(60 days)
VitalWatch is a software user intended for use by healthcare professionals to display physiological data collected by the VitalConnect Platform wireless remote monitoring system in home and healthcare is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.
VitalWatch is a software user interface designed to be manufacturer-installed and user-executed on a validated Relay device, which serves as a graphical user interface that displays physiological data provided by the VitalConnect wireless remote monitoring system.
The provided text describes the 510(k) premarket notification for the VitalWatch Software User Interface. However, it does not include detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies for AI/ML medical devices.
The document is a regulatory submission for a software user interface (VitalWatch) that displays physiological data collected by an existing wireless remote monitoring system (VitalConnect Platform). The core of this submission revolves around demonstrating substantial equivalence to a predicate device, not necessarily a new clinical performance study.
Therefore, many of the requested details about acceptance criteria, test set characteristics, expert involvement, and ground truth establishment are not present in this regulatory document, as it pertains to a user interface rather than an algorithm performing a diagnostic task.
Here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance (Based on provided text, limited information)
Since this submission focuses on "substantial equivalence" for a user interface, rather than a new diagnostic algorithm, explicit performance metrics and acceptance criteria for clinical efficacy (e.g., sensitivity, specificity, accuracy) are not detailed. The performance discussed is related to software verification and validation.
| Acceptance Criteria Type | Acceptance Criteria (Not explicitly stated for clinical performance, only for software V&V) | Reported Device Performance |
|---|---|---|
| Software Verification & Validation | Adherence to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Applying Human Factors and Usability Engineering to Medical Devices, and Postmarket Management of Cybersecurity in Medical Devices." | "Software verification and validation testing was conducted and documentation is provided in accordance with the Guidance..." |
| Level of Concern | Moderate Level of Concern addressed. | "VitalWatch software has a 'Moderate' Level of Concern." |
| Intended Use | Device displays physiological data as a secondary, adjunct monitor; not intended to replace existing standard-of-care. | The device's functionality as a display for existing data aligns with this intended use. |
| Technological Characteristics | No changes to the technological characteristics of the VitalConnect Platform. | "This 510(k) does not involve any changes to the technological characteristics of the VitalConnect Platform." |
| Substantial Equivalence | Same intended use and technological characteristics as the predicate device. | "The VitalConnect Platform, modified to include the VitalWatch software user interface, has the same intended use and technological characteristics as the predicate device and is therefore substantially equivalent to the predicate device." |
Study Details:
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1. A table of acceptance criteria and the reported device performance:
- See the table above. The focus is on software quality and functional equivalence, not clinical performance metrics like diagnostic accuracy.
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2. Sample size used for the test set and the data provenance:
- Not specified. The document mentions "software verification and validation testing," but it does not describe a clinical test set with patient data for performance evaluation in the context of an AI/ML algorithm. This is a user interface for displaying pre-existing data.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. Ground truth establishment by experts is typically relevant for diagnostic AI algorithms. For a user interface displaying data, the "ground truth" would be the accurate transmission and display of the physiological data collected by the established VitalConnect platform, which is presumed to be accurate from its own prior clearance (K152139).
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication is used to resolve discrepancies in expert readings for diagnostic or screening tasks. This is not a diagnostic device.
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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:
- No. This is not an AI-assisted diagnostic device. It is a user interface for displaying data.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a user interface, part of a system where a human professional interprets the displayed data. It's not a standalone diagnostic algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not specified in detail. For a user interface, the "ground truth" would be the integrity and accuracy of the data displayed against the raw data from the sensors. The document relies on the prior clearance of the VitalConnect Platform and the software's functional verification.
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8. The sample size for the training set:
- Not applicable. This is not a machine learning model that requires a training set.
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9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning model.
Summary:
The provided document (K170973) is a 510(k) submission for a software user interface (VitalWatch), not a new diagnostic or AI/ML algorithm. Its clearance relies on demonstrating substantial equivalence to a previously cleared predicate device (VitalConnect Platform, K152139) by showing that it has the same intended use and technological characteristics, and that software verification and validation protocols have been followed. Therefore, the details requested about clinical validation studies, expert involvement, and ground truth establishment for diagnostic performance are largely not applicable or not provided in this specific type of regulatory submission.
§ 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).