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K Number
K213530
Device Name
Nextra CH Cannulated Hammertoe System
Manufacturer
Nextremity Solutions, Inc.
Date Cleared
2021-12-09

(34 days)

Product Code
HWC,NDL
Regulation Number
888.3040
Type
Special
Panel
OR
Reference & Predicate Devices
K200840
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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:

  1. 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.

  2. 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.

  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 for an AI/ML device. Ground truth establishment by experts pertains to diagnostic or analytical AI systems.

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

    • Not applicable for an AI/ML device.

  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:

    • Not applicable for an AI/ML device. This type of study is relevant for AI-assisted diagnostic tools.

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

    • Not applicable for an AI/ML device.

  7. 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.

  8. The sample size for the training set:

    • Not applicable for an AI/ML device. There is no "training set" for a physical implant.

  9. 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.

§ 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.