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The device "RemoteNurse™ Patient Monitoring system" is a monitoring tool prescribed by a licensed physician when time-critical care is not required, and is intended for use to provide caregivers remote access to vital sign measurements of patients at home, as captured on commercially available medical devices designed for home use, and transmitted to a database retrieved from a secure website. It is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data.

The device is contraindicated for patients with uncompensated heart failure, patients at high risk of life threatening arrhythmias, patients with recent myocardial infarctions, or patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable to self-administrate it.

Clinical judgment and experience are required to check and interpret the information delivered.

Typical devices that may be connected to RemoteNurse™ Patient Station are: Blood Pressure Monitor, Glucose Meter, Weight Scale, Pulse-oxidation, Peak Flow, ECG and PT/INR. Also, digital camera may be connected to RemoteNurse™ Patient Station. The unit supports up to 8 devices in the same time.

The device "RemoteNurse™ Patient Monitoring system" is a monitoring tool prescribed by a licensed physician when time-critical care is not required, for the purpose of providing caregivers remote access to vital sign measurements of patients at home, as captured on commercially available medical devices designed for home use, and transmitted to a database retrieved from a secure website. It is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data.

The device is contraindicated for patients with uncompensated heart failure, patients at high risk of life threatening arrhythmias, patients with recent myocardial infarctions, or patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable to self-administrate it.

Clinical judgment and experience are required to check and interpret the information delivered.

The RemoteNurse™ Patient Monitoring system consists of

• (1) RemoteNurse™ Patient Station –which is a computer with a touch sensitive screen- for capturing patient's vital signs from devices manufactured by others, The RemoteNurse™ Patient Station provides a user interface for displaying reminder information as well as prompting for patient responses to pre-defined questions.
• (2) RemoteNurse™ software application for capturing, storing and forwarding patient's vital signs to a secure website via either a standard telephone lines or LAN/WAN.
• (3) RemoteAccess™ software application to allow caregiver to review patient's vital signs on the secure website, RemoteAccess™ software application allows for pre-defining limits above or below which it emails and/or pages the caregiver.
• (4) Processor software application to manage the interface between RemoteNurse™ software application and the website.

Typical devices that may be connected to RemoteNurse™ Patient Station are:

Blood Pressure Monitor, Glucose Meter, Weight Scale, Pulse-oxidation, Peak Flow, ECG and PT/INR.

Also, digital camera may be connected to RemoteNurse™ Patient Station.

The unit supports up to 8 devices in the same time.

The provided text is a 510(k) summary for the WEBVMC RemoteNurse™ Patient Monitoring system. It is a pre-market notification that aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a dedicated study.

Therefore, the information requested in your prompt regarding acceptance criteria and a study to prove their fulfillment is not present in the provided document. The document focuses on comparing the technological characteristics of the RemoteNurse™ system with predicate devices to establish substantial equivalence based on similarity in design, performance, and intended use, rather than independent performance testing against predefined acceptance criteria.

Specifically:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The document includes a "Summary comparing technological characteristics with other predicate device" table, which states "Similar" for "Performance," but this is a comparative statement for substantial equivalence, not a report of performance against specific acceptance criteria.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No test set or study data is presented.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No study data or ground truth establishment is described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is described.
• 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 monitoring system, not an AI diagnostic tool, and no MRMC study is mentioned.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device relies on human caregivers to interpret information.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth is described for performance evaluation.
• 8. The sample size for the training set: Not applicable. This document does not describe an AI or algorithm that would require a training set.
• 9. How the ground truth for the training set was established: Not applicable.

The document states: "This device is safe and effective as the other predicate devices cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)." This indicates that the claim of safety and effectiveness is based on its similarity to previously approved devices, not on the results of a new performance study.

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