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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.

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.

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):

1. 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.
2. 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.
3. 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.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. This device is a physical medical implant, not an AI/ML diagnostic system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. 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.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. 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.

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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.

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.

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.

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