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The Geodesic EEG System™ 300 (GES 300) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.

The Geodesic EEG System™ 300 (GES 300) is a digital electroencephalograph system (EEG) with dedicated electrodes. It consists of an amplifier, computer, software . Geodesic Sensor Net® (electrodes), and additional components such as cables. Modifications which constitute the GES 300 include a compact amplifier, software upgrade, additional display modes and tools, and options for computer configuration.

The provided text describes a 510(k) submission for the Geodesic EEG System™ 300 (GES 300). However, it explicitly states:

"Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

This means that the submission does not include information about acceptance criteria, device performance, or a study that proves the device meets specific criteria in terms of clinical effectiveness or diagnostic accuracy. Instead, the submission focuses on demonstrating that the GES 300 modifications (compact amplifier, software upgrade, additional display modes and tools, and computer configuration options) do not alter the technological characteristics of the predicate device (Geodesic EEG System™ K012079) and that basic verification and validation testing has been conducted to ensure the device functions as intended.

Therefore, for all the requested information, the answer is that the details are not available or not applicable based on the provided text.

Here's a breakdown of why each specific point cannot be addressed:

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

   • Not available: The document explicitly states "Comparative performance testing and clinical evaluations were not submitted." This implies no specific performance metrics or acceptance criteria for clinical efficacy were provided in this 510(k) submission. The "verification and validation testing" mentioned is likely related to engineering functionality and safety, not clinical performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not available/Not applicable: Since no comparative performance or clinical evaluations were submitted, there is no "test set" in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not available/Not applicable: No clinical test set means no ground truth established by experts.

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

   • Not available/Not applicable: No clinical test set means no adjudication method described.

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 available/Not applicable: No comparative effectiveness study was done. Also, this device is an EEG system, not typically an "AI" device that assists human readers in interpretation.

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

   • Not available/Not applicable: No standalone performance study was done. This device is an EEG recording system, not an algorithm performing interpretation independently.

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

   • Not available/Not applicable: No clinical ground truth was used as no clinical performance study was submitted.

8. The sample size for the training set

   • Not available/Not applicable: No clinical training set information is provided, as no clinical performance study was submitted.

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

   • Not available/Not applicable: No clinical training set information means no ground truth establishment method.

In summary, the 510(k) submission for the GES 300 focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and basic safety/functionality testing, rather than novel clinical performance studies.

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The Geodesic Photogrammetry System is intended for use in recording precise locations of EEG electrodes in the Geodesic Sensor Net on a patient's head.

The GPS consists of a geodesic dome structure containing 11 mounted cameras, a steel supporting structure, a dedicated computer, and accompanying software. It is used with a Geodesic Sensor Net and any EGI Geodesic EEG system. It allows the user to record the locations of the dense array EEG electrodes on a patient's head. No part of the Geodesic Photogrammetry System touches the patient.

The provided text is a 510(k) summary for the Geodesic Photogrammetry System (GPS). It clearly states that comparative performance testing and clinical evaluations were NOT submitted as part of this 510(k). Therefore, the device's acceptance criteria and studies proving it meets those criteria, as typically understood in a clinical performance context, are not available in the provided document.

The document indicates that testing was conducted only for electrical safety and electromagnetic compatibility, and the GPS passed "all essential performance tests." However, it does not detail what these "essential performance tests" entailed in terms of specific acceptance criteria or how device performance against those criteria was measured.

Based on the provided information, I cannot complete the requested tables and sections related to the device's performance regarding its intended use.

Here's a breakdown of why based on the request requirements:

• 1. A table of acceptance criteria and the reported device performance: This information is not provided. The document states "Performance testing: Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." The "essential performance tests" mentioned are not elaborated upon with specific criteria or results relevant to the device's functional intended use (recording precise EEG electrode locations).
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as performance testing was not submitted.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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, as no comparative effectiveness study was done, and this device is described as an accessory, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The 510(k) summary explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This indicates that the regulatory clearance for this device, at the time of this document, did not rely on studies demonstrating its performance in recording precise EEG electrode locations in a clinical setting against specific acceptance criteria. Instead, it seems to have been cleared based on technological characteristics being substantially equivalent to existing devices and adherence to electrical safety and electromagnetic compatibility standards.

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The Geodesic EEG System™ Series 100 products are intended to measure and record The Clectrical activity of the patient's brain. They can be used on adults, children, and infants.

The Geodesic EEG System™ Series 100 products, also known as the GES Series 100, are digital electroencephalography systems (EEG) that can accommodate up to 256 electrodes. The GES Series 100 is computer controlled and capable of acquiring, storing, and displaying data. It includes electrodes, amplifiers, a central processing unit, and software. The GES Series 100 uses some components from the previously submitted and cleared Geodesic EEG System™ Model 200. It blends these with components from another manufacturer. The combined product is new and has not been previously submitted to FDA.

