Search Results

Ask a specific question about this device

The L770-CPR Resuscitation Timer gives an audible and visual guide to the proper inspiratory time and (BPM) breaths per minute during emergency manual ventilation. It displays the actual inspiratory time, (BPM) breaths per minute, and peak airway pressure.

Not Found

This document is not primarily a study, but rather an FDA 510(k) clearance letter for a medical device called the "L770-CPR Resuscitation Timer." As such, it does not contain the detailed information about acceptance criteria or a study design that you are requesting.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. This means that the FDA determined the new device is as safe and effective as a device already on the market, but it does not require the manufacturer to conduct a full clinical study with acceptance criteria in the same way a Premarket Approval (PMA) application would.

Therefore, I cannot provide the specific information you requested in the table format or answer the detailed questions about sample sizes, ground truth establishment, or multi-reader studies, as these details are not present in this FDA clearance letter.

Ask a specific question about this device