The subject VariAx Elbow System is comprised of plates and screws, manufactured from Titanium alloy and Commercially Pure Titanium. The subject system was determined substantially quivalent in K073527. This Special 510(k) submission is intended to address the shortening of the Distal Posterior Medial Humeral Plates, left and right. Two process changes, which have been documented internally and affect the entire Distal Posterior Medial humeral Plate family, are also discussed.

AI/ML Overview

This document describes a Special 510(k) submission for the VariAx Elbow System Plate Line Extension. This is not a study focused on diagnostic accuracy or AI performance in the traditional sense. Instead, it is a submission for a medical device (bone plates and screws) and primarily discusses its substantial equivalence to a previously cleared predicate device.

Therefore, many of the typical acceptance criteria and study design elements requested in a clinical or AI performance study are not applicable to this type of submission. The focus here is on mechanical and functional equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" in the way one might for a diagnostic AI study (e.g., sensitivity, specificity thresholds). Instead, the acceptance criterion for this device modification is substantial equivalence to the predicate device in terms of mechanical strength and functional properties.

Acceptance Criteria	Reported Device Performance
Substantial equivalence in mechanical strength to predicate device (VariAx Elbow System K073527).	"Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devise in regards to mechanical strength."
Substantial equivalence in functional properties to predicate device (VariAx Elbow System K073527).	"Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject Variax Elbow System Plate Line Extension to the predicate device VariAx Elbow System K073527."
No alteration to the intended use of the predicate systems.	"The Variax Elbow System Plate Line Extension does not alter the intended use of the predicate systems as cleared in their respective premarket notifications." The stated indications for use are consistent with the predicate.
Similar manufacturing methods, packaging, and sterilization to predicate device.	"In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical."
Material composition (Titanium alloy and Commercially Pure Titanium) consistent with predicate.	"The subject and predicate devices are made from Titanium alloy (Ti-6Al-4V) and Commercially Pure Titanium."

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable in the context of clinical or AI performance data. This submission relies on mechanical and functional testing of the device itself, not patient data or a "test set" of cases. The "sample" here refers to the number of physical devices tested to demonstrate mechanical properties. The document does not specify the exact number of plates/screws tested, only that mechanical and functional testing was performed.
Data Provenance: The testing would have been conducted by the manufacturer (Howmedica Osteonics Corp.) in a laboratory setting. There is no "country of origin of the data" in the sense of patient demographics for this type of submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable. For a medical device like bone plates, "ground truth" is established through engineering and material science principles, manufacturing specifications, and international standards for mechanical testing. It's not typically established by clinical experts reviewing cases.

4. Adjudication Method for the Test Set:

Not Applicable. This concept is relevant for studies involving human reviewers or AI output that needs to be assessed for accuracy against a reference standard. For mechanical testing, the results are objective measurements (e.g., load at failure, fatigue cycles).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is for evaluating the impact of a diagnostic aid (often AI) on human reader performance. The VariAx Elbow System Plate Line Extension is a physical device for fracture fixation, not a diagnostic tool.

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

No. There is no algorithm or AI component to this device. It is a physical bone plate system.

7. The Type of Ground Truth Used:

For this submission, the "ground truth" for demonstrating device performance would be based on:
- Mechanical Test Standards: Established international and national standards for testing the strength, fatigue life, and other mechanical properties of bone plates and screws (e.g., ASTM standards).
- Predicate Device Performance Data: The established and cleared performance metrics of the previously approved VariAx Elbow System (K073527) serve as the benchmark for "substantial equivalence."

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI or machine learning product where a "training set" of data is used. The device is designed and manufactured based on engineering principles and material science.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. See point 8.

In summary: The provided document is for a "Special 510(k)" for a medical device line extension. This type of submission focuses on demonstrating substantial equivalence to a predicate device through engineering and mechanical testing, rather than clinical efficacy studies involving patient data or AI performance metrics. Therefore, many of the typical questions for AI study design are not relevant in this context.

Summary

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VARIAX ELBOW SYSTEM PLATE LINE EXTENSION

Special 510(k)

093433

510(k) Summary of Safety and Effectiveness: Variax Elbow System Plate Line Extension

Nov 2, 2009

JAN 2 8 2010

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430

For Information contact:

Melissa A. Matarese, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5116 Fax: (201) 831-4116

Date Summary Prepared:

Device Identification Proprietary Name:

Variax Elbow System Plate Line Extension

Common Name: Classification Name and Reference:

Device Product Code:

Bone plates and screws Single/multiple component metallic bone fixation appliances and accessories, 21 CFR §888.3030

HRS: Plate, Fixation, Bone

Description:

Intended Use:

The Variax Elbow System Plate Line Extension does not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below.

Indications for Use:

The Variax Elbow System Plate Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.

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VARIAX ELBOW SYSTEM PLATE LINE EXTENSION

Statement of Technological Comparison:

The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design. Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devise in regards to mechanical strength. In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical.

The subject and predicate devices are made from Titanium alloy (Ti-6Al-4V) and Commercially Pure Titanium. Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject Variax Elbow System Plate Line Extension to the predicate device VariAx Elbow System K073527.

ู้จัก

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right is a stylized representation of a bird or abstract human figure, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Howmedica Osteonics Corp. % Ms. Melissa A. Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430

JAN 2 8 2010

Re: K093433

Trade/Device Name: VariAx Elbow System Plate Line Extension Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and

accessories

Regulatory Class: II Product Code: HRS Dated: January 14, 2010 Received: January 19, 2010

Dear Ms. Matarese: ·

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have deterniined 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. Ilsting 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 device-related adverse events) (21 CFR 803); 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. Melissa A. Matarese

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.

Aoubara buekn

Mark N. Melkerson . Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K ○93イタミ

Device Name: VariAx Elbow System Plate Line Extension

Indications For Use:

. .

The Variax Elbow System Plate Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Smuta for Nixon
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093433

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.