Search Results

The Care Cycle Connect software application is intended for use with Trilogy Series ventilators by both caregivers and clinicians. The application pairs with the Trilogy device via a Bluetooth connection. The application provides the caregiver remote patient monitoring, and alarm surveillance. Alarm surveillance consists of both an audible tone and a visible alert if an alarm condition exists. The application provides the clinician with the ability to view, collect and store patient ventilator usage data. Care Cycle Connect also provides educational information on ventilator use to both caregivers and clinicians. It is intended to be used in the home, and hospital/ institutional settings. The Care Cycle connect application is intended to supplement and not replace any part of the current device monitoring procedures.

The Care Cycle Connect application is an accessory to a continuous ventilator (product code MOD). Care Cycle Connect is intended for use with the Trilogy Series of Ventilators cleared by the US FDA under K083526, K093416, K093905, and K111610. Care Cycle Connect (CCC) is a mobile software application designed to provide features and functions related to respiratory care in the home, hospital and institutional healthcare settings. The application provides the caregiver remote patient monitoring and alarm surveillance. The CCC application has been designed with two users in mind, the caregiver and the clinician. The functionality of the application is tailored to the different needs of these users and is configured when the application is installed. At the initial start-up of the application, users are asked to choose either careqiver (for patients and their in-home caregivers) or clinician mode. Functionality is based on the configuration selected. Once this choice is made, users cannot switch back and forth between the two configurations. The primary users expected to interact with Care Cycle Connect in the context of patient care in the home (the main use scenario) are caregivers and respiratory therapists (clinicians). CCC may also be used if the patient is in a hospital or institutional environment (sub-acute care facility). Caregivers are not expected to use CCC in a hospital or institutional setting. Care Cycle Connect provides constant feedback to the caregiver while the app is connected to the ventilator. This feedback is displayed via the Manometer Display feature within the application. This constant display provides data on the patient's use of the ventilator, ensuring that the ventilator is providing therapy. Care Cycle Connect will also provide educational information on the use of the ventilator to the caregiver or clinician, independent of being connected to the ventilator. The respiratory therapist will use the app when connected to a patient ventilator while on a home visit to gather ventilator data. It provides an interface for keeping patient information. When the app is not connected to the patient ventilator, the clinician can review stored data, such as appointments, journal, and vent check records. In the hospital or institutional environment. CCC may be used by clinicians to schedule and perform vent checks, which would be completed in the patient's room. Care Cycle Connect is an application that can be loaded onto an Apple device (iPad) that uses iOS 8.0 or more recent. The application relies on a Bluetooth Class 1 radio connection to a Trilogy ventilator. With the exception of low level communication protocol information (i.e., handshake connection), the Trilogy device does not accept any data, commands, or controls from the CCC Application. The Trilogy device functionality is not changed in any manner by connecting to the CCC Application. The Trilogy device simply sends information to the CCC Application on a periodic basis.

The provided text describes the acceptance criteria and study information for the "Care Cycle Connect" software application.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the test set used in "Software Verification and Validation Testing" or "Usability Testing." It mentions "complete system level testing" and "usability testing was completed," implying a sufficient set of tests were performed.

• Data Provenance: Not explicitly stated as retrospective or prospective patient data. The testing appears to be primarily laboratory/bench testing and simulated use, as it focuses on software verification, validation, and usability with the device itself, rather than clinical patient outcomes. The origin is implicitly related to the manufacturer's testing facilities (Respironics Inc., USA).

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The ground truth for the testing described seems to be based on compliance with international standards (IEC, ISO) and the device's functional design specifications, rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set. The testing described focuses on discrete pass/fail criteria against engineering requirements and established standards.

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

No. The document explicitly states: "Clinical tests were not required to demonstrate the substantial equivalence of Care Cycle Connect. Product functionality has been adequately assessed by non-clinical tests." Therefore, an MRMC comparative effectiveness study was not performed.

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

Yes, a standalone performance assessment was effectively done. The "Software Verification and Validation Testing" and "Non-Clinical Tests" describe the evaluation of the Care Cycle Connect application's functionality, adherence to software life cycle processes, alarm system compliance, and usability independent of a clinical human-in-the-loop study. These tests evaluate the algorithm's (software's) performance against its design requirements and relevant standards.

7. Type of Ground Truth Used

The ground truth used for the testing of Care Cycle Connect appears to be:

• Compliance with International Standards: e.g., IEC 62304, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 62366, ISO 14971.
• Product Requirements/Design Specifications: The software was tested against "product requirements" and various listed functionalities (device pairing, login, information display, alarm signals, etc.).
• Guidance Documents: Adherence to FDA guidance documents (e.g., for software, human factors, mobile medical apps, cybersecurity, wireless technology, home use devices).

Essentially, the "ground truth" is a combination of regulatory compliance, engineering specifications, and validated functional behavior.

8. Sample size for the Training Set

Not applicable. The document describes the verification and validation of a software application for remote monitoring and data display for a medical device. It does not mention any machine learning or AI components that would require a dedicated "training set." The software appears to be rule-based or deterministic, rather than data-driven in a way that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set for machine learning/AI.

Ask a specific question about this device