The GEO Stable System consists of symmetric, barbed and smooth, superelastic Nitinol allov compression bone staples in varying lengths and widths. The System also includes associated instrumentation consisting of a stable inserter, drill bit and locator pins. The nitinol implant material conforms to ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. GEO Staples are offered in widths ranging from 8mm – 25mm. To facilitate implantation, GEO Staples are provided preloaded in the Staple Inserter. All GEO Staple System components (implants and instruments) are provided sterile and for single use only.

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) clearance letter for the "GEO Staple System" does not contain any information about a study involving software or AI performance, acceptance criteria for such a study, or details about ground truth establishment or expert involvement.

The document is purely related to the clearance of a physical medical device (bone staples) and its equivalence to predicate devices based on material properties, mechanical testing, and biocompatibility.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them in the context of an AI/software-driven medical device. The information you are asking for (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) is not present in this document, as it pertains to the validation of a different type of medical device (AI/Software as a Medical Device).

Summary

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Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Gramercy Extremity Orthopedics, LLC Michael Simpson CEO 1239 N. Glenville Dr Richardson, Texas 75081

Re: K182212

Trade/Device Name: Geo Staple System 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 13, 2018 Received: December 14, 2018

Dear Michael Simpson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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,

Image /page/1/Figure/5 description: The image shows the name "Vesa Vuniqi" in large, bold font on the left side. To the right of the name, there is a smaller text that reads "Digitally signed by Vesa Vuniqi -S Date: 2019.01.11 21:21:09 -05'00'". The text appears to be a digital signature or authentication detail, including the date and time of the signature.

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182212

Device Name GEO STAPLE SYSTEM

Indications for Use (Describe)

The GEO Staple System is intended for fixation of small bone fragments, fixation of osteotomies, and joint arthrodesis.

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.

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

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Image /page/3/Picture/1 description: The image contains a logo for Gramercy Extremity Orthopedics. The logo has the letters GEO stacked on top of each other. The word "GRAMERCY" is written in a smaller font size below the letters GEO, and the words "EXTREMITY ORTHOPEDICS" are written in a larger font size below the word "GRAMERCY".

Submitted by/Sponsor:	Gramercy ExtremityOrthopedics, LLC.840 F. Avenue #104Richardson, TX 75081USA 972-908-9808		Mary BiggersRegulatory Affairs855-436-2278
Date Prepared:	August 14, 2018
Trade Name:	GEO Staple System
Common Name:	Staple, Fixation, Bone
Classification CodeName & Reference:	JDR	Staple, Fixation, Bone	21 CFR §888.3030
Predicate Devices	Primary: K122113; Memory Metal Staples (Stryker Corporation)K112837: Vilex eZ-Staple Superelastic Bone Fixation StapleK141550: InstaFix™ Shape Memory Fixation System

GEO Staple System 510(k) Summary

Device Description:

Indications for Use:

The GEO Staple System is intended for fixation of small bone fragments, fixation of osteotomies, and joint arthrodesis.

Technological Characteristics: The GEO Bone Staple System is comprised of Nitinol shape memory allow conforming to ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. All System components are provided sterile by gamma irritation and are disposable, for single-use only. All patient contacting components are comprised of biocompatible materials.

Comparison to Predicate

The GEO Staple System compares favorably to the primary and additional predicates with regard to technological characteristics. The intended use is the same and the indications for use are within those of the primary predicate. Unlike the primary predicate, the GEO Staple is preloaded in a Staple/Inserter assembly, is includes barbed and smooth designs whereas the primary predicate has only barbed, the GEO Staples are not electropolished (in response to surgeon preference), and there are small differences in leg length. Though these technological characteristics are considered to raise new questions of safety or effectiveness, additional predicates were cited.

Substantial Equivalence: The GEO Staple System is substantially equivalent to the Stryker Corporation Easy Clip Memory Metal Staples (Primary Predicate) cleared under K122113. Additional predicates, Vilex eZ Staple [K112837] and OT Medical InstaFix Staples [K141550] are included for specific product features described above. The GEO Staples have the same intended use and material composition as the primary predicate and the technological differences are not considered to raise new questions of safety or effectiveness.

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Image /page/4/Picture/0 description: The image contains a logo for Gramercy Extremity Orthopedics. The logo has the letters GEO stacked on top of the words GRAMERCY EXTREMITY and ORTHOPEDICS. The letters GEO are larger than the other words in the logo. The logo is in grayscale.

Performance Data

Performance testing was performed on the GEO Staples and predicate devices. The following testing was conducted in accordance with ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples: static compression testing, fatigue testing, pullout testing of both barbed and smooth staples. Corrosion resistance testing was performed in accordance with ASTM F2129-17, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. Additionally, GEO Staples were subjected to a surface chemical composition evaluation. The results of performance testing demonstrate the GEO Staples to be substantially equivalent to the predicate device.

Conclusion

Based on comparison of the GEO Staple System to the predicate device with regard to intended use, technological characteristics, and the results of performance testing, the GEO Staple System is substantially equivalent.

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.