(46 days)
The BacT/ALERT PF 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 yeast) from blood.
The BacT/ALERT PF Culture Bottle provides a sensitive method for detection of microorganisms when only a small volume of blood is available. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT PF Culture Bottle.
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Acceptance Criteria and Study for BacT/ALERT PF Culture Bottle
The provided documentation details the submission for a 510(k) premarket notification for the BacT/ALERT PF Culture Bottle, claiming substantial equivalence to the BacT/ALERT Pedi-BacT Culture Bottle. The study primarily focuses on demonstrating that the new device performs equivalently to the predicate device in terms of microbial recovery.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Implied Acceptance Criteria) | Reported Device Performance (BacT/ALERT PF Culture Bottle) | Predicate Device Performance (BacT/ALERT Pedi-BacT Culture Bottle) |
|---|---|---|
| Recovery of low levels of microorganisms | Equivalent recovery | Baseline for comparison |
| Detection of 23 specific microorganisms | Equivalent detection | Baseline for comparison |
Note: The document doesn't explicitly state quantitative acceptance criteria or specific numerical performance targets for the new device. Instead, the criterion is implied to be "equivalence" to the predicate device for microbial recovery and detection.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The "test set" consists of 23 organisms. For each organism, two concentrations were seeded into bottles of both the BacT/ALERT PF and Pedi-BacT Culture Bottles. This means a total of 23 organisms * 2 concentrations * 2 bottle types = 92 bottles were tested as a minimum, although the phrasing "utilizing 23 organisms seeded into BacT/ALERT PF and Pedi-BacT Culture Bottles" suggests a larger total number of bottles, as each organism at each concentration would need multiple replicates of each bottle type for statistical validity. However, the exact number of replicates is not specified.
- Data Provenance: The study was described as "In-house seeded studies." This indicates the data was generated within the submitter's (Organon Teknika Corporation) laboratory. The country of origin is not explicitly stated, but the company address is Durham, North Carolina, USA. The study design is an experimental, controlled study rather than retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The ground truth (presence or absence of microbial growth and detection) would have been established by direct observation and monitoring using the BacT/ALERT systems themselves or through standard microbiological culturing techniques to confirm growth.
4. Adjudication Method for the Test Set
No adjudication method is described. As the "ground truth" is determined by the objective operation of the instruments detecting microbial growth, expert adjudication (like in image interpretation studies) is not applicable here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was conducted or mentioned. This type of study is more relevant for diagnostic devices that involve human interpretation (e.g., radiology images) rather than automated microbial detection systems. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "In-house seeded studies" evaluated the performance of the BacT/ALERT PF Culture Bottle (algorithm/device only) in detecting microorganisms, comparing it directly to the predicate device. This was a direct assessment of the device's capability without human intervention in the detection process.
7. Type of Ground Truth Used
The ground truth used was the known presence and concentration of specific microorganisms (23 different organisms seeded at two specified concentrations:
§ 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.