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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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Rhythmlink International Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG), and Nerve potential signals. The electrodes are sterile and for single patient use.

Guardian Needle™ Electrodes are a sterile, single-use device. The electrodes are applied during the study of biopotentials such as electromyography (EMG), electroencephalography (EEG), nerve conduction and stimulation/response. The electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The needle is housed inside a sheath until application and secured to the patient during use with adhesive tape.

The Rhythmlink International Guardian Needle™ Electrode (subject device) is compared to the predicate device, Subdermal Needle Electrodes (K022914), to demonstrate substantial equivalence. The document primarily focuses on non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Differences: The subject device includes a needle sheath (thermoplastic polyester elastomer sheath) and adhesive tape, which differ from the predicate device (PVC tube for sheath, no adhesive tape). These differences were assessed through testing and determined not to adversely impact safety or effectiveness.

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

The document does not specify exact sample sizes for the functional performance benchtop tests (Electrical Continuity and Adhesion Testing). However, it states that "The test methods were identical to those used to assess the predicate device."

For sterilization, reevaluation of EtO residuals was performed, but the sample size is not explicitly stated.

The data provenance is from non-clinical benchtop testing conducted by Rhythmlink International, LLC. The document does not indicate any country of origin for the data that would suggest external sources. All testing appears to be retrospective relative to the submission date, as it's part of a 510(k) premarket notification.

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

This information is not provided in the document. The document describes non-clinical benchtop tests and compliance with recognized standards. There isn't an explicit "test set" in the context of expert review for establishing ground truth, as the criteria are based on engineering and biocompatibility standards.

4. Adjudication method for the test set

This information is not applicable as the document does not describe a test set requiring expert adjudication for ground truth (e.g., image interpretation). The evaluation relies on established engineering and biocompatibility testing methodologies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2)" and "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(3)."

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

This question is not applicable as the device is a physical invasive medical electrode, not a software algorithm or AI system.

7. The type of ground truth used

The "ground truth" for demonstrating the device meets acceptance criteria is primarily based on:

• Compliance with recognized industry standards: ANSI/AAMI/ISO 10993-7:2008/(R) 2012 for EtO residuals, ISO 10993 for biocompatibility, IEC 60601-1-1: 1988/a1: 1991/A2 :1995 § 56.3(c) per CFR 898.12, DIN 42802, ISO 14971, ISO 15223-1, and TIR 28:2009 Guidance for sterilization.
• Predicate device characteristics: Substantial equivalence is established by demonstrating the subject device has identical technological characteristics, intended use, and performance to a legally marketed predicate device, with differences (needle sheath, adhesive tape) assessed not to adversely impact safety or effectiveness.
• Benchtop test results: Electrical continuity and adhesion testing against predetermined acceptance criteria.

8. The sample size for the training set

This question is not applicable as the device is not an AI/ML product that undergoes training.

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

This question is not applicable as the device is not an AI/ML product that undergoes training.

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The EEG Electrode Template is intended for use as an accessory to support the placement of electroencephalograph (EEG) electrodes.

The EEG Electrode Template is intended to be used in medical environments where EEG electrode placement is required. The device provides a workflow solution to support application of EEG electrodes. The EEG Electrode Template is made from elastic webbing to conform to various head shapes and sizes. The device has between 16 to 21 holes in predetermined locations that are arranged by generally referencing the 10-20 Positioning System. The EEG Electrode Template is placed on the patient's head and is oriented with its nasion marker and secured with its chinstrap to support positioning of EEG electrodes. The elasticity of the device enables flexibility to account for various head shapes and sizes and to avoid interference with intracranial pressure monitoring, ventricular drainage, or other separate devices. Identical to the predicate (K043009), the subject device is non-invasive, non-sterile, and for single patient use.

The provided text describes information about the Rhythmlink International, LLC EEG Electrode Template (K191225). Based on the text, here's a breakdown of the requested information:

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

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

• Sample size: Not explicitly stated. The text mentions "dimensional characterization of the EEG Electrode Template," implying that the testing was performed on a sample of the manufactured device.
• Data provenance: The data is from non-clinical performance testing of the subject device (EEG Electrode Template) itself. No information about country of origin, retrospective or prospective study is provided as it's not a clinical study involving patients or human data.

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

Not applicable. The ground truth for the non-clinical dimensional characterization was based on the device's specifications, not on expert consensus.

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

Not applicable. This was a non-clinical dimensional test, not a clinical study requiring adjudication of expert opinions.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an EEG electrode template, not an AI-powered diagnostic tool, and the study was a non-clinical performance test.

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

No, this question is not applicable. The device is a physical template for electrode placement, not an algorithm.

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

The ground truth used for the performance testing was the device's own specifications for hole-to-hole spacing.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no training set.

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

Not applicable.

