Search Results

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
• Assist/Control, SIMV, or CPAP modes of ventilation.

The ventilator is suitable for use in institutional, home, or transport settings.

Not Found

This document is an FDA 510(k) clearance letter for a medical device called the LTV 1000 Ventilator. It does not contain information about acceptance criteria, device performance studies, sample sizes, or ground truth establishment for an AI/ML powered device.

The letter confirms that the FDA has reviewed the premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. This type of clearance process primarily focuses on demonstrating equivalence to existing devices, rather than requiring new clinical trials that would generate performance metrics against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device