The GES Series 100 products are composed of the following components. The Geodesic Sensor Net® is a dense array of scalp electrodes designed to allow rapid application in an even distribution across the head and is the preferred electrode system. Standard EEG electrodes and cap-type electrodes purchased from other vendors may also be used. The Neurotravel WIDE consists of multiple amplifiers for physiological signals that are fully software controlled. The central processing unit can be either Mac based or PC based. Mac based systems use the proprietary Net Station® software package to control acquisition of data, storage of digital data, and manipulation of data for review. PC based systems use the Neurotravel Win software package to control similar system features. Neither software package performs any diagnosis. Additional components of the system are an articulated arm with extended cable, isolation transformer, rack system, various cables, standard components of personal computer (monitor, keyboard, and mouse), photic stimulator, video EEG, electrolyte solution, and disinfectant.

The provided document describes the Geodesic EEG System™ Series 100 (GES Series 100), an electroencephalography system. It details its components, intended use, and technological characteristics compared to a predicate device. However, it explicitly states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This means that the document does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Geodesic EEG System™ Model 200, K012079) based on technological characteristics and compliance with general safety and electromagnetic compatibility standards, rather than clinical performance outcomes.

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The Geodesic EEG System is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.

The Geodesic EEG System is a digital electroencephalography system (EEG) with a dense sensor array of 32 to 256 channels. Like existing digital EEG systems, the Geodesic EEG System is computer controlled and capable of acquiring, storing, and displaying data. It includes scalp conductive electrodes, amplifiers, a central processing unit, and software. The Geodesic Sensor Net is a dense array of scalp electrodes designed to allow rapid application in an even distribution across the head. The Net Amps " consists of multiple amplifiers for physiological signals that are fully software controlled. Net Station® is the software package that provides control of the Geodesic EEG System, digital data storage, and operator-selected waveform displays. The software does not perform any data analysis. Additional components of the system are an articulated arm with extended cable, rack system, various cables, standard components of personal computer (monitor, keyboard, mouse), electrolyte solution, and disinfectant.

This document describes the Geodesic EEG System™, an electroencephalography system. The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria, beyond general safety and electromagnetic compatibility compliance.

Here's a breakdown of the requested information, with explanations based on the provided text:

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

   Acceptance Criteria	Reported Device Performance
   Not specified	Not specified
   General Safety (CAN/CSA C22.2 No. 601.1-M90, UL Std. No. 2601-1)	Passed
   Electromagnetic Compatibility (EN60601-1-2(1993))	Passed
   Electroencephalograph Standards (IEC 60601-2-26, CAN/CSA C22.2 No. 601.2.26)	Passed
   Biocompatibility (ISO 10993)	Passed

   Explanation: The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." The "Testing conducted" section lists compliance with various international standards related to electroencephalographs, safety, electromagnetic compatibility, and biocompatibility, and states that the "Geodesic EEG System passed all testing." However, these are general compliance standards, not specific acceptance criteria for a device's performance in, for example, detecting certain EEG patterns or achieving a particular level of signal-to-noise ratio.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   Explanation: The document states, "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, there is no information on sample size, test set characteristics, or data provenance. The 510(k) submission relied on substantial equivalence to predicate devices and compliance with general safety and performance standards, rather than a new comparative performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   Explanation: As no comparative performance or clinical evaluations were submitted, there was no test set for which ground truth needed to be established by experts.

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

   Explanation: Not applicable, as no test set or clinical evaluations were submitted.

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

   Explanation: No MRMC comparative effectiveness study was done. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Furthermore, the described device (Geodesic EEG System) is a diagnostic tool for measuring and recording EEG data; its software ("Net Station®") "does not perform any data analysis." This indicates it's a data acquisition system and not an AI-assisted diagnostic tool.

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

   Explanation: Not applicable. The device is an EEG acquisition system. Its software explicitly states it "does not perform any data analysis." Therefore, there is no algorithm for standalone performance testing in terms of diagnostic interpretation.

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

   Explanation: Not applicable, as no comparative performance or clinical evaluations were submitted that would require the establishment of an independent ground truth for diagnostic purposes.

8. The sample size for the training set

   Explanation: Not applicable. The device is an EEG acquisition system, and its software does not perform data analysis, which would typically be a function of a machine learning or AI algorithm that requires a training set. The submission is for a device that measures and records electrical activity, not one that interprets it using learned patterns.

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

   Explanation: Not applicable, for the same reasons as #8.

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