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BD BACTEC™ Lytic/10 Anaerobic/F culture vials (prereduced enriched Soybean-Casein Digest broth with CO2) are for anaerobic blood cultures. Principal use is with the BACTEC fluorescent series instruments for the qualitative culture and recovery of anaerobic microorganisms from blood.

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.

The provided document describes the BD BACTEC Lytic/10 Anaerobic/F (plastic) blood culture medium. The study aims to demonstrate substantial equivalence to its predicate device, the BD BACTEC Lytic/10 Anaerobic/F (glass) medium, by showing equivalent performance in various analytical aspects.

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Time to Detection (TTD):
  • 10-100 CFU/bottle: 342 paired sets.
  • 0-1 and 1-10 CFU/bottle: 191 paired sets (positive in both devices).
• Percent Recovery:
  • 10-100 CFU/bottle: 342 paired sets.
  • Subset of organisms (Finegoldia magna, Peptoniphilus asaccharolyticus): Sample size not explicitly stated for this subset, but demonstrated 100% recovery.
• False Positive Rate: 240 paired sets (80 bottles from each of 3 lots).
• False Negative Rate: 121 paired sets.
• BACTEC Instrument Compatibility: 114 paired sets.
• Comparison Across Lots: 342 paired sets (114 paired sets x 3 lots).

The data provenance is not explicitly stated regarding country of origin; however, the study appears to be an analytical study conducted in a laboratory setting. The data is prospective in nature, as it involves the inoculation and testing of the new device alongside the predicate.

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

This study does not involve human readers or experts establishing ground truth in the traditional sense of image interpretation or clinical diagnosis. The "ground truth" for this device, a blood culture medium, is determined by the objective growth and detection of microorganisms, followed by subculture analysis (for false negatives). Therefore, there were no experts mentioned.

4. Adjudication method for the test set

Not applicable. The study design does not involve adjudication by experts as it is an analytical study for microbial growth detection. The "ground truth" is established through laboratory protocols (e.g., terminal subculture to confirm growth in negative bottles).

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 an analytical study of a medical device (blood culture medium), not an AI-based diagnostic tool. There are no human readers or AI involved in interpreting results in this context.

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

The device itself is a standalone system in terms of its ability to detect microbial growth within the BACTEC instrument. The instrument's algorithm (growth and detection algorithms) processes the sensor data. The study primarily evaluated the performance of this "algorithm-only" or instrumental detection.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is primarily microbiological culture and detection, specifically:

• Positive growth validation: Visual confirmation of growth, and possibly subculture for confirmation of specific organisms and CFU counts used for inoculation.
• Negative validation: Absence of growth in the instrument, and crucially, terminal subculture to confirm no viable organisms were present (to rule out false negatives).

8. The sample size for the training set

Not applicable. This is an analytical study comparing a new device to a predicate device. There is no explicit "training set" in the context of machine learning or AI algorithm development because the device functions based on chemical/biological reactions and instrument-specific algorithms, not a learned model from a dataset.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned in the context of this device evaluation.

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