Search Results

The NEUROMARK™ System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.

The NEUROMARK™ System is intended for the application of Radiofrequency energy to create lesions in mucosal tissue in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis.

The NEUROMARK™ Device is a handheld bipolar radiofrequency device which is designed for use in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures along with the NEUROMARK™ Generator.

The NEUROMARK™ System comprises of two key elements which are described in this section:

• 1. The NEUROMARK™ Device and
• 2. The NEUROMARK™ Generator

The NEUROMARK™ Device is a hand-held single-use bi-polar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar micro electrodes. These electrodes deliver bipolar RF energy while monitoring feedback on the tissue bio-impedance changes allowing for controlled RF energy level delivery. The shaft of the device is pre-shaped for optimal access and delivery to the nasal cavity but is malleable to allow the user to bend or shape the shaft to accommodate variations in anatomy to access the desired treatment area(s). The NEUROMARK™ Device is operated via handle, slider and activation switch. Once in the desired position within the nasal cavity, the operator moves the slider backwards which retracts the outer sheath, deploying the end effector array. Using the switch, the user initiates a bio-impedance check, to assesses and confirm contact between the end effector and the treatment area. Once the system contact has been achieved, a subsequent press of the button initiates the RF delivery cycle.

The NEUROMARK™ Device is designed for use with the NEUROMARK™ Radiofrequency Generator; it includes features to allow compatibility and authentication once connected, via a flexible cable, to the NEUROMARK™ Radiofrequency Generator. The NEUROMARK™ Radiofrequency Generator delivers, monitors and controls RF energy to the device. The generator meets the following requirements: RF operating frequency of 460 – 480 kHz (± 5 kHz); bipolar low power energy delivery and feedback control with low overshoot capabilities.

The NEUROMARK™ Device is intended for single use and provided sterile (EtO). The NEUROMARK™ Radiofrequency Generator is mounted on an ergonomic mobile stand for ease of use. The Graphical User Interface (GUI) provides operational instructions for the procedure; directs user to select nasal cavities for treatment, indicates when the device is apposed and primed to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK™ Radiofrequency Generator works in conjunction with software.

The subject device and predicate device have similar technological characteristics. The primary differences relate to the geometry of the electrode array and the method of controlling power delivery (bioimpedance control for the subject device versus temperature control for the predicate device).

The provided text describes the Neurent Medical NEUROMARK™ System and its FDA 510(k) clearance, asserting substantial equivalence to a predicate device. However, the document does not describe a study evaluating the device's performance against specific quantitative acceptance criteria or involving human-in-the-loop performance with AI assistance (MRMC study). The information primarily focuses on the device's technical characteristics, safety, and logistical feasibility.

Therefore, many of the requested details, such as exact acceptance criteria tables, sample sizes for test sets in an AI context, expert qualifications for ground truth in an AI study, adjudication methods, and MRMC study details, are not applicable to the content of this FDA submission summary, as it does not pertain to an AI/ML powered medical device and its performance evaluation under those frameworks.

Here's a breakdown of what can be extracted from the document regarding the device's evaluation, framed within the given prompt's structure where possible, and noting where information is not available or relevant:

Acceptance Criteria and Device Performance (Based on "Clinical Tests" section)

Since this is not an AI/ML device, the "acceptance criteria" discussed are safety and technical feasibility endpoints, rather than quantitative performance metrics like sensitivity, specificity, or AUC as might be seen for an AI diagnostic tool.

Study Proving Device Meets Acceptance Criteria:

The study referenced is the RELIEVE feasibility study.

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

   • Sample Size: 11 adult patients. Since the procedure was bilateral, this involved 22 nasal cavities.
   • Data Provenance: Prospective, single-arm study conducted in the United States.

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):

   • This concept is not directly applicable to a device like the NEUROMARK™ System, which is an interventional device rather than a diagnostic tool requiring expert interpretation for ground truth. The "ground truth" for this study was the observed safety outcomes (absence of adverse events) and the successful technical delivery of the intervention. These were likely assessed by the operating physician and study coordinators, rather than a panel of independent experts establishing a 'ground truth' for an AI algorithm.

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

   • Not applicable in the context of this device's evaluation. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from expert interpretations in diagnostic imaging studies for AI. Here, safety and technical feasibility were directly observed outcomes.

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 comparative effectiveness study was not done. This study design is specific to evaluating AI-assisted diagnostic performance with human readers, which is not relevant for the NEUROMARK™ System described.

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

   • No, a standalone algorithm performance study was not done. The NEUROMARK™ System is a medical device, not an AI algorithm for diagnosis or interpretation. The "software" mentioned in the report primarily relates to control and user interface for the electrical generator, not an independent diagnostic algorithm.

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

   • For the clinical feasibility study, the "ground truth" was based on directly observed clinical outcomes and procedural success.
     • Safety: Absence of device-related serious adverse events documented through patient follow-up.
     • Technical Feasibility: Direct observation by the proceduralist of successful access to the target nasal cavity and delivery of RF energy.
     • Additional evaluations included patient-reported symptom scores (rTNSS) and discomfort/pain levels, representing patient-reported outcomes.

8. The sample size for the training set:

   • This is not applicable to the clinical study described. A "training set" refers to data used to train an AI/ML model. The RELIEVE study was a human clinical trial for device safety and feasibility, not an AI model development study. The statement "The NEUROMARK™ Radiofrequency Generator works in conjunction with software" implies embedded or controlling software for the device's function, not a learning algorithm that requires a training set.

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

   • Not applicable, as there was no AI/ML training set described in the context of this FDA submission.

Ask a specific question about this device