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The VivaTRAK™ system monitors in-bed activity and care delivery for patients susceptible to pressure ulcers and falls as well as those that require 24 hour monitoring of their general activity levels in medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities. The system providers information related to patient status and care delivered.

The VivaTRAK™ system is not intended to provide automated treatment decisions or used as a substitute for professional healthcare judgment. The VivaTRAK™ system is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

The VivaTRAK 110 system is used for monitoring in-bed patient activity and care delivery. The system monitors in-bed patient activity with the BedSense sensor, an under-the-mattress activity sensing pad, processing and wireless transmission of activity data with the ActivSense "M Bed Computer, and providing pager, email, phone and display notifications and care reports to the nursing staff, and then verifying using RFID readers that care was actually delivered with the VivaTRAKTM application. Care reports consisting of a notification, a RFID scan and bed activity are stored in a database and form the basis for reports used to improve quality of care and work flows at the facility.

The provided text is a 510(k) Pre-Market Notification Summary for the VivaTRAK™ system. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to existing devices rather than a detailed performance study with acceptance criteria and statistical analysis as might be found in a clinical trial report for AI/ML devices.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a specific device performance evaluation is not present in this document. The summary focuses on regulatory comparisons and claims of meeting functional specifications rather than presenting detailed study results in the manner an AI/ML study would.

Here's a breakdown of what can be extracted and what information is missing:

Acceptance Criteria and Reported Device Performance

The document states: "Wireless MedCARE has verified and validated that the VivaTRAK™ system meets its functional, performance, safety, and efficacy specifications and requirements." However, it does not disclose what these specific functional, performance, safety, and efficacy specifications (i.e., acceptance criteria) are, nor does it provide a table of performance metrics to demonstrate meeting those criteria.

Table of Acceptance Criteria and Reported Device Performance (Information Not Provided):

Study Information (Based on Available Text)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified.
   • Data Provenance: Not specified. The document states a "non-clinical performance summary" without detailing the type of data (e.g., patient data, simulated data) or its origin.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not specified. The document does not describe a study involving expert-established ground truth for performance evaluation in the context of diagnostic accuracy. The device monitors in-bed activity and care delivery, which is likely validated through direct observation or automated logging, rather than expert interpretation of images or signals.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. This is typically relevant for studies where human disagreement needs to be resolved for ground truth or performance assessment, which is not described for this device.

4. 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. An MRMC study was not described or implied. The VivaTRAK™ system is described as providing information to nursing staff and verifying care delivery, not as an AI/ML diagnostic aid that human readers would interpret or use to improve performance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The document implies that the system operates autonomously in monitoring activities and generating reports and notifications. It states, "The VivaTRAK™ system monitors in-bed patient activity... processing and wireless transmission of activity data... and providing pager, email, phone and display notifications and care reports to the nursing staff, and then verifying using RFID readers that care was actually delivered..." This suggests a standalone functional operation. However, no specific "standalone performance study" with detailed results (e.g., accuracy of activity detection, notification timeliness) is provided. Instead, it broadly states "meets its functional, performance, safety, and efficacy specifications."

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not explicitly stated. Given the device's function (monitoring in-bed activity and care delivery), the "ground truth" would likely be derived from direct observation of patient activity, direct logging of care delivery interactions (via RFID scans), or other objective measurements, rather than expert consensus on diagnostic images or pathology.

7. The sample size for the training set:

   • Not applicable/Not specified. While the system "processes" data, the document does not suggest it uses machine learning models that require a distinct "training set" in the common sense of AI/ML development. It's a sensor-based monitoring system.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified, as no training set for an AI/ML model is described.

Summary of Device and Performance Claims from Document:

The VivaTRAK™ system is a "Monitor, Bed Patient" that:

• Monitors in-bed patient activity with an under-the-mattress sensor (BedSense).
• Processes and wirelessly transmits activity data with an "ActivSense™ Bed Computer."
• Provides pager, email, phone, and display notifications and care reports to nursing staff.
• Verifies care delivery using RFID readers and the VivaTRAK™ application.
• Stores care reports for quality improvement and workflow analysis.

The claims regarding performance are general: "Wireless MedCARE has verified and validated that the VivaTRAK™ system meets its functional, performance, safety, and efficacy specifications and requirements." The 510(k) clearance is primarily based on demonstrating substantial equivalence to predicate devices (AFrame Digital, Inc.'s AFrame MobileCare Monitor™, Stanley Security Solution's TAS Stilite, and Emfit Ltd's SafeBed) rather than presenting novel performance metrics from a detailed clinical/technical study with specific acceptance criteria.

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