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 equivalent in K073527. This Special 510(k) submission is intended to address the addition of the 7mm washer to the predicate VariAx Elbow System.

AI/ML Overview

This 510(k) summary describes a line extension for the VariAx Elbow System, adding a 7mm washer. As such, the study primarily focuses on demonstrating the substantial equivalence of the new component to existing predicate devices, rather than establishing new performance criteria for a novel device.

Here's an analysis of the provided information, framed by your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a line extension for an existing bone fixation system, the "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence for the added component. The primary acceptance criteria for this type of device extension would be:

Acceptance Criteria	Reported Device Performance
Mechanical Strength (for new 7mm washer)	Functional and mechanical testing demonstrates comparable mechanical & functional properties of the subject VariAx Elbow System Line Extension to the predicate device VariAx Elbow System K073527. The washer has been cleared for use in K000080 and K000636.
Material Composition	Subject and predicate devices are made from Titanium (Ti-6Al-4V).
Intended Use	The VariAx Elbow System Line Extension does not alter the intended use of the predicate systems. Indications are fracture fixation of long bones, including distal humerus and proximal ulna (same as predicate).
Manufacturing Methods	Identical to predicate components.
Packaging	Identical to predicate components.
Sterilization	Identical to predicate components.

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

The document states "Functional and mechanical testing" was performed. However, it does not specify the sample size for these tests for the new 7mm washer.

The data provenance is prospective in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate equivalence. The country of origin of the data is not specified, but it can be inferred to be from the manufacturer (Howmedica Osteonics Corp.) in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for mechanical testing is established by engineering standards and validated testing protocols, not by expert consensus. There are no clinical images or diagnostic interpretations requiring expert radiologists or other medical professionals for ground truth establishment.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing results are objective measurements and do not require adjudication by human experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images. The VariAx Elbow System Line Extension is a mechanical implant, not an AI or diagnostic device.

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

No, a standalone (algorithm only) performance study was not done. This is not an AI or software-only device.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be established by validated engineering principles and standards for bone fixation devices. This might include standards for fatigue strength, torsional strength, bending strength, etc., depending on the specific mechanical tests performed. The document implies that the "comparable mechanical & functional properties" were assessed against the predicate device, which would have itself been evaluated against such standards.

8. The Sample Size for the Training Set

There is no training set mentioned or implied because this is a mechanical device undergoing physical testing, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set.

Summary

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K092671

SEP 2 3 2009

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

Submission Information

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

For Information contact:

Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430

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:

August 28, 2009

↓

VariAx Elbow System Line Extension

Common Name: Classification Name and Reference: Bone plates and screws Single/multiple component metallic bone fixation appliances and accessories, 21 CFR $888.3030

Device Product Code:

HRS: Plate, Fixation, Bone

Description:

Intended Use:

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

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K092671

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 (Ti-6Al-4V). Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject VariAx Elbow System Line Extension to the predicate device VariAx Elbow System K073527. The washer has been cleared for use in K000080 and K000636.

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త్రాల

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

SEP 23 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K092671

Trade/Device Name: VariAx Elbow System 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: August 28, 2009 Received: August 31, 2009

Dear Ms. Matarese:

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 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 (OS) 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/CDRHOffices/ucm115809.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 yours,

Barbara Brienn

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 09 26 7 ا

Device Name: VariAx Elbow System Line Extension

Indications For Use:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use

(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)

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Souther for mxn

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092671

Regulation Number and Section

N/A