(40 days)
The BacT/ALERT MP culture bottle is designed for use with the MB/BacT and the BacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.
The BacT/ALERT MP culture bottle was developed for the same intended use as the current BacT/ALERT MP Process Bottle (glass), when used in conjunction with the MB/BacT Reconstitution Fluid (for use with sterile specimens) or with MB BacT Antibiotic Supplement (for use with digesteddecontaminated clinical specimens) is a selective growth medium for the in vitro culture recovery of mycobacteria organisms commonly encountered in body fluids other than blood and from digested-decontaminated clinical specimens. An inoculated bottle is placed into the MB BacT Detection instrument or the BacT/ALERT 3D instrument where it is incubated and continuously monitored for the presence of mycobacteria that will grow in the BacT/ALERT MP bottle.
Here's an analysis of the provided text regarding the acceptance criteria and study for the bioMérieux BacT/ALERT MP Culture Bottle:
This submission is for a substantial equivalence determination for a new device (plastic bottle) compared to an existing predicate device (glass bottle) for the same intended use. Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating equivalence in performance.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical "acceptance criteria" in a typical sense (e.g., "sensitivity must be >X%"). Instead, the performance assessment is based on demonstrating substantial equivalence to the predicate device. The primary performance metric mentioned is related to recovery and detection times of mycobacterial organisms.
| Acceptance Criterion (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Equivalent recovery of mycobacterial organisms | Recovery of the 12 mycobacterial organisms was substantially equivalent. |
| Equivalent detection times for mycobacterial organisms | Detection times were substantially equivalent in both bottles. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The study was performed on 12 organisms. It's important to note this refers to the types of organisms, not necessarily the number of individual tests or specimens. The document doesn't specify how many replicates or specimens were used for each of the 12 organisms.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective clinical data. It describes "seeded studies," which typically implies laboratory-controlled experiments rather than clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study described is a "seeded study" which involves inoculating known organisms. The "ground truth" for the presence of the organisms is inherent in the experimental design (i.e., the organisms were intentionally BSL inoculated). Therefore, expert review to establish ground truth from unknown samples is not relevant for this type of test.
4. Adjudication Method for the Test Set
Not applicable. As described above, this was a seeded study with known organisms. There was no need for adjudication of results by multiple experts as the presence of the target organism was controlled experimentally.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a diagnostic culture bottle for detecting microbial growth, not an imaging or interpretation device that would involve human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this was effectively a standalone performance study of the device. The "algorithm" here is the chemical detection system within the bottle and the instrument (MB/BacT or BacT/ALERT 3D) that monitors it. The study compared the performance of the new plastic bottle against the predicate glass bottle directly on their ability to detect microbial growth, without human interpretation as part of the primary outcome measure.
7. The Type of Ground Truth Used
The ground truth used was spiking/seeding with known organisms. In a seeded study, the presence and identity of the microorganisms are precisely controlled by the researchers who introduce them into the test samples.
8. The Sample Size for the Training Set
Not applicable. This device is a diagnostic culture medium and detection system, not a machine learning or AI model that requires a "training set" in the computational sense. The "training" of the device is inherent in its design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of this device technology.
§ 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.