(46 days)
The 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 Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Aerobic 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.
The provided text describes the acceptance criteria and a study for the BacT/ALERT FA Culture Bottle. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent recovery of microorganisms | "BacT/ALERT FA culture bottle was substantially equivalent to the BacT/Alert FAN Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study." |
| Equivalent detection times | "Detection times in the test bottle were equivalent in both bottles." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: 23 organisms (strains) were diluted in human blood. The exact number of individual samples (e.g., individual blood aliquots) or runs per organism is not specified but it involved inoculating these diluted organisms into both the BacT/ALERT FA bottle and the BacT/Alert FAN bottle.
- Data Provenance: The text does not specify the country of origin of the human blood or where the study was conducted. It also does not explicitly state if it was retrospective or prospective, but the description ("Seeded studies were performed...") implies a prospective, controlled laboratory study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The ground truth was established through "Seeded studies" where specific organisms were inoculated into blood samples. This is a direct, experimental ground truth, meaning the presence and identity of the microorganisms were known by design. Therefore, no external experts were needed to establish the ground truth for the presence of the inoculated organisms.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The ground truth was experimentally determined by seeding the samples with known microorganisms, not by expert review requiring adjudication.
5. 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
No. This study is for a medical device (culture bottle), not an AI algorithm, and does not involve human readers interpreting results in a comparative effectiveness study. The comparison is between two culture bottle technologies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in a sense. The study evaluated the performance of the BacT/ALERT FA Culture Bottle as a standalone component with an automated detection system (BacT/ALERT Microbial Detection Instruments). The performance assessed was the ability of the bottle to support growth and allow for timely detection of microorganisms, without direct human interpretation influencing the detection itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth used was experimental ground truth through "seeded studies." Known microorganisms were intentionally introduced into the samples.
8. The sample size for the training set
The document does not mention a training set. This is a study for a medical device (culture bottle), not a machine learning model, so the concept of a training set is not applicable in the context described.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned or relevant to this type of device study.
§ 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.