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BD BACTEC Peds Plus™F culture vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of aerobic microorganisms (mainly bacteria and yeast) from pediatric and non-pediatric blood specimens which are generally less than 3 mL in volume.

The sample to be tested is inoculated into one or more vials which are inserted into the BD 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's fluorescence measurement is detected at regular intervals to determine the change in CO2 present in the system. A positive reading indicates the presumptive presence of viable microorganisms in the vial. BD BACTEC Peds Plus™F culture vial detection is limited to microorganisms that will grow in a particular type of medium.

The document describes the analytical performance criteria and the study conducted for the BD BACTEC™ Peds Plus™/F Culture Vials.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Instrument Time to Detection: 672 paired sets evaluated. 596 paired sets were positive in both devices.
• Percent Recovery: 492 paired sets (from the 672, specifically with 10-100 CFU) evaluated.
• Microbial Detection Limit: 180 paired sets (from the 672, specifically with 0-1, 1-10 CFU) evaluated.
• Antimicrobial Neutralization: Representative drug of its class was evaluated at the MIC level for selected strains. (Specific sample size for this part of the study is not explicitly stated as a number of paired sets, but focuses on the number of strains and drug class).

The data provenance is not explicitly stated regarding country of origin or whether it's retrospective or prospective. However, such studies for regulatory submissions are typically prospective, controlled laboratory studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The study described is an analytical performance study comparing two medical devices (plastic vial vs. glass vial) in a laboratory setting, not a clinical study involving human patients where expert readers would establish ground truth for diagnostic interpretations. Therefore, this information is not applicable to the provided text. The "ground truth" here refers to whether microorganisms grew and were detected as per the gold standard laboratory methods.

4. Adjudication Method for the Test Set:

Not applicable. This was an analytical performance study, not a clinical study requiring adjudication of expert interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-based device, nor a diagnostic imaging device typically evaluated with MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device is a culture vial used with an instrument (BD BACTEC fluorescent series instrument) for automated detection of microbial growth. The performance described is "standalone" from human interpretation in the sense that the instrument provides the detection results. There is no "human-in-the-loop" AI algorithm being evaluated.

7. The Type of Ground Truth Used:

The ground truth used for this analytical performance study is the actual growth and detection of microorganisms in the culture vials, confirmed by laboratory methods (i.e., whether growth occurred and was detected by the instrument, and confirmed by potentially subcultures or other microbiological techniques if discrepancies arose, though the document doesn't detail this level of confirmation). The study design compares the performance of a new plastic vial with an existing glass vial (control).

8. The Sample Size for the Training Set:

Not applicable. This device is a culture vial, not an AI algorithm that requires a training set. The study focuses on evaluating the analytical performance of the device itself.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of device.

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