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The Disposable Blood Pressure Transducer (DBPT) is intended for direct measurement and monitoring of fluid pressure.

The Disposable Blood Pressure Transducer (DBPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the DBPT include the DBPT module that houses a ceramic, a luer connector with locking collar that can connect to an intravascular catheter, a transducer cable that can connect to a compatible pressure monitor and a stopcock for altering direction of fluid flow. The DBPT is provided sterile and for single use.

The provided text describes a 510(k) premarket notification for a Disposable Blood Pressure Transducer (DBPT). It does not contain information related to the acceptance criteria or study results for AI/ML-based devices. The discussion of non-clinical testing refers to traditional medical device testing standards (biocompatibility, product performance, safety) and a predicate device (Transpac® Disposable Straight Pressure Transducer (DSPT)), which are typical for non-AI medical devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria based on the provided text. The document is for a traditional medical device, not an AI/ML-driven one.

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For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to add, maintain, retain moisture for the exhaled breathe of the patient. Use up to 24 hours.

The Models of the filters are A501-1, A501-2, A501-3, and A501-4. The filters are intended for patient population that weighs greater than 10Kgs.

Breathing circuit bacterial/viral filter has into two models: - 1) Bacterial/ viral filters; 2) Bacterial/viral filters HME. Breathing circuit bacterial/viral filters are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15/22 mm connectors with a gas sampling luer port. The depth filter use electrostatic media for filtration and a foam media for the HME media.

The provided document is a 510(k) premarket notification for a medical device: a Breathing Circuit Bacterial/Viral Filter manufactured by Zhejiang Haisheng Medical Device Co., Ltd. The document asserts that the device is substantially equivalent to a legally marketed predicate device (EMS Electra Filter and Filter/HME, K013122).

Based on the provided text, here's information regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is compared directly to the predicate device, implying that the predicate's performance metrics serve as the acceptance criteria for achieving substantial equivalence.

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