(289 days)
The Proxima is intended for prescription use only, to be used for adult patients that require supplemental oxygen in a hospital setting.
The Proxima Model-100 is an electronic oxygen conserving device designed for use in a hospital environment. It incorporates a sensitive pressure sensor to detect inhalation, an electronic valve to deliver precise volume of oxygen and a graphical touch screen interface. In pulsed mode the Proxima delivers flows equivalent to 1 to 15 liters per minute of continuous oxygen flow. The volume of each bolus is calculated such that the patient receives the equivalent of the set volume regardless of how slow their breath rate is. To make sure the patient receives oxygen, even if inhalation is not detected, the Proxima automatically changes from pulsed to continuous oxygen flow at the set flow rate if inhalation is not detected for 15 seconds. Proxima displays a warning message to indicate low battery, low oxygen supply pressure, dislodged cannula, lack of inhalation and low nasal airflow. The Proxima is powered using an external 9-volt DC power supply and includes an internal back-up battery. The Proxima is for use with a customer supplied, dual lumen demand nasal cannula, for example the Salter Labs 4807 or similar, to ensure proper patient usage.
The provided text is a U.S. FDA 510(k) summary for a medical device called "Proxima". It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence for regulatory clearance.
However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical or algorithmic performance study, as typically seen for AI/ML-enabled devices.
The "acceptance criteria" section you're asking for typically refers to the pre-defined performance thresholds (e.g., minimum accuracy, sensitivity, specificity, or clinically relevant metrics) that an AI/ML algorithm must meet on a test set to be considered acceptable. The "study that proves the device meets the acceptance criteria" would detail the methodology of that study, including test set characteristics, ground truth establishment, expert involvement, and the actual performance metrics achieved by the device.
The provided document focuses on bench testing for the Proxima device, which is an oxygen conserving device, not an AI/ML diagnostic or prognostic tool. The performance testing mentioned (ISO 80601-2-67) evaluates physical parameters like pulse volume, breath rate, oxygen delivery, continuous flow, leak compensation, and breath trigger pressure. These are engineering and functional performance tests for a hardware device, not a performance study for an AI/ML algorithm.
Therefore, based solely on the provided text, I cannot extract the information required to populate your requested table and answer questions 1-9 about AI/ML device performance studies. The document describes a traditional medical device clearance, not an AI/ML device.
If the "Proxima" device were an AI/ML product, the information would typically be found in sections detailing clinical performance studies, often in the "Performance Data" or "Clinical Data" sections of a 510(k) summary, which are absent or not relevant in this document for the type of device described.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).