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The Rhythmlink MR Conditional Sticky Pad Electrode is intended for use with recording, monitoring, and stimulation equipment in the study of biopotentials such as Electroencephalograph (EEG), Surface Electromyography (EMG), or Nerve Conduction Evoked Potential Signals (EP). This device is non-sterile, single-use only, and may remain on the patient in a MRI environment under specific conditions.

The MR Conditional Sticky Pad Electrode is intended to be used in medical environments where quick electrode application is required with minimal skin preparation. The device provides an easy-to-apply solution by combining conductive material used to record biosignals with a hydrogel designed for patient skin adhesion. This combination of materials, with an electrically conductive leadwire designed to fit with patient monitoring and stimulation equipment, provides a fast and easy way to record brain and muscle activity, provide stimulation for evoked potentials, and serve as a ground or reference electrode during monitoring. The MR Conditional Sticky Pad Electrodes have been specifically engineered to remain safely on a patient during MR imaging under the conditions specified in the labeling. Each MR Conditional Sticky Pad Electrode comprises the hydrogel electrode attached to a 240mm long leadwire (MR Conditional Electrode Assembly), which pairs with and connects to a 1.0m to 2.5m long, MR Unsafe Extension Cable. The extension cable provides a quick disconnect function to allow patient to be quickly moved into MR imaging without removing the hydrogel electrodes from the patient. Between 2 and 48 total MR Conditional Electrode Assemblies may remain on the patient during MR imaging in either 1.5T or 3.0T systems. The MR Conditional Electrode Assemblies are marked with yellow "MR Conditional" symbols, and the MR Unsafe Extension Cables are marked in duplicate (one at each end) with red "MR Unsafe" symbols to ensure proper use).

This document describes the regulatory approval for a medical device (MR Conditional Sticky Pad Electrode), not an AI/ML-based device. Therefore, many of the requested criteria, such as those related to AI model training, ground truth establishment, expert review, and MRMC studies, are not applicable.

However, I can extract and present the information available regarding the device's acceptance criteria and the study that proves it meets them, focusing on the non-clinical performance data provided.

Understanding the Device:

The Rhythmlink MR Conditional Sticky Pad Electrode is a cutaneous electrode designed for use with recording, monitoring, and stimulation equipment for biopotentials (EEG, EMG, EP). Its key feature is its ability to remain on a patient in an MRI environment under specific conditions, a modification from its predicate device. This MRI compatibility is a primary focus of its testing and acceptance criteria.

Acceptance Criteria and Device Performance (Non-Clinical):

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device (K052188 - Rhythmlink Cutaneous Electrode) and ensuring MRI compatibility and functional performance. The "study" proving this involves a series of non-clinical, benchtop tests.

Acceptance Criteria Table and Reported Device Performance

Detailed Study Information (Non-Clinical, as applicable):

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

   • The document does not specify the exact number of electrodes or test runs used in the benchtop testing. It refers to "benchtop testing" and "MR Safety evaluation."
   • Data Provenance: The tests were conducted internally by the manufacturer, Rhythmlink International, LLC. The testing appears to be prospective in nature, as it was performed to support the 510(k) submission for this new device. No geographical origin of data (e.g., country) is specified beyond the manufacturer's location in Columbia, South Carolina, USA.

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

   • Not Applicable. This is a hardware device undergoing physical, electrical, and MRI compatibility testing, not an AI/ML system requiring expert interpretation of medical images or data. Ground truth here refers to validated engineering measurements and compliance with established standards for medical device safety and performance.

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

   • Not Applicable. As this is non-clinical benchtop testing, there is no "adjudication method" in the sense of reconciling different expert opinions. Test results are presumably directly measured and compared against pre-defined engineering and regulatory limits.

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/ML-based device, and no MRMC study was conducted. The assessment focused on the device's intrinsic function and safety, particularly in an MRI environment.

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

   • Not Applicable. This is a physical device, not a standalone algorithm. Its "performance" is its physical and electrical characteristics.

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

   • The "ground truth" for this device's performance is based on established engineering standards, physical measurements, and regulatory requirements for cutaneous electrodes and MRI compatibility (e.g., ASTM standards for MRI safety of medical devices). This includes:
     • Electrical performance parameters (DC Offset Voltage, AC Impedance)
     • Magnetic field interactions (displacement force, torque)
     • Radiofrequency heating (SAR distribution, temperature rise)
     • Image artifact evaluation in MRI
     • Biocompatibility

7. The sample size for the training set:

   • Not Applicable. No AI/ML training set was used.

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

   • Not Applicable. No AI/ML training set was used.

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The MR Conditional Cup and Webb Electrodes are 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 non-sterile for Single Patient Use Only and may remain on the patient in a MRI environment under specific conditions.

The device consists of ABS molded disk-shaped Cup or Webb style cutaneous electrodes coated with Ag/AgCl. The electrodes are affixed to 18cm long conductive leadwires. Up to 10 leadwires are connected to a multipin touch proof connector to form an electrode array assembly, which is labeled "MR Conditional." Up to 4 electrode arrays can be used simultaneously on a patient. The device design and leadwire length have been engineered for both 1.5T (64MHz) and 3.0T (128 MHz) MRI environments. An extension cable, 1.0 to 3.0m long, is included to attach the electrode array to monitoring equipment. The extension cable is clearly labeled with "MR Unsafe" symbols on both ends, and is NOT intended to be in the MR environment. This enables users to quickly disconnect the MR Unsafe extension cable and leave the MR Conditional electrodes in place on the patient for MRI procedures.

The provided text is a 510(k) Pre-Market Notification for a medical device (MR Conditional Cup Electrode, MR Conditional Webb Electrode). It describes the device, its intended use, and comparative testing performed to demonstrate substantial equivalence to a predicate device.

Crucially, this document does NOT describe the acceptance criteria and study that proves a device meets acceptance criteria for an AI/ML-based medical device. Instead, it is focused on demonstrating the physical and functional safety and performance of a conventional medical electrode in an MRI environment compared to a previously approved device.

Therefore, I cannot extract the information required for a study proving an AI/ML device meets acceptance criteria from this document. The concepts of "test set," "ground truth," "expert consensus," "human readers," "AI assistance," "effect size," and "standalone performance" are not applicable to the type of device and testing described in this 510(k) summary.

The document states:

• "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2)."
• "The functional performance equivalency was determined by mechanical and electrical benchtop testing..."
• "The MR safety and performance equivalency of the MR Conditional Cup and Webb Electrodes were determined using the same test methodology as the predicate device..."

The acceptance criteria here pertain to physical safety and functional performance (e.g., thermal limits in MRI, signal quality) as demonstrated by benchtop and computational testing, not diagnostic performance based on algorithms or human interpretation of data.

If you have a document describing the study for an AI/ML device, please provide that, and I will be happy to assist.

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