(203 days)
The Somnitor 32K Activity Monitor is intended to monitor physical activity with an ambulatory monitoring and data logging device and after downloading the data to a personal computer, determine the periods when the patient was awake or sleeping using a validated algorithm.
The Somnitor 32K Activity Monitor is a wrist worn device consisting of an activity (movement) detector and a data logger with internal data storage. The device is used with a personal computer running software which can download data from the data logger and analyze it according to a validated algorithm to determine periods of sleep and wakefulness. Four algorithms for assessing sleep activity data may be used for analysis, including the Bounded Trigger algorithm, the Cole algorithm, the Sadeh algorithm, and a new Neurim algorithm.
The provided text describes the NEURIM SOMNITOR 32K ACTIVITY MONITOR DEVICE, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results for performance validation against specific acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's what can be inferred or stated as missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document primarily focuses on substantial equivalence to a predicate device, not on specific performance metrics or acceptance thresholds for a new study. | Not provided in the document. The document states that the device uses "validated algorithm[s]" but does not present the results of such validation or specific performance metrics. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Adjudication method: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Was it done?: Not specified. The document does not describe any human reader studies, with or without AI assistance.
- Effect size: Not applicable as no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Was it done?: Not explicitly stated with performance metrics. The document mentions "validated algorithm[s]" but provides no details of a standalone performance study.
7. The type of ground truth used:
- Type of ground truth: Not specified.
8. The sample size for the training set:
- Sample size: Not specified.
9. How the ground truth for the training set was established:
- How established: Not specified.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.