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A qualitative procedure for the culture and recovery of aerobic microorganisms (mainly bacteria and fungi) from pediatric and other blood specimens which are generally less than 3 mL in volume.

BACTEC PEDS PLUS medium is a bacterial growth medium providing an aerobic environment for the detection of bacteria and fungi. It has been designed for the recovery of microorganisms from pediatric and other blood specimens which are generally less than 3 mL in volume and is used specifically with the BACTEC NR ( non-radiometric )blood culture series instruments. Each glass vial of medium contains 20 mL of enriched Soybean-Casein Digest Broth with resins and CO2. If microorganisms are present in the test sample inoculated into the BACTEC vial, CO2 will be produced and liberated into the atmosphere when the organisms metabolize the substrates present in the vial. The instrument analyzes the vial head space gas for CO2 and, If a threshold level is exceeded, indicates that the vial is positive, i.e., that the test sample contains viable organisms.

Here's a breakdown of the acceptance criteria and study details for the BACTEC® PEDS PLUS™ Culture Vials, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 4,581 paired vials (meaning 4,581 BACTEC PEDS PLUS vials and 4,581 BACTEC NR6A vials were tested, for a total of 9,162 vials).
   • Data Provenance: Prospective, clinical studies conducted at three tertiary care pediatric hospitals. The country of origin is not specified, but given the submission is to the FDA, it's likely the US.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the text. The ground truth appears to be based on the isolation and identification of "clinically significant organisms," which implies laboratory culture and identification methods, rather than expert interpretation of results.

3. Adjudication method for the test set:

   • This information is not provided in the text.

4. 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:

   • No. This was not an MRMC study and does not involve AI. It is a comparison of two culture media.

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

   • Yes, in essence. The "device" in this context is primarily the BACTEC PEDS PLUS medium and its performance in detecting growth, measured by the BACTEC NR series instruments. The detection process itself (sensing CO2) is automated by the instrument, and the results (positive/negative, time to detection) are generated without direct human interpretation of a visual image, for example. The "algorithm" here is the instrument's CO2 detection threshold.

6. The type of ground truth used:

   • The ground truth was established by the isolation and identification of "clinically significant organisms" from the blood cultures. This implies standard microbiological culture and identification techniques, which is a form of laboratory-confirmed outcome/clinical outcome.

7. The sample size for the training set:

   • Not applicable. This study is a clinical comparison of two culture media, not an AI model requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This study is a clinical comparison of two culture media, not an AI model requiring a ground truth for a training set.

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