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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 (RF) 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 System is composed of the NEUROMARK Device and the NEUROMARK Radiofrequency (RF) Console.

The NEUROMARK Device is a hand-held, single-use, bipolar 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 electrodes that deliver RF energy while monitoring feedback on tissue bioimpedance changes allowing for controlled RF energy delivery. The shaft of the device is pre-shaped to aid access and delivery to the nasal cavity but is malleable to allow the user to bend or shape it to accommodate variations in anatomy to access the desired treatment area. The NEUROMARK Device is operated via handle, slider and activation button. Once in the desired position within the nasal cavity, the operator moves the slider backwards which retracts the outer sheath, deploying the End Effector. Using the activation button, the user initiates a bio-impedance check to assess and confirm contact between the End Effector and the treatment area. Once the System confirms contact has been achieved, a subsequent press of the activation button initiates the RF energy delivery cycle. The NEUROMARK Device is intended for single use and provided sterile (EO).

The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency (RF) Console only and is connected via a flexible interface cable.

The NEUROMARK Console delivers, monitors and controls RF energy to the Device. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure, directs the user to select nasal cavities for treatment, indicates when the device is in contact with tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK Console works in conjunction with software.

It appears there might be a misunderstanding or misinterpretation of the provided FDA 510(k) clearance letter for the NEUROMARK System. The document is for a medical device (Electrosurgical Cutting And Coagulation Device And Accessories) and not an AI or software-based diagnostic device that would require the type of extensive validation studies (MRMC, ground truth establishment, training sets, etc.) you've outlined in your request.

The 510(k) letter primarily focuses on establishing "substantial equivalence" to a predicate device. This means the manufacturer demonstrates that the new device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

Here's why the information you're asking for isn't in the provided document and what information is there:

• No AI/Software Component for Diagnostic Purposes: The NEUROMARK System is described as a device that applies radiofrequency (RF) energy to create lesions. While it has a "Graphical User Interface (GUI)" and "works in conjunction with software" to deliver, monitor, and control RF energy, this software is for device control and operational instructions, not for image analysis, diagnosis, or decision support in the way an AI diagnostic tool would. Therefore, there are no claims of "device performance" in terms of diagnostic accuracy (sensitivity, specificity, AUC) against a ground truth for a medical condition.
• Performance Data Focuses on Device Functionality and Safety: The "Performance Data" section states: "Performance testing of the NEUROMARK System consisted of design verification testing, usability testing, biocompatibility, software, and electrical and thermal safety testing to support the device modifications listed above. All testing passed and showed that the device meets design specifications, performs as intended, and performs the same as the predicate." This is standard for electrosurgical devices to ensure they safely and effectively deliver RF energy and meet engineering specifications, not diagnostic accuracy.

Therefore, I cannot populate the table or answer most of your specific questions because the provided document does not contain information related to a diagnostic AI study.

However, I can extract the relevant "performance data" that the 510(k) does discuss:

Acceptance Criteria and Study for NEUROMARK System (Based on provided 510(k) document)

This clearance pertains to a medical device (electrosurgical) and not an AI/software for diagnostic purposes. The "acceptance criteria" and "performance" are related to its functional and safety aspects, not diagnostic accuracy metrics.

Table of Acceptance Criteria and Reported Device Performance (as described for a hardware device)

Study Details (Relevant to the 510(k) for this device type):

1. Sample sizes used for the test set and the data provenance: Not applicable in the context of diagnostic AI. For hardware device testing, "samples" would refer to devices tested. The document does not specify the number of units tested for design verification, usability, etc., nor does it discuss "data provenance" in the context of patient data for diagnostic accuracy.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no diagnostic "ground truth" established for this device, as it is a therapeutic/surgical tool, not a diagnostic one.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 is not an AI diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone diagnostic algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a device like this would be its ability to safely and effectively deliver RF energy, achieve targeted lesions, and meet engineering specifications, which is verified through various engineering and bench tests, not clinical diagnostic accuracy.
7. The sample size for the training set: Not applicable. This is not an AI model requiring a training set for diagnostic classification/segmentation.
8. How the ground truth for the training set was established: Not applicable.

