The ExoToe Staple is an implant that is crimped onto bone with forceps after a k-wire has been placed to achieve fixation. The ExoToe Staple is provided in a sterile package. A kit containing four sizing templates and forceps is provided non-sterile. The staple is comprised of stainless steel and is pre-formed during manufacturing. The sizing templates and pliers are comprised of stainless steel. The sizing templates are used to select staple size. The forceps are used by a surgeon to conduct the final deformation required to anchor the staple to the bone.

AI/ML Overview

This document describes the premarket notification for the ExoToe Staple, a bone fixation device. The information provided does not pertain to an AI/ML medical device and therefore there is no discussion of acceptance criteria for an algorithm, test sets, training sets, ground truth establishment, or human reader studies.

The document discusses the substantial equivalence of the ExoToe Staple to previously marketed predicate devices (Memodyn Staple, Z-Staple, and Compressyn Staple) based on non-clinical performance data.

Here's the relevant information from the provided document regarding the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for non-clinical performance were based on demonstrating "substantial equivalence" to predicate devices. The reported device performance is presented as conclusions of substantial equivalence for various biomechanical tests.

Evaluation	Acceptance Criteria (Implied)	Reported Device Performance Conclusion
Dorsal pull-off	Substantially Equivalent	Substantially Equivalent
Static 4-point bend	Substantially Equivalent	Substantially Equivalent
Dynamic 4-point bend	Substantially Equivalent	Substantially Equivalent
Protrusion	Substantially Equivalent	Substantially Equivalent

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes (number of staples tested) for each biomechanical test. It also does not explicitly state the provenance of the data, but it is implied to be from laboratory testing conducted as part of the device development and submission process. This would be prospective testing, as it's performed specifically to support the regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The "ground truth" for a physical medical device like a bone staple is established through objective biomechanical testing according to established standards or validated test methods, not through expert consensus on interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For biomechanical testing, the results are quantitative measurements, and the "truth" is the measured value against a pre-defined acceptance threshold or comparison to predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human readers' diagnostic performance is evaluated with and without AI assistance. The ExoToe Staple is a physical implant, not an AI/ML device.

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

This information is not applicable. The ExoToe Staple is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the ExoToe Staple was established through non-clinical performance testing (biomechanical testing). This involves objective measurements of physical properties (e.g., pull-off strength, bend strength, protrusion) against defined criteria or in comparison to predicate devices, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable because the ExoToe Staple is not an AI/ML device and thus does not have a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

This information is not applicable, as there is no training set for a physical device.

Summary

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January 11, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

ExoToe LLC % Jerzy Wojcik Sr Director, QA/RA EdgeOne Medical 455 N Campbell Ave. Suite #2N Chicago, Illinois 60612

Re: K172205

Trade/Device Name: ExoToe Staple 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: December 4, 2017 Received: December 4, 2017

Dear Jerzy Wojcik:

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 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.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -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)

K172205

Device Name ExoToe Staple

Indications for Use (Describe)

ExoToe Staple is intended for fracture and osteotomy fixation and joint arthrodesis of the foot in conjunction with k-wire fixation.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Date Summary Prepared:	July 18, 2017
510(k) Owner:	ExoToe LLC
Contact Person:	Avi RoopExoToe LLC, CEOPO Box 548Grimes, Iowa 50111
510(k) Consultant Contact:	Jerzy WojcikSr Director RA/QA, EdgeOne Medical455 N Campbell Ave, Suite 2NChicago IL, 60612312-300-6643jerzy.wojcik@edgeonemedical.com
Device Name:	Device Name:Trade Name:Common Name:Classification:Class:Product Code:	ExoToe StapleExoToe StapleStaple, Fixation, Bone888.3030IIJDR
Predicate Device(s):	Primary PredicatesK161587 K121277 K140358	Memodyn StapleZ-StapleCompressyn Staple
Device Description:	The ExoToe Staple is an implant that is crimped onto bonewith forceps after a k-wire has been placed to achievefixation. The ExoToe Staple is provided in a sterile package.A kit containing four sizing templates and forceps is providednon-sterile. The staple is comprised of stainless steel and ispre-formed during manufacturing. The sizing templates andpliers are comprised of stainless steel. The sizing templatesare used to select staple size. The forceps are used by asurgeon to conduct the final deformation required to anchorthe staple to the bone.
Statement of Intended Use:	The ExoToe Staple is intended for fracture and osteotomyfixation and joint arthrodesis of the foot in conjunction withk-wire fixation.
Comparison of TechnologicalCharacteristics with PredicateDevices:	The proposed ExoToe Staple device has the sametechnology, indications, and fundamental characteristics asthe predicate. Both devices are permanent implants which

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achieve compression fixation using a stainless steel staple. Both contain barbs to maintain fixation.

Non-Clinical Performance Data:

Non-clinical performance testing was performed to verify that the performance of the ExoToe Staple device is substantially equivalent to currently marketed orthopedic instruments. Biomechanical testing verified that the ExoToe staple is substantially equivalent to the Memodyn Staple (K161587), the Z-Staple (K121277), and the Compressyn Staple (K140358) devices.

Evaluation	Conclusion
Dorsal pull-off	Substantially Equivalent
Static 4-point bend	Substantially Equivalent
Dynamic 4-point bend	Substantially Equivalent
Protrusion	Substantially Equivalent

Overall Conclusions: Based on the indication for use, technological characteristics, and comparison to the predicate devices, ExoToe Staple has been shown to be substantially equivalent to the predicates and is safe and effective for its intended use.

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.