The AOS Proximal Humeral Plate is an internal fixation device for the fixation of fractures of the humeral head and is intended as a load sharing device which may be removed once the fracture has healed.

The plate is manufactured in multiple lengths with the overall length of the plate ranging from 97mm to 236mm. The proximal portion has eight 135° angled holes to accept 4.0mm locking screw. The distal portion has 3, 5, 8, 11 and 14 hole configurations which will accept a 4.0mm locking screw or a 3.5mm cortical screw. There are three associated screws for the AOS Proximal Humeral Plate; the 4.0mm fully threaded locking screws, the 4.0mm partially threaded locking screw and the 3.5mm cortical screw. The AOS Proximal Humeral Plates and screws are manufactured from titanium alloy.

The overall length of the AOS Proximal Humeral Plate ranges from 97mm to 236mm while the proximal portion is consistent for all plates at 48mm. The proximal portion of the plate contains 8 threaded holes that accept the 4.0mm partially threaded cancellous locking screw. The proximal portion of the plate also contains six suture holes and a 2.0mm hole for positioning.

The distal shaft of the plate is manufactured in 3, 5, 8, 11 and 14 hole configurations with the first hole being a slot. These threaded holes are staggered through the length of the plate and accept a 4.0mm fully threaded cancellous locking screw or the 3.5mm cortical screw.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "AOS Proximal Humeral Plate." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a new clinical study. Therefore, the information requested about acceptance criteria, study details, and performance metrics for the device itself (like AI performance) is not directly present in this document, as it outlines a comparison to a predicate device.

Specifically, the document states: "The AOS Proximal Humeral Plate and the predicate Synthes (USA) Proximal Humeral Plate have the same indication for use, similar design geometry and are manufactured from similar material. Therefore, mechanical testing to support Substantial Equivalence was not necessary." This means the assessment was primarily based on design and material similarity to an already approved device, rather than new performance testing.

Here's an attempt to answer the questions based on the information provided, highlighting what is not applicable:

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

Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission relying on similarity to a predicate device. The "acceptance criteria" here is that the device is substantially equivalent to the predicate.
Reported Device Performance: Not reported in terms of specific numeric performance metrics, as direct performance testing was deemed unnecessary due to substantial equivalence.

Criterion	Reported Performance (for Substantial Equivalence)
Same Indication for Use	AOS Proximal Humeral Plate and predicate Synthes LCP Proximal Humeral Plate are both indicated for: "fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus."
Similar Design Geometry	The document states they have "similar design geometry." Key aspects mentioned are:Plate lengths (AOS: 97mm to 236mm; specific predicate lengths not given but implied similar range by "similar design geometry").Proximal portion: Eight 135° angled holes for 4.0mm locking screws (AOS). Contains 8 threaded holes for 4.0mm partially threaded cancellous locking screws. Six suture holes and a 2.0mm hole for positioning.Distal portion: 3, 5, 8, 11, and 14 hole configurations accepting 4.0mm locking or 3.5mm cortical screws (AOS). Threaded holes staggered.Screws: Threaded head configuration designed to lock into the plate, similar configuration in thread form and major/minor thread diameter. (AOS: 4.0mm fully threaded locking, 4.0mm partially threaded locking, 3.5mm cortical). The 3.5mm screw was already cleared for use in AOS Humeral Nail (K050241).
Similar Material	Both are manufactured from "titanium alloy."
Mechanical Testing (if deemed necessary to address differences impacting safety/effectiveness)	"mechanical testing to support Substantial Equivalence was not necessary" because of the same indication for use, similar design geometry, and similar material. The screws used were also not mechanically tested because they are of similar major and minor diameter.

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

Not applicable. This is not a study that involved a test set with patient data. It's a regulatory submission based on comparison to an existing device.

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. No ground truth was established by experts for a test set in this context. The "ground truth" for substantial equivalence is the predicate device and its established safety and effectiveness.

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

Not applicable. No test set requiring adjudication was used.

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 internal fixation, not an imaging device or AI-assisted diagnostic tool.

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

Not applicable. This is a physical orthopedic implant, not an algorithm.

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

The "ground truth" in the context of a 510(k) submission for substantial equivalence is the safety and effectiveness profile of the predicate device. This profile is established through its own prior approvals, clinical use, and potentially pre-market or post-market studies of the predicate. No new ground truth, in the sense of expert consensus, pathology, or outcomes data for the AOS Proximal Humeral Plate, was generated for this submission.

8. The sample size for the training set

Not applicable. There was no training set for a study described in this document.

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

Not applicable. There was no training set for a study described in this document.

Summary

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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 letters are black, and the background is white.

510(k) SUMMARY

MAY - 6 2008

SUBBMITTED BY:	Advanced Orthopaedic Solutions2444 205TH Street, Unit 5Torrance, CA 90501(310) 533-9966FAX (310) 533-9876
510(k) CONTACT PERSON:	Paul Doner, Vice President Operations
TRADE NAME:	AOS Proximal Humeral Plate
COMMON NAME:	External Fixation
CLASSIFICATION:	21 CFR 888.3030 Single/multiple componentmetallic bone fixation appliances andaccessories.
DEVICE CODE:	KTW
SUBSTANTIALLYEQUIVALENT DEVICE:	Synthes LCP Proximal Humeral Plate (K011815 andK04186)

DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The distal shaft of the plate is manufactured in 3, 5, 8, 11 and 14 hole configurations with the first hole being a slot. These threaded holes are staggered through the length of the

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plate and accept a 4.0mm fully threaded cancellous locking screw or the 3.5mm cortical screw.

SUBSTANTIAL EQUIVALENCE INFORMATION:

The AOS Proximal Humeral Plate and the predicate Synthes (USA) Proximal Humeral Plate have the same indication for use, similar design geometry and are manufactured from similar material. Therefore, mechanical testing to support Substantial Equivalence was not necessary.

Both the AOS Proximal Humeral Plate and the predicated Synthes Proximal Humeral Plate are indicated for: "fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus."

For both systems there are screws with a threaded head configuration which are specifically designed to lock into the plate. The screws used in the two systems are also of similar configuration in thread form and major and minor thread diameter.

The screws used in the system were not mechanically tested because they are of similar major and minor diameter. The 3.5mm is already cleared for use in the AOS Humeral Nail (K050241).

As the AQS Proximal Humeral Plate and the predicated device have similar design geometry, are manufactured from similar material and have the same indication it was determined that mechanical testing was not necessary to support substantial equivalence.

INTENDED USE:

AOS Proximal Humeral Plate is indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus.

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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-like symbol with three overlapping, curved lines forming the 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 % Mr. Paul Doner Vice President Operations 2444 205th Street, Unit 5 Torrance, CA 90501

MAY - 6 2008

Re: K080590 Trade/Device Name: AOS Proximal Humeral Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTW Dated: February 29, 2008 Received: March 3, 2008

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,

Mark N. Millican

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): _ K080590 (pg | / D

Device Name: AOS Proximal Humeral Plate

Indications for Use:

The AOS Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

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)

Neil R.P. Ogle for rkn

Division S Division of General, Restorative and Neurological Devices

510(k) Number K080590

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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.