The Easy Out™ system is indicated for temporary internal fixation of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.

Device Description

Easy Out™ system consists of various, partially threaded solid screws designed to create lag compression used for temporary internal fixation small bones and fragments. The Easy Out™ bone screws are self-tapping, self-drilling screws with thread diameters of 2.0 mm, 2.5 mm, 3.0 mm, 3.5mm, 4.0 mm, and lengths that range from 12 mm to 60 mm. All compression screws are fabricated from medical grade titanium alloy (per ASTM F-136). Associated instrumentation is available. All compression screws are offered "non sterile".

AI/ML Overview

The document describes a medical device called Easy Out™, a system for temporary internal fixation of osteotomies and fractures. It is a 510(k) premarket notification to the FDA, and as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving novel efficacy. Therefore, much of the requested information about clinical studies, ground truth establishment, and expert involvement is not present in this type of document, as those are typically required for Novel devices or PMA submissions.

Here's an analysis of the provided text in relation to your questions:

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

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail table. Instead, it describes performance testing conducted to characterize the device and demonstrate substantial equivalence to predicate devices. The reported performance is that the device "functioned as intended" and the test results "demonstrate substantial equivalence."

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
Static 3-point bend strength	Functioned as intended; demonstrated substantial equivalence to predicate devices
Dynamic 3-point bend strength	Functioned as intended; demonstrated substantial equivalence to predicate devices
Static torsional strength	Functioned as intended; demonstrated substantial equivalence to predicate devices
Axial pull-out strength	Functioned as intended; demonstrated substantial equivalence to predicate devices
Biocompatibility:	Complies with applicable voluntary standards
Sterilization:	Complies with applicable voluntary standards
Intended Use:	Same as predicate devices
Technological Characteristics:	Similar to predicate devices
Safety and Effectiveness:	Does not raise new issues of safety and effectiveness compared to predicates

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

The document mentions "Performance testing and engineering analysis," including "Static and dynamic 3-point bend tests, static torsional tests and axial pull-out tests." However, it does not specify the sample sizes used for these tests. It also does not provide any information regarding data provenance (country of origin, retrospective/prospective) for these non-clinical performance tests.

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 applicable or available from the document. The study described is non-clinical performance testing (mechanical and material characterization), not a clinical study involving diagnosis or interpretation by experts to establish a "ground truth" for a test set.

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

This information is not applicable or available from the document for the reasons stated in point 3.

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

There was no MRMC comparative effectiveness study and therefore no effect size relating to human readers or AI is provided. The device is a bone fixation screw system, not an AI-assisted diagnostic tool.

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

This information is not applicable or available from the document. The device is a physical medical implant, not an algorithm or software.

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

For the non-clinical performance tests, the "ground truth" would be the physical properties and mechanical behavior of the device measured against established engineering standards (ASTM F1264-03 (07), ASTM F543-07(e1)). It is not a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This information is not applicable or available from the document. The document describes a medical device, not an AI model that requires a training set.

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

This information is not applicable or available from the document for the reasons stated in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

February 20, 2015

Feet for Life Podiatry % Ms. Carrie Hetrick Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701

Re: K141401 Trade/Device Name: Easy Out™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 20, 2015 Received: January 21, 2015

Dear Ms. Hetrick:

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

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Page 2 - Ms. Carrie Hetrick

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/Resourcesfor You/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 vours.

Lori A. Wiggins -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) K141401

Device Name Easy Out™

Indications for Use (Describe)

The Easy Out™ system is indicated for temporary internal fixation of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

for

Easy Out™

1. Submission Sponsor

Feet For Life Podiatry Centers 8637 Delmar Blvd. Saint Louis, MO 63124 United States of America Phone: (314) 983-0303 Fax: (314) 983-2777 Contact: Dr. Michael Horwitz, CEO

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: 720.838.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com

3. Date Prepared

February 19, 2015

4. Device Identification

Trade/Proprietary Name: Easy Out™ Common/Usual Name: Temporary Internal Fixation Device Classification Name: Smooth or threaded metallic bone fixation fastener Classification Regulation: 888.3040 Classification Panel: Orthopedic Product Code: HWC Device Class: II

5. Legally Marketed Predicate Device(s)

Small Bone Innovations, Inc. SBI K-Wires (510(k) Number K051605, cleared August 10, 2005)

Zimmer®, Inc. Zimmer® Plates and Screws System (ZPS) - Non-Sterile/ Non-Sterile ZPS Screws and Washers (510(k) Number K143066, cleared November 28, 2014)

Stryker® Corporation Asnis™ Micro Cannulated Screw (formally Howmedica Osteonics Corp.) (510(k) Number: K071092) 2.0mm and 3.0mm diameter implants

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Stryker® Corporation, Asnis™ III Cannulated Screws (510(k) Number K024060, cleared December 20, 2002)

6. Device Description

7. Indication for Use Statement

The Easy Out™ system is indicated for temporary internal fixation and stabilization of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.

8. Comparison to Predicate Devices

The Feet For Life Podiatry Centers Easy Out™ system is similar in intended use, basic shape, compatible screw diameters, materials and performance characteristics to the predicate devices. The subject devices are provided non-sterile.

9. Non-Clinical Performance Data

Performance testing and engineering analysis were conducted to characterize the performance of the Easy Out™ device. The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices. Static and dynamic 3-point bend tests, static torsional tests and axial pull-out tests were conducted to support substantial equivalence. Static and dynamic Three Point Bend testing was conducted in accordance with ASTM F1264-03 (07), Standard Specification and Test Method for Intramedullary Fixation Devices. Additionally testing was conducted to characterize the torsional strength of the screw as well as axial pullout per ASTM F543-07(e1), Standard Specification and Test Methods for Metallic Medical Bone Screws.

Performance testing and engineering analysis were conducted to characterize the performance of the Feet for Life Easy Out™ device. The results of this testing demonstrate that Easy Out™ performs as intended and demonstrates that the device is substantially equivalence to its predicate devices.

The Easy Out™ device complies with the applicable voluntary standards for biocompatibility and sterilization.

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10. Clinical Performance Data

Clinical data was not needed to support the safety and effectiveness of the subject device. Easy Out™ and its predicates are all indicated for temporary fixation. Easy Out™ does not raise any new issues of safety and effectiveness.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

The Feet for Life Easy Out™ device has the same or similar intended use, indications, principles of operation, and technological characteristics as the predicate systems. Easy Out™ device is substantially equivalent to the predicate devices in terms of intended use, design, materials, and function.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.