The AOS Cannulated Bone Screw System is intended for fracture fixation of small and long bones and of the pelvis. This system is not intended for spinal use.

Device Description

The AOS Cannulated Bone Screw System consists of titanium alloy self-drilling, self-tapping cannulated screws in diameters of 4.0mm, 5.0mm and in lengths ranging from 10mm to 150mm. The screws are either partial threaded or fully threaded. There are two washers in the system, one for use with the 4.0mm and 5.0mm screws and one for use with the 7.0mm screws. All screw are packaged and sold as non-sterile.

AI/ML Overview

This document, K014185, is a 510(k) premarket notification for a medical device called the "AOS Cannulated Bone Screw System." It seeks to demonstrate substantial equivalence to previously marketed devices rather than presenting a de novo study with specific performance acceptance criteria and a detailed study report. Therefore, much of the requested information regarding acceptance criteria, study findings against those criteria, sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance studies, is not applicable or not provided in this regulatory submission.

The core of a 510(k) submission like this is to show that the new device is as safe and effective as a legally marketed predicate device, not necessarily to prove its absolute performance against predefined metrics in a clinical study.

Here's an attempt to address the request based on the provided text, indicating where information is not available:

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

Acceptance Criteria	Reported Device Performance
Not explicit for performance in this 510(k) submission. The core "acceptance criteria" here is substantial equivalence to predicate devices. This means the device must have the same intended use, technological characteristics, and safety/effectiveness profile as the predicates.	The device's technological characteristics (titanium alloy self-drilling, self-tapping cannulated screws in 4.0mm, 5.0mm, and 7.0mm diameters, lengths 10mm-150mm, partial or fully threaded) are described and asserted to be substantially equivalent to the predicate devices.

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 / Not provided. This 510(k) submission relies on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a new clinical study with a test set of patient data. There is no mention of a test set of patient data or its provenance.

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 / Not provided. As there is no clinical test set mentioned, there are no experts establishing ground truth for such a set within this document. The "experts" involved are likely the device manufacturer's engineers and regulatory specialists, and the FDA reviewers themselves, assessing the substantial equivalence claim.

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

Not applicable / Not provided. No test set or adjudication method 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 physical bone screw system, not an AI or imaging device, so MRMC studies and AI assistance metrics are 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.

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

Not applicable. For a 510(k) submission of this type, the "ground truth" is effectively the established safety and effectiveness of the identified predicate devices in the market, demonstrated through their long-term use and regulatory clearance. The submission aims to show the new device meets that de facto standard through design and material comparison.

8. The sample size for the training set

Not applicable / Not provided. No training set for an algorithm is mentioned as this is a physical device submission.

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

Not applicable / Not provided.

Summary

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K014185 1//

510(k) SUMMARY

NAME OF FIRM:

510(k) CONTACT PERSON:

TRADE NAME:

COMMON NAME:

CLASSIFICATION:

Advanced Orthopaedic Solutions

FEB 1 3 2002

Paul Doner Vice President Operations and Regulatory

AOS Cannulated Bone Screw System

Bone Fixation Screws and Washers

888.3040 Smooth or Threaded Metallic Bone Fixation Fastener 888.3030 Single/Multiple Bone Fixation Appliance and Accessories

DEVICE CODE:

SUBSTANTIALLY EQUIVALENT DEVICES:

HWC and HTN

Smith and Nephew - 5.5mm and 7.0mm Titanium and Stainless Steel Cannulated Screws

Smith and Nephew - 6.5mm and 4.0mm Cannulated Screws

Howmedica Osteonics - ASNIS III Cannulated Screw System

INTENDED USE:

The AOS Cannulated Bone Screw System is intended for fracture fixation of small and long bones and of the pelvis. This system is not intended for spinal use.

DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The AOS Cannulated Bone Screw System is substantially equivalent to the following marketed devices: Howmedica Osteonics, ASNIS III Cannulated Screw System, 4.0mm, 5.0mm, 6.5mm and 8.0mm; Smith and Nephew, 5.0mm and 7.0mm Titanium and Stainless Steel Cannulated Screws; and the Smith and Nephew, 6.5mm and 4.0mm Cannulated Screws.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2002

Mr. Paul Doner Vice President, Operations and Regulatory Advanced Orthopaedic Solutions (AOS) 333 W. 6th Street, Suite 202 San Pedro, California 90731

Re: K014185

Trade/Device Name: AOS Cannulated Bone Screw System Regulatory Number: 888.3040 and 888.3030 Regulation Name: Smooth or Threaded Metallic bone Fixation Fastener and Single/Multiple bone Fixation Appliance and Accessories Regulatory Class: II Product Code: HWC and HTN Dated: December 18, 2001 Received: December 20, 2001

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)
The Children Children Calling of a line of sourcelerse of your device to a legal This letter will allow you to begil marks.mig your antine equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale end this p premarket notification. The FDA inding of substantial equively 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 and If you desire specific advice for your do viteo diagnostic devices), please contact the Office of
additionally 21 CFR Part 809.10 for in vites diagnostic devices), please con additionally 21 CFR Part 809.10 III viato units and the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertisi Compliance at (301) 394-4639. Additionally, for questis of 904-4639. Also, please note the your device, please comact the Orited of centraliation" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket at may be obtained from the regulation entitled, "Misoranding by reference to proder the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number Division of Dinar (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K=14185 510(k) Number (if known)

AOS Cannulated Bone Screw System Device Name:

Indications for Use:

The AOS Cannulated Bone Screw System is intended for fracture fixation of small and long bones and of the pelvis. This system is not intended for spinal use.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter _____________________________________________________________________________________________________________________________________________________________

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K014185

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.