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The PressOn™ Electrode Headset is intended for use in the recording of electroencephalogram (EEG), evoked potential (EP), or as a ground and reference in an EEG or EP recording. The device is provided sterile for single patient use only.

The PressOn™ Electrode Headset is intended to be used in medical environments where quick EEG electrode application is required. The device provides a workflow solution where the availability of technologists or other specialty-trained EEG staff is limited for applying EEG electrodes.

The headset comprises between 2 to 48 PressOn™ Electrodes, each loaded into individual button applicators, which are positioned in predetermined locations and interconnected by elastic netting, altogether forming the headset. The predetermined electrode positions are arranged by generally referencing the 10-20 Positioning System, but with flexibility to account for various head shapes and sizes and to avoid interference with intracranial pressure monitoring, ventricular drainage, and other separate devices. Like the predicate, the subject device is minimally invasive and does not directly contact neural tissues.

The PressOn™ Electrode Headset is placed on the patient's head and is oriented and secured using a nasion marker and chinstrap. The distal end of the device contains the array of PressOn™ electrodes in predetermined locations that are placed on the scalp by minimal insertion of the micro needles into the epidermis layer of the skin for use during monitoring procedures. The PressOn™ electrodes in the subject device are inserted in an identical fashion as the predicate device (K130220). Minor material and dimensional changes have been made to the original applicator to allow for multiple applicators to be connected to form the headset.

At the proximal end of the subject device is a multipin connector where the electrode leadwires terminate. The multipin connector interfaces with color-coded extension cables (identical to those used in another previously cleared Rhythmlink device, reference device K172503) that terminate into single pin connectors, which are then connected to monitoring equipment.

The leadwires are constructed of ribbon cable arrays with electrode attachment points at various distances based on the predetermined locations. These features are designed with the intent for quick application by non-neurological based medical personnel with signal quality equivalent to predicate device [K130220].

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a structured format that directly maps to "AI performance metrics" commonly seen in such tables (e.g., sensitivity, specificity, AUC). Instead, it discusses functional performance equivalency to a predicate device based on benchtop tests.

However, we can infer the acceptance criteria and reported performance from the "Summary of Non-Clinical Tests" section:

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2)."

Therefore:

• Sample size for test set: Not applicable (no clinical test set).
• Data Provenance: Not applicable (benchtop testing on synthetic materials, not human data).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical tests were conducted and the "ground truth" was established based on engineering specifications and benchtop performance against predetermined criteria.

4. Adjudication Method for the Test Set

Not applicable, as no clinical tests were conducted involving expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No Clinical Tests were conducted." Therefore, no MRMC study was performed, and no effect size for human readers with and without AI assistance is reported. This device is a hardware electrode headset, not an AI algorithm.

6. Standalone (Algorithm Only) Performance Study

No. The device is a physical electrode headset, not an AI algorithm. Therefore, a standalone algorithm-only performance study is not relevant and not reported.

7. Type of Ground Truth Used

The "ground truth" for evaluating the device's performance was established via:

• Engineering specifications and predetermined acceptance criteria for mechanical and electrical properties.
• Comparison to the predicate device (K130220) for functional equivalency, implying the predicate's established performance served as a baseline.
• Benchtop measurements and visual assessments on synthetic skin and head phantoms.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device (electrode headset) and not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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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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The Rhythmlink Disposable Concentric Stimulating Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerve and spinal nerve roots during surgery.

The Rhythmlink Disposable Concentric Stimulating Probe is a single patient use device.

target nerves and to locally stimulate them in order to provide a measurable response. The stimulus will have a very small current spread to reduce the innervation of the surrounding nerves.

The concentric design has two main parts, an inner stainless steel wire and an outer cannula also insulated from reading un-intended signals.

The Inner wire is isolated from the outer stainless steel cannula using a biocompatible heat shrink tubing. This Inner Wire acts as the stimulator and is surrounded by the outer cannula. The Outer Cannula is isolated with a biocompatible heat shrink which isolates the outer cannula allowing contact in a localized area of the intended nerves of interest.

The inner wire, the cathode, is stimulated using EMG/EP electroneurodiagnostic equipment cleared for the stimulation of nerve tissue and recording muscle activity during surgical procedures (not part of this 510(k) submission) The outer cannula acts as the anode or reference.

The Inner wire and outer cannula are isolated from each other using a dielectric heat shrink and are connected to a color coded pair of leadwires which are terminated by two DIN 42 802 touch proof connectors. The concentric stimulators are terminated on the distal end inside of a plastic handle and are independently connected to the leadwires.

