The Stryker GmbH EasyStep system includes superelastic staples fabricated from Nitinol (Nickel-Titanium alloy) per ASTM F 2063. The staples range in size from 4 mm to 12 mm in 2 mm increments where the staple size refers to the step size associated with each staple. The legs of each staple are barbed to provide anchorage within the bone fragments. All implants within the system are provided sterile.

AI/ML Overview

This document is a 510(k) summary for the EasyStep system, a medical device for bone fixation. It does not describe an AI/ML powered device, therefore, many of the requested categories are not applicable.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Test Performed)	Reported Device Performance
Pull-Out Testing (per ASTM F564)	Demonstrated equivalent mechanical performance to the predicate device, Biomedical Enterprises Inc. Memograph Staple System.
Four-Point Bending Testing (per ASTM F564)	Demonstrated equivalent mechanical performance to the predicate device, Biomedical Enterprises Inc. Memograph Staple System.
Cyclic Potentiodynamic Polarization (Corrosion) Test (per ASTM F2129)	Demonstrated equivalence to the predicate device.
Bacterial Endotoxins Test (BET) (per ANSI/AAMI ST72)	Demonstrated equivalence to the predicate device.
Magnetically Induced Displacement Force (per ASTM F2052)	Demonstrated compatibility with an MR environment.
Magnetically Induced Torque (per ASTM F2213)	Demonstrated compatibility with an MR environment.
Heating by RF Fields (per ASTM F2182)	Demonstrated compatibility with an MR environment.
Image Artifacts (per ASTM F 2119)	Demonstrated compatibility with an MR environment.

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

The document states that "Non-clinical laboratory testing was performed on the worst case subject staples." It does not specify the exact sample size for each test.
The data provenance is from non-clinical laboratory testing performed by the manufacturer, Stryker GmbH. The country of origin of the data is not explicitly stated. It is prospective testing performed for the purpose of this submission.

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

This device is a hardware implant, not an AI/ML powered device. Therefore, the concept of "ground truth" established by experts for a test set in the context of device performance, as typically understood for AI, is not applicable here. The "ground truth" for the mechanical and material tests is defined by the respective ASTM standards and validated laboratory methodologies.

4. Adjudication method for the test set:

Not applicable, as this is laboratory testing of a mechanical device, not a performance study involving interpretation by 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:

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

7. The type of ground truth used:

The "ground truth" for the mechanical and material properties of the device are the physical standards and specifications outlined in the referenced ASTM and ANSI/AAMI documents. For instance, pull-out strength is assessed against a defined standard, not an expert opinion.

8. The sample size for the training set:

Not applicable. This is not an AI/ML powered device, so there is no "training set."

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of a stylized design of three human profiles facing right, with flowing lines beneath them, resembling a bird or abstract form.

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

July 26, 2016

Stryker GmbH Garry Hayeck, Ph.D. Associate Manager. Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430

Re: K160813 Trade/Device Name: EasyStep Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: June 24, 2016 Received: June 27, 2016

Dear Dr. Hayeck:

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

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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,

Vincent J. Devlin -S

for

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

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Indications for Use

510(k) Number (if known) K160813

Device Name EasyStep

Indications for Use (Describe)

The EasyStep system is intended for bone fragment and osteotomy fixation of the foot in adult patients. Indications include:

· Bone fragment fixation
Osteotomy fixation

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Submission Number:	K160813
Proprietary Name:	EasyStep
Common Name:	Staple, fixation, bone
Regulation Description:	Single/multiple component metallic bone fixation applianceand accessories
Regulation Number:	21 CFR 888.3030
Product Code:	JDR
Device Class:	Class II
Sponsor:	Stryker GmbHBohnackerweg 12545 Selzach / Switzerland
Contact Person:	Garry T. Hayeck, Ph.D.Associate Manager, Regulatory Affairs325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6802Fax: (201) 831-2802
Date Prepared:	July 22, 2016
Primary Predicate:	Biomedical Enterprises Inc. Memograph Staple System(K993714)

510(k) Summary

Description

Indications for Use

The EasyStep system is intended for bone fragment and osteotomy fixation of the foot in adult patients.

Indications include:

Bone fragment fixation
Osteotomy fixation

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Summary of Technologies

A comparison of the systems demonstrated that the subject EasyStep system is substantially equivalent to the Biomedical Enterprises Inc. Memograph Staple System in regards to intended use, material, design, and operational principles.

Non-Clinical Testing

Non-clinical laboratory testing was performed on the worst case subject staples to determine substantial equivalence. Testing demonstrated that the EasyStep system is equivalent in mechanical performance to the predicate device, the Biomedical Enterprises, Inc. Memograph Staple System.

The following testing was performed:

Pull-Out Testing per ASTM F564 .
Four-Point Bending Testing per ASTM F564
Cyclic Potentiodynamic Polarization (Corrosion) Test per ASTM F2129
Bacterial Endotoxins Test (BET) per ANSI/AAMI ST72

Testing to determine the compatibility of the EasyStep system in an MR environment was also performed. These tests included an assessment of:

Magnetically Induced Displacement Force per ASTM F2052
. Magnetically Induced Torque per ASTM F2213
Heating by RF Fields per ASTM F2182
Image Artifacts per ASTM F 2119

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

The subject EasyStep system is substantially equivalent to the predicate Biomedical Enterprises Inc. Memograph Staple System.

Regulation Number and Section

N/A