(87 days)
The mVisum Alert Alarm Management System is software intended for use to display status and alarm events from other medical devices and patient information systems and associated physiological and other patient information. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm and physiological information to mobile healthcare providers.
The mVisum Alert Alarm Management System is limited to use by qualified medical professionals who have been trained on the use of the system. It is intended to supplement and not to replace any part of the current patient monitoring systems. It is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.
The mVisum Alert Alarm Management System is a software based secondary alarm notification system that transmits alarms, text and physiological waveform data from patient monitoring devices to a graphical display. This could be either on a PC or on a mobile device carried by a trained professional in a hospital environment. It is also capable of transmitting alarms and physiological waveforms to clinician smartphones that operate on the cell phone data network. The system receives alarm conditions from patient monitoring networks through industry standard HL-7 or XML formats and transmits the notification including any waveform data to the client software component. The client software component can then display the text and the physiological waveform information to the clinician.
The mVisum system only reads alarm information and does not change it or modify it in any way. It does not diagnose alarms but transmits what the Patient Monitoring System determines to be an alarm.
The provided text describes the mVisum Alert Alarm Management System and its 510(k) clearance. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test/training sets, or information regarding ground truth establishment as requested.
The document states:
- "Verification, validation, and testing activities establish the performance, functionality, and safety of the system. Testing included system level and regression tests as well as tests driven by the Hazard Analysis."
This is a general statement about testing but lacks the specifics needed to answer the questions about acceptance criteria and the study that proves the device meets them. The focus of this 510(k) summary is on demonstrating substantial equivalence to predicate devices for its intended use as a secondary alarm notification system, rather than presenting a performance study with detailed metrics against specific acceptance criteria.
Therefore, I cannot populate the table or answer most of the questions using only the provided text.
Here's an overview of what can be extracted and a clear indication of what information is missing:
Description of the Acceptance Criteria and Study (Based on available information):
The provided 510(k) summary for the mVisum Alert Alarm Management System does not detail specific quantitative acceptance criteria or a dedicated clinical study proving the device meets them. Instead, it relies on system-level and regression testing, along with a hazard analysis, to demonstrate performance, functionality, and safety. The primary method for clearance appears to be substantial equivalence to predicate devices (GE / Data Critical Corporation Statview System and GE Web Viewer, Pocket Viewer, Cellular Viewer) based on its technological characteristics and intended use as a secondary alarm notification system. The device's function is to transmit existing alarms and physiological data, not to generate or interpret diagnostic information.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Quantitative, if available) | Reported Device Performance (Quantitative, if available) |
|---|---|
| Not specified in the provided text. | Not specified in the provided text. |
| (The document mentions "Verification, validation, and testing activities establish the performance, functionality, and safety of the system. Testing included system level and regression tests as well as tests driven by the Hazard Analysis." but does not provide specific metrics or acceptance thresholds.) | (No quantitative performance metrics are reported in the provided text.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. (The device transmits data from "patient monitoring devices," but no specific dataset or its origin for testing is mentioned.)
- Retrospective/Prospective: Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The device is a secondary notification system; it does not perform diagnostic functions that would require expert-established ground truth for its performance. It simply relays alarms from primary monitoring systems.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. (As above, this is a relay system, not a diagnostic or interpretive device that would require adjudication of findings.)
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
- MRMC Study: No. The device is not an AI-assisted diagnostic tool; it is a system for transmitting alarms and physiological data. Therefore, an MRMC comparative effectiveness study to assess human reader improvement with AI assistance is not relevant to this device's function and was not conducted or reported.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: The document describes "system level and regression tests" to establish performance and functionality. While these tests evaluate the software's ability to transmit data, they are not presented as a standalone diagnostic performance study in the way this question typically implies (e.g., sensitivity/specificity for disease detection). The device's primary function is data relay, not independent diagnostic assessment.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated as "ground truth" for a diagnostic purpose. The system's "truth" is whether it accurately receives and transmits the alarm events and physiological data as determined by the primary patient monitoring systems. The device does not establish its own diagnostic ground truth.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. This device is not described as using machine learning or AI that would involve a training set. It is a software system for data transmission.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. (No training set is mentioned as part of the device's development or testing.)
§ 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).