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The InTouch Thermal Camera is intended to view, measure and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by profession. This device is intended for use by qualified technical personnel trained in its use. Clinical judgment and experience are required to review and interpret the information transmitted.

The InTouch Thermal Camera is only for use in addition to other medical devices (i.e. Thermometer, Ultrasound, Mammography). It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition.

The InTouch Thermal Camera™ is a hardware and software package that enables thermographic imagery and data during a real-time telemedicine consultation. The system includes a 320-pixel-wide thermal camera and a USB cable that allows connection of the camera to a Windows-based computer, which serves as the patientside InTouch Health Telemedicine Device.

The InTouch Thermal Camera software consists of two components. The first is installed on a Windows-based system to serve as the InTouch Health Telemedicine Device. The second component is installed on a Windows or iOS-based system serving as the InTouch Health Provider Access device, enabling a healthcare professional access to the InTouch Health Telemedicine Device. The core software serves as a telecommunications platform that enables real-time videoconferencing and clinical communications, and provides a means of transmitting, receiving, and storing real-time audio and video data.

The InTouch Health Telemedicine System software provides a real-time link between the patient and the healthcare professional(s). The link occurs over a wired or wireless broadband connection, and includes real-time audio and video to facilitate communication between the patient-side healthcare professionals, and remote healthcare professional(s). The InTouch Health software further provides an ability to toggle between an InTouch Health Telemedicine Device's optical camera and the InTouch Thermal Camera, or to view both simultaneously.

When utilizing the InTouch Thermal Camera, the clinician is provided with interface controls to allow a variety of options in the visualization of the thermal imagery.

The basic purpose of the InTouch Thermal Camera is to allow a physician to view the heat pattern of a patient, while engaged in a telemedicine consultation. When the InTouch Thermal Camera is engaged, the InTouch Health software provides the physician with a variety of controls for visualizing temperature patterns and temperature differences.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical testing for accuracy, stating: "data was collected over multiple cameras, multiple users, and multiple temperatures ranging from 22-48 ℃." It does not specify an exact numerical sample size for the test set or the country of origin. The test was conducted as part of demonstrating substantial equivalence, implying it was a laboratory-based evaluation rather than a clinical study with patient data. Therefore, the data provenance is likely internal testing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document states: "Traceable certified reference black body calibrators and thermocouples were employed in order to establish the temperature difference accuracy and bias". This indicates that the ground truth for temperature measurements was established through certified reference instruments, not human experts. Therefore, no human experts were used for ground truth establishment in this specific accuracy test.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth was established by certified reference instruments, eliminating the need for expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The device is a thermal camera, and the provided document details non-clinical testing for its technical specifications and accuracy, not its impact on human reader performance or AI assistance. The document explicitly states: "No clinical studies were conducted."

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

The accuracy testing described ("The InTouch Thermal Camera temperature difference accuracy was calculated and verified to be +/- 1.1 °C at 99% confidence with a measurement bias within +/-0.1 °C. To determine these values, data was collected over multiple cameras, multiple users, and multiple temperatures ranging from 22-48 ℃.") can be considered a standalone performance evaluation of the device's measurement capabilities. It assesses the device's inherent ability to measure temperature differences accurately, independent of a human interpreter or an AI algorithm.

7. The type of ground truth used:

The ground truth used for the accuracy assessment was traceable certified reference black body calibrators and thermocouples. This is an instrumental, objective ground truth for temperature measurements.

8. The sample size for the training set:

The document does not provide information about a training set. The device is a thermal camera and its performance evaluation focused on its intrinsic measurement accuracy and technical specifications, not on a machine learning model that would require a distinct training set.

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

Not applicable, as no training set for a machine learning model is mentioned in the provided text.

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