(35 days)
BacT/ALERT® FA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and fungi) from blood, and other normally sterile body fluids.
The BacT/ALERT FA Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT FA 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 FA Bottle.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
Acceptance Criteria and Device Performance
The acceptance criteria for the BacT/ALERT FA Plastic Culture Bottle are implicitly defined by its substantial equivalence to the predicate device, the BacT/ALERT FA Glass Culture Bottle. The study aimed to demonstrate that the new device performs "as well or better" than the predicate and that "Detection times were equivalent in both bottles." While explicit numerical acceptance criteria are not provided (e.g., "detection time must be within X% of the predicate"), the overall performance target was parity or superiority.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent recovery of low levels of microorganisms | "Recovery of low levels of the 23 microorganisms included in the study" was shown to be equivalent. |
| Equivalent detection times for microorganisms | "Detection times were equivalent in both bottles." |
| Suitable for detection of aerobic and facultative anaerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids | The study included 23 organisms, demonstrating this capability. |
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: The study involved "23 organisms." The text doesn't specify the number of individual tests or inoculations per organism, but refers to "low levels" of these organisms, implying multiple tests or replicates to assess recovery and detection times.
- Data Provenance: The study used "human blood" for diluting the organisms. The country of origin for the data is not specified. It was a prospective study conducted specifically for this 510(k) submission to demonstrate performance characteristics of the new device relative to the predicate.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The ground truth for bacterial growth and detection in culture bottles is typically established by laboratory methods, such as visual confirmation of growth, subculture, and identification, rather than expert interpretation of images or signals that require human consensus. The "ground truth" here is the actual presence and growth of the inoculated microorganisms.
-
Adjudication method for the test set:
- This is not applicable and not provided. The study involves direct measurement of microbial growth and detection times, not a diagnostic interpretation or subjective assessment that would require an adjudication process.
-
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:
- This is not applicable and not provided. This device is an automated microbial detection system, not an AI-assisted diagnostic tool that involves human readers interpreting results.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The study compared the performance of the new BacT/ALERT FA Plastic Culture Bottle with the predicate BacT/ALERT FA Glass Culture Bottle, both of which are used with the automated BacT/ALERT Microbial Detection Systems. The system itself operates in a standalone manner to detect microbial growth. The "algorithm" here refers to the detection mechanism of the instrument when monitoring the bottles.
-
The type of ground truth used:
- The ground truth was the actual presence and growth of specific, known microorganisms at "low levels" in human blood. This is equivalent to known positive controls or spiked samples where the microbial content is precisely controlled and confirmed through standard microbiological techniques.
-
The sample size for the training set:
- The text does not mention a training set. This product is a physical culture bottle intended for use with a pre-existing detection system (BacT/ALERT Microbial Detection Instruments). The study described is a performance validation study for the new bottle material, not a development or training phase for a new algorithm.
-
How the ground truth for the training set was established:
- This is not applicable as no training set is mentioned or implied for this type of device submission.
§ 866.2560 Microbial growth monitor.
(a)
Identification. A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.