(239 days)
The Happy Ring Health Monitoring System is a wearable device system to remotely monitor physiologic parameters of patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. The device is intended for use on individuals who are 22 years of age or older.
The device supports continuous data collection for monitoring of the following physiological parameters:
- Acceleration / Movement
- Electrodermal Activity (EDA)
- Blood Oxygen Saturation
- Pulse Rate
- Peripheral Skin Temperature
The Happy Ring Health Monitoring System is intended for peripheral skin temperature monitoring, where monitoring temperature at the finger is clinically indicated.
The Happy Ring Health Monitoring System is not intended for SpO2, pulse rate, respiration rate monitoring in conditions of motion or low perfusion.
The Happy Ring Health Monitoring System is a wearable device and software platform comprising:
- A wearable medical device smart ring,
- A mobile app-based bluetooth-to-internet gateway,
- A cloud-based API,
- A set of data processing algorithms, and
- A Physician data viewer.The Ring is worn on the user's finger and continuously collects raw data via specific sensors. These raw data are transmitted via Bluetooth Low Energy to a paired mobile device. The data received are transmitted by the mobile app gateway, via the cloud-based AP, to the data processing algorithms where various physiological parameters are computed. The raw and processed data are stored, further analyzed, and accessible by healthcare providers or researchers via the Physician data viewer.
The Happy Ring Health Monitoring System is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments. It is designed to continuously collect data to support intermittent monitoring of the following physiological parameters by trained healthcare professions or researchers: Acceleration / movement, electrodermal activity (EDA), blood oxygen saturation, pulse rate, and peripheral skin temperature.
The provided text describes information about the Happy Ring Health Monitoring System, including its intended use, technological comparison to a predicate device, and a summary of non-clinical and clinical tests performed. However, it does not contain specific acceptance criteria for the device performance or detailed results of a study proving the device meets those criteria, beyond a general statement about SpO2 accuracy.
Therefore, I cannot fully complete the requested table and answer all questions with the provided text. I will extract all available information and explicitly state what is not present.
Here's a breakdown of the available information and what's missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Not explicitly stated as such, but inferred from testing standards) | Reported Device Performance |
|---|---|---|
| Blood Oxygen Saturation (SpO2) | Per ISO 80601-2-61 (Accuracy for pulse oximeters, typically ARMS within a certain percentage) | Was within 3.5% ARMS for the range of oxygen saturation measured by the device. |
| Pulse Rate | Per ISO 80601-2-61 (Accuracy for pulse oximeters) | Tested in accordance with ISO 80601-2-61, but specific quantitative performance not reported. |
| Peripheral Skin Temperature | Per ISO 80601-2-56 (Accuracy for clinical thermometers) | Tested in accordance with relevant sections of ISO 80601-2-56, but specific quantitative performance not reported. |
| Electrodermal Activity (EDA) | Bench testing to verify performance | Bench testing to verify performance, but specific quantitative performance not reported. |
| Acceleration / Movement | Bench testing to verify performance | Bench testing to verify performance, but specific quantitative performance not reported. |
| Electrical, Mechanical & Thermal Safety | IEC 60601-1 and IEC 60601-1-11 compliance | Testing in accordance with standards. |
| Electromagnetic Compatibility | IEC 60601-1-2 compliance | Testing in accordance with standards. |
| Wireless Coexistence | FDA's guidance: Radio Frequency Wireless Technology in Medical Devices compliance | Testing in accordance with guidance. |
| Usability | IEC 62366 and FDA's guidance: Applying Human Factors and Usability Engineering to Medical Devices compliance | Testing in accordance with standards/guidance. |
| Software V&V & Cybersecurity | FDA's guidance for Software Contained in Medical Devices and Cybersecurity in Medical Devices compliance | Documentation provided as recommended by guidance. |
2. Sample size used for the test set and the data provenance:
- Sample Size (SpO2 Clinical Study): 12 subjects
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. The study was described as "clinical tests" and involved "subjects," which implies a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The text mentions "oxyhemoglobin saturation using a radial arterial line" as the comparison method for SpO2, which is an objective measurement and doesn't typically involve expert consensus for ground truth establishment in the same way image interpretation might. For other physiological parameters, the ground truth establishment method is not detailed beyond "bench testing to verify performance."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Given the nature of objective physiological measurements (like radial arterial line for SpO2), a multi-reader adjudication method as seen in image interpretation studies is not typically used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not described. The study focused on the device's accuracy in measuring physiological parameters, not on how it assists human readers or clinicians in interpreting data or making decisions. The "Physician data viewer" is mentioned, suggesting human review, but no comparative effectiveness study with human readers is detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The SpO2 and other bench tests (EDA, accelerometer, temperature) assess the device's ability to measure physiological parameters independently of human interpretation. The "data processing algorithms" compute the parameters, and their accuracy is evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Reference Devices/Objective Measurements:
- For SpO2: Oxyhemoglobin saturation using a radial arterial line (a gold standard, objective measurement).
- For other parameters: Implied reference instruments for "bench testing to verify the performance." This typically means comparing the device's output against a highly accurate, calibrated reference measurement.
8. The sample size for the training set:
- Not specified. The document discusses the test set but provides no information about the training set size for the device's algorithms.
9. How the ground truth for the training set was established:
- Not specified. Since information about the training set size or its existence is not provided, the method for establishing its ground truth is also not elaborated upon in this document.
§ 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).