The AOS Proximal Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures.

Device Description

The AOS Proximal Humeral Nail is a titanium humeral intramedullary nail that is designed to enter the humerus through the greater tuberosity. It consists of an intramedullary nail. proximal and distal locking screws, and an end cap.

The AOS Proximal Humeral Nail is a cannulated nail with a 6° proximal bend and a proximal diameter of 10mm. The Humeral Nail is produced in a 15cm length with a distal diameter of 8mm. The proximal end of the nail has six holes which accept the 5.0mm cancellous screw. The distal end of the nail contains four cross locking holes which are designed to accept a 3.5mm cortical screw. The proximal end of the nail is threaded to accept an end cap.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the AOS Proximal Humeral Nail. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study or detailed standalone algorithm performance.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable to the information contained in this document.

Here's what can be extracted based on the provided text, and where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to predicate device (AOS Humeral Nail K050241) in:	Demonstrated substantial equivalence in:
- Design	- Design
- Materials	- Materials
- Intended Use	- Intended Use
- Geometry (when assembled)	- Geometry (virtually identical when assembled)
- Mechanical Testing	- Mechanical Testing

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

Not Applicable. The submission is primarily focused on demonstrating substantial equivalence through design comparison and mechanical testing, not through testing with a "test set" of patient data or images.

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

Not Applicable. There is no mention of a "test set" or human experts establishing ground truth in the context of this 510(k) submission.

4. Adjudication method for the test set

Not Applicable. No test set or adjudication process is mentioned.

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 physical intramedullary nail for fracture fixation, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Not Applicable. The "ground truth" equivalent in this context is the predicate device's established safety and effectiveness. The comparison is based on physical characteristics and mechanical properties.

8. The sample size for the training set

Not Applicable. No training set for an algorithm is relevant here.

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

Not Applicable. As there is no training set mentioned, this question is not applicable.

Summary based on the provided text:

The AOS Proximal Humeral Nail demonstrated substantial equivalence to its predicate device, the AOS Humeral Nail (K050241), through a comparison of design, materials, intended use, assembled geometry, and mechanical testing. The FDA concurrence letter confirms this finding, allowing the device to be marketed. This is a traditional medical device submission, not one related to AI or diagnostic imaging, and therefore the criteria for such technologies (like clinical studies with test sets, ground truth, and expert review) are not present in this documentation.

Summary

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K090478(jpg 1/1)

MAR 2 6 2009

510(k) SUMMARY

NAME OF FIRM:	Advanced Orthopaedic Solutions, Inc.386 Beech Ave., Unit B6Torrance, CA 90501310.533.9966FAX 310.533.9876
510(k) CONTACT PERSON:	Paul Doner, Vice President Operations
TRADE NAME:	AOS Proximal Humeral Nail
COMMON NAME:	Intramedullary Fixation Rod
CLASSIFICATION:	888.3020 Intramedullary Fixation Rod
DEVICE CODE:	HSB
SUBSTANTIALLYEQUIVALENT DEVICE:	AOS Humeral Nail (K050241, Cleared March 14, 2005)

INTENDED USE:

The AOS Proximal Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures.

DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The AOS Proximal Humeral Nail was shown to be substantially equivalent to the AOS Humeral Nail. The AOS Proximal Humeral Nail was shown to be substantially equivalent in design, materials and intended use to the device listed below. Once assembled the geometry of the AOS nail and the predicate devices are virtually identical. Additionally, mechanical testing showed that the device is substantially equivalent.

AOS Humeral Nail

K050241, Cleared March 14, 2005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is rendered in black. Surrounding the eagle is a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is also in black.

Public Health Service

MAR 2 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Orthopaedics Solutions, Inc. % Mr. Paul Doner 386 Beech Avenue, Unit B6 · Torrance, California 90501

Re: K090478

Trade/Device Name: AOS Proximal Humeral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: February 19, 2009 Received: February 24, 2009

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours. elkerson

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

Enclosure

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510(k) Number (if known): Kogo478 (ps (ps 1/1)

Device Name: AOS Humeral Nail

Indications for Use:

The AOS Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures.

Prescription Use: X (Part 21 CFR 801 Subpart D) and /or

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)

P.A. Thangmy

(Divisio) Division of General, Restorative, and Neurological Devices

51030 N - K090478

CONFIDENTIAL

Special 510(k) - AOS Humeral Nail

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.