(122 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 Biosensor 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 K163453.
The following modifications are proposed for the VitalPatch wearable biosensors:
- . An ambient temperature sensor is added to the original VitalPatch, which was most recently cleared in K163453, to measure ambient temperature. The measured ambient temperature along with the measured skin temperature cleared in K163453 are used to calculate the body temperature.
- . An updated IFU for VitalPatch has been created to reflect the temperature sensor changes.
All other 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) cleared in K163453 remain the same.
The provided document is a 510(k) summary for the VitalConnect Platform and VitalPatch Biosensor. It details the device's characteristics, indications for use, and comparison to a predicate device (K163453). However, it does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system as implied by some of the questions.
The document states that the new VitalPatch Biosensor adds an ambient temperature sensor to calculate body temperature. It focuses on demonstrating substantial equivalence to the previously cleared predicate device for general physiological monitoring (heart rate, ECG, respiratory rate, skin temperature, activity, posture, fall detection).
Here's an analysis based on the available information and a direct answer to your questions, noting what cannot be answered from the provided text:
Key Takeaway: This document describes a medical device clearance related to a hardware modification (adding an ambient temperature sensor) and a derived vital sign (body temperature). It explicitly states that clinical studies were not required for this clearance, and the substantial equivalence was based on benchtop performance testing. Therefore, many of the questions related to MRMC studies, expert consensus, and large test/training datasets for AI models are not applicable or answerable from this specific document.
1. A table of acceptance criteria and the reported device performance:
The document summarizes the performance characteristics of the proposed device by comparing them to the predicate device in Table 4. It treats "Identical" as meeting the acceptance criteria set by the predicate. For new features, it lists the range.
| Performance Characteristic | Predicate (K163453) Acceptance Criteria / Performance | Proposed Device Performance / Acceptance Criteria |
|---|---|---|
| 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 | Differential voltage from heart, digitized | Identical |
| Heart Rate | 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 | N/A (Predicate did not measure this) | Range: 15°C - 50 °C (61°F - 113°F) |
| Body Temperature | N/A (Predicate did not calculate this) | Range: 32°C - 42°C (Calculated from skin & ambient) |
| Fall Detection | Range: Fall or No Fall | Identical |
| Step Count | Range: 0 - 65535 steps | Identical |
| Posture Detection | Lying down, upright, walking, running, leaning | Identical |
| R-R Interval | Measurement of R-R peak, enhanced QRS performance | Identical |
| Heart Rate Variability | Quantifies variation in beat-to-beat interval | Identical |
| Low Power Mode | Reduced current draw when off body | Identical |
For "Body Temperature," the criteria are implied to be that the proposed device can derive this value within the specified range (32°C - 42°C). The document confirms that "Paired readings, using VitalPatch and hand-held oral thermometers simultaneously, were analyzed to verify accuracy when compared to the hand-held oral thermometers." This suggests the acceptance criterion for body temperature derivation would be accuracy against a gold standard (oral thermometer), though the specific accuracy metric (e.g., mean absolute difference, standard deviation of differences, clinical equivalence) and its threshold are not provided in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on benchtop and simulated use testing for the new modifications. It explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the VitalPatch. Instead, substantial equivalence is based upon benchtop performance testing."
For the new "Body Temperature" calculation: "Paired readings, using VitalPatch and hand-held oral thermometers simultaneously, were analyzed to verify accuracy when compared to the hand-held oral thermometers."
- Sample Size: Not specified for the paired readings.
- Data Provenance: Not specified (e.g., country). It was likely prospective, as it involved simultaneous measurements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable in the context of this 510(k) clearance document. The ground truth for the new body temperature parameter was established via a hand-held oral thermometer, which serves as a widely accepted clinical standard for temperature measurement. There is no mention of human experts interpreting physiological waveforms or images to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is typically used in studies where human readers are interpreting complex medical data (like images) and consensus is needed. The performance assessment here involved direct comparison to an established measurement device (oral thermometer) and verification of engineering specifications.
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 comparative effectiveness study was not done. The device described is a physiological data sensor, not an AI-assisted diagnostic tool that would typically involve human readers. The clearance was based on substantial equivalence and benchtop testing, not on improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
For the new body temperature feature, the "algorithm only" performance was evaluated by comparing the VitalPatch's calculated body temperature to that of a hand-held oral thermometer. The exact methodology and results (e.g., specific accuracy metrics) are not detailed beyond "analyzed to verify accuracy."
For the other parameters (heart rate, respiratory rate, etc.), they remain "Identical" to the predicate, meaning their standalone performance was previously established and is considered sufficient.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the new "Body Temperature" calculation, the ground truth was "paired readings, using VitalPatch and hand-held oral thermometers simultaneously." This represents a clinical measurement reference standard.
- For other physiological parameters, the ground truth would have been established during the clearance of the predicate device (K163453) using appropriate reference methods for each parameter (e.g., ECG for heart rate, spirometry for respiratory rate, etc.).
8. The sample size for the training set
This document does not describe the development or training of a complex AI model requiring a large training set. The "firmware" update (Version 3.1.0.1) mentioned for the new device includes "Body temperature derivation," which implies a calculation or algorithm rather than a machine learning model that undergoes "training." Therefore, the concept of a "training set" in the context of machine learning is not applicable here.
9. How the ground truth for the training set was established
As there's no "training set" for an AI model described, this question is not applicable. The body temperature derivation is listed as a "calculated value as a function of the skin and ambient temperatures," indicating a deterministic algorithm rather than a learned model.
§ 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).