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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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