(314 days)
The SOMNOscreen is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having sleep-related breathing disorders.
The SOMNOscreen is indicated for use in the recording, displaying, monitoring, and storage of biophysical parameters for the purpose of assisting in the diagnosis of Neurological and Sleep Disorders.
The SOMNOscreen is a portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical events to aid in the diagnosis of neurologic and sleep disorders. 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 a Life Support situation. This device is not designed for use on patients with cardiac pacemakers.
The system provides up to 28 channels for data acquisition; 10 AC Channels, 8 Referential and 2 Differential, 11 Respiratory and AUX Channels, 7 Internal Channels (SPO2, Pulse Rate, Plethysmogram, Body Position, Light, Patient Marker, Thorax/Abdominal Respiratory Effort)
The SOMNOscreen is available in 6 different configurations. All configurations include a Compact Flash Card and Reader, Li ION Batteries, (2000mAh) with 1 x Battery Charger, a Carry Bag for housing the SOMNOscreen and Sensors, Instruction Manuals and the DOMINO software for Initialization, Data Transfer and Analysis.
Here's a summary of the acceptance criteria and study details for the Somnomedics SOMNOscreen based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative "acceptance criteria" for the SOMNOscreen's clinical performance. Instead, it states that the device's clinical performance was found to be "equivalent to the predicate Sleepscreen and the manual scored Polysomnography." Therefore, the reported device performance is its equivalence to these established methods.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Clinical performance equivalent to predicate device (Sleepscreen/ApnoeScreen Cardio) | The SOMNOscreen's clinical performance is equivalent to the predicate Sleepscreen. |
| Clinical performance equivalent to manual scored Polysomnography (PSG) | The SOMNOscreen's clinical performance is equivalent to manual scored Polysomnography. |
| Compliance with international standards for electrical safety and EMC | The SOMNOscreen was found to be compliant with these standards. |
| Functions operate as designed; measured parameters meet required ranges and accuracies | All functions verified to operate as designed; measured parameters met required ranges and accuracies. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 25 patients
- Data Provenance: Not explicitly stated, but the applicant (Somnomedics GmbH & Co.KG) is based in Kist, Germany. It is common for clinical studies associated with German manufacturers to originate from Germany or other European countries; however, this is not confirmed in the document. The study evaluates the device "when used as intended in the targeted patient population," implying prospective data collection for this validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document states that the comparison was made against "manual scored Polysomnography." This heavily implies that sleep experts (e.g., polysomnography technologists, sleep physicians) were involved in scoring the PSG data, which would serve as the ground truth. However:
- Number of experts: Not specified.
- Qualifications of experts: Not specified, but generally, manual PSG scoring is performed by registered polysomnographic technologists (RPSGTs) and interpreted by board-certified sleep physicians.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "manual scored Polysomnography" itself is considered the reference standard, and deviations from this standard for the SOMNOscreen's output would be assessed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The study described compares the SOMNOscreen to a predicate device and manual PSG. It does not appear to be an MRMC study designed to evaluate the improvement in human reader performance with or without AI assistance. The SOMNOscreen, as described, is a physiological signal recording system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations that would then be reviewed by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The study evaluates the "clinical performance of the SOMNOscreen" itself against predicate devices and manual PSG. While a human would still interpret the output from the SOMNOscreen, the study aims to validate the device's ability to record, display, monitor, print, and store biophysical events reliably, standalone from a human "AI assistance" workflow. The device does not appear to have an AI component for automated interpretation that would undergo a separate standalone performance evaluation.
7. The Type of Ground Truth Used
The ground truth used was manual scored Polysomnography (PSG), which is typically considered the gold standard for sleep disorder diagnosis.
8. The Sample Size for the Training Set
The document does not mention a training set or any details about an algorithm that would require one. The SOMNOscreen is described as a physiological signal recording system, implying it captures raw physiological data rather than employing a machine learning algorithm that would need training.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned and the device appears to be a data acquisition system rather than an AI/ML-based interpretive algorithm, this information is not applicable and not provided in the document.
§ 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).