(28 days)
BacT/ALERT® PF Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
The BacT/ALERT PF Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT PF Glass Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections. 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 PF Bottle.
This document describes the 510(k) Premarket Notification for the bioMérieux, Inc. BacT/ALERT PF (Plastic) Culture Bottle. The submission establishes substantial equivalence to the predicate device, the BacT/ALERT PF Glass Culture Bottle.
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative manner (e.g., a specific percentage of agreed-upon results). Instead, the substantial equivalence is based on comparable performance to the predicate device in terms of organism recovery and detection times.
| Feature / Criteria | Acceptance Criteria (Implied by equivalence to predicate) | Reported Device Performance (BacT/ALERT PF Plastic) |
|---|---|---|
| Recovery of microorganisms | Equivalent to BacT/ALERT PF Glass Culture Bottle | Equivalent to BacT/ALERT PF Glass Culture Bottle |
| Detection times | Equivalent to BacT/ALERT PF Glass Culture Bottle | Equivalent to BacT/ALERT PF Glass Culture Bottle |
| Intended Use | Same as BacT/ALERT PF Glass Culture Bottle | Same |
| Target Population | Pediatric | Pediatric |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Test Set: 23 organisms were used in seeded studies. The number of individual bottles or replicates for each organism is not specified.
- Data Provenance: The studies were performed using human blood, implying a laboratory-controlled environment rather than retrospective or prospective clinical patient data. The country of origin is not explicitly stated, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This type of information is not applicable to this study. The "ground truth" for these performance studies is based on the known presence and growth of specific, well-characterized microorganisms in controlled seeded conditions, rather than expert interpretation of clinical samples.
4. Adjudication Method for the Test Set:
Not applicable. The "ground truth" for the test set is based on the known inoculation of specific organisms, not on subjective assessment 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:
This information is not applicable. This device is a microbial growth monitor, not an AI-assisted diagnostic tool requiring human readability studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The entire study focuses on the standalone performance of the device (BacT/ALERT PF Plastic Culture Bottle) in detecting microbial growth, compared to its predicate (BacT/ALERT PF Glass Culture Bottle). It's an "algorithm only" in the sense that the BacT/ALERT system automatically detects growth based on reflectance changes, without human-in-the-loop performance for detection.
7. The Type of Ground Truth Used:
The ground truth used was known microbial inoculation and growth. Specifically, "seeded studies were performed on 23 organisms diluted in human blood and inoculated into the BacT/ALERT PF Plastic Culture bottle and the BacT/ALERT PF Glass Culture bottle." This means that for each test, it was known which organism was present and expected to grow.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a "Microbial Growth Monitor" that uses chemical detection (reflectance changes based on CO2 production, utilizing Xylenol Blue in Silicone Emulsion). It is not an AI-based system that requires a "training set" in the context of machine learning. The "training" for such a system would be its initial design and calibration during manufacturing.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device. The detection mechanism is chemical/physical, not based on learned patterns from a dataset.
§ 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.