(79 days)
MB/BacT Blood Culture Bottles in combination with the MB/BacT Enrichment Fluid are specifically designed for the cultivation of Mycobacterium sp. commonly isolated from blood when used in conjunction with the MB/BacT Mycobacterial Detection Systems (nonshaking detection systems) and the BacT/Alert Microbial Detection Systems (shaking detection systems).
MB/BacT Blood Culture Bottles are specifically designed for the cultivation of Mycobacterium sp. Commonly isolated from blood.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MB/BacT™ Blood Culture Bottle:
This document focuses on establishing substantial equivalence for an expanded indication of an existing device (MB/BacT™ Blood Culture Bottle) in a new system (BacT/Alert Microbial Detection System). As such, the "acceptance criteria" are implied by the comparison to a predicate device, rather than explicit numerical thresholds.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission seeking substantial equivalence for an expanded indication rather than a de novo approval, the "acceptance criteria" are framed by comparison to the predicate device, the BACTEC 13A Blood Bottle. The primary goal is to demonstrate comparable performance. The document does not explicitly state numerical acceptance criteria, but rather a qualitative assessment of "comparable" or "favorable" performance.
| Acceptance Criteria (Implied by Comparison to Predicate) | Reported Device Performance (MB/BacT™ Blood Culture Bottle) |
|---|---|
| Recovery and detection of Mycobacteria in blood comparable to predicate device. | "yielded test results, both in clinical studies and in-house studies, comparable to that seen with the predicate device, the Bactec 13A Blood Culture Bottle." |
| Favorable growth performance of Mycobacterial isolates. | "Overall, favorable growth performance was achieved with the cultures." |
| Overall organism isolation rate comparable to predicate. | From 491 paired bottles: 41 organisms isolated by both; 7 by MB/BacT™ alone; 2 by Bactec 13A alone. (Indicates competitive, if not slightly superior, isolation). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Clinical Studies: 491 paired bottles.
- Nonclinical/In-house Studies (Mycobacterial Isolates): 20 mycobacterial isolates representing 10 different species, each tested at two inoculum levels (1 x 10² and 1 x 10³ CFU).
- Data Provenance: The document does not explicitly state the country of origin for the clinical data. It generally refers to "clinical studies" and "in-house studies." Given the submitter's address (Durham, North Carolina, USA), it is highly probable the in-house studies were conducted in the US. The clinical studies are not specified as retrospective or prospective; however, "studies were carried out" implies prospective data collection for the comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing the ground truth in the clinical or nonclinical studies. For blood culture systems, the "ground truth" for organism isolation and identification is typically established by standard microbiology laboratory procedures, which would involve trained microbiologists, but this is not detailed in the provided text.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set results. The comparison seems to be based on direct laboratory findings from the two different culture systems.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable to this device. This device is an in-vitro diagnostic (IVD) blood culture bottle, not an imaging or diagnostic device requiring human interpretation of visual data where reader variability would be a primary concern. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor would it typically be relevant for this type of IVD.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is implicitly a standalone study in terms of the device performance. The MB/BacT™ Blood Culture Bottle is used in conjunction with the BacT/Alert Microbial Detection System. The system automatically detects microbial growth. While laboratory personnel retrieve positive bottles and perform subsequent identification, the "performance" discussed here relates to the ability of the bottle/system combination to detect mycobacteria. There is no "human-in-the-loop" performance component that would modify the detection algorithm itself. The comparison is between two automated detection systems (MB/BacT™ on BacT/Alert vs. BACTEC 13A).
7. Type of Ground Truth Used
The ground truth used for both the clinical and nonclinical studies appears to be based on microbial isolation and identification.
- In nonclinical studies: Known mycobacterial isolates at specific inoculum levels were used to assess "growth performance."
- In clinical studies: Organisms "isolated by both" or "isolated by... alone" implies standard microbiological culture and identification methods as the ground truth for presence/absence of mycobacteria in the blood samples.
8. Sample Size for the Training Set
The document does not provide information regarding a "training set." The studies described are performance evaluation studies, comparing the new device's performance to a predicate. This type of 510(k) submission generally relies on demonstrating equivalence through direct comparison rather than an AI/machine learning model that would require distinct training and test sets.
9. How the Ground Truth for the Training Set Was Established
As no "training set" is mentioned in the context of an AI/machine learning model, this information is not applicable and therefore not provided in the document.
§ 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.