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The CareCompanion Patient Station is intended to be used in conjunction with the CareCompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.

The CareCompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The information is collected from the CareCompanion Patient Station and transmitted over standard telephone lines to a health care professional.

The device does not send any real-time alarms. The device a aid. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The CareCompanion System consists of two components: a transportable Patient Station installed typically in a patient's home; and the Nurse Station, installed in a healthcare provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.

The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.

Using vital signs measurement devices integrated with the Patient Station, the Patient Station is designed to monitor the patient's blood pressure, pulse rate, blood glucose level, weight, blood oxygen saturation level and/or heart, lung and bowel sounds, and transmit this data to the Nurse Station. The data is displayed to the caregiver operating the Nurse Station and also automatically recorded in a patient information database. The heart, lung and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.

The Nurse Station consists of two sub-components, the Nurse Station PC, which is a standard PC with supporting peripherals connected to a videophone, which provides the video conferencing functions for the Nurse Station. The Nurse Station PC may also operate as a standalone device for patient data management and record keeping functions.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Neptec CareCompanion system.

Based on the provided text, the Acceptance Criteria and the Study that proves the device meets them are primarily focused on Substantial Equivalence to a predicate device, specifically regarding the addition of a pulse oximeter. There's limited information on standalone performance metrics for each vital sign, rather the testing emphasizes functional equivalence.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: The document does not specify the sample size for any of the performance tests. It states "Testing was performed" and "The pulse oximeter was tested."
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be internal validation by the manufacturer, rather than a clinical study.

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

   • Not applicable. The document describes functional testing against existing specifications and predicate devices, not the establishment of ground truth by human experts for a diagnostic or interpretive task.

3. Adjudication Method for the Test Set:

   • Not applicable. The testing described focuses on functional performance and conformance to specifications, not on inter-rater agreement for a diagnostic outcome.

4. 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:

   • No. This is not an AI-assisted diagnostic device, but rather a telemedicine system for vital signs collection and communication. Therefore, an MRMC study is not relevant here.

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

   • The core of the "Performance Testing" section describes standalone testing of the integrated vital signs measurement devices (e.g., "show that they operate equivalently when integrated with CareCompanion as when operated as independent devices") and the pulse oximeter against its manufacturer's specifications. This can be considered a form of standalone performance assessment for the individual measurement components within the system. The system itself is explicitly designed to be human-in-the-loop, with a "caregiver operating the Nurse Station" and clinical judgment required.

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

   • The "ground truth" for the performance testing cited appears to be:
     • Manufacturer's specifications: For the pulse oximeter.
     • Performance of independent devices: For the other integrated vital signs measurement devices. The equivalence to these "independent devices" is the reference.
     • Applicable mechanical, electrical, and environmental standards: For general system performance.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that would require a "training set."

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

   • Not applicable, as there is no training set.

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