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The MODS is intended to convert liquid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery to a patient at one-half (0.5) to fifteen (15) LPM and fifty (50) psig.

The MODS has a portable, thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient, and is accompanied by tubing intended for connection to an oxygen mask.

The MODS is portable. The MODS houses the thermally insulated stainless steel container, which stores liquid oxygen, and is set on casters while the accompanying unit, the patient distribution kit, is encased with a handle. The MODS converts liquid oxygen (99.9% pure) from the insulated container through a heat exchanger into gaseous oxygen and finally the gaseous oxygen is distributed through the tubing in the accompanying interconnect hose or hose reel assembly and ultimately through the tubing in the accompanying patient distribution kit. After connecting the tube end to an oxygen mask, cannula, simulator ventilator, or other similar medical device (none of these devices is included in the MODS) the patient can inhale the gaseous oxygen.

The accompanying patient distribution kit has ten outlet ports that are capable of delivering oxygen to a maximum of ten patients. Multiple patient distribution kits can be used to deliver oxygen to more than patients.

The MODS has the capacity to store seventy-five (75) liters of LOX and convert it to a gaseous state. It can be filled using a fill harness and current commercially available LOX storage/filling systems such as a variable gas/liquid (VGL) cylinder. When using the MODS with external LOX cylinders, the system will run indefinitely under normal operating conditions (indoors at room temperature) as long as the LOX cylinders are rotated between each of two MODS external hookup ports. When filled with LOX, the MODS provides an uninterrupted supply of oxygen for delivery to patients at a maximum system flow rate of four hundred fifty (450) liters per minute (LPM) and, when connected to a patient distribution kit, at an individual patient flow rate of one-half (0.5) to fifteen (15) LPM. The nominal operating system pressure of the MODS is two hundred (200) psig and, when connected to a patient distribution kit, the individual hose pressure is fifty (50) psig.

This document describes a 510(k) Pre-market Notification for the Mass Oxygen Distribution System (MODS). The document DOES NOT contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria.

The provided text describes a medical device, the Mass Oxygen Distribution System (MODS), and its substantial equivalence to a predicate device (NPTLOX). It details the device's function, technical specifications, and intended use. The document explicitly states that "Essex Cryogenics of Missouri, Inc. engineering personnel completed extensive MODS capability, performance, and environmental testing with no issues arising regarding its safety and efficiency." However, it does not provide specific acceptance criteria or detailed study results that would allow for the completion of the requested table and information points about an AI device.

Therefore, I cannot fulfill the request as the provided text pertains to a liquid oxygen distribution system and does not mention any AI device, acceptance criteria or studies related to AI performance.

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