(113 days)
The SOMNOwatch is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having movement-correlated sleep disturbances.
The SOMNOwatch is a small, portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical events 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 SOMNOwatch is a small, typically wrist-worn activity monitor. The device is intended to be used to analyze circadian rhythms, automatically collect and score data for sleep parameters. These parameters, representing the number and intensity of limb movements, are directly associated to movement-correlated sleep disturbances. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desired. For PLM-detection two identical SOMNOwatches may be affixed to the patients legs, one to each leg.
The SOMNOwatch 510(k) Premarket Application (K081485) describes the device, its intended use, and a summary of nonclinical and clinical testing. However, it does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) or provide a detailed study that proves the device meets such criteria. Instead, the submission focuses on establishing substantial equivalence to predicate devices primarily through nonclinical performance testing and a "clinical comparison" study, without providing quantitative results against predefined thresholds.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain explicit numerical acceptance criteria or quantifiable performance metrics (like sensitivity, specificity, or accuracy for diagnosing sleep disturbances) for the SOMNOwatch itself. The "reported device performance" is broadly stated as:
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Compliance to device specifications | All functions were verified to operate as designed. |
| Compliance to international standards for electrical safety and electromagnetic compatibility | Found to be compliant with the requirements of these standards for its intended use. |
| Safety and effectiveness outcomes substantially equivalent to predicate devices | Clinical comparison studies found the subject device can be expected to provide safety and effectiveness outcomes substantially equivalent to the predicates. |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document only mentions "clinical comparison studies" without detailing the number of participants or the data size.
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The document does not describe how ground truth was established for any clinical comparison.
4. Adjudication method for the test set
Not specified. There is no mention of an adjudication method.
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 study was described. The SOMNOwatch is an activity recording device that provides raw data and analysis software (DOMINOlight) but the document does not discuss human reader performance improvement with or without AI assistance. The focus is on the device's ability to record and score data for sleep parameters related to movement-correlated sleep disturbances.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is intended to "automatically collect and score data for sleep parameters," implying a standalone algorithmic analysis. The "DOMINOlight software retrieves the data from the SOMNOwatch, displays the data, and can store data for future reference and comparison. DOMINOlight also allows automatic analysis of all signals including the body position." However, no specific standalone performance metrics (e.g., for automated PLM detection accuracy) are provided in this summary. The evaluation focuses on equivalence to predicate devices rather than direct algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not specified. The document does not describe the specific type of ground truth used in its "clinical comparison studies." Given the device's function to "automatically collect and score data for sleep parameters" related to movement, it's possible that the comparison was against similar data from predicate devices or established polysomnography (PSG) techniques, but this is not explicitly stated.
8. The sample size for the training set
Not applicable/Not specified. The document does not mention a training set, as it does not describe the development or validation of a new AI/ML algorithm through traditional training/testing splits with a separate training set. The clinical evaluation mentioned is a "comparison study" to predicate devices for substantial equivalence.
9. How the ground truth for the training set was established
Not applicable/Not specified as no training set was described.
§ 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).