The Arthrex Modified Osteotomy System, designed for Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial Osteotomies, and High Tibial Closing Osteotomies, is used in conjunction with bone screws to provide fixation following surgery. Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia, distal femur, and distal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. Specially sloped plates can be used in cases when a tibial slope adjustment is needed. This system consists of plates and screws that join together to correct abnormalities or trauma related injuries. It is intended to be used with adequate post-operative immobilization.

Device Description

The Arthrex Modified Osteotomy System consists of plates and screws that join together to correct abnormalities or trauma related injuries. Different sizes and configurations of the Modified Osteotomy System are available to address patient needs. The plates are configured to provide as much support as possible. The plates and screws are manufactured from stainless steel and are sold non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for the "Modified Arthrex Opening Wedge Osteotomy System," submitted in 2002. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. The document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way that would be provided for a novel diagnostic algorithm or image analysis software.

Instead, the submission focuses on demonstrating substantial equivalence to existing devices. This typically involves comparing design, materials, manufacturing processes, and intended use. Performance testing for a device like a bone fixation system would usually involve mechanical bench testing (e.g., fatigue, static strength) to ensure the device performs as expected and is comparable to predicate devices in terms of its structural integrity and ability to provide fixation. However, these specific test results and acceptance criteria are not detailed in this 510(k) summary.

Therefore, many of the requested items (e.g., sample size for test sets, expert ground truth, MRMC studies, standalone performance for algorithms) are not applicable or not present in this type of regulatory document for a bone fixation system.

Here's an analysis based on the information available in the provided text:

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

Not provided in this 510(k) summary. This document emphasizes substantial equivalence to existing predicate devices rather than specific quantitative performance metrics against acceptance criteria. For a bone fixation system, performance criteria would typically include mechanical properties (e.g., strength, fatigue life), biocompatibility, and sterilization effectiveness, but these details are not present.

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

Not applicable / Not provided. No "test set" in the context of diagnostic performance or algorithmic evaluation is mentioned. The device is a physical bone fixation system.

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. This concept is generally relevant for diagnostic or AI-driven devices where human experts establish ground truth for algorithm training or evaluation.

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

Not applicable / Not provided.

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 / Not provided. This type of study is for diagnostic devices, particularly those involving human interpretation of images, often with AI assistance. The Modified Arthrex Opening Wedge Osteotomy System is a surgical implant.

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

Not applicable / Not provided. This is relevant for AI algorithms.

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

Not applicable / Not provided.

8. The sample size for the training set

Not applicable / Not provided.

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

Not applicable / Not provided.

Summary of Device Information from the 510(k):

Device Name: Modified Arthrex Opening Wedge Osteotomy System
Intended Use: For Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial Osteotomies, and High Tibial Closing Osteotomies, used with bone screws for fixation following surgery. Treats non-union, malunion, and various fractures of proximal tibia, distal femur, and distal tibia. Intended to be used with adequate post-operative immobilization.
Description: Consists of plates and screws made from stainless steel, sold non-sterile. Designed to provide support and correct abnormalities or trauma-related injuries.
Substantial Equivalence: Claimed to be substantially equivalent to predicate devices with the same basic features and intended uses. Minor differences are stated not to raise questions concerning safety and effectiveness or affect performance, function, or intended use.

Conclusion:

The provided 510(k) summary (K0141555) for the Modified Arthrex Opening Wedge Osteotomy System focuses on establishing substantial equivalence to legally marketed predicate devices, which is the primary regulatory pathway for this type of medical device. It does not contain the detailed performance study data, acceptance criteria, or ground truth establishment methods typically associated with diagnostic or AI-driven medical devices. Information regarding specific mechanical testing parameters, sample sizes for such tests, or the acceptance criteria for those tests is not included in this high-level summary.

Summary

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K0141555

510(k) Summary

MAR 1 8 2002

510(k) Number:
Contact Person:	Ann Waterhouse, Regulatory Affairs Specialist
Date Prepared:	December 13, 2001

Trade/Proprietary Name:	Modified Arthrex Opening Wedge Osteotomy System
Regulation Number:	888.3030
Product Code:	HRS
Classification Name:	Plate, fixation, bone,

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Intended Use:

Description:

Substantial Equivalence:

The Arthrex Modified Osteotomy System is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Modified Osteotomy System and predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract, curved shapes that resemble an eagle or bird in flight. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2002

Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex, Incorporated 2885 South Horseshoe Drive Naples, Florida 34104

Re: K014155

Trade Name: Modified Osteotomy System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Date: December 17, 2001 Received: December 19, 2001

Dear Ms. Waterhouse:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - Ms. Waterhouse

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and h your e FDA finding of substantial equivalence of your device to a legally promation in a classification 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark N. Millikan

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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510(k) Number (if known):

Device Name: Arthrex Modified Osteotomy System

Indications for Use:

The Arthrex Modified Osteotomy System, designed for Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial osteotomies, and High Tibial Closing Osteotomies, is used in conjunction with bone screws to provide fixation following surgery. Specifically for use in treatment of nonunion, malunion, and fractures of proximal tibia, distal femur, and distal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. Specially sloped plates can be used in cases when a tibial slope adjustment is needed. This system consists of plates and screws which join together to correct abnormalities or trauma related injuries. It is intended to be used with adequate post-operative immobilization.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark A. Millison

(Option Format 3-10-98)

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

510(k) Number

00007

KO1415

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.