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Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age.

This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.

This VITALS360® device is intended for use in a clinical or home environment.

This VITALS360® device is a reusable device following thorough cleaning between uses.

The Vitals360® is a device designed for spot-checking measuring of the patient's physiological parameters. It can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology. Additionally, it can record single lead ECG signal.

The Vitals360® capabilities include storing, displaying measuring data.

This document describes the regulatory submission for the Vitals360® Multi-Vitals Mobile Monitor (K210086). The device is intended for measuring, displaying, reviewing, and storing non-invasive blood pressure (NIBP), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), and ECG in adults 18 years of age and older.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a single table of acceptance criteria and specific reported device performance in a dedicated section with pass/fail outcomes. Instead, it describes performance characteristics and accuracies within the "Comparison to the Predicate Device" section and lists the standards to which clinical studies were conducted under "Performance Data."

Based on the information provided, we can infer the acceptance criteria for individual parameters from the device's specifications and the adherence to relevant ISO standards for medical devices. The "reported device performance" is essentially the device's stated specifications and accuracies.

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The VoCare MyHealth Tablet™ is a remote patient monitor device available by prescription. The VoCare MyHealth Tablet™ is designed to be used in the home of a patient undergoing remote monitoring for maintenance of chronic disease. The VoCare MyHealth Tablet™ provides quidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and realtime video conferencing technology.

The VoCare MyHealth Tablet™ connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters. The VoCare MyHealth Tablet™ stores and displays the information on the LCD screen and transmits the information to the VoCare secure host server using FCC approved Wi-Fi or Ethernet.

Healthcare professionals can review the transmitted information utilizing the VoCare Clinician Access System and set thresholds to trigger alerts based on specific thresholds being exceeded.

The VoCare System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when timecritical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Judgment and experience by a caregiver or by a family member are required to check and interpret the information delivered.

A list of devices that are compatible with the VoCare MyHealth Tablet™ will be available in the user's manual and the VoCare website.

The VoCare MyHealth Tablet™ is a remote patient monitoring device available via prescription.

The VoCare MyHealth Tablet™ connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters, stores and displays the information on the LCD screen and transmits the information to the VoCare secure server. Healthcare professionals can review the transmitted information utilizing the VoCare Clinician Access System.

The VoCare System consists of:

1. VoCare System Hardware:
   The physical component of VoCare System is the VoCare MyHealth Tablet™, which is an electronic device contained in an acrylonitrile butadiene styrene (ABS) thermoplastic enclosure with a touch screen, built-in video camera, microphone, speaker, and a reminder light mounted on top left corner of the case. The VoCare MyHealth Tablet™ contains front and back panels that provide standard USB 2.0 connectors, Ethernet connector, power connector and power button, as well as volume controls.

2. VoCare MyHealth Tablet™ Software Application:
   The VoCare MyHealth Tablet™ executes the VoCare MyHealth Tablet™ Software Application, which connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters, stores and displays the information on the LCD screen and transmits the information to the VoCare secure server.

3. VoCare Clinician Access System (CAS) Software Application:
   The VoCare Clinician Access System (CAS), which is associated with and manages multiple VoCare MyHealth Tablet™ devices, is designed to allow doctors and nurses to create and access electronic health records as well as provide a user-friendly interface into a patient's health condition.

The VoCare System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when, timecritical care is not required. The system is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

The provided document is a 510(k) Premarket Notification for the VoCare MyHealth Tablet™. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria for performance metrics.

Therefore, the document does not contain a study that proves the device meets specific acceptance criteria in the format requested. It focuses on non-clinical testing and substantial equivalence.

Here's an analysis of the information available in the document related to your questions:

Acceptance Criteria and Device Performance

The document does not explicitly define acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a medical device that performs diagnosis or classification. The "acceptance criteria" here relate to the successful completion of non-clinical engineering and usability tests.

Specific Study Details Not Applicable/Provided

Given this is a 510(k) submission based on non-clinical testing and substantial equivalence, the following points are largely not applicable or not provided in the document:

2. Sample size used for the test set and the data provenance: Not applicable as there isn't a "test set" in the context of clinical performance metrics for diagnosis/classification. The non-clinical testing likely involved a limited number of devices/systems under test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the sense of clinical diagnoses or outcomes, was not established for this submission. The "ground truth" for non-clinical engineering tests would be the established engineering specifications.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a remote patient monitoring system, not an AI-powered diagnostic tool requiring MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a system for collecting and transmitting data; it does not perform "standalone" diagnostic algorithms. It facilitates data collection for human review.
7. The type of ground truth used: For regulatory purposes in this 510(k), the "ground truth" for the non-clinical tests was adherence to engineering specifications and international standards (IEC 60601-1, IEC 60601-1-2).
8. The sample size for the training set: Not applicable. This is not a machine learning/AI diagnostic model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Device and Submission Type

The VoCare MyHealth Tablet™ is a remote patient monitoring system intended to connect to various medical sensors (glucose meters, weight scales, blood pressure monitors, pulse oximeters), collect and display data, and transmit it to a secure server for healthcare professionals to review.

Key points from the submission:

• Intended Use: Remote patient monitoring, not diagnosis or real-time data for time-critical care.
• Non-Clinical Testing: Bench testing, usability testing, and compliance with IEC 60601-1 and IEC 60601-1-2 standards were performed.
• Conclusion: The non-clinical tests demonstrated the system met performance and design specifications. The device was deemed substantially equivalent to predicate devices based on technological characteristics and intended use.

This 510(k) submission demonstrates that for a device like the VoCare MyHealth Tablet™ (a data collection and transmission system), the regulatory burden is met through non-clinical engineering and usability testing, as well as by demonstrating substantial equivalence to pre-existing, legally marketed devices, rather than through clinical studies with specific diagnostic acceptance criteria.

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