(315 days)
Sleepiz One+ is a contactless medical device intended to measure heart rate and respiration rate in adult patients, at rest or during sleep (in non-motion condition).
The Sleepiz One+ hardware unit is intended to be used by a healthcare professional when the recordings are performed in a clinical setting, or by patients or their caregivers when the recordings are performed in a home environment. The Sleepiz One+ web application is Intended for use by healthcare professionals.
Sleepiz One+ device can also detect the presence of patients and their body movements at rest or during sleep. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not indicated for use on pregnant women or patients with active implantable devices.
Sleepiz One+ is a contactless medical device that uses radar technology to measure respiration rate and heart rate. The device is placed on a bedside table or a stand, mounted slightly higher than the mattress level, from where it detects the presence of a patient and their physiological signals. From that position, distance changes between the device and the patient's body are captured by Doppler radar. The recorded signals are then transmitted to the cloud software where these are analyzed by the signal processing software ("Sleep Analytics Software") to obtain respiration rate, heart rate and facilitate the monitoring of the presence of the patient and their body movement. These outputs are then displayed on the web application to allow the annotation of the data, compilation of results into reports, and the management of the hardware units.
Here's a breakdown of the acceptance criteria and study information for the Sleepiz One+ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Respiration Rate Accuracy | The subject device performs comparably to established methods for respiration rate measurement. | Compared to Respiratory Effort Belt: |
- Accuracy: +/- 3 breaths per minute (99% accuracy rate)
- 95% Limits of Agreement: -1.42 to 0.97 breaths/min (for neurorehabilitation ward patients)
- 95% Limits of Agreement: -1.3 to 0.8 breaths/minute (for patients suspected of sleep apnea)
Compared to end-tidal CO2 (etCO2) via capnography:
- Accuracy: +/- 2 breaths/minute (93.7% accuracy)
- 95% Limits of Agreement (instantaneous breathing rate): -2.51 to 2.04 breaths/minute
- Mean Absolute Error (average breathing rate): 0.79 breaths/minute
- 95% Limits of Agreement (average breathing rate): -2.63 to 2.01 breaths/minute |
| Heart Rate Accuracy | The subject device performs comparably to established methods for heart rate measurement. | Compared to Electrocardiography (ECG): - Accuracy: +/- 5 beats per minute (94% accuracy rate)
- 95% Limits of Agreement: -2.64 to 5.82 beats/min (for neurorehabilitation ward patients)
- 96% heart rate accuracy (for patients suspected of sleep apnea) |
| Safety | Complies with relevant electrical, mechanical, and emission safety standards. | Passed all electrical and mechanical safety tests per ANSI AAMI ES60601-1 and IEC 60601-1-11. Passed all emission tests per IEC 62304 and Federal Register CFR 47 Part 15 subpart B. Passed Coexistence Immunity and Wireless Crosstalk tests per 27701:2019 and ANSI IEEE C63.27-2017. |
| Software Performance | Software components function as intended and meet user needs. | All software components verified against System Requirements Specifications and system-level validated against user needs. All tests passed. |
| Risk Management | Identified hazards are mitigated through risk controls. | Risk analysis performed per ISO 14971; risk controls implemented. Cybersecurity risks identified and addressed through penetration testing. |
| Usability | Device is usable for intended users in intended environments. | Extensive Human Factor Engineering/Usability Engineering performed per IEC 62366-1 and FDA guidance; found substantially equivalent for intended users, uses, and environments. |
2. Sample Size Used for the Test Set and Data Provenance
The clinical studies involved a total of 199 subjects.
The data provenance is from clinical studies conducted with patients in a neurorehabilitation ward and patients suspected of suffering from sleep apnea. The studies were prospective as patients were continuously monitored overnight.
Specific sample sizes for each comparison are:
- Neurorehabilitation ward patients: 59 patients for respiration rate (compared to respiratory effort belt), 32 patients for heart rate (compared to ECG).
- Patients suspected of sleep apnea: 105 patients for respiration rate, 73 patients for heart rate.
- etCO2 comparison: 35 participants.
The country of origin is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The text indicates that some measurements were "manually scored by a healthcare professional" for the comparison with end-tidal CO2 (etCO2). However, it does not specify the number of experts involved or their specific qualifications (e.g., years of experience, specialty). For other comparisons (respiratory effort belt, ECG), the ground truth devices are referenced, but expert involvement in scoring those particular signals is not detailed beyond the etCO2 mention.
4. Adjudication Method for the Test Set
The text does not explicitly state an adjudication method (e.g., 2+1, 3+1). It implies that the comparator device measurements (e.g., respiratory effort belt, ECG, etCO2) served as the direct reference or "ground truth." For the "manually scored" etCO2 data, it's not clear if multiple healthcare professionals scored the data and an adjudication process was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not explicitly mentioned or performed to assess improvement of human readers with AI assistance. The studies described are focused on the device's accuracy against established medical reference standards.
6. Standalone (Algorithm Only) Performance
Yes, the studies described are primarily standalone (algorithm only) performance evaluations. The Sleepiz One+ outputs (heart rate, respiration rate) were compared directly against reference devices (ECG, pulse oximetry, respiratory effort belt, nasal cannula, etCO2 measurements). While the device records and transmits data for healthcare professionals to view, the reported accuracy metrics are for the device's automated estimation of these vital signs.
7. Type of Ground Truth Used
The ground truth for the test set was established using:
- Established Medical Devices: Electrocardiography (ECG), pulse oximetry, respiratory effort belt, nasal cannula, and an FDA-cleared device for end-tidal CO2 (etCO2) measurements.
- Expert Scoring: For the etCO2 comparison, the ground truth was "manually scored by a healthcare professional."
Polysomnography devices (Somnotouch RESP (K140861), Nox A1 (K192469)) were used as comparator devices in the clinical studies, specifically using subsets of their channels for the performance assessment.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set for the Sleepiz One+ device's algorithms.
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for the training set was established. It only describes the methodology for the performance evaluation (test set).
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).