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EEG-1260A Neurofax System
The EEG-1260A series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in sleep disorders, epilepsies and other related disorders as an aid in diagnosis. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic, or nursing home or outside of a medical facility under direct supervision of a medical professional.

JE-940A EEG Amplifier Unit
The EEG amplifier unit is intended to acquire and record the EEG and other biological signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, pulse waveform) of a patient, and transmit the measurement data to the electroencephalograph. The transmitted measurement data is displayed on the electroencephalograph screen and provides information to evaluate the functional state of the brain, brain-related diseases and disorders, and sleep disorders.

The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel.

The device is available for use on any patient as determined by qualified medical personnel.

LS-940A Photic Light
The photic stimulator is a light source for photic stimulation to confirm the responsiveness of EEG to photic stimulation during EEG tests and to test visual evoked potentials.

The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel.

The device is available for use on any patient as determined by qualified medical personnel.

The EEG-1260A Neurofax is an electroencephalograph system specifically designed for use in healthcare facilities. This device is designed to measure and display the patient's electroencephalogram (EEG) and polysomnography (PSG) signals, providing information and analysis of brain electrical activity.

The JE-940A EEG amplifier unit is a new amplifier unit and is an input unit of the EEG-1260A. The JE-940A Amplifier unit acquires and measures EEG and other polysomnography signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, and pulse waveforms) associated with EEG/PSG testing, and transmits the acquired data to the EEG-1260A Neurofax. The JE940A operates on AC power or on battery power for mobile EEG measurements. The JE-940A offers an option to connect with the JE-944A Mini electrode junction box, which enhances the operational efficiency and mobility in EEG measurements.

The LS-940A Photic stimulator is a device which provides visual stimuli in the form of flashing light and is used to assess a patient's EEG responses to light stimulation. The parameters for flashing the light signal are controlled by the EEG-1260A Neurofax.

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The UltraPro is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The UltraPro with Natus Elite Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The UltraPro with Natus Elite Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The UltraPro with Natus Elite Software is intended to be used by a qualified healthcare provider.

The UltraPro S100 system is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform Nerve Conduction (NCS). Electromyography (EMG), Evoked Potentials (EP), and Autonomic Responses. UltraPro S100 system provides a variety of tests spanning the various modalities.

The UltraPro S100 system consists of the following major components:

• Main unit (also known as base unit or main base unit) with integrated control panel; ●
• Amplifier (3- or 4-channel);
• . Computer- laptop or desktop (with keyboard and mouse)
• Display Monitor (for desktop system)
• . Application Software (Natus Elite)

The UltraPro S100 has the following optional accessories/ components:

• Audio stimulators (Headphones or other auditory transducers)
• Visual stimulators (LED goggles or stimulus monitor)
• . Electrical stimulators (RS10 probes, stimulus probe with controls)
• Cart and associated accessories when using cart such as isolation transformer
• Miscellaneous accessories such as Patient Response button, Triple footswitch, Reflex hammer, temperature probe and adapter, ultrasound device, printer, etc.

The electrodiagnostics system is powered by a connection to mains.

The entire user interface of UltraPro S100 system consists of two major elements:

• The primary means to interact with the system is via a personal computer (PC) running ● Natus Elite.
• The second means of interaction is the user interface elements on the hardware.

The UltraPro S100 is intended to be used by a qualified healthcare provider. This device does not provide any diagnostic conclusion about the patient's condition to the user. The intended use environment is in a professional healthcare facility environment.

The provided text is a 510(k) Summary for the Natus Ultrapro S100 device. While it describes the device's indications for use and compares its technological characteristics to predicate devices, it does not contain information about the acceptance criteria or the specific study that proves the device meets those criteria, such as a clinical performance study with defined metrics like sensitivity, specificity, or accuracy. This document focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications and intended use.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes used for test/training sets, data provenance, number or qualifications of experts, adjudication methods, or details about MRMC or standalone studies based on the provided text. The document is primarily a comparison of features and intended use.

