The VariAx Foot system is intended for use in internal fixation or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures include but are not limited to:

· Replantation
· Lag screw techniques
· Joint fusions
· Corrective osteotomies
Treatment of fractures

Device Description

VariAx Foot is a system used for internal fixation applications. VariAx Foot consists of self-fapping locking and non-locking screws, as well as corresponding washers and compatible bone plates. Since its original submission (K063875), the screws of the system have been modified. The modification includes the addition of a cutting flute to the 2.7mm and 3.5mm locking and nonlocking screws and a change in the Tox head of the 2.7mm screws. The lengths of the 2.7mm diameter screws range from 8-50mm. The lengths of the 3.5mm diameter screws range from 10-70mm.

AI/ML Overview

This document is a 510(k) premarket notification for the VariAx Foot system, a metallic bone fixation appliance. It is a submission to demonstrate substantial equivalence to a predicate device, not a study evaluating device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert review, adjudication methods, and MRMC studies is not applicable to this type of regulatory submission.

Here's why and what information can be extracted:

No Acceptance Criteria or Device Performance Study (in the sense of AI/ML or diagnostic accuracy): This 510(k) submission is for a physical medical device (bone fixation system). The "acceptance criteria" here are related to demonstrating substantial equivalence for regulatory approval, primarily through non-clinical testing focused on mechanical properties and biocompatibility. It's not about the accuracy or performance of an algorithm or diagnostic tool.
No Sample Sizes for Test/Training Sets, Ground Truth, Experts, or Adjudication: These concepts are relevant to studies evaluating diagnostic accuracy, often in AI/ML contexts. This submission discusses mechanical testing, not diagnostic performance.
No MRMC or Standalone Studies: Again, these are specific to evaluations of diagnostic or AI-assisted tools, which the VariAx Foot system is not.

While the requested table and categories are not directly applicable, I can provide a summary based on the information that is present in the document.

Summary of Device and Regulatory Submission:

The VariAx Foot system is a metallic bone fixation appliance used for internal fixation or arthrodesis of small bones in the foot and ankle, and treatment of fractures, among other procedures.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (What was demonstrated)	Reported Device Performance (How determined)
Substantial Equivalence to Predicate	Demonstrates equivalence in intended use, material, design, and operational principles to the Stryker Foot Plating System (K063875).	Conclusion: The subject VariAx Foot system is substantially equivalent to the predicate Stryker Foot Plating System (K063875).
Insertion Torque & Pull Out Force	Equivalence to the predicate device.	Demonstrated: Engineering rational provided to demonstrate equivalence.
LAL (Limulus Amebocyte Lysate) Testing	Less than 20 EU/device limit (for endotoxin levels).	Result: LAL testing performed to establish that the subject devices meet the less than 20 EU/device limit.
Clinical Testing (needed for 510(k) here)	Not required for this submission.	Result: Clinical Testing was not required for this submission.

2. Sample size used for the test set and the data provenance

Not Applicable: This document describes a 510(k) submission for a physical medical device, not a study involving a "test set" in the context of diagnostic accuracy or AI/ML. The "testing" referred to is non-clinical mechanical and biocompatibility testing. The data provenance would be from internal lab testing by Stryker GmbH.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: No "ground truth" or "experts" for diagnostic assessment are mentioned or relevant to this type of submission.

4. Adjudication method for the test set

Not Applicable: No adjudication method for a "test set" is mentioned or relevant.

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 is a physical bone fixation device, not an AI or diagnostic imaging device.

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

Not Applicable: This is a physical bone fixation device, not an algorithm.

7. The type of ground truth used

Not Applicable: No "ground truth" (in the sense of diagnostic accuracy) is mentioned. The "truth" in this context is the physical and biological performance of the device as assessed through non-clinical methods.

8. The sample size for the training set

Not Applicable: No "training set" is relevant to this device or submission.

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

Not Applicable: No "training set" or "ground truth" for it is relevant to this device or submission.

Summary

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November 22, 2019

Stryker GmbH Jemin Dedania Associate Manager Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430

Re: K192675

Trade/Device Name: VariAx Foot Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: September 24, 2019 Received: September 26, 2019

Dear Jemin Dedania:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192675

Device Name VariAx Foot

Indications for Use (Describe)

· Replantation
· Lag screw techniques
· Joint fusions
· Corrective osteotomies
Treatment of fractures

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary
Proprietary Name:	VariAx Foot
Common Name:	Screw, Fixation, BonePlate, Fixation, Bone
Regulation Description:	Smooth or threaded metallic bone fixation fastenerSingle/Multiple component metallic bone fixationappliances and accessories
Regulation Number:	21 CFR 888.3030, 21 CFR 888.3040
Product Code:	HWC (Screw, Fixation, Bone/Washer)HRS (Plate Fixation, Bone)
Device Class:	Class II
Sponsor:	Stryker GMBHBohnackerweg 12545 Selzach / Switzerland
Contact Person:	Jemin DedaniaAssociate Manager Regulatory Affairs325 Corporate DriveMahwah, NJ 07430Phone: (201)-831-6461Fax: (201) - 831-6500
Additional Contact Person:	Christine AdibRegulatory Affairs Intern
Date Prepared:	08/26/2019
Primary Predicate:	Stryker Foot Plating System (K063875)
Reference Predicate Device:	VariAx Elbow System (K101056)

Description

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diameter screws range from 8-50mm. The lengths of the 3.5mm diameter screws range from 10-70mm.

Indications for Use

VariAx Foot is intended for use in internal fixation, reconstruction or anthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to:

. Replantation
lag screw techniques
joint fusions ●
. corrective osteotomies
treatment of fractures.

Summary of Technologies

A comparison of the systems demonstrated that the subject VariAx Foot is substantially equivalent to the Stryker Foot Plating System (K063875) in regard to intended use, material, design, and operational principles.

Non-Clinical Testing

An engineering rational has been provided to demonstrate equivalence of the subject device to the predicate with respect to insertion torque and pull out force.

LAL testing was performed to establish that the subject devices meet the less than 20 EU/device limit.

Clinical Testing

Clinical Testing was not required for this submission.

Conclusion

The subject VariAx Foot system described in this submission has the same indications, intended use, target patient population, technological characteristics, and materials as the predicate devices. The subject VariAx Foot system is substantially equivalent to the predicate Stryker Foot Plating System (K063875).

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.