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BacT/ALERT® FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood, and other normally sterile body fluids.

The BacT/ALERT FN Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT FN Glass Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FN Bottle.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BacT/ALERT FN Culture Bottle:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for recovery or detection time. Instead, the study's aim was to demonstrate "substantial equivalence" to the predicate device, meaning performance was expected to be comparable or better. The conclusion states equivalence was achieved.

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

• Test Set Sample Size: 9 organisms. The document doesn't specify the number of individual tests or bottles per organism, but mentions "low levels of the 9 microorganisms."
• Data Provenance: Human blood (used for dilution) inoculated into the culture bottles. The origin (country/retrospective/prospective) of the human blood samples is not specified, but the study design ("seeded studies") indicates a controlled, likely prospective, laboratory-based study.

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

This information is not provided in the document. For a microbial growth monitor, the ground truth is typically established by laboratory methods confirming the presence and growth of specific microorganisms, not by human expert interpretation in the same way as, for example, radiology images.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of this device. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective interpretations (e.g., medical image diagnosis). For a microbial growth monitor, the "ground truth" relies on objective lab measurements (e.g., confirmed microbial growth, identification, and quantification).

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. The BacT/ALERT FN Culture Bottle is a device for detecting microbial growth, not for interpretation by human readers in the same manner.

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

Yes, the study described is essentially a standalone performance study. The device (BacT/ALERT FN Plastic Culture Bottle) was tested directly for its ability to recover and detect microorganisms, and its performance was compared to a predicate device (BacT/ALERT FN Glass Culture Bottle). There's no indication of a human-in-the-loop component in the primary performance evaluation.

7. The Type of Ground Truth Used

The ground truth used was the confirmed presence and growth of specific microorganisms (9 known organisms) inoculated into blood samples at "low levels." This is a laboratory-established ground truth based on microbiology techniques.

8. The Sample Size for the Training Set

This information is not applicable/provided. The BacT/ALERT FN Culture Bottle is a physical culture medium and detection system, not an AI/machine learning algorithm that requires a training set in the conventional sense. The "development" of the device would involve R&D and testing, but not a "training set" of data for algorithmic learning.

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

This information is not applicable/provided for the reasons stated above (not an AI/ML device requiring a training set).

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