, CA 90501 Phone: (310) 533-9966

CONTACT PERSON:

Julie Glendrange Advanced Orthopaedic Solutions. Inc. 386 Beech Avenue, Unit B6 Torrance, CA 90501 Phone: (310) 533-9966

AOS Antegrade Femoral Nail System

COMMON NAME:

DEVICE NAME:

CLASSIFICATION:

DEVICE CODE:

SUBSTANTIALLY EQUIVALENT DEVICE:

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

Internal Fixation

Class II, 21 CFR 888.3020 Intramedullary Fixation Rod

нав

AOS Modular Femoral System (510(k): K012190, Cleared September 24, 2001)

The AOS Antegrade Femoral Nail System consists of Titanium Alloy Rods, Screws and End Caps for femur fracture fixation.

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SUBSTANTIAL EQUIVALENCE:

Information presented supports substantial equivalence of the AOS Antegrade Femoral Nail System to the predicate device. The proposed system has the same indications for use, is similar in shape and design, has the same fundamental technology and is made of the same material.

PRECLINICAL TESTING:

The AOS Antegrade Femoral Nail System was subjected to comparative mechanical testing per a test based on ASTM F384, as well as In Vitro testing of the accessory screws and components. A cadaver study was also done to assess various anatomical elements of the system. The results demonstrate that the AOS Antegrade Femoral Nails and accessories are substantially equivalent to the predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

May 24, 2013

Advanced Orthopaedic Solutions, Incorporated % Ms. Julie Glendrange Regulatory Specialist 386 Beech Avenue, Unit B6 Torrance, California 90501

Re: K123569

Trade/Device Name: AOS Antegrade Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: April 23, 2013 Received: April 26, 2013

Dear Ms. Glendrange:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Julie Glendrange

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Erin DKeith

For

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

Enclosure

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7. INDICATIONS FOR USE STATEMENT

Traditional 510(k) Premarket Notification Indication for Use Statement AOS Antegrade Femoral Nail System

510(k) Number (if known): _ K123569

Device Name: AOS Antegrade Femoral Nail System

Indications for Use:

The AOS Antegrade Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following:

. Open and closed femoral fractures
Pseudoarthrosis and correction osteotomy .
Pathologic fractures, impending pathologic fractures, and turnor resections .
Supracondylar fractures, including those with severe comminution and . intraarticular extension
lpsilateral femur fractures .
Bone lengthening .
Fractures proximal to a total knee arthroplasty or prosthesis
Fractures distal to a hip joint
Nonunions and malunions
Fractures resulting from osteoporosis

Prescription Use: X AND/OR (Part 21 CFR 801 Subpart D)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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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.