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The VM-2000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation in emergency and transport situations. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients, who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask).
• Assist/Control, SIMV, CPAP and NPPV modes of ventilation.
  The ventilator is suitable for use in institutional or transport settings.

The VM-2000 allows for rapid initiation of emergency ventilation based on default parameters. An operator can quickly begin ventilation by connecting the patient to the breathing circuit, and if necessary, adjusting ventilatory settings using the touch screen input before selecting start.
Once the therapy is initiated, breaths are delivered to the patient based on the configured settings. If the situation allows, qualified operators can adjust desired Mode, Tidal Vol, Respiratory Rate, PEEP, PIP, T Insp, P Insp and Sensitivity. Operators can monitor patients closely through a graphical breath-by-breath display to deliver highquality care. Audio and visual alarm indicators help troubleshoot issues.
The VM-2000 uses a single-patient-use breathing circuit with a Pressure Monitoring Line, and Flow Sensor to deliver air to patients using a motor-blower system. The unit has a Type BF Applied Part, which is the breathing circuit. The device can run on AC wall power and / or batteries. To support use in environments where compressed Oxygen is unavailable or ill-advised, the device does not require compressed Oxygen. The VM-2000 is compatible with low pressure oxygen sources and blenders but will function without supplemental FiO2.

This document does not contain the specific information required to complete the requested table and study description regarding acceptance criteria and performance data for a device, particularly an AI-powered one.

The provided text is an FDA 510(k) clearance letter and a summary for the Ventis Medical VM-2000 ventilator. This device is a continuous ventilator, not an AI-powered diagnostic or therapeutic device that would typically have acceptance criteria presented as sensitivity, specificity, or other performance metrics against a "ground truth" established by experts.

Instead, the document details a comparison of the VM-2000 to predicate ventilator devices (Cardinal Health LTV 1200 and Respironics Trilogy EVO) to establish substantial equivalence. The "performance testing" mentioned refers to compliance with various safety and performance standards for medical devices (e.g., IEC 60601 series, ISO 80601 series, MIL-STD-810G), not a study demonstrating AI performance on a test set.

Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and reported device performance related to AI.
• Sample size used for an AI test set or data provenance.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study results.
• Standalone AI performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for an AI training set.
• How ground truth for a training set was established.

The "Performance Testing" section (page 13) simply lists the standards the device was tested against and states that the "non-clinical performance testing included testing of a set of ventilation modes... The data demonstrates that the technological characteristics of the VM-2000 ventilator are substantially equivalent with the predicate device." This refers to engineering and safety performance, not AI-driven diagnostic accuracy.

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