(46 days)
Viridia Wave Viewer may be used to provide limited ECG and SpO2 information to the clinician. Patient assessment includes uses similar to:
- Determination of a patient's tolerance to exercise during ambulation (e.g. while walking down a hallway).
- Patient assessment while waiting for monitoring equipment to arrive (e.g. a patient collapses in the hallway).
- Additional input to a routine physical assessment of a patient (e.g. for use on rounds).
Patient assessment does not include uses such as:
- Continuous monitoring of a patient (not intended for use as a bedside monitor).
- Determining detailed ECG diagnosis such as ST segment values, R-R variability or any other diagnostic ECG values.
The patient population is adult and pediatric patients.
There are no alarms. The device turns off after 10 minutes to prevent long term "monitoring" use. Viridia Wave Viewer is not intended to be a patient monitor.
In the USA, Federal law restricts Viridia Wave Viewer to sale by or on the order of a physician.
It is intended to be used in a professional health care facility. It is not intended for home use.
The device is intended to be used as an assessment tool that enables licensed clinicians in a clinical environment to determine the quality of ECG and SpO2 signals at the location of telemetry monitored patients. In addition, limited assessment of patients ECG and SpO2 vital signs can be determined. Viridia Wave Viewer is not intended for monitoring and has no alarm functions. The device is not intended for home use and is not suitable for patient monitoring.
Viridia Wave Viewer is a software application that executes on a palmtop computer. Viridia Wave Viewer software enables the palmtop computer to communicate with the M2601A transmitter using an infrared link for the purpose of displaying ECG waveform, or an SpO2 pleth waveform, and numerics for SpO2 and Pulse. Viridia Wave Viewer also allows the user to estimate the heart rate, HR, by using electronic calipers to measure the distance between two R-peaks. Viridia Wave Viewer does not operate on the information received except to format it for display on the palmtop screen. It performs no calculations except for estimating HR. It has no detection capability. It can not, therefore, annunciate any alarms.
This document, K974567, details a 510(k) submission for the Hewlett-Packard M2605A Viridia Wave Viewer. However, it does not contain specific acceptance criteria, performance metrics, or a detailed study description that would allow for a complete response to your request. The document acts as a summary for FDA clearance, not a full scientific study report.
The "Verification and Validation" section (6.0) states: "Viridia Wave Viewer has been verified and validated to provide the test results needed to show substantial equivalence to legally marketed devices." This implies that testing was performed, but the details are not provided within this summary.
Therefore, I can only provide information based on what is available in the provided text. Many sections of your request cannot be answered due to the lack of detailed study information.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The document states that verification and validation were performed to show substantial equivalence, but it does not list specific numeric acceptance criteria (e.g., accuracy, precision) or the results of those tests.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present in the provided document. The document refers to "extensive testing" but does not specify sample sizes or data origin (country, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not present in the provided document.
4. Adjudication Method for the Test Set
This information is not present in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device, Viridia Wave Viewer, is described as a software application for a palmtop computer that displays ECG and SpO2 waveforms and numerics. It specifically states: "Viridia Wave Viewer does not operate on the information received except to format it for display on the palmtop screen. It performs no calculations except for estimating HR. It has no detection capability. It can not, therefore, annunciate any alarms." This functionality suggests a display-only device with a simple HR estimation, not one that would typically be involved in a comparative effectiveness study of AI assistance for human readers in decision-making.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This document does not report a standalone performance study. While testing certainly occurred to ensure proper display and basic HR estimation, the nature of this device (a display and rudimentary HR estimation tool) means that "standalone performance" in the sense of a complex algorithm's diagnostic accuracy is not applicable or elaborated upon here. Its function is to present data from existing monitoring equipment.
7. Type of Ground Truth Used
This information is not explicitly stated in the provided document. Given the device's function to display ECG and SpO2 waveforms and numerics from existing monitoring equipment, the "ground truth" for its verification and validation would likely involve:
- Comparison to the source monitoring equipment: Ensuring the displayed waveforms and numerics accurately reflect what the M2601A transmitter is sending.
- Manual calculation verification: For the estimated heart rate, comparison to a manually calculated heart rate derived from the displayed ECG.
8. Sample Size for the Training Set
This information is not present in the provided document. As the device mainly displays information and performs a simple HR estimation, it is unlikely to have a "training set" in the sense of a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not present in the provided document. As mentioned above, a "training set" in the context of device learning is likely not applicable to this particular device's functionality.
§ 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).