(84 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 includes 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). Data is transmitted wirelessly to a central location where it is stored for analysis. The Vital Connect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls 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 is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients.
The VitalConnect Platform is a wireless data collection system that monitors physiological data and consists of the following sub systems:
• VitalConnect Sensor (includes adhesive Patch and Sensor Module)
• Relay Software Library
• Server Software Library
VitalConnect Platform sub-system includes:
• VitalConnect Sensor
a) Adhesive Patch
The Patch is designed as a disposable self-adhesive interface to the body.
b) Sensor Module
Residing within the patch, the sensor module performs processing functions related to capture of physiological data and also performs bi-directional communication with the relay device.
• VitalConnect Relay Software Library
The Relay Software Library manages bi-directional communication between the Sensor Module and the Server Software Library and is installed on a relay device.
• VitalConnect Secure Server Software Library
The Server Software Library is installed on a central server, manages the upload, processing and storage of sensor data, as well as configuration of and notifications from the VitalConnect Platform.
The VitalConnect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via a bi-directional relay to the central server. During normal operation, continuous wireless transmission occurs with a delay or latency of seconds between continuous data collection and transmission. However, for continuous transmission of data to a healthcare professional, a continuous connection is needed between the module, the relay, and the server. Data can be stored on the VitalConnect Sensor for several hours and then transferred once connectivity is reestablished.
The VitalConnect Sensor is a battery-operated adhesive patch with integrated sensors and wireless transceiver module, worn on the torso to record 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).
The provided text describes the VitalConnect Platform, a wireless remote monitoring system. While it mentions non-clinical bench testing for various physiological parameters and a "Long-term Field Study for Home Use," it does not provide specific acceptance criteria or reported device performance values in a table. It also does not present a formal clinical study designed to prove the device meets pre-defined acceptance criteria with detailed statistical analysis.
Therefore, many of the requested details cannot be extracted directly from the provided text.
Here's an attempt to answer based on the available information, with clear indications of what is not present:
Acceptance Criteria and Study Details for VitalConnect Platform (K141161 JIII 2 9 2014)
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or reported device performance values are provided in the document. The non-clinical testing section lists various parameters that were tested (e.g., ECG, Heart rate, Respiration rate, etc.), but does not give quantitative thresholds or specific results.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study):
- Sample Size: 76 participants
- Data Provenance: The study was conducted by Vital Connect, likely in the USA. It was a "Long-term Field Study for Home Use." The context implies it was a prospective study focused on usability and wearability in a home setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The clinical study described is focused on "usability" and "long-term wearability," rather than diagnostic accuracy against an expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided as the study described does not appear to involve expert adjudication for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The study described focuses on the device's performance (usability, wearability) in a home setting rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
While "Non-clinical bench testing" was performed for various physiological parameters, the document does not report standalone algorithm performance metrics (e.g., sensitivity, specificity, accuracy) that would demonstrate the algorithm's performance in isolation without human intervention. The mention of "Measurement accuracy" in non-clinical testing suggests this was assessed, but no results are given.
7. Type of Ground Truth Used
For the "Long-term Field Study for Home Use," the "ground truth" implicitly relates to the successful use and wearability in a real-world setting, as assessed by participants and potentially monitored by the study conductors. It does not mention a gold standard for physiological measurement accuracy, pathology, or specific clinical outcomes data as the primary ground truth for the clinical study described. The non-clinical testing likely used calibrated reference instruments for accuracy assessments, but this is not explicitly stated for a "ground truth" as typically understood in clinical validation studies.
8. Sample Size for the Training Set
The document does not mention any details about a training set for an AI algorithm. It refers to a "VitalConnect Platform," which suggests an integrated system rather than a separately described AI component with a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned for an AI algorithm, this information is not provided.
§ 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).