This document describes a 510(k) submission for the Rhythmlink Disposable Concentric Stimulation Probe. It outlines the safety and effectiveness testing to demonstrate substantial equivalence to a predicate device, not the performance of an AI model. Therefore, many of the requested fields related to AI model acceptance criteria and study design are not applicable.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and the Reported Device Performance

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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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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 design of the Rhythmlink Disposable MR Conditional Cup and Webb electrodes are identical to the existing Cup and Webb electrodes used to record neurological activity during electroencephalograph (EEG) and evoked potential (EP) procedures. The device consists of a disk shaped electrode with a Cup or Webb shape ABS molded plastic and coated with Ag/AgCl. The Electrode is permanently attached to a leadwire using a validated crimp process and is covered with a biocompatible heat shrink material. The Cup and Webb electrodes are connected to a 10cm (100mm) long multi-strand copper cable with PVC insulation over the tinned copper conductors. An accessory cable is supplied to attach to the 10cm electrode leadwire to create 1.0 to 3.0 meter traditional lengths to attach to the monitoring equipment. This accessory cable is labeled "MR Unsafe" and is NOT intended to be in the MR environment. The significantly shorter 10cm lead wire is permanently attached to the electrode and reduces the effects of matching the electrode leadwire length to the wave length and reduces the likelihood of an increase in the heating effect. This will enable users to leave the electrodes in place during magnetic resonance imaging (MRI) procedures.

This is a 510(k) summary for a medical device: MR Conditional Cup Electrode and MR Conditional Webb Electrode. Note that 510(k) clearances are for demonstrating substantial equivalence to a predicate device, not necessarily for proving absolute safety and effectiveness through extensive clinical trials. Therefore, the details provided often focus on bench testing and comparisons to established devices rather than large-scale clinical studies.

Here's an analysis of the provided information:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format typical for performance studies. Instead, it describes various tests and concludes that the device performs "equal to the predicate devices" and "did not raise any additional questions of safety and efficacy."

However, we can infer some criteria and reported performance from the "Summary of Non-Clinical Tests":

Study Information

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

   • Test Set Sample Size: The document does not specify a distinct "test set" in terms of patient samples. Instead, it refers to numerical simulations and non-simulated physical testing using phantoms.
     • Numerical Simulations: Involved three different electrode types (Cup, Webb, PressOn™) with various configurations (e.g., "Z" axis with two electrodes, different head sizes and populations) and field strengths (1.5T [68 MHZ] and 3.0T [128MHZ]). The exact number of simulation runs or parameters is not quantified as a "sample size" in the traditional sense, but it was comprehensive enough to determine a "worst-case configuration."
     • Physical Testing: Used phantoms "in accordance with appropriate ASTM Standards." The number of phantoms or individual tests performed is not explicitly stated.
   • Data Provenance: The data is from bench testing and numerical simulations (conducted by MR:comp Services on behalf of Rhythmlink International), not human or animal subjects. Therefore, there is no direct country of origin for patient data, nor is it retrospective or prospective in the clinical sense.

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

   • This information is not provided as there was no "ground truth" derived from expert consensus on clinical data for a test set. The study relies on engineering and physics principles, simulation software (SIMCAD X with FDTD modeling), and ASTM standards for physical phantom testing.

3. Adjudication method for the test set:

   • Not applicable. There was no human expert adjudication of results for a test set derived from clinical images or data, as this was a bench and simulation study.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. An MRMC comparative effectiveness study was not performed. This type of study involves multiple human readers evaluating cases with and without AI assistance, which is not relevant to the magnetic resonance compatibility testing of an electrode.

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

   • Not applicable in the typical sense of an "algorithm." The "device" being evaluated is a physical electrode, not a diagnostic algorithm. The safety evaluation was performed in a standalone manner on the device itself through simulations and physical tests, without a human-in-the-loop interacting with the device for performance measurement.

6. The type of ground truth used:

   • The "ground truth" for the MR safety evaluation was based on physical measurements (temperature, torque, artifact) and validated numerical simulation models (SIMCAD X with FDTD modeling, referencing ASTM Standards for phantoms) that predict the behavior of the electrode in an MRI environment. It's an engineering and physics-based ground truth.

7. The sample size for the training set:

   • Not applicable for this device and study type. There was no "training set" in the context of machine learning or AI algorithms, as this is a physical medical device.

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

   • Not applicable. See point 7.

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The PressOn™ Electrode is intended for use in the recording of the Electroencephalogram (EEG), Evoked Potential (EP), or as Ground and Reference in an EEG or EP recording.

Not Found

The provided text is a 510(k) premarket notification document from the FDA regarding a medical device called the "Persyst PressOn™ Electrode." This document determines the substantial equivalence of the device to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The text primarily focuses on:

• FDA's substantial equivalence determination: Stating that the device is substantially equivalent to predicate devices.
• Regulatory information: Such as regulation numbers, product codes, and applicable CFR sections.
• Manufacturer information: Including the company name and contact person.
• Indications for Use statement: Describing the intended use of the Persyst PressOn™ Electrode for recording Electroencephalograms (EEG), Evoked Potentials (EP), or as ground and reference in EEG/EP recordings.

Therefore, I cannot provide the requested table or information about the study, as these details are not present in the provided input.

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