The "Conclusion" section on page 14 states: "Verification and validation activities were conducted to establish the performance and safety characteristics of the UltraPro S100. The results of these activities demonstrate that the UltraPro S100 is safe, effective, and performance is substantially equivalent to the predicate devices." However, it does not elaborate on what these activities entailed or the specific criteria and results.

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The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.

SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

The SafeOp™ 3: Neural Informatix System (SafeOp 3 System), consists of the SafeOp patient interface with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, MEP Activator, Cranial Hub, PMAP Dilators and stimulating probe or clip contained in various kits.

The subject device is intended for use by trained healthcare professionals, clinical neurophysiologists/technologists and appropriately trained non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by both clinical and trained non-clinical personnel.

The subject device records the following modalities:

• Somatosensory evoked potentials (SSEP)
• Motor evoked potentials (MEP),
• . Train-of-four neuromuscular junction (TO4),
• Triggered electromyography (tEMG) and ●
• . Free run electromyography (sEMG)

The provided text does not contain detailed information about specific acceptance criteria for the device's performance, nor does it describe a study that rigorously proves the device meets such criteria through a clinical validation or similar performance evaluation.

The document is a 510(k) premarket notification summary for the "SafeOp 3: Neural Informatix System." Its primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (SafeOp2: Neural Informatix System, K213849, and reference device Cascade IOMAX Intraoperative Monitor, K162199), rather than to present a full clinical performance study with defined acceptance criteria and detailed results.

Here's a breakdown of what the document does say, and what it lacks in relation to your request:

What the document provides:

• Device Name: SafeOp 3: Neural Informatix System
• Intended Use/Indications for Use: Monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ) during various surgical procedures.
• Technological Comparison: A table comparing the SafeOp 3 System to predicate and reference devices, focusing on technical specifications like monitoring modalities, amplifier channels, stimulation parameters (voltage, current, pulse duration, repetition rate), and filter ranges. This comparison primarily aims to establish that the differences in technology do not raise new questions of safety or effectiveness.
• Performance Data (Non-clinical): Mentions that "Nonclinical performance testing demonstrates that the subject SafeOp 3 System meets the functional, system, and software requirements." It also states "EMC and Electrical Safety Testing... was performed to ensure all functions... are electrically safe, and comply with recognized electrical safety standards." Usability testing was also performed.
• Clinical Information Disclaimer: Explicitly states, "Determination of substantial equivalence is not based on an assessment of clinical performance data."

What the document lacks significantly for your request:

• A table of acceptance criteria and reported device performance: This is the most significant omission for your request. The document details technical specifications and comparisons but does not provide quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific error rates) against pre-defined acceptance thresholds for any of its functionalities (MEP, SSEP, EMG, NMJ). The performance data mentioned are non-clinical (functional, system, software, EMC, electrical safety, usability), not clinical performance metrics.
• Sample size used for the test set and data provenance: Since specific clinical performance studies are not detailed, this information is not provided.
• Number of experts used to establish ground truth and qualifications: Not applicable as a clinical ground truth establishment process for performance evaluation is not described.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: No such study is mentioned or detailed.
• Standalone (algorithm only) performance: While the device is an "algorithm only" in a sense (it processes physiological signals), its performance isn't quantified in a standalone clinical evaluation or comparative study.
• Type of ground truth used: No clinical ground truth is described for performance evaluation.
• Sample size for the training set: Not applicable, as this is related to AI/ML development and training, which is not described. The device is a neuromonitoring system, not explicitly stated to be an AI/ML device in the context of this submission.
• How the ground truth for the training set was established: Not applicable.

Why this information is missing:

The FDA 510(k) pathway for "substantial equivalence" often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate, without necessarily requiring new clinical trials or detailed performance studies if the technological differences are minor and well-understood. The focus is on showing that any differences do not introduce new safety or effectiveness concerns.

In summary, based solely on the provided text, I cannot complete the table of acceptance criteria or describe a study that proves the device meets these criteria in a clinical performance context. The document focuses on demonstrating substantial equivalence through technical comparison and non-clinical testing, rather than presenting clinical performance metrics.

