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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.

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.

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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 System.

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 MB/BacT™ Blood Culture Bottle's acceptance criteria and supporting study:

The document is a 510(k) Premarket Notification for the MB/BacT™ Blood Culture Bottle, which is designed for the recovery and detection of Mycobacteria from blood. The device is being compared to the predicate device, the BACTEC 13A Blood Bottle (K863191).

Acceptance Criteria and Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a pass/fail format. Instead, it focuses on demonstrating substantial equivalence to the predicate device. The performance is gauged by whether the MB/BacT bottles yield comparable results to the BACTEC 13A.

Here's a table summarizing the reported device performance in relation to the predicate device:

Study Details

2. Sample size used for the test set and the data provenance:

• Non-clinical (In-house) Test Set: 20 mycobacterial isolates representing 10 different species.
• Clinical Test Set: 238 paired bottles.
• Data Provenance: Not explicitly stated, but the submission is from the United States (Organon Teknika Corporation, Durham, North Carolina). Given the nature of a 510(k) submission, it would typically involve prospective or retrospective data collected under a controlled study protocol. The phrase "Two clinical studies were carried out" suggests a prospective design for the clinical evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The document does not specify the number of experts used or their qualifications for establishing ground truth. The determination of "organism isolation" would typically be performed by trained laboratory personnel, but no explicit details on expert involvement are provided.

4. Adjudication method for the test set:

• The document does not describe an explicit adjudication method. The outcome is presented as isolated organisms by either device or both. It implies that the presence of a Mycobacteria species would be confirmed by standard laboratory identification methods once detected by either bottle, but no specific adjudication process for discrepancies is detailed.

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 device is a blood culture bottle for detecting microbial growth, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Yes, in essence. The performance of the MB/BacT™ Blood Culture Bottle (which operates using a colorimetric sensor to monitor CO₂ production) is inherently standalone in its detection mechanism. The study directly compares the detection capability of this bottle technology to the predicate BACTEC 13A technology, without explicitly involving varying human interpretations of the growth signals from the device itself. The "organism isolation" is the direct output of the bottle's function.

7. The type of ground truth used:

• Microbial Growth/Identification: The ground truth is the actual isolation and identification of Mycobacterium sp. from the blood samples. This would typically be confirmed by subsequent laboratory procedures (e.g., staining, culturing on specific media, biochemical tests, or molecular methods) after a "positive" signal from the blood culture bottle.

8. The sample size for the training set:

• The document does not mention a separate training set. This type of device (a diagnostic culture medium) doesn't typically involve a "training set" in the machine learning sense. Its performance is evaluated based on its ability to support microbial growth and detect metabolic byproducts.

9. How the ground truth for the training set was established:

• As no training set is mentioned in the context of machine learning, this question is not applicable. The device's mechanism of action (colorimetric detection of CO2) is based on established biological principles, not on
  learned patterns from a training dataset.

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