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

Device Description

The Nextra® CH Cannulated Hammertoe System (originally cleared as DuoHex™ CH Cannulated Hammertoe System- K200840) 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 FDA submission is for the Nextra® CH Cannulated Hammertoe System, a medical device, not an AI/ML algorithm. Therefore, the questions regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets are not applicable in the context of an AI/ML device.

Here's why and what information is available in the provided document:

Why the questions are not applicable:

The provided text is a 510(k) premarket notification for a physical medical device (implants and instruments for Hammertoe surgery). The questions in your prompt are specifically designed to evaluate the performance and validation of Artificial Intelligence (AI) or Machine Learning (ML) algorithms, which require different types of testing and validation compared to hardware medical devices.

What is available in the document regarding device performance and criteria:

The FDA letter and 510(k) summary pertain to demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria for an AI model.

Here's a breakdown of what the document does provide in relation to traditional medical device clearance:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied by Substantial Equivalence): The primary "acceptance criteria" for this type of device clearance is demonstrating substantial equivalence to a predicate device in terms of:
  - Intended Use
  - Materials
  - Design
  - Sizes
  - Mechanical Properties
- Reported Device Performance (as demonstrated for substantial equivalence):
  - Non-Clinical Testing: Endotoxin testing was performed using the Limulus Ameebocyte Lysate (LAL) method (AAMI ST72, USP 161 and USP 85). Results met the Endotoxin limit of ≤20 EU per device. This is a safety criterion, not a functional performance criterion in the AI sense.
  - Mechanical Properties: The summary states that differences in mechanical properties do not raise new safety or effectiveness concerns, implying that the mechanical properties are considered equivalent or acceptable. Specific numerical performance values are not given in this summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for an AI/ML device. For this physical device, there wasn't a "test set" in the AI sense. The evaluation was based on engineering principles, materials science, and a comparison to an existing device.
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 for an AI/ML device. Ground truth establishment by experts pertains to diagnostic or analytical AI systems.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for an AI/ML device.
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 for an AI/ML device. This type of study is relevant for AI-assisted diagnostic tools.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable for an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for an AI/ML device. For a physical implant, "ground truth" relates to its physical and biological performance, which is assessed through material testing, biocompatibility studies (like endotoxin testing), and clinical experience with the predicate device.
The sample size for the training set:
- Not applicable for an AI/ML device. There is no "training set" for a physical implant.
How the ground truth for the training set was established:
- Not applicable for an AI/ML device.

In summary, the provided document details the regulatory clearance of a physical medical device based on substantial equivalence, not the validation of an AI/ML algorithm.

Summary

{0}------------------------------------------------

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 is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 9, 2021

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

Re: K213530

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, NDL Dated: November 4, 2021 Received: November 5, 2021

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.

{1}------------------------------------------------

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

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K213530

Device Name

Nextra® CH Cannulated Hammertoe System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary
Prepared:	November 4, 2021
Submitter:	Nextremity Solutions, Inc.1195 Polk DriveWarsaw, IN 46582
Contact:	Elise FoxQuality and Regulatory Specialistelise.fox@nextremity.comPhone: 574-376-2062
Proprietary Name:	Nextra® CH Cannulated Hammertoe System
Common Name:	Screw, Fixation, Bone- PrimaryPin, Fixation, Smooth, Metallic
Classification:	II
Regulation Number:	21 CFR § 888.3040 Smooth or threaded metallic bone fixation fastener
Panel:	87/Orthopedic
Product Code:	HWC- Primary, NDL

Substantially Equivalent Devices:

. Nextremity Solutions, Nextra® CH Cannulated Hammertoe System (cleared as DuoHexTM CH Cannulated Hammertoe System)- K200840- Predicate Device

Device Description:

{4}------------------------------------------------

instruments, including implant specific drivers. The implants and instruments of the system are provided sterile for single use.

Intended Use / Indications:

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

Summary of Technologies/Substantial Equivalence:

The modified Nextra CH Cannulated Hammertoe system is substantially equivalent to the predicate devices regarding the intended use and indications, material. design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions.

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.

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:

Differences between modified Nextra CH Cannulated Hammertoe system and the predicate device do not raise new types of safety and effectiveness questions. The modified Nextra CH Cannulated Hammertoe system is substantially equivalent to the predicate device in regard to 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.