(116 days)
The Honeywell HomMed Genesis Touch Retrospective Physiological Monitoring System is designed to retrospectively monitor vital signs include noninvasive blood pressure, pulse oximetry, pulse rate, weight and manually entered temperature. The Genesis Touch Retrospective Physiological Monitoring System collects, displays and transmits vital signs measurements captured from commercially available FDA cleared wireless medical devices designed for home use. Collected measurement data from the Genesis Touch System can be transmitted.via a communication module to a central viewing station where the data can be viewed and analyzed by a healthcare professional.
The Genesis Touch Retrospective Physiological Monitoring System is intended for home use by adult and pediatric patients over twelve years of age or in a healthcare related environment by healthcare providers. The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring and does not have auditory or visual alarms for out-of-limit parameters.
The Honeywell HomMed Genesis Touch™ Retrospective Physiological Monitoring System uses text and voice prompts to help the user acquire vital signs information. Once all data is collected, it is forwarded at the user's discretion, as a data packet to a central viewing station for retrospective review by a healthcare provider. The Genesis Touch Retrospective Physiological Monitoring System is intended for use with adult and pediatric patients over twelve years of age. The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring.
The provided text does not contain specific acceptance criteria or reported device performance metrics in a tabular format. It focuses on regulatory aspects and substantial equivalence to a predicate device rather than detailed performance study results.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table specifying acceptance criteria (e.g., minimum accuracy percentages, specific thresholds for vital sign measurement agreement) or corresponding quantitative device performance results. The performance section mentions "Risk based verification and validation testing" but does not elaborate on specific metrics or acceptance thresholds.
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "Due to the equivalent indications for use of this system to its predicate, no clinical tests were performed as part of the performance testing." This implies that there was no dedicated test set with human or patient data for a clinical performance study of the Genesis Touch System itself, as its performance relies on the FDA-cleared wireless medical devices it connects to.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
As no clinical tests were performed, there were no experts used to establish ground truth for a test set related to the Genesis Touch System's vital sign measurement accuracy. The system's function is data collection, display, and transmission, relying on the accuracy of connected, already-cleared medical devices.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set for performance was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or reported. The device is a "Retrospective Physiological Monitoring System" that collects and transmits data; it is not an AI-driven diagnostic tool that would typically involve human reader improvement studies.
6. Standalone Performance:
The document states, "Risk based verification and validation testing based on FDA guidance... was performed to ensure that the data is collected and transmitted as intended to the central server."
While this indicates standalone testing of the software's functionality, it does not provide specific standalone performance metrics like accuracy, sensitivity, or specificity for vital sign measurements, as the device itself does not measure vital signs directly but rather collects them from other FDA-cleared devices. The "performance" refers to the correct collection, display, and transmission of data.
7. Type of Ground Truth Used:
For the "Risk based verification and validation testing," the ground truth would likely be established by:
- Known input values: For data collection and transmission tests, the input from the connected vital sign devices would be considered the "ground truth" for what the system should collect and transmit.
- System specifications/requirements: The ground truth for software functionality would be whether the software performs according to its defined specifications for data handling, user interface, and communication protocols.
8. Sample Size for the Training Set:
The document does not mention a "training set" in the context of machine learning or AI, as the device is described as a "proprietary software application" for data collection and transmission, not an AI model that requires training.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set for an AI 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).