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The Nurochek-II System is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment.

The Nurochek-II System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display, and store electroencephalograms (EEGs) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 16 and 46 years old who have sustained a potential head injury in the past 72 hours (3 days).

The Nurochek-II System is a portable system designed to generate visual evoked potentials (VEPs) in patients and acquire, transmit, display, and store the resulting electroencephalogram (EEG). It is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years, to aid in the diagnosis of mild traumatic brain injury (mTBI). The primary components of the Nurochek-II System are the wearable headset, the Nurochek-II software application, and the Nurochek-II server.

Here's a breakdown of the acceptance criteria and the study details for the Nurochek-II System:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state "acceptance criteria" for sensitivity and specificity in a separate section. However, it presents the performance of the Nurochek-II System and compares it to a predicate and reference device, implying these metrics are key for demonstrating substantial equivalence. Given the context, the performance metrics reported for the Nurochek-II System are the results of its performance against a clinical diagnosis.

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

• Sample Size for Test Set: 110 individual Steady-State Visual-Evoked Potential (SSVEP) readings.
• Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer, Headsafe MFG Pty Ltd., is based in Surry Hills, NSW, Australia, suggesting the study may have been conducted in Australia or related clinical sites.
• Retrospective or Prospective: The study is described as a "clinical investigation" with a "clinical research protocol" and the collection of readings within 72 hours of suspected head injury, followed by a clinical evaluation. This indicates a prospective study design.

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

• Number of Experts: Not explicitly stated as a specific number. The document mentions "Each highly trained physician." This phrasing suggests multiple physicians were involved, but the exact count is not provided.
• Qualifications of Experts: "Highly trained physician" using "their education and experience to deliver their mTBI determination." This included a neurological examination, a concussion-related signs and symptom evaluation, and a review of all relevant information provided by the study subject.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1). It states that "Each highly trained physician used their education and experience to deliver their mTBI determination." This implies that the individual physician's diagnosis served as the ground truth without a stated consensus or adjudication process among multiple ground truth experts for each case.

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 explicitly described. The study focuses on the standalone performance of the Nurochek-II System against a clinical diagnosis. There is no information provided about human readers improving with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The reported sensitivity, specificity, PPV, and NPV are for the Nurochek-II System's classification algorithm in differentiating between subjects with and without mTBI, based solely on the analysis of captured EEG signals.

7. The Type of Ground Truth Used

The ground truth used was expert clinical diagnosis. This was established by "a licensed healthcare professional" (a "highly trained physician") based on a standard neurological assessment, a concussion-related signs and symptom evaluation, and a review of relevant patient information.

8. The Sample Size for the Training Set

The classification algorithm was "generated with 372 individual steady-state visual-evoked potential (SSVEP) readings." This indicates that the training set consisted of 372 individual SSVEP readings.

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

The ground truth for the training set was established through the same method as the test set: a clinical evaluation by a licensed physician. The protocol required readings to be collected within 72 hours of suspected head injury, in addition to a clinical evaluation by a licensed physician. Their determination was based on a neurological examination, a concussion-related signs and symptom evaluation, and a review of all relevant information.

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The E3 and Profile system is an electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG), visual evoked potential (VEP) and sensory electro-oculogram (EOG) signals, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals, for use with patients who are experiencing visual system abnormalities.

Photopic stimuli are presented to the patient using LEDs or a monitor, using various number of elements in separately stimulated fields. Various modes are available for preferential stimulation of different retinal mechanism and isolation of signal from different retinal lavers. Data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device). During the period of time that the system is acquiring data (1-20 minutes), there is a real time display of the raw and processed data presented to the user. Once the resulting individual waveforms are acquired, the signals are analyzed by software using algorithms for spatial filtering and artifact rejection. Data may be presented in a number of forms, including waves recorded at each of the points tested, color plots, or 3D topographical representation.

