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The X-Series System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, transmit, display and store physiological signals from patients ages 6 and older. The X-Series system requires operation by a trained technician. The X-Series System acquires, transmits, displays and stores electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer signals. The X-Series System only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

The X-Series System is indicated for acquiring, transmitting, displaying and storing physiological data in patients. It can be used with ambulatory patients in the home, health care facility, or clinical research environment. The X-Series system requires operation by a trained technician. The X-Series System.is comprised the X10 and X24 Headsets and accessories, Synapse Cream, X-Series Basic Software and BT receiving unit. The X-Series Basic Software is also compatible with the Models X4-E, and X4-M (K130013) when used in wireless mode. The X-Series System combines hardware, firmware and software to acquire physiological signals. It acquires physiological data through a battery powered headset worn by the patient and provides a flexible platform for applying sensors using synapse cream and acquiring signals from multiple locations on the head or body, transmitting and recording the signals and providing visual indications to ensure high quality data are obtained. Model X24 provides for acquisition of twenty channels of electroencephalography (EEG) and four optional channels connected to two sensors via a dual-lead connector. Model X10 provides for acquisition of nine channels of electroencephalography (EEG) and an optional channel connected to two sensors via a dual-lead connector. Both models measure movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by a technician and displays the signals via a wireless connection during acquisition. The X-Series Basic software monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired. The X-Series Basic software provides a means to: a) initiate a study and track patient information, b) acquire and wirelessly transmit signals from the device, c) visually inspect the signal quality. The acquired signals are saved in a universal data format (European Data Format Plus, EDF+) that is intended to be analyzed by a Physician using FDA cleared third party software, i.e. Persyst Software (K011397).

This document describes the X-Series System, an electroencephalograph device for acquiring, transmitting, displaying, and storing physiological data. The submission focuses on demonstrating substantial equivalence to a predicate device (K130013 X4 System) through non-clinical and limited clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document leverages comparison to a predicate device and adherence to recognized standards as its primary acceptance criteria. Performance metrics are largely presented as being equivalent to the predicate.

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

• Non-clinical bench tests (EEG, ECG, Actigraph comparison): The sample size is not explicitly stated as 'n=X' but implies a sufficient number of measurements were taken from the X-Series and predicate devices to compare their performance in a jig and with an oscilloscope/signal generator.
• Biocompatibility: The specific number of items/animals per test is mentioned in the results (e.g., "all the animals," "all test animals").
  • Cytotoxicity: Mammalian cell cultures (mouse fibroblast L929).
  • Sensitization: Albino guinea pigs.
  • Irritation: New Zealand White rabbits.
• Clinical tests (for ages 6+):
  • Sample size: Seven children aged 6-8 and seven adults.
  • Data provenance: "A subset of data from a research study was analyzed." This suggests the data was retrospective and likely collected in a clinical research environment (Country of origin not specified, but likely USA given the FDA submission).

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

• Non-clinical tests: The document implies standard laboratory testing procedures and comparisons to the predicate, overseen by qualified personnel. No specific "experts" for ground truth establishment are mentioned as the tests rely on objective measurements and established standards.
• Clinical tests (for ages 6+): The document states that the acquired EEG recordings "could be further examined in third-party software" by a Physician. While a physician would interpret the EEG, their role in establishing "ground truth" for the device's acquisition capabilities (the focus of this study) is not explicitly detailed. The acceptance criteria here are about the ability to acquire appropriate EEG recordings and data quality equivalence, which are evaluated directly from the device's output. The "ground truth" for this aspect is the objective quality of the signals themselves, compared between subject groups.

4. Adjudication Method for the Test Set:

• No formal adjudication method (like 2+1 or 3+1) is mentioned for any of the studies.
• The non-clinical tests rely on objective measurement against defined specifications or predicate device performance.
• The clinical study for children's EEG acquisition focused on the presence of "appropriate EEG recordings" and data quality equivalence, which would likely be assessed by comparing signal characteristics.

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 MRMC comparative effectiveness study was done.
• The X-Series System is a data acquisition device; it explicitly states, "The X-Series System only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability." It is not an AI-assisted diagnostic tool.

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

• Not applicable. This device is purely for data acquisition and display, to be interpreted by a physician using separate (third-party) software. There is no algorithm providing diagnostic or analytical output within the X-Series System itself.

