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BacT/ALERT® FA Plus Culture Bottles are used with BacT/ALERT® Microbial Detection Systems in qualitative procedures for recovery and detection of aerobic microorganisms (bacteria and yeast) from blood and other normally sterile body fluids.

BacT/ALERT® PF Plus Culture Bottles are used with BacT/ALERT® Microbial Detection Systems in qualitative procedures for recovery and detection of aerobic microorganisms (bacteria and yeast) from blood.

The BacT/ALERT® Microbial Detection Systems utilizes a colorimetric sensor and reflected light to monitor the presence and production of carbon dioxide (CO2) dissolved in the culture medium. If microorganisms are present in the test sample, carbon dioxide is produced as the microorganisms metabolize the substrates in the culture medium. When growth of the microorganisms produces CO2 the color of the gas-permeable sensor installed in the bottom of each culture bottle changes from blue-green to yellow. The lighter color results in an increase of reflectance units monitored by the system. Bottle reflectance is monitored and recorded by the instrument every 10 minutes.

BacT/ALERT® Microbial Detection Systems are used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having bacteremia/fungemia. The BacT/ALERT® Systems and culture bottles provide both a microbial detection system and a culture medium with suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and other normally sterile body fluid infections. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorqanisms that will grow in the BacT/ALERT® FA Plus or PF Plus Culture Bottle (The BacT/ALERT® PF Plus Culture Bottle provides for detection of microorganisms when a small volume of blood is available.).

The provided text describes the performance characteristics of the BacT/ALERT® FA Plus and BacT/ALERT® PF Plus culture bottles, which are microbial detection systems. The study aims to demonstrate the equivalency of a modified formulation of these devices to their predicate devices.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Growth Performance: A panel of 39 clinically significant microorganisms.
• Antimicrobial Neutralization: Representative antimicrobials from claimed drug categories. Specific numbers of combinations are mentioned (e.g., five echinocandin/microorganism combinations, specific antimicrobial/organism pairs).
• Limit of Detection: A panel of 11 microorganisms listed in the IFU.
• Delayed Entry: A panel of 11 microorganisms.
• Repeatability: Multiple organisms and multiple organism/antimicrobial combinations, replicates from three bottle lots.

Data Provenance: The studies were described as "internal (bioMérieux) verification studies." This suggests the data was generated internally by the device manufacturer. The text does not specify the country of origin of the data or explicitly state if the studies were retrospective or prospective, but "verification studies" implies prospective testing of the modified devices.

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

This document describes the performance of a microbial detection system (culture bottles). The "ground truth" here is the actual presence and growth of microorganisms in the culture media, which is determined by the inherent biological phenomenon and observed by the instrument. This type of device does not involve human expert interpretation for "ground truth" establishment in the same way an imaging or diagnostic AI device would. The performance metrics rely on comparison to established microbiological methods or the predicate device's performance.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the ground truth is based on the biological growth of microorganisms detected by the instrument, not on expert human interpretation that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This is a microbial detection system, not an AI-assisted diagnostic tool that involves human readers. Therefore, an MRMC study and a human-in-the-loop performance evaluation are not relevant in this context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance data presented here is effectively standalone performance of the device (BacT/ALERT® FA Plus and PF Plus culture bottles with the BacT/ALERT® Microbial Detection Systems). The device functions autonomously to detect microbial growth.

7. The Type of Ground Truth Used

The ground truth used in these studies is the microbiological growth and detection of specific microorganisms in the culture bottles. This is established by direct observation of microbial growth (either visually or primarily, through the instrument's detection of metabolic byproducts like CO2) and comparison to expected growth profiles for known inocula.

8. The Sample Size for the Training Set

The provided text describes verification studies for a modification to a microbial culture medium. It does not mention a "training set" in the context of machine learning or AI. The modified device's performance is compared against a predicate device and established criteria, not against a model trained on a dataset.

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

Not applicable, as there is no "training set" mentioned or implied for this device type.

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