(18 days)
BacT/ALERT® SN Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for the recovery and detection of anaerobic and facultative anaerobic microorganisms (bacteria) from blood and other normally sterile body fluids.
The BacT/ALERT SN Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT SN 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 SN Bottle.
Here's an analysis of the provided 510(k) summary regarding the BacT/ALERT SN (Plastic) Culture Bottle, focusing on acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance
The provided document describes a substantial equivalence submission, which means the new device (BacT/ALERT SN Plastic Culture Bottle) is compared to a legally marketed predicate device (BacT/ALERT SN Glass Culture Bottle). The acceptance criteria are implicitly defined by demonstrating equivalent performance to the predicate device.
Table 1: Acceptance Criteria and Reported Device Performance
Performance Metric/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (BacT/ALERT SN Plastic Culture Bottle) |
---|---|---|
Microorganism Recovery | Equivalent recovery of low levels of 9 test microorganisms to the predicate device. | "Recovery of low levels of the 9 microorganisms included in the study" was equivalent to the predicate device. |
Detection Times | Equivalent detection times to the predicate device. | "Detection times were equivalent in both bottles." |
Study Information
The type of study conducted is a comparative performance study against the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states "Seeded studies were performed on 9 organisms." This indicates that nine specific microorganisms were tested. The number of replicates or individual tests per organism is not specified in this summary.
- Data Provenance: The study involved "human blood," indicating the biological matrix used. The origin country of the human blood or where the study was conducted is not specified. The study is by nature prospective, as it involves direct experimentation with the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This type of study (microbial growth and detection) typically relies on laboratory-based microbiological techniques as the ground truth, rather than expert interpretation of images or clinical data. Therefore, no external experts were explicitly mentioned for establishing ground truth as one might see in imaging studies. The "ground truth" for positive growth and detection times would be determined by the instrument's (BacT/ALERT Microbial Detection Systems) readings and potentially confirmed by standard microbiological methods (e.g., subculturing). The qualifications of the laboratory personnel performing these tests are not specified.
4. Adjudication Method:
- None explicitly mentioned or applicable in the context of this performance study. The device's automated detection system and established microbiological methods would determine the outcome directly.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and aims to measure the impact of AI assistance on human performance. This submission is for an automated microbial detection system, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance Study:
- Yes, implicitly. The study directly measures the performance of the BacT/ALERT SN Plastic Culture Bottle in conjunction with the BacT/ALERT Microbial Detection System. Since the system (including the bottle) provides an automated output (detection of microbial growth), this can be considered a standalone performance assessment of the device and its associated technology without human intervention in the detection process itself.
7. Type of Ground Truth Used:
- The ground truth is based on direct microbiological observation/culturing and instrumental detection. The "ground truth" for microorganism recovery and detection times is established by the known inoculation of specific organisms and the automated detection by the BacT/ALERT Microbial Detection System, which is a well-established technology for this purpose.
8. Sample Size for the Training Set:
- Not applicable/not specified. This document describes a performance validation study for a device, not the development or training of a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML model development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an AI/ML algorithm described, this question is not relevant to the provided documentation.
§ 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.