The AOS Small External Fixation System is intended to be used with the AOS External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures in anatomies such as the hand, wrist, forearm, foot, and ankle where soft tissue injury may preclude the use of other fracture treatments.

The AOS Small External Fixation System is intended to be non-weight bearing.

Device Description

The AOS Small External Fixation System is an external fixation device comprised of rods, clamps, and threaded pins used for the management of bone fractures and reconstructive orthopedic surgery. The system is a modular system designed to provide options in frame construction, simplicity in frame components, and ease of use. The AOS Small External Fixation System is manufactured with threaded half pins and rods of 5.0mm shaft diameter, which allows for connectivity with AOS' External Fixation System (510(k) cleared: K080408) for support with bone fractures. The system is comprised of titanium and stainless steel (pin-to-rod and multi-pin) clamps, stainless steel threaded half pins and k-wires, carbon fiber connector rods, and pin caps. The AOS Small External Fixation System is a non-sterile single use fixation device.

The pin-to-rod clamps are designed to clamp to the 5.0mm carbon fiber rods and to the 2.0mm and 3.0mm stainless steel pins. The multi-pin clamps are designed to stabilize fractures using multiple pins in close proximity to each other. The multi-pin clamps can be used individually or as part of a larger construct.

The stainless steel threaded pins come in thread diameters of 2.0mm and 3.0mm with a 5.0mm shaft diameter. Thread lengths are available in 5mm increments from 10mm to 25mm long. Overall pin lengths of 55mm, 75mm, 100mm and 140mm are available. The stainless steel k-wires are provided in a 1.5mm diameter.

The connecting rods are carbon fiber composite with an diameter of 5.0mm and are in lengths of 50mm, 75mm, 100mm, 125mm, 150mm, 200mm, 250mm, and 300mm.

The surgical technique used for the AOS Small External Fixation System is a standard method used for external fixation and is the same as the technique used for the predicate devices. The instrumentation for the system consists of a wrench, two T-wrenches, a drill quide, and drills.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "AOS Small External Fixation System," a medical device for stabilizing bone fractures. The document is primarily focused on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable or not available in this type of submission.

Here's a breakdown of the information that is and is not present, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the format of acceptance criteria with corresponding performance results. The submission relies on "substantial equivalence" to predicate devices, meaning its performance is considered comparable to already cleared devices based on design and intended use, rather than unique, quantitatively measured performance against specific criteria.

2. Sample size used for the test set and the data provenance

Not applicable. No specific test set to measure performance against acceptance criteria is described. The submission focuses on comparison to predicate devices, not de novo performance testing.

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

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable. No adjudication method for a test set is described.

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 device is a mechanical external fixation system, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

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

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

Not applicable. No specific ground truth for performance evaluation is mentioned. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

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

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

Not applicable. As above, this is not an AI model.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "acceptance criteria" in this context are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "study" that proves this is primarily a comparative analysis of design features, operating principles, materials, and indications for use between the new device and the predicate devices.

The crucial statement is:

"The construct of the AOS Small External Fixation System and the predicate devices are virtually identical. Since the devices are substantially equivalent in design, geometry, construction, materials of construction, and indications, it was determined that no mechanical testing was necessary to demonstrate substantial equivalence."

This indicates that the FDA accepted the argument that because the device is so similar to existing, cleared devices, specific performance testing to define new acceptance criteria and then meet them was not required in this 510(k) submission. Therefore, the "study" is effectively the documentation and argument for substantial equivalence, which was deemed sufficient by the FDA for clearance.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three stylized human profiles facing to the right, with flowing lines beneath them.

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

October 29, 2014

Advanced Orthopaedic Solutions, Incorporated Anna Hwang Regulatory Associate 3203 Kashiwa Street Torrance. California 90505

Re: K141912 Trade/Device Name: AOS Small External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDW Dated: September 12, 2014 Received: September 16, 2014

Dear Ms. Hwang,

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

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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 Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

Lori A. Wiggins -S

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) K141912

Device Name AOS Small External Fixation System

Indications for Use (Describe)

The AOS Small External Fixation System is intended to be non-weight bearing.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" in blue, the "O" in blue, and the "S" in gray. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The text is black.

5. TRADITIONAL 510(K) SUMMARY

DATE PREPARED:	September 8, 2014
SUBMITTED BY:	Advanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505Phone: (310) 533-9966
CONTACT PERSON:	Anna HwangAdvanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505Phone: (310) 533-9966
DEVICE NAME:	AOS Small External Fixation System
COMMON NAME:	External Fixation
CLASSIFICATION:	Class II, 21 CFR 888.3030, Single/Multiple componentMetallic Bone Fixation Appliance and Accessories
DEVICE CODE:	KTT; JDW
SUBSTANTIALLYEQUIVALENT DEVICES:	AOS External Fixation System (510(k): K080408, ClearedApril 25, 2008); Stryker Hoffmann II Compact ExternalFixation System and Hoffmann Fixation Pin System(510(k): K971755/K861766, Cleared July 17, 1997 andJuly 08, 1986); Hoffmann II Micro External FixationSystem, K042019(Cleared September 24, 2004); DePuySynthes Small External Fixation System (510(k): K122455,Cleared April 11, 2013)
DEVICE DESCRIPTION:	The AOS Small External Fixation System is an externalfixation device comprised of rods, clamps, and threadedpins used for the management of bone fractures andreconstructive orthopedic surgery. The system is amodular system designed to provide options in frameconstruction, simplicity in frame components, and ease ofuse. The AOS Small External Fixation System ismanufactured with threaded half pins and rods of 5.0mmshaft diameter, which allows for connectivity with AOS'External Fixation System (510(k) cleared: K080408) forsupport with bone fractures. The system is comprised oftitanium and stainless steel (pin-to-rod and multi-pin)clamps, stainless steel threaded half pins and k-wires,carbon fiber connector rods, and pin caps. The AOS Small

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External Fixation System is a non-sterile single use fixation device.

The connecting rods are carbon fiber composite with an diameter of 5.0mm and are in lengths of 50mm, 75mm, 100mm, 125mm, 150mm, 200mm, 250mm, and 300mm.

INDICATIONS FOR USE: The AOS Small External Fixation System is intended to be used with the AOS External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures in anatomies such as the hand, wrist, forearm, foot, and ankle where the soft tissue injury may preclude the use of other fracture treatments. The AOS Small External Fixation System is intended to be non-weight bearing.

SUBSTANTIAL EQUIVALENCE: Information presented supports substantial equivalence of the AOS Small External Fixation System due to the similarity in indication for use, design features, operating principles, and material of composition to the AOS External Fixation System, K080408; Stryker Hoffmann II Compact External Fixation System and Hoffmann Fixation Pin System K971755/K861766; Hoffmann II Micro External Fixation System, K042019; and DePuy Synthes Small External Fixation System, K122455.

The construct of the AOS Small External Fixation System and the predicate devices are virtually identical. Since the devices are substantially equivalent in design, geometry, construction, materials of construction, and indications, it was determined that no mechanical testing was necessary to demonstrate substantial equivalence.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.