The AOS Small Fragment Plating System is intended to be used for fixations of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

Device Description

The AOS Small Fragment Plating System consists of titanium plates, screws, and washers in various configurations and sizes. The system includes Kirschner wires, non-locking screws in diameters of 2.7mm, 3.5mm, and 4.0mm. The system includes variable angle locking screws in diameters of 2.7mm, and 3.5mm. The plate system includes 3.5mm headless compression screws, 4.0mm cannulated screws, and 4.0mm partially threaded cannulated screws.

AI/ML Overview

This document describes a Special 510(k) premarket notification for the AOS Small Fragment Plating System, which is a metallic bone fixation appliance. The purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, K152732. This submission does not involve an AI/ML powered device, therefore the information requested is not present.

Here's a breakdown of the relevant information from the provided text:

Device Name: AOS Small Fragment Plating System
Regulation Number & Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories. Also 21 CFR 888.3040, Smooth/threaded metallic bone fixation fastener.
Regulatory Class: Class II
Product Code: HRS, HWC, HTN
Indications for Use: Fixations of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
Predicate Device: AOS Small Fragment Plating System (510k): K152732
Modifications in K161913 (this submission): Longer and shorter plates, shorter screws, and screw cannulation.
Basis for Substantial Equivalence: The modified device has the same intended use, indications for use, raw material, method of manufacture, design, type of interface, shelf life, biocompatibility, sterilization, packing methods, and physical limitations as the predicate. It also has similar sizes and dimensions.

Information related to acceptance criteria and study for an AI/ML device (which this is not):

The provided document details a mechanical testing study for a medical device (bone plating system), not an AI/ML powered device. Therefore, the specific criteria requested for AI/ML device performance (such as sensitivity, specificity, AUC, etc.) and studies like MRMC comparative effectiveness studies are not applicable and not present in this document.

The "study" described in this document is a pre-clinical mechanical test:

Preclinical Testing: "The AOS Small Fragment Plating System was subjected to comparative mechanical testing per a four point bend test based on ASTM F382-14. The results demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicate."
Acceptance Criteria & Reported Performance: The document states that the results of the comparative mechanical testing "demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicate." It implies that the acceptance criteria were met if the mechanical performance of the modified device was comparable to the predicate device per ASTM F382-14. The specific numerical values for performance are not included in this summary, but the conclusion of substantial equivalence implies they were acceptable.
Clinical Data: The document explicitly states: "There is no clinical data referenced in this special 510(k)".

Therefore, the requested information for an AI/ML device is not applicable to this submission. This document pertains to a physical medical device (bone plates and screws) and its mechanical performance.

Summary

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

Advanced Orthopaedic Solutions, Inc. (AOS) Alex Bhaskarla Regulatory Affairs Manager 3203 Kashiwa Street Torrance, California 90505

November 4, 2016

Re: K161913 Trade/Device Name: AOS Small Fragment Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC, HTN Dated: October 12, 2016 Received: October 14, 2016

Dear Mr. Bhaskarla:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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, 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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Indications for Use

510(k) Number (if known) K161913

Device Name

AOS Small Fragment Plating System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X 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 a lighter color than the "OS". Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The overall design is clean and professional.

4. Special 510(K) SUMMARY

DATE PREPARED:	June 13, 2015
SUBMITTED BY:	Advanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505Phone: (310) 533-9966Establishment Registration #: 2032480Owner Operator Number: 9046896
CONTACT PERSON:	Alex BhaskarlaAdvanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505Phone: (310) 533-9966
DEVICE NAME:	AOS Small Fragment Plating System
COMMON NAME:	Small Fragment Plate
CLASSIFICATION:	Class II, 21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories and 21 CFR 888.3040Smooth/threaded metallic bone fixation fastener.
	No performance standards have been established under Section 514 ofthe Food, Drug and Cosmetic Act for small fragment plates.
DEVICE CODE:	HRS, HWC, HTN
SUBSTANTIALLYEQUIVALENT DEVICES:	AOS Small Fragment Plating System(510k):K152732 Cleared December 10, 2015
DEVICE DESCRIPTION:	The AOS Small Fragment Plating System consists of titanium plates,screws, and washers in various configurations and sizes. The systemincludes Kirschner wires, non-locking screws in diameters of 2.7mm,3.5mm, and 4.0mm. The system includes variable angle locking screws indiameters of 2.7mm, and 3.5mm. The plate system includes 3.5mmheadless compression screws, 4.0mm cannulated screws, and 4.0mmpartially threaded cannulated screws.
INDICATIONS FOR USE:	The AOS Small Fragment Plating System is intended to be used forfixations of fractures, osteotomies, and non-unions of the clavicle,scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula,particularly in osteopenic bone.
SUBSTANTIAL EQUIVALENCE:	Information presented supports substantial equivalence for modificationsto the AOS Small Fragment Plating System to the predicate devices. Theproposed system has the same indications for use, is similar in shape anddesign, and has the same fundamental technology.

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Image /page/4/Picture/0 description: The image contains the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" in blue and the "O" and "S" in a lighter shade of blue. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font.

BASIS FOR SUBSTANTIALEQUIVALENCE:	The modification to AOS Small Fragment Plating System has the following similarities to the AOS Small Fragment Plating System (K152732): same intended usesame indications for usesame raw materialsame method of manufacturesame designsimilar sizes and dimensionssame type of interfacesame shelf lifesame biocompatibilitysame sterilizationsame packing methodssame physical limitations The modified AOS Small Fragment Plating System has longer and shorter plates, shorter screws, and screw cannulation.
PRECLINICAL TESTING:	The AOS Small Fragment Plating System was subjected to comparative mechanical testing per a four point bend test based on ASTM F382-14. The results demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicate.
STANDARDS:	Recognized industry standards are cited in the Standards Report
CLINICAL DATA:	There is no clinical data referenced in this special 510(k)

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.