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.

Device Description

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.

AI/ML Overview

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)

Acceptance Criteria Category	Reported Device Performance (Met/Passed)
Design Verification Testing	Passed
Usability Testing	Passed
Biocompatibility Testing	Passed
Software Testing	Passed
Electrical Safety Testing	Passed
Thermal Safety Testing	Passed
Meets Design Specifications	Yes
Performs as Intended	Yes
Performs the Same as Predicate	Yes (demonstrates substantial equivalence)

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

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.
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone diagnostic algorithm.
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.
The sample size for the training set: Not applicable. This is not an AI model requiring a training set for diagnostic classification/segmentation.
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.

Summary

FDA 510(k) Clearance Letter - NEUROMARK System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 29, 2025

Neurent Medical Ltd.
Fay Dalton
Senior Regulatory Affairs Specialist
No. 1 Oranpoint, Main Street
Oranmore
Galway, N/A H91D7X2
Ireland

Re: K250048
Trade/Device Name: NEUROMARK System (NMK00301)
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories
Regulatory Class: Class II
Product Code: GEI
Dated: May 1, 2025
Received: May 1, 2025

Dear Fay Dalton:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K250048 - Fay Dalton
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K250048 - Fay Dalton
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Sincerely,

Joyce C. Lin -S

for Shu-Chen Peng, Ph.D.
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K250048

Device Name
NEUROMARK System (NMK00301)

Indications for Use (Describe)
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.

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

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Neurent Medical
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510(k) Summary

Date Prepared: January 8, 2025

Submitter Information: Neurent Medical
1 Oranpoint, Main Street
Oranmore, Co. Galway, H91 D7X2
Ireland

Establishment Registration: 3016813690

Contact Information: Fay Dalton
Senior Regulatory Affairs Specialist
Neurent Medical
+353 85 7289921
fay@neurentmedical.com

Device Information:

Field	Value
Trade Name	NEUROMARK® System
Common Name	Radiofrequency Probe
Classification Name	Electrosurgical cutting and coagulation device and accessories
Product Code	GEI
Classification	Class II
Regulation Number	21 CFR 878.4400
Predicate Device	NEUROMARK® System [K222032]

Device Description:

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

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

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Neurent Medical
Page 2 of 2

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.

Indication for Use:

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.

Technological Characteristics:

The NEUROMARK System (subject device) has the same intended use, indications for use and fundamental scientific technology as the predicate NEUROMARK System [K222032].

The subject device has the same technological characteristics (i.e., principle of operation, anatomical location of use, design configuration, functionality, energy type, standard medical grade materials, biocompatibility, feedback control, thermal lesion characteristics, electrical and thermal safety, performance specifications, shelf-life, and sterilization) as the predicate device.

The treatment tip of the subject device has fewer leaflets and minor changes in material from that of the predicate device. The shaft of the subject device has minor changes in material and dimensions from that of the predicate device. The subject device activation button, slider, connector, interface cable, and sterile barrier packaging configuration were modified for simplicity.

Performance Data:

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.

Substantial Equivalence:

The NEUROMARK System has the same intended use, indications for use and fundamental scientific technology as the predicate device. Evaluation of the impact of the device modifications was completed. The minor changes made to the subject device do not raise different questions of safety and effectiveness. Performance testing was completed to ensure the subject device meets intended use, product specifications, and performs the same as the predicate device. The NEUROMARK System is substantially equivalent to the predicate device.

Conclusion:

In conclusion, the intended use, indications for use and fundamental technological characteristics are the same as the predicate device. Performance testing has demonstrated that the device is as safe and effective and that its performance is substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.