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The BrainView QEEG Software Package is to be used by qualified medical or clinical professionals for the statistical evaluation of the human electroencephalogram (EEG).

BrainView QEEG Software Package is a software program for the post-hoc statistical analysis of the human electroencephalogram (EEG). EEG recorded on a separate device (i.e., the host system) is transferred to the BrainView QEEG software package for display and user-review. The device herein described consists of a set of tables that represent the reference means and standard deviations for representative samples. These tables are implemented as computer files that provide access to the exact tabular data resource for use by software that uses the tables as an information resource. The system requires that the user select reliable samples of artifact-free, eyes-closed or eyes open, resting digital EEG for purposes of analysis. Analysis consists of the Fast-Fourier Transformation (FFT) of the data to extract the spectral power for each of the designated frequency bands (e.g. delta, theta, alpha, and beta), and frequency information from the EEG. The results of this analysis are then displayed in statistical tables and topographical brain maps of absolute and relative power asymmetry, and coherence for 19 monopolar and 171 selected bipolar derivations of the EEG. In all over 4,000 measures are derived for comparison against carefully constructed and statistically controlled age-regressed, normative database in which the variables have been transformed and validated for their Gaussian distribution. Each variable extracted by the analysis is compared to the database using parametric statistical procedures that express the differences between the patient and an appropriate age-matched reference group in the form of z-scores.

Acceptance Criteria and Study for BrainView QEEG Software Package

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "small" sample size of "selected subjects." The text specifies that 10-minute EEG recordings for eyes closed and eyes open were used. Although the initial sample size was small, it was used to derive 23 age-grouped sets of Z-scores for each subject, covering ages 4 to 85.
• Data Provenance: The data used for clinical testing consisted of "clinically acquired EEG waveforms." The document does not explicitly state the country of origin but implies it was collected in a clinical setting. It is retrospective as the data was "clinically acquired" and then used to validate the device's performance against a predicate.

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

The document does not explicitly mention the number or qualifications of experts used to establish a separate "ground truth" for the clinical test set. The validation was a direct comparison to the predicate device's output, implying the predicate itself served as a de facto reference. The "qualified medical or clinical professionals" are mentioned in the context of the device's intended use and not specifically to establish ground truth for this validation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The comparison was primarily a quantitative analysis of Z-scores against the predicate device's output.

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 study focuses on the agreement between the subject device and a predicate device, not on human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

Yes, the clinical testing described is a standalone (algorithm only) performance study. The BrainView QEEG software's output (Z-scores for absolute power) was directly compared to the output of the predicate device. The text explicitly states that the "BrainView QEEG software package is used as a standalone diagnostic system in the absence of other clinical data" (though this is also mentioned as a potential misuse scenario, it confirms its standalone operational capability).

7. The Type of Ground Truth Used

The ground truth for the clinical test set was effectively the output of the legally marketed predicate device (NeuroGuide Analysis System K041263). The study's acceptance criteria were based on agreement with this predicate device's results.

8. The Sample Size for the Training Set

The training set for the BrainView QEEG software's normative database consisted of:

• 2303 subjects for eyes closed EEG data.
• 1965 subjects for eyes open EEG data.

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

The ground truth for the training set (normative database) was established through "carefully constructed and statistically controlled age-regressed, normative database in which the variables have been transformed and validated for their Gaussian distribution." This implies the data was collected from a large, healthy population across a wide age range (4-85 years) and processed to establish statistical norms ("reference means and standard deviations"). While not explicitly detailing every step of "ground truth" establishment, this points to a robust statistical methodology based on data from a large population.

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The NeuralScan System is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and Event-related Potentials (ERP), obtained by placing two or more electrodes on the head to aid in diagnosis.

The NeuralScan System is comprised of the NeuralScan Amplifier with embedded firmware for acquisition and transmission of physiological signals, an EEG cap, a Subject Response Device, a laptop computer preloaded with the NeuralScan Evoke software, and a charging kit (that consists of a USB cable, clip kit, and wall adapter).

The NeuralScan Evoke software runs in a Windows Operating System environment and controls the 23 channel (21 EEG and 2 bio channels) NeuralScan EEG amplifier via a USB cable or Wi-Fi connection. The software has a graphical user interface that allows the user to input patient information, create new records, conduct studies to collect EEG and ERP data, view live data streams of the laptop display, record data to a file, analyze resultant test data using standard Frequency EEG analysis and EP display methods and print the results. The software includes a mode to measure the cap electrode impedances which is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location. Interpretation of the data is the responsibility of the physician as the software does not provide any diagnosis based on the data.

