(65 days)
The 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 Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Anaerobic 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 Instrument where it is incubated and continously monitored for the presence of microorganisms that will grow in the BacT/ALERT FN Culture Bottle.
Here's an analysis of the provided text to extract the requested information regarding the acceptance criteria and the study that proves the device meets them:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Recovery of anaerobic organisms from human blood | Equivalent to the predicate device (BacT/Alert FAN Anaerobic Culture Bottle) |
| Time to detection of anaerobic organisms | Equivalent to the predicate device (BacT/Alert FAN Anaerobic Culture Bottle) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated, but the study involved "low levels of eleven anaerobic organisms diluted in human blood." The number of samples (bottles) per organism or per blood sample is not provided.
- Data Provenance: The data was generated through "seeded studies" using "human blood." The country of origin is not specified, but the submission is to the FDA in the USA. Given this, it's a prospective study conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a diagnostic tool for microbial growth. The "ground truth" for the test set would be the confirmed presence and identity of the seeded anaerobic organisms, which is determined by standard microbiological culture and identification methods, not expert reader consensus.
4. Adjudication method for the test set
Not applicable. As described above, the ground truth for microbial growth detection is based on the inherent biology and laboratory confirmation of the seeded organisms, not expert adjudication of images or diagnoses.
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
Not applicable. This device is a fully automated microbial detection system, not an AI-assisted diagnostic tool that aids human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was performed. The BacT/ALERT FN Culture Bottle, in conjunction with the BacT/ALERT Microbial Detection Instrument, operates automatically to detect microbial growth. The study compared the performance of this system (BacT/ALERT FN Culture Bottle + Instrument) directly against the predicate device's system (BacT/Alert FAN Anaerobic Culture Bottle + Instrument).
7. The type of ground truth used
The ground truth was established by seeding known anaerobic organisms into human blood at "low levels" and then measuring their recovery and time to detection. This is essentially a controlled laboratory setup where the presence and type of microorganism are known beforehand.
8. The sample size for the training set
Not applicable. This document describes a new iteration of an existing diagnostic culture bottle, not a machine learning algorithm that requires a training set in the conventional sense. The "training" for the device would have been its design and development based on established microbiological principles.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.