(302 days)
The SOMNOtouch RESP is a portable physiological signal recorder. It is indicated for use in the recording, displaying, monitoring, printing, and storage of biophysical parameters for the purpose of assisting in the diagnosis of sleep disorders and sleep related respiratory disorders of adult patients. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home.
This device is NOT designed to be used in life support situations.
The SOMNOtouch™ RESP is a small, portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical parameters to aid in the diagnosis of sleep disorders. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home.
The SOMNOtouch™ RESP consists of the following:
- The recording device (worn on the thorax),
- the finger probe, which is used to detect SpO2,
- the external effort sensor,
- two effort belts to measure thoracic and abdominal expansion,
- the nasal cannula.
- the Software DOMINOlight for visualization of the recorded data.
The SOMNOtouch™ RESP typically will be worn at the thorax, attached by a thorax belt. It contains a sensor to measure the respiratory effort signal of the thorax. The device has an internal accelerometer, measuring body position and motion activity. It provides a connector to attach a nasal cannula, which allows the recording of respiratory flow and snore signals with the internal pressure sensor. Arterial oxygen saturation (SpO2) and pulse rate can be determined via a pulse oximetric finger sensor. Abdominal respiratory effort is measured with an external sensor, attached with a belt to the abdomen. This information is stored in the internal memory of the device.
The system provides up to 10 internal channels for data acquisition, Pressure/Flow, Thoracic Effort, SpO2, Pulserate, Snoring, Finger Plethysmogram, Body Position, Movement, Patient Marker, CPAP, and 1 external Abdominal Effort Sensor. The data from all channels can be recorded separately or in any combination with the other channels.
Information is stored on an internal 512 MB flash memory and can be transferred to a PC via a USB docking station. The DOMINOlight software retrieves the data from the SOMNOtouch™ RESP, displays and analyzes the data, and can store data for future reference and comparison. The SOMNOtouch RESP does not provide automatic diagnosis and is not designed to be used in Life Support situations.
The SOMNOtouch™ RESP device is a portable physiological signal recorder used to assist in diagnosing sleep disorders and sleep-related respiratory disorders in adult patients. The acceptance criteria and supporting study details are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implicit from Equivalence) | Reported Device Performance |
|---|---|---|
| Clinical Performance | Ability to detect breathing events (hypopnea and apnea) with comparable quality to the predicate device (SOMNOscreen, K060708). | The clinical study aimed to assess SOMNOtouch™ RESP's ability to detect breathing events like hypopnea and apnea during sleep with comparable quality to the results from the predicate device. Statistical evaluation included regression analysis and sensitivity/specificity calculation for Apnea-Hypopnea Index (AHI). The comparison found the subject device can be expected to provide safety and effectiveness outcomes substantially equivalent to the predicates. |
| Safety | Compliance with electrical safety and electromagnetic compatibility standards. | Compliant with DIN EN 60601-1 and DIN EN 60601-1-2. No nonconformities detected. No adverse effects or complications occurred during the clinical study. |
| Functionality | All functions operate as designed and comply with device specifications. | All functions were verified to operate as designed. All tests were passed successfully. |
2. Sample Size and Data Provenance (for test set, which is the clinical study)
- Sample Size: "Subjects were recruited out of the regular patient collective of the sleep lab where the study was conducted." The exact number of subjects is not specified in the provided text.
- Data Provenance: The study was performed in a "professional sleep lab" in Germany (based on the applicant's country). This indicates prospective data collection for the purpose of the study.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: "different qualified professionals"
- Qualifications of Experts: Not explicitly stated beyond "qualified professionals". It is implied that they are qualified to manually score sleep study data.
4. Adjudication Method (Test Set)
- The text states: "Data sets were scored manually by different qualified professionals." This implies independent scoring of the data by multiple experts, but it does not specify an adjudication method like 2+1 or 3+1 for resolving discrepancies.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done regarding human readers' improvement with or without AI assistance. The study described compares the device's performance to a predicate device, not the impact on human reader performance.
6. Standalone Performance Study
- Yes, a standalone study was performed. The clinical study evaluated the SOMNOtouch™ RESP's ability to detect breathing events and provide AHI measurements, which is the algorithm's direct output. The comparison was to the predicate device's output, indicating a standalone assessment of the new device.
7. Type of Ground Truth Used
- Expert Consensus: The ground truth for the clinical study was established by "manual scoring by different qualified professionals" of the sleep study data.
8. Sample Size for the Training Set
- The document does not provide information on a training set or its sample size. This submission is for a medical device that records physiological signals for diagnosis, and the "clinical study" described is a validation study rather than directly evaluating an AI/ML algorithm that would typically require a training set. The device itself performs measurements and records data, which are then manually interpreted by experts.
9. How the Ground Truth for the Training Set Was Established
- As no training set is mentioned or implied for an AI/ML algorithm, this information is not applicable.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).