The provided text describes the regulatory clearance of a medical device, the E3 and Profile system, but it does not contain the detailed information necessary to answer the questions about acceptance criteria and study proving device performance in the context of an AI/ML device.

The document states:

• The device is an electrodiagnostic device used to generate photic signals and to measure and display electrical signals generated by the retina and visual nervous system (ERG, VEP, EOG).
• It displays digitized signals, power spectra, and topographic maps.
• These functions are controlled and interpreted by trained medical professionals.
• The device was tested against various IEC and ISO standards related to medical electrical equipment, risk management, usability, and software life cycle.

Crucially, there is no mention of an AI/ML component in the E3 and Profile system, nor any studies that would involve AI-specific acceptance criteria, human reader improvement with AI assistance, standalone AI performance, or ground truth establishment relevant to AI model training and testing. The "software" mentioned appears to be for data acquisition, processing, and display, interpreted by human experts, rather than an AI performing diagnostic tasks.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to a predicate device based on device features and specifications and intended use, not on the performance of an AI algorithm against specific acceptance criteria.

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The Vision Monitor MonCvONE system is a non-invasive medical device used to generate photic stimulations and to register the responses including electrical responses generated by the retina and the visual nervous system in addition to psychophysical and pupillary responses. It displays digitized electroretinogram (ERG), visual evoked potential (VEP), sensory electro-oculogram (EOG), light and dark adapted perimetry thresholds, dark adaptometry, full field stimulus threshold (FST), photo aversion thresholds (PAT), pupillometry as curves, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.

Photopic stimuli are presented to the patient on a hemispherical cupola. Various modes are available for preferential stimulation of different visual functions. Electrophysiological data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device). Psychophysical responses are recorded with a press button and pupillometry responses recorded with an eye tracker.

During the period of time that the system is acquiring data (1-20 minutes), there is a real time display of the raw and processed data presented to the operator. Once the resulting individual responses are acquired, the signals are analyzed by software using algorithms for spatial filtering and artifact rejection. Data may be presented in a number of forms, including waves recorded at each of the points tested, color plots, or 3D topographical representation.

Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the Vision Monitor-MonCvONE device:

Acceptance Criteria and Device Performance

Study Details

Based on the provided text, the submission describes non-clinical testing rather than a clinical study involving human patients to establish the device's performance against ground truth.

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

   • The document describes non-clinical bench testing including technical, functional, and compatibility tests. It does not mention a test set of patient data with a specific sample size. The testing focuses on the device's adherence to standards and its internal components' functionality.
   • Data provenance: Not applicable as no patient data test set is described.

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

   • Not applicable. The document describes engineering and safety testing against defined standards and specifications, not interpretation of medical data by experts to establish ground truth for a test set.

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

   • Not applicable. There is no mention of a test set requiring adjudication. The testing described is based on engineering principles and regulatory standards.

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:

   • No. The document does not describe an MRMC study, nor does it indicate that the device involves AI for interpretation by human readers. The device generates and displays physiological data; "These functions are controlled and interpreted by trained medical professionals."

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

   • The document describes the device as a system that generates photic stimulations and registers responses, with software for analysis and display. However, it explicitly states, "These functions are controlled and interpreted by trained medical professionals." This indicates that the device is intended for use with human-in-the-loop interpretation, and no standalone (algorithm-only) performance claim or study is detailed. The described tests are about the device's performance in generating and recording data, and its software's functionality, not its diagnostic accuracy in an unsupervised manner.

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

   • The ground truth for the described testing is based on engineering specifications, regulatory standards (e.g., IEC 60601-1, ISO 14971), and functional requirements for generating, recording, and processing electrophysiological signals. There is no mention of a clinical ground truth (like pathology or expert consensus on patient cases) being used for the performance claims in this submission.

7. The sample size for the training set:

   • Not applicable. The device is a measurement and display system, not an AI or machine learning algorithm that requires a training set of data.

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

   • Not applicable, as there is no training set mentioned for this device.

