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BacT/Alert® FAN™ Culture Bottles are used with the BacT/Alert® Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids.

The BacT/Alert® FAN Culture Bottles contain media, an adsorbent and an internal sensor that detects CO2 as an indicator of microbial growth when used in connection with the BacT/Alert® Microbial Detection System.

Here's a breakdown of the acceptance criteria and the study details for the BacT/Alert™ FAN Culture Bottles, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative or pass/fail format for this premarket notification. Instead, it focuses on demonstrating substantial equivalence to traditional culture methodology.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not specify a numerical sample size for the test set used in the clinical tests. It generally states that "Testing was performed to establish the performance characteristics."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

The document does not provide information on:

• The number of experts used to establish ground truth.
• The qualifications of any such experts.
• The type of ground truth (expert consensus, pathology, outcomes data, etc.).

For this type of device (microbial growth monitor), "ground truth" would typically refer to confirmed culture results from established laboratory methods, but the document doesn't detail how this was established for the comparison.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done? No. This type of study (MRMC) is typically relevant for interpretative diagnostic devices where human reading is a primary component. The BacT/Alert™ FAN Culture Bottles are automated microbial detection systems.
• Effect Size: Not applicable as an MRMC study was not performed.

6. Standalone Performance Study

• Was it done? Yes, in essence. The clinical tests performed were to establish the performance characteristics of the new device, including comparison to traditional culture. This comparison serves as a standalone performance assessment against a predicate. The device "detects CO2 as an indicator of microbial growth when used in connection with the BacT/Alert® Microbial Detection System," which implies an automated, standalone detection process once the bottles are inoculated and placed in the system.

7. Type of Ground Truth Used (for Test Set)

The document implicitly suggests that "traditional culture methodology" was used as the reference or ground truth for comparison. This would generally involve established laboratory techniques for isolating, identifying, and culturing microorganisms.

8. Sample Size for the Training Set

The document does not provide information on a training set sample size. For a device like this, which is a culture medium/bottle rather than a machine learning algorithm, the concept of a "training set" in the context of AI/ML is not directly applicable. The device's performance is based on its chemical and biological composition and its interaction with the BacT/Alert system, which would have undergone its own development and validation.

9. How Ground Truth for the Training Set Was Established

As the concept of a "training set" for an AI/ML algorithm is not applicable here, there is no information provided on how ground truth for a training set was established. Device performance is based on its intrinsic design and validation against established microbiological methods.

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