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BacT/ALERT® SA Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.

The BacT/ALERT SA Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT SA Glass 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 SA Bottle.

Here's an analysis of the acceptance criteria and study proving device efficacy, drawn from the provided 510(k) Premarket Notification for the BacT/ALERT SA (Plastic) Culture Bottle:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document focuses on demonstrating substantial equivalence rather than explicit quantitative acceptance criteria as might be seen for a novel device. The primary "acceptance criterion" is functional equivalence in detecting microorganisms and equivalent detection times compared to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: "Seeded studies were performed on 23 organisms diluted in human blood and inoculated into the BacT/ALERT SA Plastic Culture bottle and the BacT/ALERT SA Glass Culture bottle."
  • While 23 organisms were tested, the number of individual samples (bottles) per organism and per bottle type is not explicitly stated. It's implied there were multiple replicates for each organism to assess recovery and detection time. Given it's a seed study, this usually means a controlled number of organisms were inoculated into a controlled number of samples for each condition.
• Data Provenance: The study used human blood as the sample matrix. The specific country of origin for the blood or where the study was conducted is not stated in the provided text. The study design (seeded studies) means it was a prospective experimental study conducted under controlled laboratory conditions, not a retrospective analysis of clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This type of study does not typically involve human experts establishing "ground truth" in the same way an imaging AI study would. The "ground truth" here is the known presence and type of seeded organisms. The detection and identification of these organisms would likely be performed by trained laboratory personnel using standard microbiological methods, rather than clinical experts providing diagnoses.
• No information is provided regarding the number or qualifications of any experts involved in assessing the results, other than implicit assumption of qualified laboratory personnel.

4. Adjudication Method for the Test Set

• None applicable in the context of this type of microbiological assay. Adjudication methods like 2+1 or 3+1 are typically used for subjective clinical assessments or image interpretations where multiple experts provide independent reads that need to be resolved. In this seeded study, the outcome (growth/no growth, time to detection, organism identity) is objectively determined by the instrument and subsequent laboratory confirmation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC study was not done. This type of study is designed to assess the performance of diagnostic devices or AI algorithms in the hands of multiple human readers, often comparing performance with and without assistance from the device. The BacT/ALERT system is a standalone diagnostic instrument for microbial detection, not an AI-assisted tool for human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, this was a standalone performance study. The BacT/ALERT system (both glass and plastic bottles) is designed to operate autonomously, detecting microbial growth and alerting the user. The study compared the performance of the new plastic bottle (as part of the BacT/ALERT system) and the predicate glass bottle directly, without human intervention in the detection process itself. The "algorithm" here is the instrument's detection mechanism for CO2 production.

7. Type of Ground Truth Used

• The ground truth was established by known seeding of specific microorganisms at controlled concentrations. This is a form of controlled experimental ground truth, where the input (what organisms are present in what amount) is precisely defined by the study design. Subsequent identification of recovered organisms would typically be confirmed by standard microbiological identification methods after the instrument detected growth.

8. Sample Size for the Training Set

• The concept of a "training set" is not applicable to this type of device. The BacT/ALERT system is a pre-calibrated instrument that detects a physiological change (CO2 production indicating microbial metabolism). It does not use machine learning algorithms that require a training set to "learn" patterns. Therefore, no training set was used.

9. How the Ground Truth for the Training Set Was Established

• As no training set was used, this question is not applicable.

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BacT/ALERT SA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for the recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.

The BacT/ALERT SA Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic 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 SA Bottle.

Here's a breakdown of the acceptance criteria and the study details for the BacT/ALERT SA Culture Bottle, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit numerical acceptance criteria for a new mode of operation. The primary "acceptance criteria" can be inferred as "recovery of low levels of 23 microorganisms and equivalent detection times" compared to the predicate device.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Seeds studies were performed on 23 organisms. The document doesn't specify the number of individual tests or bottles used per organism, but refers to "seeded studies."
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is from Organon Teknika Corporation in Durham, North Carolina, USA, suggesting the study was likely conducted in the US.
  • Retrospective or Prospective: The description "Seeded studies were performed" indicates a prospective study design where the researchers inoculated samples under controlled conditions.

3. Number, Qualifications, and Adjudication of Experts for Ground Truth

This type of device (microbial culture bottle) does not typically involve human experts for establishing ground truth in the same way an imaging AI device would. The "ground truth" is determined by the objective growth and detection of microorganisms, which is inherent to the function of the culture bottles themselves.

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.
• Adjudication Method: Not applicable.

4. MRMC Comparative Effectiveness Study

• Was an MRMC study done? No. This type of study is not relevant for a microbial culture bottle, as it does not involve human readers interpreting output.

5. Standalone Performance

• Was a standalone (algorithm only without human-in-the-loop performance) study done? Yes, in essence. The comparison between the new device and the predicate device is a standalone performance comparison, where the "performance" is the ability of the bottle (and the associated instrument) to detect microbial growth. There is no human involved in the detection process itself; the instrument continuously monitors and flags growth.

6. Type of Ground Truth Used

• Ground Truth: The ground truth for this device is the actual growth of the seeded microorganisms within the culture bottle. This is an objective biological outcome. The success of the device is its ability to accurately detect this growth.

7. Sample Size for Training Set

• The document does not specify a separate training set or details on how the training data was collected. For this type of device, which is a physical consumable for microbial detection rather than a machine learning algorithm, the concept of a "training set" for an AI model is not applicable. The development would involve optimizing the medium and sensor through laboratory testing, likely a continuous process rather than a distinct "training set" as understood in AI/ML contexts.

8. How Ground Truth for Training Set Was Established

• As a training set (in the AI/ML sense) is not applicable here, the method of establishing ground truth for it is also not applicable. The design and validation of the device components (e.g., culture medium, sensor) would have relied on standard microbiological techniques to confirm microbial growth and detection capabilities during product development.

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