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LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic (EEG) studies. It always has to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation. The product must be used only by qualified personnel (physicians or technicians of neurophysiopathology) for the execution of EEG exams in a professional environment.

LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic(EEG) studies. It is to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation.

The LED PHOTIC Systemis managed by the EEG system software for setting some parameters, IC, and the power supply called LED PHOTIC IC POWER is an integral part of the LED PHOTIC System.

The provided text describes the regulatory clearance for a medical device called "LED PHOTIC System" and its comparison to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

The document is a 510(k) premarket notification summary for a Class II medical device, which is an accessory for EEG studies to provide photic stimulation. The performance testing mentioned focuses on safety standards (electrical safety, usability, EMC compliance, photobiological safety), not on accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/ML device evaluations.

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and the reported device performance: The document only lists safety standard compliance, not performance criteria for diagnostic accuracy or similar AI/ML metrics.
• Sample size used for the test set and the data provenance: No such testing is described for diagnostic performance. The safety tests would have their own sample sizes (e.g., number of units tested) but these are not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic performance study described.
• Adjudication method 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, as the device is a photic stimulator, not an AI/ML diagnostic aid.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable (no AI/ML algorithm mentioned).
• How the ground truth for the training set was established: Not applicable.

The "Performance Testing" section only states:

• The LED PHOTIC System was tested and found compliant to the following safety standards:
  • IEC 60601-1:2005+A1:2012: Medical Electrical safety
  • IEC 60601-1-6:2010+A1:2013: Usability
  • IEC 60601-2:2014: EMC Compliance
  • IEC 62471:2006: Photobiological Safety

This submission is about establishing substantial equivalence to a predicate device (Lifelines Photic Stimulator K101691) primarily based on shared intended use, similar operational principles, and compliance with general medical device safety standards. It is not an evaluation of an AI-driven system.

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The Vision Monitor MonPackONE system is an electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG), visual evoked potential (VEP) and sensory electro-oculogram (EOG) signals, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.

Photopic stimuli are presented to the patient on a LCD-screen at a various number of elements in separately stimulated fields. Various modes are available for preferential stimulation of different retinal mechanism and isolation of signal from different retinal layers. Data is recorded by up to 5 recording channels using conventional EEG electrodes (not provided with the device).

During the period of time that the system is acquiring data (1-20 minutes), there is a real time display of the raw and processed data presented to the user. Once the resulting individual waveforms are acquired, the signals are analyzed by software using algorithms for spatial filtering and artifact rejection. Data may be presented in a number of forms, including waves recorded at each of the points tested, color plots, or 3D topoqraphical representation.

The provided text is a 510(k) summary for the Vision Monitor MonPackONE device and does not contain information about the acceptance criteria and study proving a device meets those criteria in the context of an AI/ML algorithm. The document primarily focuses on establishing substantial equivalence to a predicate device for a medical device that measures and displays electrophysiological signals from the retina and visual nervous system.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies, as these types of details typically apply to studies validating AI/ML diagnostic tools, which is not the subject of this 510(k) summary.

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The EEG NeuroAmp II.5s is intended to acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories.

The EEG NeuroAmp II.5s can also be used for biofeedback and relaxation purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback.

The EEG NeuroAmp II.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use.

The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings.

The EEG NeuroAmp II.5s is a user-friendly high-performance interface between client and clinician computer. It can be used in two different functionalities: In an EEG/ERP measurement and in an EEG biofeedback (neurofeedback) and/or peripheral biofeedback setting. The EEG NeuroAmp 11.5s device itself contains three function blocks:

• 1. EEG amplifier, two channels, interface for 23- or 39-channel EEG recording front-end
• 2. Impedance meter function
• 3. peripheral channels for additional sensors, ERP synchronization and biofeedback

Apart from the EEG-biofeedback functionality, together with the x23/x39 accessories, it is possible to utilize the equipment as an EEG/ERP measurement device. A 23- or 39-channel EEG can be measured with conventional EEG caps, which are not part of the device, according to the standard 10-20 system. The device does not draw any diagnostic conclusions and does not invite the clinician to do so. Recorded data of electroencephalogram (EEG) signals need to be interpreted by a clinical expert. The results of such interpretation must be considered in conjunction with other clinical findings to provide context. There is no therapeutic effect of the EEG NeuroAmp II.5s used in this setting.

