The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients.

Indications include the following:

. osteotomies, and non-unions
. fixation of fractures
normal bone density and osteopenic bone .

Device Description

This Special 510(k) submission is being supplied to the U.S. FDA seeking clearance for a device modification of VariAx 2 One-Third Tubular Plates previously cleared in K141204 (VariAx 2 One-Third Tubular Plating System). Modification includes a change of plate thickness and addition of grooves to the waist part of the plate to improve mechanical behavior.

The VariAx 2 One-Third Tubular Plating System is an internal fixation device that consists of straight plates used with compatible screws to fit different types of fractures in the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 23-191mm in length.

AI/ML Overview

The request asks for specific information regarding acceptance criteria and a study proving device performance, based on the provided document. However, the document is a 510(k) summary for a medical device (VariAx 2 One-Third Tubular Plating System) seeking clearance for a modification to a previously cleared device. It explicitly states that clinical testing was not required for this submission and focuses on non-clinical testing and comparison to a predicate device for substantial equivalence.

Therefore, many of the requested items, which relate to clinical studies, ground truth establishment, and expert involvement, are not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Acceptance Criteria: The document mentions that a risk analysis was performed according to DIN EN ISO 14971 and "the subject device met the performance requirements." However, the specific numerical acceptance criteria (e.g., a specific tensile strength, fatigue life, or accuracy metric) are not explicitly stated in this summary. The "performance requirements" are only broadly referenced.
Reported Device Performance: The document states that the "evaluation demonstrated that the subject device did not present a new worst case and that the same verification methods were applied to the subject device in comparison to the previously cleared predicate device (K141204)." It concludes that the device "is as safe and effective as the predicate device" based on non-clinical tests. Again, specific quantitative performance results are not provided.

Acceptance Criteria (Not explicitly numbered/quantified in document)	Reported Device Performance (Summary)
Met performance requirements identified through risk analysis (DIN EN ISO 14971)	Did not present a new worst case compared to predicate.
Same verification methods as predicate applied.	Met performance requirements.
As safe and effective as predicate device.	Deemed as safe and effective as predicate device.

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

This information is not provided. The document explicitly states "Clinical testing was not required for this submission" and focuses on non-clinical tests and comparison to a predicate device. Thus, there is no "test set" in the context of clinical data, no sample size, and no data provenance from clinical studies.

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)

This information is not provided. As explained above, no clinical test set requiring expert-established ground truth was performed for this submission.

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

This information is not provided. No clinical test set requiring adjudication was performed for this submission.

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

This information is not provided. This device is a bone fixation system, not an AI-assisted diagnostic tool. An MRMC study is irrelevant to this device type, and no such study was performed or mentioned.

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

This information is not provided. This device is a mechanical implant, not an algorithm.

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

This information is not provided. Given that no clinical studies were performed for this submission, there's no mention of ground truth types for a clinical test set. For non-clinical tests, "ground truth" would refer to measured physical properties, which are not detailed.

8. The sample size for the training set

This information is not provided. No training set is mentioned as this is a non-clinical device modification submission.

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

This information is not provided. No training set is mentioned in the document.

In summary: The provided document is a 510(k) summary for a device modification focusing on non-clinical testing and substantial equivalence to a predicate device. It explicitly states that clinical testing was not required. Therefore, most questions related to clinical studies, test sets, ground truth establishment, and AI performance are not applicable or answerable from this document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human face in profile, with three overlapping faces.

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

August 6, 2015

Stryker GmbH. Dr. Heike Gustke Regulatory Affairs Specialist Prof. - Kuentscher - Str. 1-5 24232 Schoenkirchen, Schleswig-Holstein Germany

Re: K151879

Trade/Device Name: VariAx 2 One-Third Tubular Plating System 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: July 6, 2015 Received: July 9, 2015

Dear Dr. Gustke:

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.

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

{1}------------------------------------------------

Page 2 - Dr. Heike Gustke

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151879

Device Name VariAx 2 One-Third Tubular Plating System

Indications for Use (Describe)

The Stryker VariAx 2 One-Third Tubular Plating System is internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients.

Indications include the following:

· osteotomies, and non-unions

· fixation of fractures

· normal bone density and osteopenic bone

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

{3}------------------------------------------------

6 510(k) Summary

Proprietary Name:	VariAx 2 One-Third Tubular Plating System
Common Name:	Bone plates
Regulation Description:	Single/multiple component metallic bone fixation appliancesand accessories
Regulation Number:	21 CFR 888.3030
Product Code:	HRS (Plate, Fixation, Bone)
Class:	Class II
Sponsor:	Stryker GmbHBohnackerweg 12545 Selzach / Switzerland
Contact Person:	Dr. Heike GustkeRegulatory Affairs SpecialistProf.-Kuentscher-Str. 1-524232 Schoenkirchen / Germanyheike.gustke@stryker.comPhone: +49 4348 702 637Fax: +49 4348 702 8637
Date Prepared:	June 30, 2015

Description

{4}------------------------------------------------

fore, mid- and hind foot in adult patients. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 23-191mm in length.

Intended Use

The Stryker Variax 2 One-Third Tubular Plating System is intended for internal fixation of bones in adult patients.

Indications for Use

Indications include the following:

. osteotomies, and non-unions
. fixation of fractures
normal bone density and osteopenic bone .

Summary of Technologies

Device comparison demonstrated that the subject device is substantially equivalent to the previously cleared VariAx 2 One-Third Tubular Plating System (K141204) in regards to intended use, indications for use, material, and operational principles as well as similar in regards to design for internal fixation of bones in adult patients.

Non-Clinical Test

A risk analysis was performed according to the requirements of DIN EN ISO 14971 'Medical devices - Application of risk management to medical devices'. Records of risk analysis process are retained in design history file. The evaluation demonstrated that the subject device did not present a new worst case and that the same verification methods were applied to the subject device in comparison to the previously cleared predicate device (K141204). The analyses demonstrated that the subject device met the performance requirements and is as safe and effective as the predicate device.

{5}------------------------------------------------

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

The VariAx 2 One-Third Tubular Plating System is substantially equivalent to the predicate device identified in this premarket notification.

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.