AxSOS 3 Ti is intended for long bone fracture fixation. Indications include: · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures • Non-unions and malunions · Normal and osteopenic bone · Osteotomies · Periprosthetic fractures of the femur and proximal tibia The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of: · Periprosthetic fractures • Diaphyseal and metaphyseal areas of long bones in pediatric patients. The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.

Device Description

The AxSOS 3 Ti Plating System consists of various monoaxial plates and screws made from Ti-6AI-4V (ASTM F-136 ELI). The system contains previously cleared distal lateral femur plates, proximal lateral tibial plates, distal anterolateral tibia plates, distal medial plates, proximal medial tibia plates and proximal humerus plates provided in various lengths (K123964, K133440, K141121, and K143138). This premarket notification introduces 4.0 mm waisted compression plates and 5.0 mm broad and narrow waisted compression plates in various lengths and number of holes. The system contains previously cleared screws with various lengths and diameters and provided in various configurations (fully or partially threaded) identified in previously cleared premarket notifications (K123964, K133440, K141121, and K143138). This premarket notification introduces blind screws used with the 4.0 mm and 5.0 mm waisted compression plates.

AI/ML Overview

The provided text is a 510(k) summary for the AxSOS 3 Ti device, a bone fixation system. It details the device's indications for use, its description, and its substantial equivalence to predicate devices based on bench testing. However, it explicitly states that clinical testing, and therefore, any studies proving the device meets acceptance criteria, were not required or performed for this submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no such study is described in this document. The submission relies on demonstrating substantial equivalence to previously cleared devices through bench testing and engineering analysis, rather than a clinical trial with specific performance metrics.

Here's a breakdown of why each specific point you requested cannot be fully addressed based on the provided text:

A table of acceptance criteria and the reported device performance: Not available. The document does not define specific acceptance criteria for a clinical study or report device performance in that context. The "performance" mentioned refers to characteristics demonstrated during bench testing, not clinical outcomes.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No clinical test set was used. The submission relies on bench testing and engineering analysis.
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): Not applicable. No clinical test set with ground truth established by experts was used.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set was used.
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 device is a physical medical implant (bone fixation system), not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic imaging devices or AI algorithms.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was established for the purpose of this submission. The "ground truth" for the substantial equivalence would implicitly be the established safety and effectiveness of the predicate devices.
The sample size for the training set: Not applicable. This is not an AI algorithm, so there is no training set in that context.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence for a physical medical device (bone fixation system), not on presenting clinical study data with specific performance metrics or AI algorithm validation.

Summary

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

Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

May 26, 2016

Stryker GmbH Saad Attiyah Senior Regulatory Affairs Manager Bohnackerweg 1 2545 Selzach, CH 2545 SWITZERLAND

Re: K153379 Trade/Device Name: AxSOS 3 Ti 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: April 25, 2016 Received: April 26, 2016

Dear Saad Attiyah:

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 (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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 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}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K153379

Device Name AxSOS 3 Ti

Indications for Use (Describe)

AxSOS 3 Ti is intended for long bone fracture fixation.

Indications include:

· Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
· Non-unions and malunions
· Normal and osteopenic bone
· Osteotomies
· Periprosthetic fractures of the femur and proximal tibia

The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:

· Periprosthetic fractures
· Diaphyseal and metaphyseal areas of long bones in pediatric patients.

The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.

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."

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

Pg.1/3

Section 7. 510(k) Summary

Submitter:	Stryker GmbHBohnackerweg 12545 SelzachSwitzerland
Contact Person:	Saad AttiyahSenior Regulatory Affairs ManagerPhone: 201-831-5655Fax: 201-831-4691
Establishment NumberDate Prepared:	8031020May 24, 2016
Name of Device:	AxSOS 3 Ti
Common or Usual Name	Bone PlatesBone Screws
Classification Name:	Single/multiple component metallicbone fixationAppliance and accessories
	21 CFR §888.3030
	Smooth or threaded metallic bonefixation fastener
Regulatory Class:	21 CFR §888.3040II
Product Codes:	HRS: Plate, Fixation, BoneHWC: Screw, Fixation, Bone
Predicate Device:	AxSOS 3 Ti Locking Plate System(K141121)AxSOS 3 Ti Locking Plate System(K143138)OrthoHelix Surgical Design (K113048,K122005, K132591)
Reference Device:	Zimmer NCB Blind Screw Insert(K113718)

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

The AxSOS 3 Ti Locking Plate System is

intended for long bone fracture fixation Indications for Use: AxSOS 3 Ti is intended for long bone fracture fixation. Indications include: · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures • Non-unions and malunions · Normal and osteopenic bone · Osteotomies · Periprosthetic fractures of the femur and proximal tibia The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of: · Periprosthetic fractures • Diaphyseal and metaphyseal areas of long bones in pediatric patients. The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis. Description: The AxSOS 3 Ti Plating System consists of various monoaxial plates and screws made from Ti-6AI-4V (ASTM F-136 ELI). The system contains previously cleared distal lateral femur plates, proximal lateral tibial plates, distal anterolateral tibia plates, distal medial plates, proximal medial tibia plates and proximal humerus plates provided in various lengths (K123964, K133440, K141121, and K143138). This premarket notification introduces 4.0 mm waisted compression plates and 5.0 mm broad

Intended Use:

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

	K153379	Pg.3/3
	and narrow waisted compressionplates in various lengths and number ofholes.The system contains previously clearedscrews with various lengths anddiameters and provided in variousconfigurations (fully or partiallythreaded) identified in previouslycleared premarket notifications(K123964, K133440, K141121, andK143138). This premarket notificationintroduces blind screws used with the4.0 mm and 5.0 mm waistedcompression plates.
Bench Testing:	An engineering analysis was performedcomparing the specific predicatedevices.
Animal Testing:	Animal testing was not required for thissubmission.
Clinical Testing:	Clinical testing was not required for thissubmission.
Substantial Equivalence Statement:	Documentation is provided whichdemonstrates that the AxSOS 3 Ti issubstantially equivalent to its predicateand reference devices in terms of itsmaterial, design, and indications foruse, and performance characteristics.

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.