The NeuroAmp x23/x39 devices are a full 23-/39-channel digital EEG recording front-end with integrated impedance meter. They are an accessory to the EEG NeuroAmp 11.5s and work only in conjunction with it.

The Corscience EEG NeuroAmp II.5s is an electroencephalograph device that functions for EEG/ERP measurement and biofeedback. The device received 510(k) clearance based on substantial equivalence to predicate devices, demonstrating its safety and effectiveness through performance testing against relevant IEC and ISO standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EEG NeuroAmp II.5s are implicitly defined by its performance against the specified technical requirements, which are shown to be equivalent or superior to predicate devices. The "Discussion on safety and effectiveness" column in the comparative table effectively serves as the acceptance criteria and performance review.

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

The document does not describe a clinical study with a "test set" of patient data for the device to be evaluated. The performance testing conducted was:

• Electrical Safety: Bench testing according to IEC 60601-1.
• Electromagnetic Compatibility: Bench testing according to IEC 60601-1-2 and IEC 60601-2-26.
• Performance Testing (Hardware): Bench testing in accordance with internal requirements and applicable clauses of IEC 62366-1, IEC 80601-2-26, and IEC 60601-2-40.

The accessorizes were also tested to ISO 10993-1, IEC 60601-1 and IEC 60601-1-2.

Therefore, there is no mention of sample size or data provenance in terms of patient data.

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

This information is not applicable as there was no test set of patient data requiring expert ground truth establishment. The device capabilities were verified through technical bench testing against established engineering standards and specifications.

4. Adjudication method for the test set

This information is not applicable as there was no test set of patient data requiring adjudication.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

No MRMC study was performed or described. The study focused on technical equivalence and performance against predicate devices and standards, not on human reader performance with or without AI assistance. The device does not draw any diagnostic conclusion and requires interpretation by a clinical expert.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) study

No standalone performance study of an algorithm was conducted or described. The device is a hardware system for acquiring, displaying, storing, and archiving EEG signals, with capabilities for biofeedback and evoked response potentials. It's explicitly stated that the device "does not draw any diagnostic conclusion" and "Recorded data... need to be interpreted by a clinical expert."

7. Type of ground truth used

The "ground truth" for evaluating the EEG NeuroAmp II.5s was based on:

• Adherence to international electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 10993-1 for accessories).
• Compliance with device-specific performance standards for electroencephalographs and evoked response equipment (IEC 80601-2-26, IEC 60601-2-40).
• Comparison of technical specifications against legally marketed predicate devices (Mitsar EEG K143233, Natus Brain Monitor K180290, EEG NeuroAmp K073557) to demonstrate substantial equivalence and often superior performance.

8. Sample size for the training set

This information is not applicable as the device is a medical measurement instrument and not an AI/ML algorithm that requires a training set of data.

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

This information is not applicable as there was no training set of data.

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The Cadwell Apollo System is indicated for prescription use to acquire, record, transmit, and display physiological and environmental data for electroencephic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages.

The Cadwell Apollo System (Apollo) is used to acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages. The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K180269) with support for Apollo hardware using single or combinations of amplifiers, a photic stimulator, and interfaces with a Cadwell or 3rd party oximeter devices. Additional channels can be added with multiple amplifiers. Apollo is intended for use in both home healthcare and professional healthcare environments.

The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML powered device. The document is a 510(k) premarket notification for the Cadwell Apollo System, an electroencephalograph, and focuses on demonstrating substantial equivalence to a predicate device through engineering and software testing for safety and performance against established standards.

Therefore, the requested table and detailed information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for an AI/ML component cannot be extracted from this document. The document describes traditional device testing, not AI/ML model validation.

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