(64 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Recovery of low levels of 23 microorganisms from human blood | Equivalent to the BacT/Alert Standard Aerobic Culture Bottle |
| Equivalent detection times compared to predicate device | Equivalent to the BacT/Alert Standard Aerobic Culture Bottle |
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.
§ 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.