The Nextremity Solutions Nextra® CH Cannulated Hammertoe System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

Device Description

The Nextra® CH Cannulated Hammertoe System consists of a two-part cannulated bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implant diameters range from 2.75mm to 4.2mm. The middle screw implant diameters range from 2.75mm to 5.0mm in increments of 0.75mm. The proximal and distal screw implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system offers an optional fixation method using a Kirschner wire (K-wire) in conjunction with the screw implants for additional fixation and temporary stabilization. The K-Wire is intended to be removed at the discretion of the physician upon joint fusion. The k-wires provided are manufactured from 316 Stainless Steel conforming to ASTM F138. The system includes the necessary surgical site preparation and insertion instruments, including implant specific drivers. The implants and instruments of the system are provided sterile for single use.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "Nextra® CH Cannulated Hammertoe System." It is not a document assessing the performance of an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, human reader performance, AI standalone performance, and ground truth establishment is not present in this text.

The document focuses on demonstrating substantial equivalence of the new device to a legally marketed predicate device (K213530). This process typically relies on comparing indications for use, technological characteristics (materials, design, sizes, mechanical properties), and performance data (often non-clinical) to show that the new device is as safe and effective as the predicate.

Here's a breakdown of what can be extracted from the document, and what cannot:

What is present in the document:

Device Name: Nextra® CH Cannulated Hammertoe System
Indicated Use: Small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.
Predicate Device: Nextra® CH Cannulated Hammertoe System (K213530)
Basis for SE: "There are no differences between the subject device system and the predicate device systems. The Nextra CH Cannulated Hammertoe system is substantially equivalent to the predicate device regarding the intended use and indications, material, design, sizes, and mechanical properties."
Non-Clinical Testing Mentioned:
- Endotoxin testing (Limulus Amebocyte Lysate (LAL) method) - Results met the Endotoxin limit of ≤20 EU per device.
- Clinically representative cadaver study: "evaluated by varying levels of surgeon proficiency is confirmed to produce repeating successful outcomes with equal or greater fixation compared to the standard of care." (No specific sample size or detailed outcomes provided).
- Verification bench test: "evaluate implant assembly/disassembly force... results demonstrated the average assembly force of the implants threaded into bone foam by the subject device driver is greater than the average assembly force of implants threaded into bone foam by the predicate driver." (No specific quantitative acceptance criteria or results beyond "greater than" provided).
Absence of Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the Nextra CH Cannulated Hammertoe System to the predicate device."

What is NOT present in the document (and therefore cannot be answered from the provided text):

A table of acceptance criteria and the reported device performance (in the context of AI/ML evaluation): The document refers to "acceptance criteria" only implicitly through "meeting the Endotoxin limit" and "greater than" for assembly force, but these are not specific quantitative values for a device performance study in the way you've outlined for an AI/ML system. There are no detailed tables of performance metrics.
Sample size used for the test set and the data provenance: While a "clinically representative cadaver study with statistically relevant sample size" is mentioned, the specific sample size is not disclosed. Data provenance (country, retrospective/prospective) is also not stated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system is not relevant here. The cadaver study involved "varying levels of surgeon proficiency," but not for establishing ground truth as you've defined it.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 device is a physical medical implant, not an AI/ML diagnostic system.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/ML system's evaluation. For the cadaver study, "successful outcomes" and "fixation" were evaluated, but the method for establishing "ground truth" (e.g., a definitive measure of fusion success) for that study is not detailed here.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

In summary: The provided text is an FDA 510(k) clearance letter and summary for a physical orthopedic implant. It does not contain the information requested about the evaluation of an AI/ML medical device.

Summary

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November 4, 2022

Image /page/0/Picture/1 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.

Nextremity Solutions, Inc. Elise Fox Ouality and Regulatory Specialist 1195 Polk Drive Warsaw, Indiana 46582

Re: K221610

Trade/Device Name: Nextra CH Cannulated Hammertoe System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 1, 2022 Received: June 3, 2022

Dear Elise Fox:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali-S

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221610

Device Name

Nextra® CH Cannulated Hammertoe System

Indications for Use (Describe)

The Nextremity Solutions Nextra® CH Cannulated Hammertoe System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

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

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

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K221610

510(k) Summary

Prepared:	November 4, 2022
Submitter:	Medartis Inc.1195 Polk DriveWarsaw, IN 46582
Contact:	Elise FoxRegulatory Managerelise.fox@medartis.comPhone: 574-376-2062
Proprietary Name:	Nextra® CH Cannulated Hammertoe System
Common Name:	Screw, Fixation, Bone- Primary
Classification:	II
Regulation Number:	21 CFR § 888.3040 Smooth or threaded metallic bone fixation fastener
Panel:	87/Orthopedic
Product Code:	HWC
Substantially

Equivalent Devices:

. Nextra® CH Cannulated Hammertoe System- K213530- Predicate Device

Device Description:

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Intended Use / Indications:

The Nextremity Solutions Nextra CH Cannulated Hammertoe System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

Summary of Technologies/Substantial Equivalence:

There are no differences between the subject device system and the predicate device systems. The Nextra CH Cannulated Hammertoe system is substantially equivalent to the predicate device regarding the intended use and indications, material, design, sizes, and mechanical properties.

Non-Clinical Testing:

Endotoxin testing was performed using the Limulus Amebocyte Lysate (LAL) method according to AAMI ST72, USP 161 and USP 85. Results met the Endotoxin limit of ≤20 EU per device. A clinically representative cadaver study with statically relevant sample size was conducted using the subject device system in its final finished form. Results demonstrated that the Nextra CH Cannulated Hammertoe System in its final state, evaluated by varying levels of surgeon proficiency is confirmed to produce repeating successful outcomes with equal or greater fixation compared to the standard of care. A verification bench test was performed to evaluate implant assembly/disassembly force after being threaded into a worst case medium. Test results demonstrated the average assembly force of the implants threaded into bone foam by the subject device driver is greater than the average assembly force of implants threaded into bone foam by the predicate driver.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Nextra CH Cannulated Hammertoe System to the predicate device.

Conclusions/Substantial Equivalence:

There are no differences between the Nextra CH Cannulated Hammertoe system and the predicate device and no new types of safety and effectiveness questions for the subject device. The Nextra CH Cannulated Hammertoe system is substantially equivalent to the predicate device in its intended use, material, design, sizes, and mechanical properties.

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.