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The SafeCircuit Manifold/Pulmonary Unit, is intended to scavenging of waste anesthetic gases from patients recovery for general anesthesia and provide supplemental oxygen. When used with the SafeCircuit Adhesive mask and a standard breathing circuit. the unit helps to reduce the amount of anesthetic aqents and airborne contaminants released to the work environment of the healthcare worker.

The SafeCircuit ManifoldPulmonary Unit is comprised of a single manifold unit which has been divided into two (2) halves or functional chambers which function to: 1) Deliver supplemental oxygen during inhalation and, 2) Scavenge the patient's exhaled breath. The SafeCircuit Manifold / Pulmonary Unit incorporates directional valves similar to the directional valves of the standard CO2 absorber system of anesthesia gas machines and the Dryden disposable CO absorber to establish the inhalation flow of gases. In addition, as required in the Standard Specification for Anesthetic Equipment - Scavenging Systems for Anesthetic Gases. ASTM 1343-91. there must be a means to relieve excess positive and negative pressures. The SafeCircuit Manifold utilizes relief valves, similar to the Ohmeda Waste Gas unit and the Dryden SONRA, which will - 1. "Pop-off" or release any excess positive pressure on the exhalation side into the room should there be excess positive pressures. (Labeled EPPRV) 2. Entrain room air, should there be excess negative pressure from the vacuum so that this excess negative pressure is not directed toward the patient circuit. (Labeled ENPRV) In order to provide safe and effective oxygen delivery / inhalation unit, the use of excess positive and negative pressure relief valves are also incorporated in the inhalation side of the patient circuit. In this case they function to perform when - 1. Insufficient or no flow of oxygen occurs then, the patient can entrain room air, 21% oxygen through the excess negative pressure valve. (Labeled INPRV) 2. If there is excess oxygen flow, then the excess positive pressure valve will "pop-off" and the excess flow and / or pressure relieved to the outside. (Labeled IPPRV) The method of connecting the SafeCircuit Manifold to the patient is via a standard breathing circuit which is comprised of two (2) tubes, wye piece to connect to a mask and a reservoir bag to collect excess gases and allow for manual ventilation if required. This circuit would connect to the SafeCircuit Adhesive Mask, approved K950771, to provide an effective seal between the patient's face / airway and the SafeCircuit Manifold. As on the Waste Gas Interface Systems of Ohmeda a scavenging reservoir bag, with 19 / 30 mm fitting, is utilized, the SafeCircuit Manifold/ Pulmonary Unit will also have this overflow (expiratory) reservoir bag. It is intended to utilize a 30 mm fitting for this scavenge reservoir bag as the proposed international, ISO, standard is 30 mm. The unit has also incorporated filters at the back of the unit at each excess relief condition port opening to fitter the air released to the environment or entrained when excess positive or negative oressure conditions occur. These filters are to reduce any airborne contaminants, dust, dirt from the air entrained or released during exhalation. The SafeCircuit Manifold/Pulmonary Unit is designed to be mounted on the wall or on a pole so that the device can be conveniently located next to the patient and various wall outlets - oxygen and vacuum.

The provided text describes a medical device, the "SafeCircuit Manifold / Pulmonary Unit," and compares its features to several predicate devices. It does not contain information about acceptance criteria, study methodologies, or performance metrics in a way that allows for the completion of the requested table and detailed study description. The document is primarily a device description and a comparison table of features with predicate devices, likely for a 510(k) submission.

Therefore, I cannot extract the requested information. The text does not elaborate on:

1. Specific acceptance criteria: While it lists features and briefly mentions ASTM standards, it doesn't define quantitative acceptance criteria for performance.
2. Reported device performance: The table only states "Yes" or "No" for features, not actual performance values (e.g., specific pressure relief levels, flow rates, scavenging efficiency percentage).
3. Study type, sample size, or data provenance: There is no mention of any study conducted to prove the device meets performance criteria.
4. Expert involvement, ground truth, or adjudication methods: These details are entirely absent, as there's no mention of a study involving human-in-the-loop or standalone algorithm performance.
5. Training set information: This is irrelevant as no algorithm or AI is mentioned.

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