(54 days)
The BacT/ALERT MP Process Bottle is designed for use with the MB/BacT and the The DacT/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 Process Bottle was developed for the same intended use as the current MB/BacT Process Bottle, provide suitable nutritional and environmental conditions for mycobacterial organisms commonly encountered in body fluids. 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 Process Bottle.
Here's a breakdown of the acceptance criteria and study information for the BacT/ALERT MP Process Bottle, based on the provided K993576 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly state numerical acceptance criteria (e.g., "sensitivity must be > X"). Instead, the acceptance criterion is implied as substantial equivalence to the predicate device (MB/BacT Process Bottles) in terms of recovery and detection times for mycobacterial organisms.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in recovery of mycobacterial organisms. | The BacT/ALERT MP Process Bottle showed equivalent recovery for 12 organisms. |
| Substantial equivalence in 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 (Test Set): 12 organisms were used. The document does not specify the number of replicate bottles per organism or the total number of individual tests performed.
- Data Provenance: The document does not specify the country of origin. The studies appear to be prospective seeded studies as organisms were inoculated into bottles for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the seeded studies. For seeded studies in microbiology, the "ground truth" is typically the known presence and identity of the inoculated organism.
4. Adjudication Method for the Test Set
Not applicable. The study involved a direct comparison of the new device's performance against a predicate device using known inoculated organisms (ground truth). There was no mention of human interpretation requiring adjudication.
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 microbial growth monitor, and performance is based on automated detection by instrumentation, not human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The device's performance (recovery and detection time) was evaluated directly by the BacT/ALERT 3D System or MB/BacT Mycobacterial Detection Systems after inoculation and incubation, without human intervention for result interpretation.
7. The Type of Ground Truth Used
The ground truth used was the known inoculation of specific mycobacterial organisms into the test bottles. This provides a definitive "positive" control for the presence of the target organisms.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. The studies described are performance validation tests for the physical bottle. If there was any internal algorithm development for the detection systems themselves, that information is not provided in this 510(k) summary. The 12 organisms tested were part of the test set to demonstrate equivalence.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned for an algorithm, this question is not directly applicable. For the performance studies described, the ground truth was inherently established by the controlled inoculation of known organisms.
§ 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.