The patient contacting accessories are commercially sourced and used without modification. The device and the accessories are not sterile and are not intended to be sterilized.

The provided text describes the regulatory clearance for the "NeuralScan System" and includes a summary of non-clinical testing performed to demonstrate its substantial equivalence to predicate devices. However, it explicitly states: "No Clinical testing was necessary to determine substantial equivalence."

Therefore, based on the provided document, the device did not undergo a clinical study involving human subjects to prove its performance against acceptance criteria for diagnostic accuracy or clinical effectiveness. The acceptance criteria and performance data are entirely based on bench testing (non-clinical data) for the device's functional integrity as an electroencephalograph (EEG) and Event-related Potentials (ERP) system.

Given this, I can only provide information derived from the non-clinical testing detailed in the document.

Acceptance Criteria and Reported Device Performance (Non-Clinical Study)

The acceptance criteria and performance measurements for the NeuralScan System are based on bench testing to confirm compliance with recognized medical device standards (primarily IEC 60601-2-26 for electroencephalographs). These tests evaluate the hardware and software's ability to accurately acquire, reproduce, and transmit physiological signals.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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VitalScan ANS is intended for non-invasive measurements of pulse waveforms by photoelectric plethysmography (PPG), heart rate electrocardiograph (ECG), Heart Variability measurements (HRV) and blood pressure (NIBP) in response to paced respiration and controlled testing procedures for physician assessment of the Cardiovascular Systems.

VitalScan ANS also measures/calculates a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assessing development of peripheral arterial disease (PAD).

The device is intended for use on transitional adolescents and adults, including those with unilateral lower limb amputation, in medical clinics, healthcare practices and out-patient departments of hospitals.

The physician has the responsibility of interpreting the significance of the resulting data.

VitalScan ANS system collects multi-parameter patient data including: Electrocardiography (ECG), Plethysmogram (PPG), Pulse Volume Recording (PVR), Blood Pressure, Heart Rate, and Peripheral capillary Oxygen saturation (SpO2).

The system comprises: USB plug and play device hardware and Software installed on a computer.

VitalScan ANS is intended to measure a patient's variations in the heart rate (R-R beat-to-beat intervals from ECG) and perform Heart Rate Variability (HRV) analysis to assess Autonomic Nervous System (ANS) Function;

VitalScan ANS also measure a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assess the risk of developing peripheral arterial disease (PAD).

The results are saved in a backup and can also be printed.

The device does not provide any direct diagnosis rather the device provides information to the physician for inclusion in their decision making process.

The provided document is a 510(k) summary for the VitalScan ANS device. It primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and non-clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison table (pages 7-8) that highlights the VitalScan ANS device's specifications against predicate devices. While this table shows performance characteristics, it does not explicitly state "acceptance criteria" in a quantifiable sense for the VitalScan ANS itself. Instead, it demonstrates that the VitalScan ANS either matches or is similar to the established performance of legally marketed predicate devices.

Here's an extracted and summarized table based on the direct comparison for the VitalScan ANS device's performance, using the predicate device values as a proxy for what would be considered acceptable based on substantial equivalence:

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

The document explicitly states: "No Clinical testing was necessary to determine substantial equivalence." (Page 6, section b2). This means there was no test set of patient data used to evaluate the device's clinical performance. The evaluation was based on non-clinical (bench) testing and comparison to predicate devices, not on direct human data.

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

Since no clinical testing was performed, there were no experts used to establish ground truth for a clinical test set. The substantial equivalence was determined by comparing the device's technical specifications and safety/performance data (from bench testing) to those of already approved predicate devices.

4. Adjudication method for the test set

Not applicable, as no clinical test set was used.

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 device is not an AI-assisted diagnostic tool that would typically involve human readers.

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

Yes, if we interpret "standalone" as the device operating according to its technical specifications and algorithms during non-clinical (bench) testing. The document states:

• "Bench testing was carried out on the following characteristics: Electrocardiograph (ECG), Heart rate variability (R-R interval), Heart rate, SpO2 and Plethysmogram, Blood-Pressure Measurement accuracy, Communication, data transmission and storage integrity, Electromagnetic compatibility (EMC), Electrical safety testing, Software verification and validation testing, Biocompatibility verification." (Page 5, section b1)
• And, "The VitalScan ANS device was tested and meets the applicable requirements of following performance Standards and is in accordance with FDA Class II Special Controls Guidance Document" followed by a list of relevant IEC and ISO standards (pages 5-6).

