(125 days)
The Vital Connect 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, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the Vital Connect Sensor for storage and analysis. The Vital Connect 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 Vital Connect 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 Vital Connect Platform is a wireless data collection system that monitors physiological data and consists of the following sub-systems:
- Vital Connect Sensor (includes Adhesive Patch and Sensor Module) .
- a) Adhesive Patch
The Adhesive Patch is designed as a disposable self-adhesive interface to the body.
-
b) Sensor Module
The Sensor Module performs processing functions related to capture of physiologic data and also performs bi-directional communication with the Relay Software Library. -
Relay Software Library
The Relay Software Library manages communication with the Vital Connect Sensor. The Relay Software Library also manages the communication with the Secure Server when the Secure Server is deployed. The Relay Software Library is installed on a relay device.
The Vital Connect Platform offers an optional sub-system:
- . Secure Server
The Secure Server manages the upload, processing and storage of sensor data, as well as real-time configuration and notification communications with the Relay Software Library.
The Vital Connect 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, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the Vital Connect Sensor for storage and analysis. The Vital Connect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.
The Vital Connect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via bi-directional communication to the relay device when in range of the relay. The encrypted wireless data provided by the Sensor may be downloaded from the relay device for storage, or integrated into a Third-Party Relay Application via the APIs of the Relay Software Library. In addition, the wireless data may be transferred to the Vital Connect Secure Server where they are stored for analysis with the deployment of the server.
During normal operation, data are collected on the Vital Connect Sensor and transmitted to the Relay immediately. A continuous connection is needed between the Sensor and the Relay in order to facilitate continuous data transmission. The continuous wireless transmission of the data occurs with a delay or latency of seconds between continuous data collection and transmission. Data can be stored and downloaded from the Relay. Data can continue to be transferred to the Vital Connect Server with a server connection. If an interruption occurs between the Sensor and the Relay, data will be stored on the Sensor for several hours until the connection is re-established.
The provided text is a 510(k) summary for the Vital Connect Platform. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device. However, it does not contain specific acceptance criteria or an explicit study proving the device meets those criteria for its physiological monitoring functions (heart rate, ECG, respiratory rate, etc.) in a traditional sense.
Instead, the document focuses on:
- Biocompatibility testing: Conducted according to ISO 10993-1.
- Electrical safety and EMC testing: Compliance with IEC 60601 series standards and FCC CRF47 Part 15 Subpart C.
- Software verification and validation: Following FDA guidance for "moderate" level of concern software.
- Bench testing: In-vitro tests for shelf life, packaging, water resistance, static load, compression, and drop test.
- Reliance on prior clinical testing: Stating that "Prior clinical testing was performed to support the clearance of the predicate device and is still relevant to the proposed device."
Given this, I cannot construct a table of acceptance criteria and reported device performance from the provided text for the physiological monitoring aspects. The document asserts that the device met "all acceptance criteria" during bench testing and that "safety and performance characteristics" were established through verification and validation, but it does not detail those criteria or the specific performance results for the physiological measurements.
Here's a breakdown of what can be extracted or inferred based on your request, with explicit notes on what is not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric Category | Acceptance Criteria (Not Explicitly Stated for Physiological Data) | Reported Device Performance (Not Explicitly Stated for Physiological Data) |
|---|---|---|
| Physiological Data Accuracy | Not explicitly detailed in this document. Implied adherence to performance of predicate device. | Not explicitly detailed in this document. Implied performance similar to predicate device. |
| Biocompatibility | ISO 10993-1 recommendations for in-vitro cytotoxicity, irritation, and sensitization. | Passed (Previously conducted testing for predicate; "still relevant"). |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-2-25, IEC 60601-2-47, IEC 60601-1-2, IEC/TS 62657-2, and FCC CRF47 Part 15 Subpart C. | Complies. |
| Software Verification & Validation | Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for "moderate" level of concern software. | Conducted and documentation provided. |
| Bench Testing (Shelf life, Packaging, etc.) | Met "all acceptance criteria" for shelf life, packaging integrity, operation and storage conditions, water resistance, static load, compression, and drop test. (Specific acceptance values for these tests are not provided). Also, "performed similarly to the predicate device." | Met "all acceptance criteria" and "performed similarly to the predicate device." (Specific performance results are not provided). |
| Clinical Performance | Not explicitly detailed for the modified device; relies on predicate device's clearance. | "Prior clinical testing was performed to support the clearance of the predicate device and is still relevant to the proposed device." (No new clinical data for the modified device presented). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified for any physiological data validation. The document states "Prior clinical testing was performed to support the clearance of the predicate device," but the sample size for that prior predicate testing is not provided. For bench testing, "in vitro bench testing" was conducted, but sample sizes for these tests are not specified.
- Data Provenance: Not specified for any physiological data. The previous clinical data would be from the predicate device's clearance. The current document does not specify country of origin or whether it was retrospective/prospective for any data related to physiological performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Provided: The document does not describe a study involving expert-established ground truth for physiological measurements for the modified device nor for the predicate device's clinical testing.
4. Adjudication method for the test set
- Not Applicable/Not Provided: No adjudication method is mentioned as there's no described study involving human readers or expert consensus for the physiological data.
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: No MRMC study or study demonstrating human reader improvement with AI assistance is mentioned. The device is a "wireless remote monitoring system" for continuous collection of physiological data, not an AI diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied: The device is a standalone physiological data collection system (Vital Connect Sensor) that transmits data. Its performance is assessed through its ability to accurately capture and transmit these physiological parameters. However, specific standalone performance metrics (e.g., accuracy of HR measurement against a gold standard) are not detailed in this document; it relies on the "substantial equivalence" of its technology and the predicate device's prior clinical validation.
7. The type of ground truth used
- Not explicitly detailed for physiological data: For biocompatibility, electrical safety, software, and bench testing, the "ground truth" is adherence to established standards and successful verification/validation. For physiological measurements, it's implied that the predicate device's clinical testing used appropriate reference methods (e.g., clinical monitoring equipment for heart rate, ECG, respiratory rate) to establish ground truth.
8. The sample size for the training set
- Not Applicable/Not Provided: The document does not mention any machine learning or AI components that would require a separate training set. It describes a system for collecting and transmitting physiological data.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: As no training set is mentioned, the method for establishing its ground truth is also not applicable.
§ 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).