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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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The Remote Presence Robotic System is a communications tool that provides a means of transmitting, receiving, and storing real-time audio and video, and patient data. The Remote Presence Robotic also can be used in conjunction with 510(k)-cleared devices that transmit patient biometric data including vital signs information. The Remote Presence Robotic System transmits and receives information over high speed connection between patients and health professional, and is intended to be used in a hospital or clinic environment. Clinical judgment and experience are required to review and interpret the information transmitted.

The Remote Presence Robotic System is a mobile, robotic telecommunications platform that enables real-time videoconferencing. The Remote Presence Robotic System consists of a ControlStation (a desktop or laptop computer) and the RP-7 mobile robot, which is most often linked via broadband Internet and an 802.11 wireless network. The Robot and ControlStation are each equipped with cameras, displays, microphones and speakers, allowing two-way audio-video communication. Additionally, the ControlStation is equipped with a joystick that the operator uses to control the movement of the Robot in the remote location. As a result, the user can move through a remote facility and engage in conversations as if physically present while seated at a ControlStation in a remote facility with broadband Internet access. As an option, the Remote Presence Robotic System includes an integrated electronic stethoscope. The stethoscope is a FDA-cleared device which is used for the same purpose for which it received 510(k) clearance, i.e., to transmit auscultation sounds from a patient at one location to a clinic at a different location. The System provides a channel for the digital data that the stethoscope transmits.

The provided document describes the InTouch Health® Remote Presence Robotic System, a mobile, robotic telecommunications platform for real-time videoconferencing, sometimes including an integrated electronic stethoscope.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria in terms of numerical thresholds (e.g., "accuracy must be >90%"). Instead, it broadly states that the system's performance was demonstrated through validation testing, and its communication channel for the electronic stethoscope was proven effective by independent tests. The overall conclusion is that the device "is as safe and effective, and performs as well as or better than the predicate devices."

Therefore, based on the provided text, a table of specific numerical acceptance criteria and performance cannot be generated. The acceptance criteria appear to be based on demonstrating equivalence in safety and effectiveness to predicate devices through various tests.

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

The document does not specify the sample size used for any test sets.
It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth. It states that "Clinical judgment and experience are required to review and interpret the information transmitted," but this refers to the end-user's interpretation of the transmitted data, not the establishment of ground truth for testing.

4. Adjudication Method

The document does not mention any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not mentioned or implied in the provided text. The device is a communication and presence robot, not an AI diagnostic tool that would typically involve human readers interpreting images. The closest mention of human interpretation is for the end-user of the system.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The device itself is a "remote presence robotic system," which inherently involves a "human-in-the-loop" (the physician controlling it). While data transmission aspects (audio/video, stethoscope data) could be considered "standalone" in their function, the overall device's primary purpose is to facilitate human communication and control. The document does not present any performance metrics for a standalone algorithm without human interaction in a way that is typically understood in AI/diagnostic device contexts. The "effectiveness of ... the videoconferencing link" and the "communication channel used by the electronic stethoscope" being proven effective refer to the technical fidelity of data transmission, not an autonomous algorithmic interpretation or decision.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for any testing. Given the nature of the device (communication and remote presence), "ground truth" would likely relate to the fidelity and reliability of audio/video transmission, robot control, and potentially the accurate transmission of stethoscope data, rather than medical diagnoses (which are left to the human user).

8. Sample Size for the Training Set

The document describes a "Remote Presence Robotic System," which appears to be a hardware and software system for telepresence, not an AI/machine learning device that typically requires a distinct "training set." Therefore, no information on a training set sample size is provided, as it's likely not applicable in the conventional sense for this type of device.

9. How Ground Truth for the Training Set Was Established

As there's no mention of a training set, this information is not applicable and not provided.

Summary of Device and Performance Information from the Document:

• Device: InTouch Health® Remote Presence Robotic System (Model RP-7)
• Purpose: Mobile, robotic telecommunications platform for real-time videoconferencing, allowing a remote user to control a robot at a distant location. Can optionally integrate an FDA-cleared electronic stethoscope for transmitting auscultation sounds.
• Key Features: ControlStation (desktop/laptop), RP-7 mobile robot, cameras, displays, microphones, speakers for two-way audio-video, joystick for robot movement.
• Intended Use: Transmitting, receiving, and storing real-time audio, video, and patient data; can be used with other 510(k)-cleared devices for biometric data. Intended for hospital or clinic environments, requiring clinical judgment for interpretation.
• Technological Characteristics: Real-time audio/video link over broadband Internet. Transfers data from other 510(k)-cleared devices (e.g., stethoscope). Differentiator from predicates: physician-controlled mobility of the robotic platform.
• Performance Data: "Redundant safeguards are designed into the Remote Presence Robotic System to address risks associated with the mobility of the robotic platform. The effectiveness of these measures, and the videoconferencing link were demonstrated by the validation testing performed on the system. The communication channel used by the electronic stethoscope was also proven effective by independent tests."
• Conclusion: "The performance data discussed in this 510(k) application demonstrate that the Remote Presence Robotic System is as safe and effective, and performs as well as or better than the predicate devices."

The provided text focuses on establishing substantial equivalence to predicate devices for regulatory approval rather than detailing specific quantitative performance metrics and study designs typical for AI/diagnostic algorithms.

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