Search Results

The Venner™ Tracheal Seal Monitor (TSM) is indicated for use to monitor, maintain and regulate the pressure within the PneuX P.Y.TM Endotracheal or Tracheostomy Tube Cuff in adult patients who have been confined to hospital ICU units where intubation is expected to be more than 24 hours, but less than or equal to 30 days.

The Venner™ Tracheal Seal Monitor consists of an automatic inflation cuff controller (control unit) that connects to the Venner™ PneuX P.Y.TM Endotracheal or Tracheostomy Tube using a single patient use, sterile extension tube. The Venner™ Tracheal Seal Monitor regulates and maintains cuff pressure in endotracheal and tracheostomy tubes in adult patients in the intensive care unit (ICU) setting. The device is intended to measure, monitor and maintain a stable cuff pressure in endotracheal and tracheostomy tubes. The Venner™ Tracheal Seal Monitor consists of an electronic automatic pressure controller with a pressure sensors and a pump, and provides a user interface with adjustable settings, indicators and alarms.

The Venner™ Tracheal Seal Monitor is indicated for use to monitor, maintain, and regulate the pressure within the PneuX P.Y.™ Endotracheal or Tracheostomy Tube Cuff in adult patients in ICU units where intubation is expected to be more than 24 hours but less than or equal to 30 days.

Acceptance Criteria and Device Performance

Study Details

Sample Size and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). While "a variety of settings" and "other devices" are mentioned as comparators, specific details are lacking.

Number of Experts and Qualifications:
Not specified. The document does not indicate the number of experts used to establish ground truth or their qualifications.

Adjudication Method:
Not specified. The document does not describe any adjudication method for establishing ground truth.

Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The performance testing focused on the device's technical specifications and engineering performance rather than its impact on human reader performance.

Standalone Performance (Algorithm Only):
Yes, a standalone performance study was done. The performance testing evaluated the device's ability to maintain and regulate cuff pressure, its reaction time to change pressure, and the performance of its safety over-pressure valve. This involved testing the device against its specifications in various physical settings and environmental stresses. The device also underwent system-level software verification and validation testing to ensure it performed as intended and met its requirements.

Type of Ground Truth:
The ground truth used for performance testing appears to be based on engineering specifications and predefined thresholds. For example, the pressure accuracy was compared against a ± 5% tolerance, and the safety valve operation was evaluated against specific pressure thresholds (57 mmHg for opening, 27 mmHg for closing/resetting).

Sample Size for Training Set:
Not applicable. The described testing is not typical for an AI/ML algorithm that would require a "training set." The device is an electro-mechanical control unit with software, and its validation focused on meeting pre-defined engineering and safety standards.

How Ground Truth for Training Set Was Established:
Not applicable, as there was no explicit "training set" in the context of an AI/ML algorithm. The ground truth for the device's performance was established through its design specifications and industry safety standards to demonstrate functional accuracy and safety.

Ask a specific question about this device