The MotoCLIP™/HiMAX™ Step Staple Implant System gives the surgeon a means of bone fixation in the management of bone fractures and reconstruction surgery. The MotoCLIP™/HiMAX™ Step Staple Implant System includes implants and the related instruments needed for implantation. The implants are made of nitinol. Prior to implantation, the legs of the implant are held substantially parallel to facilitate insertion into the prepared bone. Once implanted and released from the insertion device, the implant will move towards each other in a converging fashion. This movement creates compression across the adjoining bone members.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the MotoCLIP™/HiMAX™ Step Staple Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a clinical or standalone performance study in the way one would for an AI/ML device.

Therefore, many of the requested sections (acceptance criteria table, sample size for test/training sets, experts, adjudication, MRMC, standalone performance, ground truth establishment) are not applicable in the context of this 510(k) submission, as it relies on different types of evidence.

However, I can extract information related to the device performance testing and the standard for acceptance in this regulatory pathway.

Here's a breakdown based on the provided document:

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

For a 510(k) submission, the "acceptance criteria" for demonstrating substantial equivalence primarily revolve around meeting or exceeding the performance of the predicate device(s) in relevant testing. The reported "performance" is a demonstration of this equivalence.

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate)	Reported Device Performance (MotoCLIP™/HiMAX™)
Similar Indications for Use: Indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.	The MotoCLIP™/HiMAX™ Step Staple Implant System is "indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis." (Page 2 & 4). This matches the stated indications of the predicate devices.
Similar Technological Characteristics: Basic design, materials of manufacture, mechanical properties, and intended effect.	- Design: Uses a staple design where legs move convergently for compression. (Page 3) - Materials: Implants are made of nitinol. (Page 3) - Mechanical Properties (Functional Performance): Demonstrated substantial equivalence in bending strength, bending stiffness, and pullout strength compared to the predicate. (Page 4) - Intended Effect: Provides bone fixation in the management of bone fractures and reconstruction surgery. (Page 3)
Performance Testing: No new questions of safety and effectiveness are raised compared to the predicate device.	"Mechanical analysis has shown the subject devices to be substantially equivalent in mechanical strength to the previously cleared CrossCLIP™ Staple (K142727). Thus, it can be concluded that the subject devices raise no new questions of safety and effectiveness and are substantially equivalent to the predicate devices." (Page 4). Specifically, "Finite element analysis was performed utilizing the worst-case sizes... This analysis showed the subject device to be substantially equivalent in terms of bending strength, bending stiffness, and pullout strength to the predicate CrossRoads CrossCLIP™ Staple (K142727)." (Page 4)

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

Sample Size: Not applicable in the context of a clinical test set. The performance testing was based on finite element analysis (FEA), which is a computational simulation method, not a physical test on a "sample size" of devices in the traditional sense or a patient data set. The FEA was performed "utilizing the worst-case sizes" of the device.
Data Provenance: Not applicable. FEA is a computational modeling technique, not derived from patient data.

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):

Not Applicable. This is not an AI/ML device requiring human expert annotation for ground truth. The "ground truth" here is established by engineering principles and the performance of the predicate device as a benchmark.

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

Not Applicable. There was no human "adjudication" of a test set as this is not a study involving human interpretation of data (e.g., images).

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:

No. An MRMC study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool.

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

Yes, in spirit. The "standalone performance" of this device was assessed through Finite Element Analysis (FEA) to predict its mechanical properties (bending strength, stiffness, pullout strength) without human intervention in the device's function or the analysis itself (though humans design the FEA). This is the "algorithm only" equivalent for a mechanical device.

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

For this mechanical device, the ground truth for substantial equivalence is primarily the established mechanical performance and safety profile of the predicate device(s). The FEA results are compared to these established benchmarks to demonstrate that the subject device performs equivalently.

8. The sample size for the training set:

Not Applicable. There is no "training set" in the context of a 510(k) submission for a mechanical device like this. This is not an AI/ML product that learns from data.

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

Not Applicable. As there is no training set.

Summary

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CrossRoads Extremity Systems, LLC % Theresa Leister Senior Consultant MRC-X. LLC 6075 Poplar Ave Memphis. Tennessee 38119

August 9, 2018

Re: K181866

Trade/Device Name: MotoCLIP/HiMAX Step Staple Implant 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: July 11, 2018 Received: July 12, 2018

Dear Theresa Leister:

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.

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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 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 (OS) 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 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,

Mark N. Melkerson -S

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) K181866

Device Name

MotoCLIP™/HiMAX™ Step Staple Implant System

Indications for Use (Describe)

The MotoCLIP™/HiMAX™ Step Staple Implant System is indicated for hand and foot bone fragment osteotomy fixation 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)

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510(k) Summary

MotoCLIP™/HiMAX™ Step Staple Implant System July 29, 2018

Company:	CrossRoads Extremity Systems, LLC6055 Primacy Parkway, Suite 140Memphis, TN 38119
EstablishmentRegistration:	3011421599
Primary Contact:	Theresa LeisterPhone: 901-489-1715
Company Contact:	Chad HollisPhone: 901-221-8406
Trade Name:	MotoCLIP™/HiMAX™ Step Staple Implant System
Common Name:	Staple, Fixation, Bone
Classification:	Class II

Regulation Number: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)

Panel:	87- Orthopedic
Product Code:	JDR
Predicate Devices:	CrossRoads CrossCLIPTM Staple (K142727)CrossRoads MotoCLIPTM/HiMAX Implant System (K181410)Biomedical Enterprises, Speed Shift (K124022)

Device Description:

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Indications for Use:

The MotoCLIP™/HiMAX™ Step Staple Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

Substantial Equivalence:

The subject MotoCLIP™HiMAX™ Step Staple Implant System components are substantially equivalent to the following predicate devices:

Primary Predicate: CrossRoads CrossCLIP™ Staple (K142727) Additional Predicate: CrossRoads MotoCLIP™/HiMAX Implant System (K181410) Biomedical Enterprises, Speed Shift (K124022)

The subject components are similar to the predicate devices in terms of indications, geometry, and materials. Mechanical analysis has shown the subject devices to be substantially equivalent in mechanical strength to the previously cleared CrossCLIP™ Staple (K142727). Thus, it can be concluded that the subject devices raise no new questions of safety and effectiveness and are substantially equivalent to the predicate devices.

Performance Testing:

Finite element analysis was performed utilizing the worst-case sizes the subject MotoCLIP™/HiMAX™ Step Staple Implant System. This analysis showed the subject device to be substantially equivalent in terms of bending strength, bending stiffness, and pullout strength to the predicate CrossRoads CrossCLIP™ Staple (K142727).

Conclusion:

There are no substantial differences between the MotoCLIP™/HiMAX™ Step Staple Implant System and the predicate devices with respect to intended use and technological characteristics, including basic design, materials of manufacture, mechanical properties, and intended effect.

Therefore, the MotoCLIP™/HiMAX™ Step Staple Implant System can be found substantially equivalent to the cited predicate, as it does not raise new questions of safety and effectiveness.

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.