(269 days)
The WAVE Clinical Platform is software intended to route, store, and display data, alarms, results and diagnostic information from medical devices, Electronic Medical Records (EMR), and Clinical Information Systems (CIS).
The WAVE Clinical Platform is a remote monitoring platform that displays physiologic data, waveforms, alarms, results and diagnostic information routed the WAVE Clinical Platform from supported devices and systems. The WAVE Clinical Platform is intended for use in hospital type environments. The WAVE Clinical Platform is intended to be used by healthcare professionals for the following purposes:
· To remotely consult regarding patients' statuses:
· To remotely review other standard or critical near real-time patient data, waveforms, and results in order to utilize this information to aid in clinical decisions.
Warning: The WAVE Clinical Platform is intended to supplement and not to replace any part of the hospital's device monitoring or electronic data management systems. Do not rely on the WAVE Clinical Platform product as the sole source of alarms.
Excel Medical's WAVE Clinical Platform is a software platform that gathers and stores data from patient monitoring and other medical devices, hospital information systems, and clinical analytics data sources for near real-time and retrospective remote display for clinicians to use in clinical decision support. The WAVE Clinical Platform can also route and forward these data to third party systems.
The WAVE Clinical Platform can utilize the hospital's existing network and hardware for installation and display on any device that is web-enabled. The WAVE Clinical Platform does not control any of the medical devices or systems it is connected with.
The provided document is a 510(k) summary for the Excel Medical Electronics WAVE Clinical Platform. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantitative performance metrics.
Therefore, many of the requested elements for describing acceptance criteria and a study proving performance are not explicitly present in the given text. The document primarily outlines the device's functionality, intended use, and compares its technical characteristics to a predicate device to argue for substantial equivalence.
Based on the provided text, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly provided in the format of specific, measurable acceptance criteria and corresponding performance values for the WAVE Clinical Platform. The document states that "Safety, efficacy and substantial equivalence was shown through system level tests, user interface verification, device compatibility verification, performance tests and safety testing," and concludes that "The WAVE Clinical Platform test results on non-clinical testing demonstrate the device is substantially equivalent to the predicate device - the Covidien Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform in terms of safety, features and performance." However, the exact criteria (e.g., latency thresholds, data accuracy percentages) and the numerical results are not detailed.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The document mentions "system level tests, user interface verification, device compatibility verification, performance tests and safety testing" but does not specify the sample size of data, patients, or scenarios used in these tests, nor the origin (country, retrospective/prospective nature) of any data used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided. The concept of "ground truth" as typically used in AI/diagnostic device studies (e.g., expert consensus on medical images or diagnoses) is not discussed, as this 510(k) is for a data management and display platform, not a diagnostic AI.
4. Adjudication Method for the Test Set:
This information is not provided. Given that no specific "ground truth" or expert review process is detailed for performance evaluation, an adjudication method is also not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The device is a "Clinical Platform" for routing, storing, and displaying data, not a diagnostic AI that would be evaluated for human reader improvement. The document explicitly states: "Clinical Performance: Not Applicable. Clinical evidence was not necessary to show substantial equivalence."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document describes "system level tests, user interface verification, device compatibility verification, performance tests and safety testing" (page 10). These non-clinical tests would represent a form of "standalone" evaluation of the system's technical functionality (e.g., data routing speed, display accuracy, alarm fidelity). However, specific metrics or a detailed account of these standalone performance evaluations are not provided. The focus is on demonstrating that its functions are similar to the predicate device rather than presenting quantitative performance data for these tests.
7. The Type of Ground Truth Used:
For the purpose of this device (a data management and display platform), the "ground truth" for non-clinical performance testing would likely refer to the correctness of data transmission, storage, and display as compared to the original source data or expected outputs. For example, verifying that a heart rate value displayed on the platform matches the value from the connected monitor. However, the document does not explicitly state how this "ground truth" was established or verified in detail. It refers broadly to "system level tests, user interface verification, device compatibility verification, performance tests and safety testing."
8. The Sample Size for the Training Set:
This information is not applicable/provided. The WAVE Clinical Platform is described as software for routing, storing, and displaying data, not an algorithm that learns from a training set (e.g., an AI/ML diagnostic algorithm).
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided. As above, the device is not an AI/ML algorithm that requires a "training set" with established ground truth.
Summary of available information regarding the "study" proving acceptance criteria (non-clinical performance):
- Study Type: Non-clinical performance testing, including system level tests, user interface verification, device compatibility verification, performance tests, and safety testing.
- Purpose: To demonstrate substantial equivalence to the predicate device (Covidien Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform) in terms of safety, features, and performance.
- Conclusion: "The WAVE Clinical Platform test results on non-clinical testing demonstrate the device is substantially equivalent to the predicate device... in terms of safety, features and performance." "No new questions of safety and effectiveness have been raised."
- Lack of Detail: Specific acceptance criteria, quantitative performance results, sample sizes, methodology details for establishing ground truth, or expert involvement are not provided in this 510(k) summary 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).