7. The Type of Ground Truth Used:

• Non-clinical/Bench tests: Objective measurements (e.g., signal generator output, oscilloscope readings, defined angles for actigraph, standard test methods for biocompatibility and cleaning). The comparison to the predicate device serves as a de facto "ground truth" for performance equivalence where applicable.
• Clinical tests (for ages 6+): The "ground truth" for this specific study was the presence of "appropriate EEG recordings" and subjectively assessed "equivalent data quality" for the acquired signals between age groups. This relies on the qualitative assessment of electrical signal characteristics typically reviewed by trained professionals.

8. The Sample Size for the Training Set:

• Not explicitly stated, nor is a dedicated "training set" relevant for this device. The X-Series System is a data acquisition device, not a machine learning model that requires a training set. The clinical study for ages 6+ was a validation of its acquisition capabilities, not for training an algorithm.

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

• Not applicable, as no training set was used for a machine learning algorithm.

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The X4 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals from adult patients. The X4 System acquires, records, transmits and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), accelerometer, acoustical and photoplethesmographic signals. The X4 system only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

The X4 system is used for configurable acquisition of physiological signals. Model X4-E provides for acquisition of three channels of electroencephalography (EEG) and one photoplethesmographic (PPG) signal from a head strip, with an optional channel connected to two sensors via a dual-lead connector with twice the gain. Model X4-M provides four channels of EEG with the dual-lead connector providing the input for reference sensors. Both models measure sound via an acoustic microphone, and movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by the patient and to record data. Alternatively, a technician can affix the device and display the signals via a wireless connection during acquisition. The X4 system firmware monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired.

The X4 software provides a means to: a) initiate a study and track patient information, b) acquire and save signals to the memory of the device, c) acquire and wirelessly transmit signals from the device, d) upload data saved in the memory of the device to a PC, and e) visually inspect the signal quality.

The acquired signals are saved in a universal data format (European Data Format - EDF). The study record, once saved on the PC, is available for analysis by Advanced Brain Monitoring's Sleep Profiler software application. The X4's downloaded study will reside on either or local PC or a cloud server, which can be a physical or virtual server. Software on the cloud server is accessed via web portal software.

The Advanced Brain Monitoring, Inc. X4 System (K130013) is a device for configurable acquisition of physiological signals, including EEG, EOG, ECG, EMG, accelerometer, acoustical, and photoplethysmographic signals. It is intended for prescription use in various environments to acquire, record, transmit, and display these signals from adult patients.

The documentation indicates that no clinical studies were performed to establish substantial equivalence for this particular submission (K130013). Instead, the determination of substantial equivalence was based on non-clinical tests, specifically focusing on risk management and software testing. The X4 System (K130013) is described as identical to a previously cleared X4 System (K120447), with the only change being the development of a Device Manager Module accessible via a web portal, which duplicates functions already present in the PC software.

Therefore, the following information is based on the provided text, and it's important to note that the acceptance criteria and performance are related to the software functionality as evaluated for this specific 510(k) submission, rather than the accuracy of physiological signal acquisition, for which no new claims are being made.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the test set. The evaluation was based on "thoroughly tested through verification of specifications and validation, including software validation." This typically implies a systematic testing process of software functions rather than a patient-based test set size.
• Data Provenance: Not applicable in the context of this software-focused non-clinical evaluation. The tests were performed on the software itself.

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 this software evaluation was the expected functional behavior of the software, as defined by its specifications. The evaluation confirmed whether the software performed these functions identically between two interfaces (desktop vs. web portal). This does not involve expert interpretation of data.

4. Adjudication method for the test set

Not applicable. As the testing focused on software functionality and identical performance, adjudication methods typically used in clinical studies (e.g., 2+1, 3+1) were not employed. The performance was assessed by direct comparison of software behavior.

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. An MRMC comparative effectiveness study was not done. The device does not involve AI for interpretation or human-in-the-loop assistance. The device is for signal acquisition and display only, and "no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability."

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

Yes, in a sense, but not for diagnostic interpretation. A standalone software functionality verification and validation was done for the Device Manager module. This evaluated the module's ability to perform its specified tasks (formatting device, uploading study info, downloading data, uploading firmware) independently and identically across different interfaces (desktop vs. web portal). This is an algorithm/software-only evaluation for its operational functions, not for clinical diagnostic performance.

7. The type of ground truth used

The ground truth used was the functional specifications and expected behavior of the Device Manager software. The verification and validation activities confirmed that the software's performance matched these predefined specifications, particularly that its functions were identical between the desktop and web portal versions.

