(63 days)
The BacT/ALERT SN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for recovery and detection of anaerobic microorganisms (bacteria) from blood and other normally sterile body fluids.
The BacT/ALERT SN Culture Bottle was developed for the same intended use as the current BacT/Alert Standard 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 Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SN Bottle.
Here's a breakdown of the acceptance criteria and study information for the BacT/ALERT SN Culture Bottle, based on the provided text:
Acceptance Criteria and Device Performance
The core of the acceptance criteria for the BacT/ALERT SN Culture Bottle revolved around demonstrating substantial equivalence to its predicate device, the BacT/Alert Standard Anaerobic Culture Bottle. This was primarily assessed by comparing the recovery and detection times of various microorganisms.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (BacT/ALERT SN) |
|---|---|---|
| Microorganism Recovery | Equivalent recovery of low levels of 11 specific microorganisms | Demonstrated equivalent recovery of low levels of the 11 microorganisms included in the study compared to the predicate device. |
| Detection Times | Comparable detection times for the 11 specific microorganisms | Detection times were comparable in both bottles (BacT/ALERT SN and predicate). |
| Technological Equivalence | Same detection technology | Utilizes the same reflectance technology. |
| Color Change Mechanism | Color change based on CO2 production | Yes, exhibits color change based on CO2 production. |
| Indicator Material | Same indicator material as predicate | Yes, uses the same indicator material. |
| Instrument Compatibility | Compatibility with BacT/ALERT Microbial Detection Systems | Compatible with BacT/ALERT Microbial Detection Systems. |
| Sample Source | Intended for blood and body fluids | Processes blood and body fluids. |
| Target Population | Intended for adult population | Intended for the adult population. |
Study Details
This document describes a 510(k) Premarket Notification, which typically relies on demonstrating substantial equivalence rather than a full-scale clinical trial with acceptance criteria defined by specific clinical endpoints like sensitivity or specificity percentages. The study performed here is a comparative non-clinical study.
2. Sample size used for the test set and the data provenance:
- Sample Size: "Seeded studies were performed on 11 organisms diluted in human blood and inoculated into the BacT/ALERT SN bottle and the BacT/Alert Standard Anaerobic bottle." The exact number of replicates or individual test instances for each organism is not specified.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, suggesting the study was likely conducted in the U.S. or by a company with operations there.
- Retrospective or Prospective: The description "Seeded studies were performed" implies a prospective experimental design, where samples were created and tested specifically for the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of study (comparative performance of culture bottles) does not typically involve human experts establishing a "ground truth" in the same way an imaging AI algorithm might. The ground truth in this context is the confirmed presence and growth rate of the seeded microorganisms, which is measured by the BacT/ALERT system itself. The expertise would lie in the microbiological techniques used for organism preparation, inoculation, and confirmation, rather than diagnostic interpretation. The document does not specify the number or qualifications of these microbiological experts.
4. Adjudication method for the test set:
- No adjudication method is described, as the "outcome" is a direct measurement by the BacT/ALERT instrument (detection of growth and time to detection). The comparison is between the new device and the predicate device's performance, not human interpretations.
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 was a non-clinical, in-vitro diagnostic (IVD) device study comparing the performance of two culture bottles. MRMC studies are typically used for imaging AI algorithms where human interpretation is a key component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The BacT/ALERT system (both with the new SN bottle and the predicate bottle) operates as an automated, standalone system for detecting microbial growth. The study assessed the performance of the new bottle within this automated context. There isn't a "human-in-the-loop" for interpreting the primary outcome of microbial growth detection; the instrument provides a positive/negative result and a time to detection.
7. The type of ground truth used:
- The ground truth was established by seeded microorganisms of known species and concentrations, diluted in human blood. The expected outcome was the growth of these specific microorganisms. The "truth" is the fact of microbial presence and their growth characteristics.
8. The sample size for the training set:
- This document does not describe a training set. This is not an AI/machine learning device that requires a training set. It's a medical device (culture bottle) that undergoes performance testing.
9. How the ground truth for the training set was established:
- As there is no training set for this device, this question is not applicable.
§ 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.