(130 days)
QuietCare-Networked is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. QuietCare-Networked recognizes and monitors certain patterns of activity including but not limited to bathroom and bedroom activity, residence entry/exit, and interaction with food and medication storage.
Caregivers are provided with information and notification about the occurrence of, and changes in, these monitored activity patterns and environmental conditions. Noteworthy occurrences and changes are communicated to caregivers through direct notification (pager, voice alert, email) as well as a secure Internet website.
Data from QuietCare-Networked should not be relied on as medical advice or clinical diagnosis. Caregivers should always rely on licensed medical professionals in making all health decisions and should use the information provided by QuietCare as a resource in that process.
Caregivers should not rely solely on the use of QuietCare-Networked for care management of clients/residents. Caregivers should use standard care practices established within their care organization to ensure the safety and wellness of senior clients/residents.
Care Innovations QuietCare-Networked uses advanced motion sensors to monitor Activities of Daily Living for senior residents who require care assistance. It provides alerts and reporting information to care givers when conditions or trends are detected that indicate the senior resident may need care intervention.
The Intel-GE Care Innovations QuietCare-Networked device is a Class I Bed-Patient Monitor that uses motion sensors to monitor Activities of Daily Living for senior residents.
This submission explicitly states that clinical performance data was not used to demonstrate safety and efficacy. The device's equivalency was established by comparing its technological characteristics to predicate devices. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and adjudication methods is not applicable to this particular 510(k) submission.
The device was deemed substantially equivalent based on similarities in software functionality, data collection methods, sensor types, communication methods, connectivity, communication protocol, and display method to existing commercially distributed predicate devices.
Here's a breakdown of why many of your excellent questions cannot be answered from the provided document:
- Acceptance Criteria & Reported Device Performance: Not provided as no clinical performance study was conducted.
- Sample Size (Test Set) & Data Provenance: Not applicable as there was no test set or clinical study.
- Number of Experts & Qualifications: Not applicable as there was no ground truth establishment by experts for a clinical study.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not conducted or presented.
- Standalone Performance (Algorithm Only): Not performed as a separate clinical study.
- Type of Ground Truth Used: Not applicable, as no clinical ground truth was established for performance evaluation.
- Sample Size for Training Set: Not applicable, as no training set for a clinical algorithm was mentioned.
- How Ground Truth for Training Set was Established: Not applicable.
Summary from the provided 510(k) Notification:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (no clinical performance data was presented) | Not applicable (safety and efficacy demonstrated through substantial equivalence to predicate devices based on technological characteristics) |
Study Details:
The 510(k) submission for the Intel-GE Care Innovations QuietCare-Networked did not rely on an assessment of clinical performance data to demonstrate safety and efficacy. Instead, substantial equivalence was claimed based on a comparison of technological characteristics with predicate devices.
Therefore, the following details are not applicable in this context:
- Sample size used for the test set and data provenance: N/A (no test set/clinical study performed).
- Number of experts used to establish the ground truth for the test set and their qualifications: N/A (no ground truth established for a clinical study).
- Adjudication method for the test set: N/A.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No standalone performance study was described.
- The type of ground truth used: N/A (no clinical ground truth was established).
- The sample size for the training set: N/A (no training set for clinical performance was mentioned).
- How the ground truth for the training set was established: N/A.
The submission concluded that the device introduces no new questions concerning safety or efficacy because its technological characteristics (software functionality, data collection, sensor types, communication methods, connectivity, communication protocol, and display method) are substantially equivalent to the predicate devices.
§ 880.2400 Bed-patient monitor.
(a)
Identification. A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.