(117 days)
The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.
The ViSi Mobile InSight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSi Mobile patient worn device.
The ViSi Mobile Monitoring System is a lightweight, body-worn vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is designed to continuously non-invasively measure ECG, heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. The ViSi Mobile Monitoring System is capable of one-time and continuous NIBP measurements.
The provided text describes a 510(k) premarket notification for the ViSi Mobile Monitoring System with the addition of the ViSi Mobile InSight secondary notification system. The document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML algorithm's performance on a test set.
Specifically, there is no information in the provided text regarding:
- A table of acceptance criteria and reported device performance for an AI/ML algorithm.
- Sample sizes used for a test set for an AI/ML algorithm, or data provenance.
- Number of experts and their qualifications for establishing ground truth for an AI/ML test set.
- Adjudication method for an AI/ML test set.
- MRMC comparative effectiveness study details (effect size, human reader improvement with AI).
- Standalone (algorithm only) performance of an AI/ML system.
- Type of ground truth used for an AI/ML system (pathology, outcomes data, etc.).
- Sample size for the training set of an AI/ML algorithm.
- How ground truth for the training set was established for an AI/ML algorithm.
The document discusses performance testing for the ViSi Mobile InSight system, which appears to be a notification and alarm management system, not an AI/ML diagnostic or predictive algorithm. The "Performance Testing" section on page 5 details:
- Human Factors testing: Assessed usability and readability with clinicians familiar with the ViSi Mobile System (not InSight). Used simulated alarms, no patients. Results satisfied defined acceptance criteria.
- Verification activities: Code reviews and unit testing of software components.
- Validation testing: Ensured all software requirements were met. All test steps passed.
- Performance testing in a hospital environment: Characterized alarm receipt and latency under full load (64 transceivers).
This testing is focused on the functionality and usability of the alarm notification system, rather than the diagnostic or predictive performance of an AI/ML model. Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study data from this document.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).