(259 days)
The Biobeat Platform is a wireless nonitoring system intended for use by healthcare professionals for spot check collection of physiological data in home and healthcare settings. This can include, functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, blood pressure, respiration rate (RRp), and body temperature.
The Biobeat Platform tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor.
The Biobeat Platform is intended for spot-checking changes of adult patients in hospitals, clinics, long-term care, and at home. The Biobeat Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.
The Biobeat Platform and the BB-613WP Patch sensor include a device that is attached to the patient's chest to collect physiological data for later review by their healthcare provider. The device consists of a light source (LEDs), thermistors and sensor array on the backside of the LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. This allows measurement of arterial oxygenation, pulse rate, change in blood pressure, and respiration rate. Body temperature is measured by the thermistors. Data is transmitted to a gateway via Bluetooth and then uploaded to the cloud. From the cloud, data is transmitted and presented in a web application for review by a healthcare professional. The device does not contain any alarms.
Here is an analysis of the acceptance criteria and study information for the Biobeat Platform, BB-613WP Patch, based on the provided FDA 510(k) summary:
Analysis of Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary provides accuracy specifications for several physiological parameters. These can be considered the acceptance criteria for those parameters. The document states that the clinical validations showed the Biobeat Platform met the pre-specified efficacy requirements and performed in a manner substantially equivalent to the predicate devices. Therefore, the reported device performance is indicated to be within these accuracy ranges.
| Parameter | Acceptance Criteria (Accuracy) | Reported Device Performance (Implied) |
|---|---|---|
| Oxygen Saturation (SpO2) | ±2% | Within ±2% |
| Pulse Rate (PR) | ±3% | Within ±3% |
| Blood Pressure (BP) | ±5 mmHg | Within ±5 mmHg |
| Respiration Rate (RRp) | ±3 RPM | Within ±3 RPM |
| Body Temperature | ±0.3 °C | Within ±0.3 °C |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Clinical validations of respiration rate and body temperature were performed to evaluate the efficacy of the new parameters." However, it does not explicitly state the sample sizes for these clinical test sets.
The data provenance is not specified. It does not mention the country of origin of the data, nor whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method
The document does not specify any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study or any effect size for human reader improvement with AI assistance. This device is an automated physiological data collection system, not an AI-assisted diagnostic imaging tool that typically involves human readers.
6. Standalone Performance Study (Algorithm Only)
The document implies a standalone performance study. It states that the device "uses the same algorithm to compute SpO2 and pulse rate and to compute and track changes in blood pressure. Therefore, these signals' evaluation testing, which was submitted in K190792, remains applicable to the subject device." For respiration rate and body temperature, "Clinical validations... were performed to evaluate the efficacy of the new parameters." This indicates that the device's algorithms were evaluated for their ability to measure these parameters against a reference, which constitutes a standalone performance evaluation.
7. Type of Ground Truth Used
The type of ground truth used for the clinical validations of respiration rate and body temperature is not explicitly stated. However, for physiological monitoring devices, the ground truth is typically established using:
- Reference medical devices: Often, highly accurate, clinically accepted devices (e.g., a spirometer for respiration rate, a core body temperature probe for temperature, or an invasive blood pressure monitor for BP) are used as the "ground truth" during validation studies.
- Given the "clinical validation" claim, it's highly probable these reference measurements were taken directly from human subjects.
The document mentions that the device tracks blood pressure "following a calibration process using an FDA-cleared oscillometric blood pressure monitor." This suggests that an FDA-cleared oscillometric device serves as the reference for BP calibration.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for any training set. It primarily discusses performance data (validation testing) rather than aspects of model training. It mentions "a new algorithm, derived from the existing photoplethysmogram, was added for measuring respiration rate (RRp)." This implies an algorithm was developed, but details on its training are absent.
9. How Ground Truth for the Training Set Was Established
Since information on a training set or its sample size is not provided, there is no information on how ground truth for a training set was established.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).