8. The sample size for the training set

Not applicable. As this submission focused on software functionality and its equivalence to a predicate, there was no machine learning component, and thus, no "training set."

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

Not applicable, as there was no training set.

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The Apnea Risk Evaluation System (ARES™), Model 610 is indicated for use in the diagnostic evaluation by a physician of adult patients with possible sleep apnea. The ARES™ can record and score respiratory events during sleep (e.g., apneas, hypopneas, mixed apneas and flow limiting events). The device is designed for prescription use in home diagnosis of adults with possible sleep-related breathing disorders.

The Apnea Risk Evaluation System (ARES™) includes a device called a Unicorder which records oxygen saturation, pulse rate, snoring level, head movement and head position, airflow, and a physiological signal from the forehead used to stage sleep. The battery powered Unicorder provides sufficient capacity to record two nights of data. The device monitors signal quality during acquisition and notifies the user via voice messages when adjustments are required. A standard USB cable connects the Unicorder to a USB port on a host computer when patient data is to be uploaded or downloaded. The USB cable provides power to the Unicorder during recharging from the host computer or from a USB wall charger. The Unicorder cannot record nor can it be worn by the patient when connected to the host computer or the wall charger. Software controls the uploading and downloading of data to the Unicorder, processes the sleep study data and generates a sleep study report. The ARES can auto-detect positional and non-positional obstructive and mixed apneas and hypopneas similarly to polysomnography. It can detect sleep/wake and REM and non-REM. After the sleep study has been completed, data is transferred off the Unicorder is prepared for the next study. The downloaded sleep study record is then processed with the ARES™ Insight software to transform the raw signals and derive and assess changes in oxygen saturation (SpO2), pulse rate, head movement, head position, snoring sounds, airflow, and EEG. The red and IR signals are used to calculate the SpO2 and pulse rate. The actigraphy signals are transformed to obtain head movement and head position. ARES™ Screener can predict pre-test probability of obstructive sleep apnea (OSA). The ARES can assist the physician to identify patients who will likely have a successful OSA treatment outcome, including CPAP and oral appliance therapies. ARES™ can also help identify patients who would benefit from a laboratory PAP titration.

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 for Clinical Tests: 14 subjects.
• Number of Overnight Sleep Studies: 20.
• Data Provenance: Not explicitly stated, but the study was conducted to compare the new model to the predicate, implying it was likely a prospective study undertaken specifically for this submission. The country of origin is not specified.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. The study focused on comparing the performance of the stabilizing strap and enclosure pad of the ARES™ Model 610 to the ARES™ Model 600 regarding signal quality, comfort, and pressure. It appears to be a technical comparison rather than a diagnostic accuracy study requiring expert-established ground truth for medical outcomes.

4. Adjudication method for the test set

Not applicable. The clinical study was a direct comparison of physical components (stabilizing strap and enclosure pad) between two device models, focusing on comfort and pressure applied, rather than a diagnostic accuracy study that would typically involve adjudication of diagnostic outcomes.

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 submission is for a modified version of an existing device (ARES™ Model 610 vs. ARES™ Model 600) and focused on demonstrating equivalent performance of physical components and compliance with safety and performance standards, not on AI assistance for human readers.

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

The document does not explicitly state that a standalone (algorithm only) performance study was conducted. The main clinical study focused on the physical components of the device (stabilizing strap and enclosure pad) and ensuring equivalent signal quality and comfort compared to the predicate device. The ARES™ Insight software processes sleep study data and auto-detects events, which implies an algorithm, but a standalone performance study with metrics like sensitivity/specificity for these detections (separate from the physical modifications) is not detailed in this submission.

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

For the clinical study described, the "ground truth" was related to the equivalent signal quality, comfort, and pressure applied to the forehead sensor as compared to the predicate device. This was likely assessed via subjective feedback (comfort) and objective measurements of signal quality, with the predicate device (Model 600) serving as the reference for equivalence. It wasn't about diagnostic accuracy for sleep apnea via expert consensus, pathology, or outcomes data in this specific submission.

8. The sample size for the training set

The document does not mention the sample size for a training set. This submission is for a modification of an existing device, and the testing described is primarily for demonstrating equivalence and compliance with standards for the modified hardware, not for developing or training a new algorithm.

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

Not applicable, as no training set or its ground truth establishment is described in this submission.

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