This 510(k) submission is intended to add bone plates with a different geometry to the VariAx " fibular plate line which was cleared in K081284. The new plates are termed "Fibula Straight Plates" and consist of the shaft portion of the cleared plate plus an oblong screw hole in some configurations. Additionally, other fixation plates (predicates) have been cleared with the approximate plate length of the subject device, including the Synthes 3.5 mm LCP® Medial Distal Tibia Plates (K001945) and Synthes One-Third Tubular Dynamic Compression Locking (DCL) (K011335).

AI/ML Overview

The provided text is for a 510(k) summary for a medical device (VariAx™ Locked Plating System Line Extension for Addition of Fibula Straight Plates), which is a regulatory document to demonstrate substantial equivalence to a legally marketed predicate device. It does not describe a study involving an algorithm or artificial intelligence, nor does it involve performance criteria typically associated with such technologies.

The acceptance criteria and "study" described here pertain to mechanical and material equivalence for a physical medical implant.

Here's a breakdown based on the provided text, heavily formatted to address your specific points even if they don't perfectly align with the nature of this submission:

Acceptance Criteria and Device Performance

The "acceptance criteria" in this context refer to demonstrating substantial equivalence in mechanical properties to predicate devices. The "reported device performance" indicates that these criteria were met.

Acceptance Criterion (for Mechanical/Material Equivalence)	Reported Device Performance
Median fatigue limits equivalent to predicate fibula plates	Found equivalent to existing fibula plates in the predicate system
Stiffness equivalent to predicate fibula plates	Found equivalent to existing fibula plates in the predicate system

Study Details (as applicable to a physical device equivalence study)

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size (number of plates tested) for the fatigue and stiffness tests.
- Data Provenance: The tests were performed to compare the subject device's mechanical properties to predicate devices (Synthes 3.5 mm LCP® Medial Distal Tibia Plates (K001945) and Synthes One-Third Tubular Dynamic Compression Locking (DCL) (K011335)). This is laboratory-generated data, not patient data, and does not have a "country of origin" in the same sense as clinical data. It is a prospective test in that new plates were manufactured and tested for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. For mechanical testing of medical devices, "ground truth" is established by standardized testing methods and measurements, not expert human interpretation. The "truth" is objective physical properties.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or clinical outcomes. This study involves objective mechanical measurements.
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. This is a 510(k) for a physical bone plate, not an AI or imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm, but a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is based on objective mechanical properties and material composition, established through standardized physical testing (4-point bending test) to compare the subject device to existing predicate devices.
The sample size for the training set:
- Not applicable. This submission describes mechanical testing of a physical device, not an AI algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary of the "Study" for this device:

The study was a benchtop mechanical comparison of the subject device (VariAx™ Fibula Straight Plates) against predicate devices (Synthes 3.5 mm LCP® Medial Distal Tibia Plates and Synthes One-Third Tubular Dynamic Compression Locking plates).

Methods: Fatigue strength verification and stiffness analysis were evaluated using a 4-point bending test.
Findings: The median fatigue limits and stiffness of the VariAx™ Fibula Straight Plates were found to be equivalent to the existing fibula plates in the predicate system.
Conclusion: This data demonstrated substantial equivalence to the predicate devices, a key regulatory requirement for 510(k) clearance.

Summary

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K102282
pg 1 of 2

510(k) Summary of Safety and Effectiveness: VariAx" Locked Plating System Line Extension for Addition of Fibula Straight Plates

DEC - 7 2010

Submission Information
Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430
For Information contact:	Stephanie M. Fitts, Director RegulatoryAffairs and Regulatory ComplianceHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5405Fax: (201) 831-4405
Date Summary Prepared:	November 29, 2010
Device Identification
Proprietary Name:	VariAxTM Locked Plating System LineExtension for addition of Fibula StraightPlates
Common Name:	Bone plates and screws
Classification Name and Reference:	Single/multiple component metallic bonefixation appliances and accessories, 21 CFR§888.3030
Device Product Code:	87 HRS: Plate, Fixation, Bone

Description:

Intended Use:

The VariAx " Fibula Locked Plating System Line Extension addition of Fibula Straight Plates does not alter the intended use of the predicate system as cleared in K081284. The indications for use for the subject plates are provided below.

Indications for Use:

The VariAx " Fibula Straight Plates are intended for use in internal fixation of the distal fibula.

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Statement of Technological Comparison:

The subject and predicate devices are made from Titanium Grade 2 with type II anodization. Fatigue strength verification and stiffness analysis were evaluated by way of a 4-point bending test. Median fatigue limits and stiffness of the subject VariAxTM Fibula Straight Plates were found equivalent to the existing fibula plates in the predicate system, Synthes One-Third Tubular Dynamic Compression Locking plates. The data presented demonstrates substantial equivalence to the predicate devices.

<1022f2

202

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

Howmedica Osteonics Corp. % Ms. Stephanie M. Fitts Director Regulatory 325 Corporate Drive Mahwah, New Jersey 07430

Re: K102282

Trade/Device Name: Variax™ Fibula Straight Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 05, 2010 Received: November 09, 2010

Dear Ms. Fitts:

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. 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.

DEC - 7 2010

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Page 2 - Ms. Stephanie M. Fitts

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.

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,

for
Mark N. Melkerson

Mark N. Me 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): K102282

DEC - 7 2010

K102282

Device Name: Variax™ Fibula Straight Plates

Indications For Use:

The VariAx™ Fibula Straight Plates are intended for use in internal fixation of the distal fibula.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

(21 CFR 807 Subpart C)

Over-The-Counter Use

(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

for M. Mulkerson
(Division Signee)

(Division Sign-Off) Division of Surger al, Orthopedic, and Restorative Devices

510(k) Number K102282

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.