The AOS Tibial Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the tibia. The AOS Tibial Nail System is indicated for long bone fracture fixation of tibial fractures, which may include the following: transverse, oblique, spiral, segmental and comminuted fractures; fractures with bone loss and bone transport; open and closed fractures, pathologic fractures; corrective osteotomies; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.

Device Description

The AOS Tibial Nail is an intramedullary fixation device for the temporary fixation of fractures of the tibia and is intended as a load sharing device which may be removed once the fracture has healed. The AOS Tibial Nail is a titanium intramedullary nail system consisting of an intramedullary nail, proximal and distal locking screws and end caps. The Tibial Nail is a cannulated nail with a 10° proximal bend and a 3° distal bend. The proximal diameter of the nail is 11.5mm and it is produced in 8mm, 9mm, 10mm and 11mm distal diameters. The proximal end of the nail has two holes to accept the 5,0 mm cortical screw and one slot which also accept the 5.0mm cortical screw. The proximal end of the nail is threaded to accept an end cap. The distal end of the nail contains three cross locking holes which accept a 5.0mm cortical screw for diameter of 9mm, 10mm and 11mm and a 4.2mm screw for the 8mm diameter nail.

AI/ML Overview

The provided document is a 510(k) Summary for the AOS Tibial Nail, an intramedullary fixation rod. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for a novel medical AI device.

Therefore, the information required for a medical AI device, such as acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies, is not present in this document.

The document states: "Mechanical testing has shown that the AOS Tibial Nail is substantially equivalent to the predicate device." This indicates that the "study" conducted was mechanical testing to compare the new device to existing, legally marketed devices, rather than a clinical study evaluating diagnostic performance.

Here's how to address each point based on the provided text:

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

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a diagnostic device. The acceptance criterion is "substantial equivalence" to predicate devices, supported by mechanical testing.
Reported Device Performance: The document only states that "Mechanical testing has shown that the AOS Tibial Nail is substantially equivalent to the predicate device." No specific performance numbers (e.g., accuracy, sensitivity, specificity, or mechanical strength values) are reported in this summary.

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

Not applicable. This is a mechanical device, and the "test set" would refer to the physical nails subjected to mechanical testing. The document does not specify the number of nails tested or the origin of the data beyond "Mechanical testing."

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 as typically understood for AI or diagnostic devices (e.g., expert consensus on images, pathology results) is not relevant for demonstrating substantial equivalence of a mechanical orthopedic device. The "ground truth" here would be the physical properties and performance of the predicate devices.

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

Not applicable. This concept is for diagnostic interpretation, not mechanical device comparison.

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. This is completely irrelevant for a mechanical fixation device. An MRMC study is for evaluating diagnostic performance, typically of an AI system, with human readers.

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

Not applicable. This is a mechanical device, not an algorithm.

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

Not applicable in the AI/diagnostic sense. The "ground truth" for demonstrating substantial equivalence of a mechanical device typically involves engineering specifications, material properties, and performance benchmarks of legally marketed predicate devices, against which the new device undergoes mechanical testing.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI model requiring a training set.

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

Not applicable.

Summary

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ADVANCED ORTHOPAEDIC SOLUTIONS

H070444

510(k) SUMMARY

JUN 1 4 2007

SUBBMITTED BY:	Advanced Orthopaedic Solutions2444 205 TH Street, Unit 5Torrance, CA, 90501(310) 533-9966FAX (310) 533-9876
510(k) CONTACT PERSON:	Paul Doner, Vice President Operations
TRADE NAME:	AOS Tibial Nail
COMMON NAME:	Intramedullary Fixation Rod
CLASSIFICATION:	21 CFR 888.3020 Intramedullary Fixation Rod
DEVICE CODE:	HSB
SUBSTANTIALLYEQUIVALENT DEVICE:	DePuy VersaNail Tibial Nail (K032097)Smith & Nephew TriGen Meta-Nail Tibial Nail System(K061019)Stryker Trauma T2 Tibial Nail System

DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The AOS Tibial Nail is a titanium intramedullary nail system consisting of an intramedullary nail, proximal and distal locking screws and end caps.

The Tibial Nail is a cannulated nail with a 10° proximal bend and a 3° distal bend. The proximal diameter of the nail is 11.5mm and it is produced in 8mm, 9mm, 10mm and 11mm distal diameters. The proximal end of the nail has two holes to accept the 5,0 mm cortical screw and one slot which also accept the 5.0mm cortical screw. The proximal end of the nail is threaded to accept an end cap.

The distal end of the nail contains three cross locking holes which accept a 5.0mm cortical screw for diameter of 9mm, 10mm and 11mm and a 4.2mm screw for the 8mm diameter nail.

2444 205" Street Unit 5, Torrance, CA 90501 ● (310) 533-9966 ● FAX (310) 533-9876

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SUBSTANTIAL EQUIVALENCE INFORMATION:

The principals of operation of this device are similar to that of the predicate device. There are no chances in the intended use, and the operating principles, performance specification and materials of composition are similar to that of the predicate device. Mechanical testing has shown that the AOS Tibial Nail is substantially equivalent to the predicate device.

INTENDED USE:

The AOS Tibial Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The AOS Tibial Nail System is indicated for long bone fracture fixation of tibial fractures, which may include the following: transverse, oblique, spiral, segmental and comminuted fractures; fractures with bone loss and bone transport; open and closed fractures, pathologic fractures; corrective osteotomies; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Orthopaedic Solutions, Inc. c/o Mr. Paul Doner Vice President Operation 2444 205th Street, Unit 5 Torrance, California 90501

Re: K070444

Trade/Device Name: AOS Tibial Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 17, 2007 Received: May 18, 2007

JUN I 4 2007

Dear Mr. Doner:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Paul Doner

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or on the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

Barbara Buehrig

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indication for Use Statement

510(k) Number (if known):

Device Name: AOS Tibial Nail

Indications for Use:

The AOS Tibial Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the tibia.

The AOS Tibial Nail System is indicated for long bone fracture fixation of tibial fractures, which may include the following:

Transverse, oblique, spiral, segmental and comminuted fractures; .
Fractures with bone loss and bone transport; ●
Open and closed fractures, pathologic fractures; .
Corrective osteotomies; pseudarthrosis of the tibial shaft; .
Nonunions, malunions, metaphyseal and epiphyseal fractures. .

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Harbau Boenehu

. Restorative. and Neurological Devices

510(k) Number Ko 70444

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.