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 Nails are intramedullary fixation devices for the temporary fixation of various types of fractures of the tibia and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Tibial Nail System consists of titanium intramedullary nails, proximal and distal locking screws, and end caps. This Special 510(k) proposes the addition of 12mm and 13mm diameter nails to the system.

AI/ML Overview

The provided document is a 510(k) summary for the AOS 12mm and 13mm Tibial Nails, which is an intramedullary fixation device. This submission is a "Special 510(k)" which typically means that the changes to the device (the addition of new sizes) do not raise new questions of safety and effectiveness and can be demonstrated through reliance on predicate device data and design controls.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Equivalence to Predicate Device: The 12mm and 13mm Tibial Nails should have similar strength characteristics to the predicate nails (AOS Tibial Nail System, K070444).	The proposed nails "do not present a worst-case scenario with respect to strength characteristics" compared to the predicate nails.
Material Equivalence: Made of the same material as the predicate device (Ti-6Al-4V ELI, per ASTM F136).	The proposed nails are made of "the same material (Ti-6Al-4V ELI, per ASTM F136) as the predicate nails."
Indications for Use Equivalence: Same indications for use as the predicate device.	The proposed nails "have the same indications for use" as the predicate device.
Geometry and Design Similarity: Similar in geometry and design to the predicate device.	The proposed nails are "similar in geometry and design" to the predicate device.
Fundamental Scientific Technology Equivalence: Same fundamental scientific technology as the predicate device.	The proposed nails "have the same fundamental scientific technology" as the predicate device.

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

The document states that "physical testing was deemed unnecessary" because the proposed nails were determined to be substantially equivalent in strength and geometry to the predicate nails. Therefore, there was no specific "test set" of device samples for physical performance testing against which acceptance criteria were directly measured in this submission. The evaluation was primarily based on a comparison to the predicate device's established performance and material specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As indicated above, no physical testing and thus no "ground truth" establishment by experts on device performance was conducted in this 510(k) submission. The "ground truth" for the predicate device would have been established during its original clearance, but that information is not provided here.

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

Not applicable. No physical testing was conducted, so no adjudication method was used for a test set.

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 a medical device for orthopedic fixation (tibial nails), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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

Not applicable. This device is not an algorithm or AI system.

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

The "ground truth" in this context is the established performance and safety of the predicate device (AOS Tibial Nail System, K070444). The submission relies on the concept of substantial equivalence, meaning that the new devices are considered safe and effective because they are sufficiently similar to a device already legally marketed. For the predicate device, ground truth would have been established through a combination of:

Pre-clinical mechanical testing (e.g., fatigue, static strength)
Material characterization
Potentially clinical experience or literature (though not explicitly stated in this summary for the predicate)

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this traditional medical device submission.

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

Not applicable. There is no "training set" or explicit "ground truth" establishment for a training set in this submission. The assessment is based on comparison to an already cleared predicate device.

Summary

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K130625 page 1 of 2

Image /page/0/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a bold, sans-serif font. Below the letters is the text "ADVANCED ORTHOPAEDIC SOLUTIONS" in a smaller, sans-serif font. The logo is simple and professional, and it conveys the company's focus on orthopaedics.

MAR 2 8 2013

8. SPECIAL 510(K) SUMMARY

March 7. 2013

HSB

SUMMARY PREPARED ON:

SUBMITTED BY:

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

CONTACT PERSON:

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

AOS 12mm and 13mm Tibial Nails

DEVICE NAME: COMMON NAME: CLASSIFICATION:

DEVICE CODE:

SUBSTANTIALLY EQUIVALENT DEVICE:

DEVICE DESCRIPTION:

AOS Tibial Nail System (K070444, June 14, 2007)

Rod, Fixation, Intramedullary and Accessories

Class II, 21 CFR 888.3020 Intramedullary fixation rod

This Special 510(k) proposes the addition of 12mm and 13mm diameter nails to the system.

INDICATIONS FOR USE:

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SUBSTANTIAL EQUIVALENCE:

Information presented supports substantial equivalence of the 12mm and 13mm Tibial Nails to the predicate device. The proposed nails have the same indications for use, are similar in geometry and design, have the same fundamental scientific technology, and are made of the same material (Ti-6Al-4V ELI, per ASTM F136) as the predicate nails. As detailed in the submission, the proposed nails do . not present a worst-case scenario with respect to strength characteristics, and because of their similarity to the current nails, physical testing was deemed unnecessary, and substantial equivalence was determined in strength and geometry between the proposed nails and the predicate nails.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Letter dated: March 28, 2013

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

Advanced Orthopaedic Solutions, Incorporated % Ms. Allyson Parks Regulatory Associate 386 Beech Avenue, Unit B6 Torrance, California 90501

Re: K130625

Trade/Device Name: AOS 12mm and 13mm Tibial Nails Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: March 7, 2013 Received: March 18, 2013

Dear Ms. Parks:

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. Iisting 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. Allyson Parks

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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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Image /page/4/Picture/0 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a bold, sans-serif font. Below the letters is the text "ADVANCED ORTHOPAEDIC SOLUTIONS" in a smaller, sans-serif font. The logo is simple and professional.

7. INDICATIONS FOR USE STATEMENT

Special 510(k) Premarket Notification Indication for Use Statement AOS 12mm and 13mm Tibial Nails

510(k) Number (if known): _K130625

Device Name: AOS 12mm and 13mm Tibial Nails

Indications for Use:

AND/OR Prescription Use: X (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)

Casey L. Hanley, Ph.D
Division of Orthopaedic Devices

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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.