Summary of the FDA 510(k) Clearance for NEUROMARK System:

The FDA clearance for the NEUROMARK System (K250048) on May 29, 2025, is a 510(k) substantial equivalence determination for an electrosurgical cutting and coagulation device and accessories (Product Code GEI, Regulation Number 21 CFR 878.4400, Class II).

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

The core of the submission was to demonstrate substantial equivalence to a predicate device, the NEUROMARK System [K222032]. The manufacturer states that the subject device has the same intended use, indications for use, and fundamental scientific technology as the predicate device.

Minor modifications were made to the subject device (e.g., fewer leaflets on the treatment tip, minor material and dimension changes to the shaft, and simplified activation button, slider, connector, interface cable, and sterile barrier packaging).

The study that proves the device meets the acceptance criteria (stated as "Performance Data" in the 510(k) summary) consisted of:

• Design verification testing: To ensure the device performs according to its design specifications.
• Usability testing: To evaluate its ease of use and user interface.
• Biocompatibility testing: To ensure materials are safe for human contact.
• Software testing: To verify the proper functioning of the control software (which manages RF energy delivery, GUI, etc.).
• Electrical safety testing: To ensure it meets electrical safety standards.
• Thermal safety testing: To ensure controlled thermal effects.

All this testing "passed and showed that the device meets design specifications, performs as intended, and performs the same as the predicate," thereby demonstrating substantial equivalence in terms of safety and effectiveness for its intended surgical use.

There is no mention or requirement for a diagnostic AI performance study (e.g., MRMC or algorithm-only performance against a ground truth derived from expert consensus or pathology) because this device is a therapeutic electrosurgical instrument, not an AI-powered diagnostic tool.

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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 (RF) 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® System is composed of the NEUROMARK® Device and the NEUROMARK® Radiofrequency (RF) Console. The NEUROMARK® Device is a hand-held, single-use, bipolar 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 electrodes that deliver RF energy while monitoring feedback on tissue bio-impedance changes allowing for controlled RF energy delivery. The shaft of the device is pre-shaped to aid access and delivery to the nasal cavity but is malleable to allow the user to bend or shape it to accommodate variations in anatomy to access the desired treatment area. The NEUROMARK® Device is operated via handle, slider and activation button. Once in the desired position within the nasal cavity, the operator moves the slider backwards which retracts the outer sheath, deploying the End Effector. Using the activation button, the user initiates a bio-impedance check to assess and confirm contact between the End Effector and the treatment area. Once the System confirms contact has been achieved, a subsequent press of the activation button initiates the RF energy delivery cycle. The NEUROMARK® Device is intended for single use and provided sterile (EO). The NEUROMARK® Device is designed for use with the NEUROMARK® Radiofrequency (RF) Console; it includes features to allow compatibility and authentication once connected, via a flexible interface cable, to the Console. The NEUROMARK® Console delivers, monitors and controls RF energy to the Device. The Console is mounted on an ergonomic mobile stand for ease of use. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure, directs the user to select nasal cavities for treatment, indicates when the device is in contact with tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK® Console works in conjunction with software.

This document describes the 510(k) summary for the NEUROMARK® System (K222032). However, it does not contain details about specific acceptance criteria and the study proving the device meets them in the format requested.

The document states that:

• The NEUROMARK® System (K222032) is substantially equivalent to the predicate NEUROMARK® System (K212666).
• "Performance testing of the NEUROMARK® System consisted of design verification testing, biocompatibility, software, and electrical and thermal safety testing to support the device modifications listed above. All testing passed and showed that the device meets design specifications and performed as intended."

This implies that there were acceptance criteria and studies (performance testing), but the specifics requested in your prompt (e.g., a table of criteria/performance, sample size, expert details, MRMC study, standalone performance) are not provided in this regulatory summary.

Therefore, I cannot populate the requested sections with information from this document. It merely confirms that such testing was conducted and passed, without detailing the results or methodology.

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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.

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