(41 days)
The SOMNOscreen EEG10-20 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 EEG10-20 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.
The SOMNOscreen EEG10-20, a portable physiological signal recording system, did not undergo a study with acceptance criteria in the provided documentation. Instead, its substantial equivalence to a predicate device, the Somnomedics SOMNOscreen (K060708), was established through performance testing and a comparison of technological characteristics.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Compliance to Device Specifications | All functions operate as designed; measured parameters meet required ranges and accuracies. | Confirmed, all functions verified to operate as designed. Measured parameters met required ranges and accuracies. |
| Electrical Safety | Compliance with international standards for electrical safety. | Found to be compliant with the requirements of these standards. |
| Electromagnetic Compatibility (EMC) | Compliance with international standards for electromagnetic compatibility. | Found to be compliant with the requirements of these standards. |
| Consistency with Predicate Device (K060708) | Only difference is the number of AC-Channels; no new concerns about safety and effectiveness; identical indications for use; consistent labeling; same principles of operation and technological characteristics. | SOMNOscreen EEG10-20 provides up to 40 channels (22 AC Channels, 20 Referential, 11 Respiratory and AUX, 7 Internal). Predicate Device (K060708) provides up to 28 channels (10 AC Channels, 8 Referential and 2 Differential, 11 Respiratory and AUX, 7 Internal). This difference in channel count was deemed not to raise new safety or effectiveness concerns, maintaining substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The submission describes performance testing for device specifications and compliance with standards, not a clinical study with a patient test set.
- Data Provenance: Not applicable. The testing was described as "performance testing" and "testing to the international standards," which implies internal device validation rather than clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This information is not provided because no clinical (human subject) test set requiring expert adjudication was conducted for this 510(k) submission.
4. Adjudication Method
- Not applicable. No clinical test set requiring ground truth establishment through expert adjudication was mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not described in the provided text. The device is a physiological signal recording system, and the submission focuses on its technical performance and equivalence to a predicate, not on human reader interpretation or AI assistance.
6. Standalone Performance Study
- Yes, effectively. The performance testing described ("Performance testing was conducted to confirm compliance to device specifications; all functions were verified to operate as designed. Measured parameters met required ranges and accuracies.") can be considered a standalone assessment of the device's functional performance, albeit at a technical level rather than a clinical performance (e.g., diagnostic accuracy) level. The submission is for a recording device, not an analytical algorithm.
7. Type of Ground Truth Used
- Technical specifications/Compliance Standards. The "ground truth" for the performance testing was derived from the device's technical specifications and the requirements of international standards for electrical safety and electromagnetic compatibility. This is not clinical ground truth like pathology or expert consensus.
8. Sample Size for the Training Set
- Not applicable. This device is a physiological signal recording system, not an AI/ML algorithm that requires a training set of data for development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device is not an AI/ML algorithm, it does not have a training set.
§ 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).