Search Results

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.

Ask a specific question about this device