(59 days)
The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.
The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect 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.
VitalPatch is a wearable biosensor designed to measure a patient's vital signs, including heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). VitalPatch was most recently cleared in K183078.
The following modifications are proposed for the VitalPatch wearable biosensors:
- . Increasing the duration for use from 5 days (120 hours) to 7 days (168 hours). This includes a minor software change and minor changes to the IFU.
All other vital signs, including heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall) cleared in K183078 remain the same.
Below is the information regarding the acceptance criteria and the study proving the device meets those criteria, extracted from the provided text.
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A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets for each physiological measurement (e.g., heart rate accuracy within X BPM). Instead, it states that the "Performance Characteristics" of the proposed device are "Identical" to the predicate device (K183078) for all listed physiological data types and other features. The "Performance Characteristic" table (Table 4) lists the capabilities and ranges for each measured parameter. Therefore, the "acceptance criteria" are implied to be the same as the established performance of the predicate device.
Performance Characteristic Predicate (K183078) Performance (Implied Acceptance Criteria) Proposed Device Performance (Reported) Wireless Transmission Bluetooth Low Energy (BT4.1) technology Identical Data encryption Advanced Encryption Standard-CCM mode Identical Radio Frequency 2.4GHz ISM band, FCC Part 15 Complied Identical ECG Dynamic Range Range: -10mV to +10mV Identical Heart Rate (stationary & ambulatory) Range: 30 - 200 BPM Identical Respiratory Rate Range: 10-30 breaths per minute Identical Skin Temperature Range: 15°C - 50 °C (61°F - 113°F) Identical Ambient Temperature Range: 15°C - 50 °C (61°F - 113°F) Identical Body Temperature Range: 32°C - 42°C Identical Fall Detection Range: Fall or No Fall Identical Step Count Range: 0 - 65535 steps Identical Posture Detection Postures detected include lying down, upright, walking, running and leaning. Identical R-R Interval Measurement of the interval from the R wave peak of one QRS complex to the next R-wave peak on the electrocardiogram, enhanced QRS performance during motion. Identical Heart Rate Variability Quantifies the variation in the beat-to-beat interval time series obtained from the ECG waveform. Detects each QRS peak with high temporal accuracy. Measurement of the R wave to R wave (RR) interval allows short and long-term variability analysis to determine analytics such as mean, median, standard deviation, frequency content, etc. Identical Low Power Mode When patch is off the body, processor goes into a low power mode, resulting in reduced current draw. Identical | || New Feature/Modification | Predicate (K183078) Performance | Proposed Device Performance |
| Duration of Use | 5 days (120 hours) | 7 days (168 hours) | -
Sample size used for the test set and the data provenance
- The document states that substantial equivalence is based upon "benchtop performance testing" and lists several tests: "Wear Duration Testing", "Battery operating life testing", and "EOL Detection after 168 hours".
- The sample size for these tests is not specified in the provided text.
- The data provenance is not specified (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as the provided documentation describes benchtop performance testing, not a study involving human interpretation or ground truth established by experts for a test set.
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Adjudication method for the test set
- This information is not applicable as the provided documentation describes benchtop performance testing, not a study requiring adjudication of expert interpretations.
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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
- An MRMC comparative effectiveness study was not done. The study described is a benchtop performance validation for an extended wear duration, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document refers to "benchtop performance testing" which is essentially a standalone evaluation of the device's technical specifications and extended wear duration. It is not an "algorithm only" performance study in the context of AI, but rather a direct measurement of the device's physical and functional performance (e.g., battery life, EOL detection).
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The type of ground truth used
- For the benchtop tests (Wear Duration, Battery operating life, EOL Detection), the ground truth would be objective pre-defined technical specifications and direct measurements (e.g., a timer measuring 168 hours, battery voltage measurements, sensor output at end-of-life).
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The sample size for the training set
- This information is not applicable. The device (VitalPatch Biosensor) measures physiological parameters through sensors and firmware. It's not an AI/ML device that requires a training set in the typical sense for classification or prediction from complex data (like images). The firmware updates are minor changes to support extended duration and bug fixes.
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How the ground truth for the training set was established
- This information is not applicable for the reasons stated above. The device is not based on machine learning from a training set with established ground truth.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).