Search Results

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.

Ask a specific question about this device

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) that is intended to be analyzed with third party software, including Advanced Brain Monitoring's Sleep Profile Software (K120450).

The provided text describes the X4 System, a device for acquiring physiological signals. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and a limited clinical study.

Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the X4 System, as articulated in the clinical tests, is based on the interpretability of the acquired signals and the ease of device application.

Study Details for Acceptance Criteria

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

• Test set sample size: While a specific number for the sample size for the clinical test is not explicitly stated, it refers to "all subjects" and "over 90% of studies recorded overnight." This suggests a prospective clinical study involving multiple subjects.
• Data provenance: Not explicitly stated, but the context of a 510(k) submission to the FDA for a US company suggests it would likely involve data from the US, potentially a prospective clinical trial.

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)

• The summary states that "signals acquired with the X4 System provide similar information as compared to the predicate device that would allow a physician to interpret the signals." and that "over 90% of studies recorded overnight with the X4 are interpretable."
• This implies that physicians are the experts who would interpret the signals to determine interpretability. However, the number of experts and their specific qualifications (e.g., board-certified sleep physicians, neurologists, years of experience) are not specified in the provided text.

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

• The text does not specify an adjudication method. It mentions that "physicians" would interpret the signals, but it does not detail how potential disagreements among interpreters would be resolved or if multiple interpreters were used for each case.

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 X4 System is described as a device for acquiring, recording, transmitting, and displaying physiological signals, with "no claims being made for analysis of the acquired signals with respect to the accuracy, precision and reliability." This indicates that the device itself does not perform AI-assisted analysis and therefore, a study on human reader improvement with AI assistance would not be applicable to this submission.

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

• No, a standalone (algorithm only) performance study was not done.
• The device's intended use is to acquire, record, transmit, and display physiological signals. It explicitly states "no claims are being made for analysis of the acquired signals." Thus, there is no standalone algorithm being evaluated for diagnostic or analytical performance.

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

• The ground truth for the clinical study appears to be expert interpretation (physician interpretability) of the acquired signals. The study aimed to demonstrate that the signals are "interpretable" and "behave as expected," which would rely on a physician's assessment.

8. The sample size for the training set

• Not applicable / Not provided. The X4 System is a signal acquisition and display device, not an analytical or AI-driven system. Therefore, it does not involve a "training set" in the context of machine learning algorithms.

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

• Not applicable. As a signal acquisition device without analytical claims, there is no training set or associated ground truth establishment process for algorithm training.

Ask a specific question about this device