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The MR Conditional PressOn™ Electrode is intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording. This device is provided sterile for Single Patient Use Only and may remain on the patient in a MRI environment under specific conditions.

The design of the Rhythmlink Disposable MR Conditional PressOn electrode is identical to the existing PressOn electrodes used to record neurological activity during electroencephalograph (EEG) and evoked potential (EP) procedures.

The device consists of a disk shaped electrode with three sets of flat tyne or micro needles made from Nitinol. The Electrode is permanently attached to a leadwire which is 10cm (100mm) in length. An accessory cable is supplied to attach to the 10cm electrode leadwire to create a 1.0, 1.5, 2.0 or 2.5 meter traditional lengths during the Monitoring procedure. This accessory cable is labeled "MR Unsafe" and is NOT intended to be in the MR environment at any time. A significantly shorter lead wire of 10cm is permanently attached to the electrode and reduces the effects of matching the electrode leadwire length to the wave length of the RF component. This condition reduces the probability of matching the RF wave length to the leadwire length and reduces the likely hood of an increase in the heating effect. This will enable users to leave the electrodes in place during magnetic resonance imaging (MRI) procedures.

The provided text describes a 510(k) summary for a medical device, the "MR Conditional PressOn™ Electrode." This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and simulated testing related to MRI compatibility, rather than clinical efficacy studies. Therefore, many of the requested details regarding clinical study design, ground truth establishment, expert adjudication, and MRMC studies related to AI performance are not applicable to the information provided.

Based on the information given, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The primary acceptance criterion for this device, as stated, is related to temperature rise during MRI exposure, with the performance being compared against the IEC 60601-1-1 §11.1.2 standard.

2. Sample size used for the test set and the data provenance

The "test set" in this context primarily refers to the conditions simulated and tested for MRI compatibility, not a clinical patient dataset for evaluating diagnostic accuracy.

• Sample Size:
  • Simulation (SIMCAD X with FDTD modeling): Three different electrode types were simulated: Cup Electrodes, WEBB Electrodes, and PressOn™ Electrode. The PressOn™ electrode was determined to be the "worst-case configuration." The simulation data was then compared to actual MRI testing, using field strengths of 1.5T and 3.0T, and 68 MHZ and 128 MHZ respectively.
  • Real-time MRI Physical Testing: This testing was conducted using the "known worst-case configuration" (the PressOn electrode). The exact number of physical tests or specimens is not specified beyond this.
• Data Provenance: Not specified regarding country of origin. The studies were non-clinical (bench and simulation testing) and prospective in the sense that they were specifically conducted for this submission to evaluate the redesigned device's MRI compatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device submission focuses on the physical properties and safety during MRI exposure, not on diagnostic accuracy requiring expert interpretation or ground truth derived from clinical experts for image analysis. The "ground truth" here is the physical measurement of temperature and torque under defined MRI conditions.

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

Not applicable. Adjudication methods are typically used in clinical studies involving human interpretation (e.g., radiologist reads) to establish consensus on challenging cases. For physical testing (temperature, torque), the results are objective measurements.

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 submission is for a neurological electrode, not an AI-powered diagnostic device. No human reader studies (MRMC) were conducted as part of this submission. The device's function is to record EEG/EP signals and remain safe in an MRI environment, not to assist human interpretation of medical images or data.

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

Not applicable. This is not an algorithmic device. Performance was evaluated for the physical device itself (its interaction with the MRI environment).

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

The ground truth used was objective physical measurements and simulations based on established engineering principles and standards (e.g., temperature measurements, torque measurements, and FDTD modeling). The performance was compared against a defined safety standard (IEC 60601-1-1 §11.1.2 for temperature).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As noted above, this is not an AI/ML device requiring a training set with established ground truth in the context of expert labels or outcomes.

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