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510(k) Data Aggregation
(228 days)
The Spire Health Remote Patient Monitoring System is intended for reusable bedside and mobile multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The Spire Health Remote Patient Monitoring System is intended for longitudinal monitoring of the following parameters in adults:
- Pulse Rate
- Respiratory Rate
- Sleep/Wake Behavior
- Activity associated with Movement
The Spire Health Remote Patient Monitoring System is intended only for general, non-diagnostic sleep and wake behavioral monitoring. It is not intended to assess sleep staging nor diagnose sleep disorders.
The Spire Health Remote Patient Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Spire Health Remote Patient Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG.
The Spire Health Remote Patient Monitoring System is not a substitute for an ECG monitor.
The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data and share this data with healthcare providers with a view to improving patient health and outcomes. The RPM is intended for longitudinal monitoring of pulse rate, respiratory rate, sleep/wake behavior, and activity associated with movement.
The RPM solution is comprised of four components - a Medical Health Tag (MHT), a Spire Mobile Application (Mobile App), a Cloud Platform (Platform) and a Healthcare Professional Dashboard (HPD). The patient facing components of the MHT and Mobile App) are intended for daily use in professional healthcare facilities or in the home. The MHT is a component designed to be affixed semi-permanently via an adhesive backing to the patient's first layer of clothing (e.g. underwear, bras, or pajamas), passing through laundry cycles without detaching. It does not require charging by the user.
The Spire Health Remote Patient Monitoring System was evaluated for various performance metrics, including Pulse Rate and Respiratory Rate Validation, and Activity associated with Movement Validation.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pulse Rate Validation | The RPM was tested to confirm the accuracy of pulse rate monitoring of the system in accordance with ISO 80601-2-61. Detailed acceptance criteria for ISO 80601-2-61 are not provided in the document, but it generally refers to standards for basic safety and essential performance of medical electrical equipment. | PASS |
| Respiratory Rate Validation | The RPM was clinically tested in comparison to end-tidal CO2 to confirm the accuracy of respiration rate measurement. Specific numerical acceptance criteria (e.g., accuracy range relative to end-tidal CO2) are not provided in the document. | PASS |
| Activity associated with Movement Validation | The RPM was clinically tested to confirm the accuracy of the activity tracking. Specific numerical acceptance criteria (e.g., accuracy against a gold standard for movement tracking) are not provided in the document. | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide specific details on the sample sizes used for the test sets for Pulse Rate, Respiratory Rate, or Activity associated with Movement Validation. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
The document does not specify the number of experts used to establish the ground truth for any of the test sets, nor does it detail their qualifications.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for the test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size of human readers improving with AI vs. without AI assistance. This type of study appears to be not applicable to the reported performance evaluations which focus on device accuracy for physiological parameters and activity.
6. Standalone Performance:
Yes, a standalone performance evaluation was done for the algorithm (device itself) without human-in-the-loop performance, as indicated by the "Pulse Rate Validation," "Respiratory Rate Validation," and "Activity associated with Movement Validation" tests. These tests assess the intrinsic accuracy and functionality of the device's measurements.
7. Type of Ground Truth Used:
- Pulse Rate Validation: Ground truth was established by comparison to the standards outlined in ISO 80601-2-61.
- Respiratory Rate Validation: Ground truth was established through a clinical comparison to end-tidal CO2.
- Activity associated with Movement Validation: Ground truth was established through clinical testing to confirm accuracy, though the specific reference method is not detailed.
8. Sample Size for the Training Set:
The document does not provide details on the sample size used for any training set for the device's algorithms.
9. How Ground Truth for the Training Set Was Established:
The document does not provide information on how ground truth was established for any training set.
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