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510(k) Data Aggregation
(100 days)
The X8 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. All X8 models (SP40, SP29, and XS29) acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals. Model SP29 additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. The X8 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 X8 System is indicated for acquiring, recording/storing, transmitting, and displaying physiological data in patients. It can be used by patients in the home, healthcare facility, or clinical research environment. Patients can move within their home or healthcare environment without having to remove the device (e.g. walk to the restroom).
The X8 System is comprised of the X8 device which is worn on the patient's head and body, accessories, the Device Manager software, and the X-Series Basic-Utility Software. The study records are saved to the PC in EDF format and are available for analysis by third party software applications, such as Persyst Reveal (K011397).
The X8 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 and acquiring signals from multiple locations on the head or body, transmitting and recording the signals, and providing visual and auditory indications to ensure high quality data are obtained.
Model SP40 Sleep Profiler is applied by the patient to acquire and record electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals during sleep. This model utilizes the X8 Sleep Profiler Strip.
Model SP29 Sleep Profiler PSG2 is applied by the patient to acquire and record electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals during sleep. This model additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. This model utilizes the X8 Sleep Profiler Strip.
Model XS29 X8 Stat is applied by a technician to acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals acquired during non-sleep conditions. This model utilizes either the X8 Midline or the X8 Referential strip.
The Device Manager software application provides a means to communicate with the X8 Device, transfer study data, and format a device. The software transfers data saved in the memory of the X8 device using either a PC application or a web-based data entry application operating in a cloud server environment.
The X-Series Basic-Utility Software acquires, presents, and stores physiological signals from the X8 Device. The software has a modular architecture that allows the users to interact using either the Graphical User Interface (GUI) provided with the installation, or programmatically via a Software Development Kit. Additional functionalities provided by X-Series Basic-Utility Software include impedance measurements, custom markers, and interface with the Bluetooth Receiving Dongle.
Here's a breakdown of the acceptance criteria and study details based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Device: X8 System (Sleep Profiler (SP40), Sleep Profiler PSG2 (SP29), Stat X8 (XS29))
Study Type: Prospective Comparison and Self-Application Study of X8 System Model SP29
| Acceptance Criterion (Primary Endpoint) | Reported Device Performance and Outcome |
|---|---|
| A) Comparison of Signals (X8 System airflow and respiratory effort vs. predicate device Compumedics Somte (K072201)) | |
| No more than 10% of the breathing events recorded with the X8-PSG2 airflow signal were inferior to predicate signal. | Achieved: No events recorded with the X8-PSG2 airflow signal (0%) were found inferior to the predicate signal. |
| No more than 20% of the breathing events recorded with the X8-PSG2 respiratory effort will be inferior to the predicate signal. | Achieved: The X8 thorax and abdomen belts were inferior to the predicate in only 4.0% (9/225) and 1.3% (3/232) of the events, respectively (both well below 20%). |
| B) Demonstrate that high quality signals can be obtained when the X8 System is self-applied with the user instructions. | |
| At least 80% of subjects will be able to acquire at least one night of data (i.e., the entire period they were in bed). | Achieved: 91% (10 of 11 subjects) were able to acquire at least one night of data for the entire night. |
| At least 70% of each night of recording time will be valid across the oximetry, nasal pressure, and effort belt signals. (While not identified as a primary endpoint for cardio-respiratory signal quality, high EEG quality was also assessed.) | Achieved: The percentage of good data obtained for oximetry, nasal pressure (airflow), and respiratory effort (thorax and abdomen) exceeded 90% on each night. High EEG quality was also obtained in over 90% of the recording time on each night. |
| At least 70% of subjects did not report X8-PSG2 audio alerts (for signal quality) substantially affected (i.e., strongly agreed) their ability to stay asleep. | Achieved: 90% (9 of 10 subjects) did not "strongly agree" that the PSG2 made it difficult for them to stay asleep. (Note: One subject was excluded from this calculation, resulting in 10 subjects for this specific endpoint, even though 11 were initially reported for data acquisition ability). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For comparison of airflow and respiratory effort signals (part A of the study): The specific number of breathing events analyzed is provided (225 for thorax, 232 for abdomen), but the number of subjects contributing to these events is not explicitly stated.
- For self-application and signal quality (part B of the study): 11 subjects.
- For audio alerts acceptance criterion: 10 subjects (one subject was excluded from this analysis).
- Data Provenance: The study was described as "prospective," indicating that the data was collected specifically for this study under controlled conditions defined prior to data collection. The document does not specify the country of origin for the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth for this comparative study. However, the ground truth for part A (comparison of signals) was implicitly the readings from the predicate device, Compumedics Somte (K072201), an FDA-cleared device. For part B (self-application and signal quality), the ground truth for signal quality likely involved assessment against predefined criteria or by qualified personnel, but this is not detailed.
4. Adjudication Method for the Test Set
The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). For the comparative study (part A), the comparison was against an "FDA cleared device," implying the predicate device's output served as the reference standard. For self-application (part B), signal quality was assessed, presumably against accepted norms for such physiological signals, but no multi-expert adjudication process is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, 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 conducted or described in this document. The X8 System "acquires and displays physiological signals; no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability." Therefore, this device does not involve AI analysis or human reader interpretation for diagnostic claims, but rather accurate signal acquisition.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device's intended use is to "acquire, record, transmit, and display physiological signals." It does not include automated analysis or diagnostic algorithms. Therefore, a standalone algorithm performance study was not applicable and not done. The focus of the performance study was on the quality and equivalence of the acquired physiological signals.
7. The Type of Ground Truth Used
- For comparison of airflow and respiratory effort signals (Part A): The ground truth was based on the signals obtained from an FDA-cleared predicate device (Compumedics Somte (K072201)).
- For self-application and signal quality (Part B): The ground truth for "valid" recording time and "high EEG quality" would have been established by assessing the acquired physiological signals against accepted physiological standards and criteria for signal integrity, likely by trained professionals. The specific method of establishing this ground truth is not detailed beyond the term "good data."
8. The Sample Size for the Training Set
The document describes "prospective studies" for verification and validation. Given that the device's function is signal acquisition and display, and no claims for analysis accuracy or reliability are being made, there isn't a "training set" in the context of machine learning. The studies described are performance evaluations of the hardware and software's ability to accurately capture and transmit signals.
9. How the Ground Truth for the Training Set Was Established
As noted above, no "training set" in the machine learning sense is described for this device. The ground truth for performance evaluation was established through comparison with a predicate FDA-cleared device and assessment against physiological signal quality standards.
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