(114 days)
The TeleVital VitalWare VMS is a vital sign monitoring and patient information software product intended to be used in conjunction with independent monitoring devices, and ancillary systems for the real-time collection, storage, and transmission to remote viewing sites.
The system is intended to be used in a hospital or clinic environment. Clinical judgment and experience are required to check and interpret the information delivered. VitalWare VMS is not intended to, and is not capable of controlling any of the medical devices it interfaces with.
The TeleVital VitalWare VMS is a software system utilized for the real-time collection, storage, transmission, surveillance and management of vital sign data. The system can be used with any supported monitoring device or ancillary system connected directly to a PC computer or a network. The vital sign data is made available on any workstation on the network and/or Internet allowing health care professionals at the point of care to receive assistance from a supplementary care location. A typical deployment is composed of more than one PC workstation connected to one or more servers, receiving data from one or more medical devices over a network.
The provided 510(k) summary for the TeleVital VitalWare VMS device describes a software system for managing vital sign data. However, it does not include granular details about specific acceptance criteria, study methodologies, or performance metrics typically associated with AI/ML-based device evaluations.
Based on the provided text, here's what can be extracted and what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or specific quantitative performance metrics for the VitalWare VMS. Instead, it refers to overall performance and reliability characteristics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Not Specified |
| (e.g., Data collection accuracy, Data transmission reliability, System uptime, User interface responsiveness) | (Evaluated against product specifications, risk analysis, and usability in hospital/clinic settings) |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document states "usability tests within an Inpatient Intensive Care Unit and an Outpatient Clinic environment" and "validation studies conducted in two states," but without specifying the number of patients, data points, or cases used in these tests.
- Data Provenance: The validation studies were "conducted in two states," implying clinical environments within the United States. It's not explicitly stated whether the data was retrospective or prospective, though "real-time collection" suggests some prospective element to its intended use and testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not specified. The document mentions that "Clinical judgment and experience are required to check and interpret the information delivered," but does not detail how ground truth was established by experts during testing or validation.
4. Adjudication Method for the Test Set:
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not explicitly described. The device is a "Physiological Transmitter and Receiver" and a "software system utilized for the real-time collection, storage, transmission, surveillance and management of vital sign data," not an AI/ML-driven diagnostic tool that would typically involve human readers interpreting results. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply here.
6. Standalone (Algorithm Only) Performance Study:
- No, an explicit standalone performance study of an algorithm was not described. The VitalWare VMS is presented as a software system that interfaces with independent monitoring devices. Its performance is tied to the overall system's ability to collect, store, transmit, and display data reliably. The testing involved "verification and validation activities...to establish the performance and reliability characteristics...based on product specifications, safety testing based on risk analysis, and usability tests."
7. Type of Ground Truth Used:
- Not specified directly in a way applicable to diagnostic accuracy (e.g., pathology, outcomes data). For a vital sign management system, ground truth would likely refer to the actual vital signs recorded by the independent monitoring devices and the accurate representation and transmission of that data by the VitalWare VMS. Usability testing would also involve ground truth regarding user workflows and satisfaction.
8. Sample Size for the Training Set:
- Not applicable. The VitalWare VMS is described as a software system for data management, not an AI/ML device that undergoes a training phase with a specific dataset.
9. How Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set for an AI/ML model.
Summary of what is available vs. missing:
The 510(k) summary focuses on the device's intended use, technological characteristics, and comparison to predicate devices, emphasizing that the system's "performance and reliability characteristics" were established through "tests based on product specifications, safety testing...and usability tests." It concludes that these tests provide "a very high confidence level that the device is safe and effective when used as intended."
However, for the specific details requested regarding AI/ML device evaluation (such as defined acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, and explicit ground truth establishment for diagnostic performance), the document does not provide this level of detail. This is consistent with a 2005 submission for a vital sign data management system, which predates the widespread FDA guidance and requirements for AI/ML-based medical devices.
§ 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).