These non-clinical tests demonstrate the device's performance in a standalone capacity against established technical and safety standards.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by the specifications and measurement accuracies defined in the referenced standards (e.g., IEC 60601-1, AAMI / ANSI 80601-2-30 for blood pressure accuracy). The device's measurements were compared against calibrated instruments or reference signals as part of these bench tests. The substantial equivalence argument also uses the established performance of the legally marketed predicate devices as a form of "ground truth" for acceptable performance.

8. The sample size for the training set

Not applicable. This device is not described as utilizing machine learning or artificial intelligence that would require a "training set" of data. Its functionalities are based on established physiological measurement principles and algorithms.

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

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

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QBioScan is indicated for the measurement of galvanic skin response to aid in the assessment of the sudomotor function. The device is intended for use on the general adult population in medical clinics, healthcare practices and out-patient departments of hospitals.

QBioScan™ is a galvanic skin response measurement device intended for the collection and display of galvanic skin response recorded by the device consists of the following components:

• . an off-the-shelf computer with proprietary device software pre-installed
• . a custom electronics box that houses the QBioScan circuitry
• a USB cable to connect the electronics box to the computer .
• reusable electrode lead cables .
• reusable hand and foot electrodes and optional disposable forehead electrodes .
• . an off-the-shelf printer (optional)
  The device allows for a evaluation of sweat gland function based on a measuring method where patients are in contact with surface electrodes (reusable stainless-steel plates and optional disposable electrodes) and are exposed to an incremental low voltage (under the 60601-1 standard safety limits). The device tests the electrochemical reaction between electrodes and the chloride ion released by the stimulated sweat glands. This active test method provides information and evidence of a sweat gland dysfunction that might otherwise not be detectable in a physiological examination. The Bioelectrical Conductance (BEC, in micro-Siemens, uS) representing galvanic skin response for the hands and feet are expressed as quantitative results along with an asymmetry value expressed as the percent difference between the BEC values of the right / left hands and the right / left feet. The device does not provide any direct diagnosis rather the device provides information to the physician for inclusion in their decision making process.

The QBioScan device does not appear to have acceptance criteria for clinical performance explicitly stated in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (Sudoscan) primarily through technological characteristics and non-clinical testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As there are no specific performance acceptance criteria for clinical outcomes mentioned, a table cannot be fully provided. The non-clinical testing refers to compliance with safety and EMC standards and software V&V, which are typically pass/fail.

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

• No clinical test set was used for a performance study. The document explicitly states: "No Clinical testing was necessary to determine substantial equivalence."
• Data Provenance: Not applicable for clinical testing. For the non-clinical testing (electrical safety, EMC, software V&V), the data would have been generated internally by Medeia, Inc. or by a contract testing laboratory.

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

• Not applicable as no clinical test set with human subjects requiring ground truth establishment was used.

4. Adjudication Method for the Test Set

• Not applicable as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. The document states, "No Clinical testing was necessary to determine substantial equivalence." This type of study would fall under clinical testing.

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

• Not explicitly described as a standalone performance study. The device is a "galvanic skin response measurement device" which directly measures a physiological signal. While it processes data and displays it, it's not an "algorithm only" device in the context of, for example, an AI diagnostic tool. The focus is on the device's ability to accurately measure the physiological parameter, which is addressed through the technological comparison to the predicate and non-clinical safety/EMC testing.

7. The Type of Ground Truth Used

• Not applicable for clinical validation, as no clinical studies were performed. For the technical aspects, the "ground truth" would be the established safety standards (IEC 60601-1, EN 60601-1-2) and the functional specifications of the device itself (for software V&V).

8. The Sample Size for the Training Set

• Not applicable. This device is a measurement device, not an AI/machine learning device that requires a training set in the conventional sense. Its "training" would be its design and engineering to accurately measure galvanic skin response.

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

• Not applicable, as there is no training set in the context of AI/ML.

Summary of Approach:

The manufacturer, Medeia, Inc., pursued a 510(k) pathway for substantial equivalence. Their strategy was to demonstrate that the QBioScan device shares the same intended use and similar technological characteristics with a legally marketed predicate device (Sudoscan), and that any differences do not raise new questions of safety or effectiveness. This allowed them to forgo clinical testing and rely on non-clinical (electrical safety, EMC, software verification, and validation) testing, alongside a detailed technological comparison.

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