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The VitalLink3 Mobile Vital Signs Monitor is intended for use as a portable vital signs monitor for patients who are remotely located from medical professionals. The system can be used to acquire and display vital signs data from patients in remote locations and transmit that data, in real time, to a medical professional located at a call centre / different location in order to help determine the patients transport needs.

The VitalLink3 (VL3) Mobile Vital Signs System is intend for use as a portable vital signs monitor for patients who are remotely located from medical professionals. The system can be used to acquire and display vital signs from patients in remote locations and transmit the data, real time, to a medical professional at a Medical Call Center / Medical Service Provider in order to help determine the patient's transportation needs.

The VitalLink3 System is a modular hardware/software system for acquiring, monitoring and/or communicating patient vital signs data.

The VitalLink system acquires vital signs date from patients in remote locations (on land, in aircraft or on ships at sea) and communicates the data in real time to a medical professional at a call centre (Medical Service provider) in order to help determine the patient's need for transportation to a medical facility.

The VitalLink® System is comprised of the following discrete units:

a. The VitalLink3 (VL3) monitors 4 vital sign parameters: 6/12 lead EKG, Non-invasive blood pressure (NiBP), blood oxygen saturation (SpO2), pulse rate and core temperature. The VitalLink user interface includes a built in display for viewing collected data real time and a series of programmable soft keys for choosing communication preferences and manage communications with a medical service provider. The VitalLink also has onboard memory for storing the data collected from the parameters.
The Vitall ink is delivered to users in a fabric case with integrated compartments for the VitalLink3, the sensor components, battery chargers, labelling, and consumable accessories.

b. Parameters: The EKG and SpO2 parameters identified in "6.a" above communicate with the VitalLink3 via a Bluetooth RF link. The parameters are paired with a VitalLink3 and the RF link tested just prior to when the device is packaged for shipping.

c. Clinical Interface: The Clinical Interface is a TeleMedic Systems developed proprietary software application that receives data from a VitalLink®, decrypts the data and displays the information for use by medical professional / clinician in making a patient transport decision. The Clinical interface application is installed on a computer at the clinician's location.

d. Communication Options: There are six (6) possible means by which the VitalLink® can be configured to communicate with the Clinical Interface: Dialup telephone landline, direct wired connection to an IP network (Ethernet), satellite phone, satellite based data services, cellular phone and wireless 802-11 b/g networks.

This document describes the TeleMedic Systems VitalLink3 Mobile Vital Signs System, primarily focusing on its regulatory submission (510(k) summary) rather than a detailed performance study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance study details (like sample size, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth for training) is not explicitly present in the provided text.

Based on the information provided, here's what can be extracted:

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

The document does not provide a table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity, or precision) and corresponding reported device performance. Instead, it references adherence to recognized voluntary performance standards and mentions substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance

The document does not provide details about a specific clinical "test set" in terms of patient sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating adherence to voluntary performance standards and substantial equivalence to a predicate device rather than presenting a de novo clinical performance study.

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

This information is not provided in the document. Given the nature of a 510(k) submission focused on substantial equivalence and compliance with engineering standards, a formal clinical study with expert-established ground truth as one might see for an AI diagnostic device is not detailed.

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

This information is not provided.

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

This document does not describe an MRMC comparative effectiveness study or any AI components that would assist human readers. The VitalLink3 is a vital signs monitor and communication system, not an AI-assisted diagnostic tool in the typical sense.

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

The device is described as acquiring and transmitting vital signs data for a medical professional to "determine the patient's transport needs." This inherently involves a human-in-the-loop for clinical decision-making. There is no mention of a standalone algorithm performance without human interpretation or action.

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

The document does not detail specific "ground truth" types in the context of a clinical performance study. For a vital signs monitor, the "ground truth" would typically refer to the accuracy of the physiological parameter measurements themselves, which are assessed through calibration and comparison to reference standards (implied by adherence to standards like IEC60601-2-27 for EKG).

8. The sample size for the training set

The document does not describe a "training set" as it would for a machine learning or AI-driven device.

9. How the ground truth for the training set was established

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

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