(75 days)
BacT/Alert Culture Bottles are used with the BacT/Alert Microbial Detection System in qualitative procedures for recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids.
The BacT/Alert® Culture Bottles contain media and an internal sensor that detects CO2 as an indicator of microbial growth when used in connection with the BacT/Alert® Microbial Detection System.
The provided documents are a 510(k) summary and FDA clearance letter for the BacT/Alert Culture Bottles. This device is a microbial growth monitor used for the recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids.
Based on the information provided, the submission focuses on demonstrating substantial equivalence to traditional culture methodology, rather than setting specific quantitative acceptance criteria for the device's performance. The document describes the type of testing performed and the conclusions drawn, but it does not detail specific acceptance criteria or provide the raw performance data from a study that would "prove" the device meets such criteria in a quantitative sense as typically seen for AI/ML devices with metrics like sensitivity and specificity.
Therefore, for aspects related to specific quantitative acceptance criteria, sample sizes, expert involvement, and ground truth methodologies, the information is largely absent or not applicable in the context of this 510(k) submission which primarily relies on equivalence to an established method.
Here's an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Recovery and detection of aerobic and anaerobic microorganisms from body fluids. | BacT/Alert® Culture Bottles are used for "recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids," which is "the same intended use" as traditional culture methodology. |
| Methodology Equivalence: In-vitro diagnostic test systems based on microbial growth in media. | Both BacT/Alert® Culture Bottles and conventional methods are "in-vitro diagnostic test systems which are based on microbial growth in media." |
| Result Comparability: Yield test results comparable to conventional culture methodology. | "Organon Teknika's BacT/Alert® Culture Bottles yield test results comparable to that seen with conventional culture methodology." |
| Overall Performance Equivalence: Safe, effective, and performs as well or better than the legally marketed predicate device. | "BacT/Alert® Culture Bottles perform equivalent to conventional culture methodology." |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Testing was performed to establish the performance characteristics of the new device including comparison to traditional culture methodology." However, no specific sample size for the test set is provided.
- Data Provenance: Not explicitly stated, but clinical testing was performed for comparison. The context implies it would be retrospective or prospective clinical samples as part of a comparative study against standard methods. There is no mention of country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable / Not Provided: This type of information is typically relevant for studies using expert consensus for ground truth, especially in image analysis or diagnostic interpretation by human readers. For a microbial growth detection system, the "ground truth" would likely be established through confirmed microbial culture results (e.g., Gram stain, subculture, identification), rather than expert interpretation of a specific output from the device, and then compared to the BacT/Alert's detection. The document does not specify the method or process for establishing ground truth for the comparison methodology.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided: Adjudication methods (like 2+1, 3+1) are typically used when multiple human readers interpret results and their disagreements need to be resolved to establish ground truth or a consensus reading. In this case, the device detects microbial growth, and the comparison is to "traditional culture methodology." The "ground truth" for the traditional method would be based on established laboratory procedures for culture and identification, not on adjudication of human interpretations of the BacT/Alert output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, not explicitly stated or implied. An MRMC study is designed to assess the diagnostic performance of multiple readers on multiple cases and is common in imaging studies involving human interpretation. This submission describes a device that automates a detection process and compares its results to traditional laboratory methods, not to human readers interpreting raw data from the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, implicitly. The BacT/Alert® Culture Bottles with the BacT/Alert® Microbial Detection System likely operate in a standalone manner for detecting microbial growth (i.e., the system flags positive results based on CO2 detection). The "performance characteristics" established for the device would represent this standalone performance, although the document doesn't explicitly use the term "standalone performance." The comparison is between the device's output and the output of conventional culture methodology.
7. The Type of Ground Truth Used
- The ground truth for comparison was "conventional culture methodology." This implies that other established laboratory tests and procedures (e.g., subculturing, Gram staining, biochemical identification) were used to confirm the presence and nature of microorganisms in samples, which then served as the reference standard against which the BacT/Alert system's detection capability was evaluated.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided: This device is a detection system for microbial growth, not an AI/ML device that requires a training set in the typical sense (i.e., for learning patterns from data to make predictions or classifications). Its function is based on a chemical-mechanical principle (CO2 detection via a sensor), not an algorithm trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided: As noted above, this device is not described as an AI/ML system that utilizes a training set in the conventional manner.
§ 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.