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The BD BACTEC Plus PRIME Aerobic/F blood culture 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.

Here's an analysis of the provided text regarding the BD BACTEC Plus PRIME Aerobic/F medium:

Key Takeaway: This document is a 510(k) summary for a medical device (blood culture medium) seeking FDA clearance. It's a "substantial equivalence" claim, meaning the device is compared to a legally marketed predicate device rather than a ground-up demonstration of safety and effectiveness as in a PMA. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within this comparison to the predicate device. The performance data focuses on demonstrating that the new device performs equivalently or, in some cases, better than the predicate.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by achieving performance that is not significantly different or clinically equivalent to the predicate device, or statistically better where a difference is desirable (like antimicrobial neutralization).

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

• Time to Detection:
  • 333 paired sets (positive in both new and predicate devices).
  • 244 paired sets (at 10-100 CFU inoculum level).
• Percent Recovery: 246 paired sets.
• False Positive Rate: 120 paired sets (comprised of 40 bottles from each of 3 lots).
• False Negative Rate: 93 paired sets.
• Antimicrobial Neutralization Capability:
  • MIC level: No specific count of paired sets provided, but "Eleven drugs representative of their classes were evaluated."
  • Peak serum level: 150 paired sets.

Data Provenance: The document does not specify the country of origin of the data. Given it's a submission to the FDA, it's typically assumed to be North American, but this is not explicitly stated. The studies described are prospective in nature, as they involve inoculating fresh human blood and organisms into the new and predicate devices under controlled test conditions to evaluate performance parameters.

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

This type of study for a blood culture medium does not typically involve human experts in the way clinical diagnostic imaging or pathology studies do. The "ground truth" is established through laboratory methods (e.g., known bacterial/yeast cultures, plate counts for CFU, confirmation of growth via subculture) and comparison against the results of a legally marketed predicate device (BD BACTEC Plus Aerobic/F medium).

4. Adjudication Method for the Test Set

Not applicable. This is not a study assessing human reader performance. "Ground truth" is based on laboratory results and instrumental readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This study pertains to the performance of a culture medium and an instrument's ability to detect microbial growth, not human interpretation of medical images or data.

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

Yes, the studies described are standalone in nature. The "device" (BD BACTEC Plus PRIME Aerobic/F medium used with the BACTEC fluorescent series instruments) operates without human intervention once the sample is inoculated and inserted into the instrument. The instrument's algorithm (detection of CO2 increase via fluorescence) determines a positive result. The performance metrics (TTD, recovery, false positive/negative rates) are based solely on the device's output.

7. The Type of Ground Truth Used

The ground truth is based on microbiological assay results and instrumental detection of microbial growth, compared against the performance of a well-established predicate device. Specifically:

• Known organisms and inoculum levels: Organisms are spiked into the blood samples at controlled concentrations (e.g., 10-100 CFU).
• Positive/negative status: Determined by the instrument's detection of metabolic activity (CO2 production) or confirmed by terminal subcultures.
• Comparison to predicate: The predicate device serves as the primary benchmark for "expected" performance under similar conditions.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning or AI models. This device is a culture medium, and its development and validation are based on traditional microbiology and analytical studies, not a machine learning approach that would typically involve distinct training and test sets for an algorithm. If there were implicit "training" it would have been the historical data and R&D leading to the formulation, which is not detailed here.

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

As mentioned above, the concept of a "training set" and associated ground truth establishment (as in AI/ML) is not applicable to this type of device and study. The development of such a medium relies on biochemical principles, empirical formulation, and iterative testing in a laboratory setting.

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