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The BD BACTEC Plus Aerobic/F medium is used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTEC fluorescent series instruments.

The sample to be tested is inoculated into one or more vials which are inserted into the BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.

Resins have been described for the treatment of blood specimens both prior to and after their inoculation into culture media. Resins have been incorporated into BACTEC culture media to enhance recovery of organisms without a need for special processing.

The provided submission describes a device comparison study rather than independent validation against a predefined acceptance criterion. The study aims to demonstrate substantial equivalence of the new device (BD BACTEC Plus Aerobic/F in a plastic bottle) to a predicate device (BD BACTEC Plus Aerobic/F in a glass bottle) in terms of performance. Therefore, the "acceptance criteria" are implicitly defined by the performance of the predicate device.

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

Since specific, quantitative acceptance criteria are not explicitly stated in isolation (i.e., "device must achieve X accuracy"), the acceptance criteria are inferred as demonstrating statistical equivalence or non-inferiority to the predicate device in various performance metrics.

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