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For use with pulmonary function testing. To filter air between the patient's exhaled air and the testing equipment. Single patient use.

The EMS PFT Filter is acompact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace and resistance of 07. cm H2O at 720 Ipm per ATS spirometry or 0.5 cm I-120 @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.

The provided text describes a Premarket Notification 510(k) for the EMS PFT Filter. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a study that establishes performance against predefined acceptance criteria for a novel device.

However, the document does list performance attributes for the EMS PFT Filter and compares them to those of a predicate device (PDS KoKo K934475), which can be interpreted as demonstrating that the EMS device meets performance levels comparable to a legally marketed device.

Here's an attempt to structure the information according to your request, with the understanding that this is a 510(k) submission, and the "study" is more of a comparison against a predicate, rather than a de novo clinical trial with specific acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for substantial equivalence, the "acceptance criteria" are derived from the performance of the predicate device. The EMS PFT Filter is considered acceptable if its performance is comparable to or better than the predicate's.

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