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(24 days)
The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram negative and Gram- positive bacteria of human origin.
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae and most gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.
This premarket notification is for the addition of the antimicrobial Moxifloxacin at concentrations of 0.125-2 ug/mL to Gram negative ID/AST or AST only Phoenix panels. Moxifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.
The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:
- BD Phoenix instrument and software.
- BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents for AST determinations.
- BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum.
- . BD Phoenix AST Broth used for performing AST tests only.
- . BD Phoenix AST Indicator solution added to the AST broth to aid in bacterial growth determination.
The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a gram-negative or gram-positive isolate. For each isolation equivalent to 0.5 McFarland standard is prepared in Phoenix ID broth.
The Phoenix AST method is a broth based microdilution test. The Phoenix system utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. Measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.
The instrument houses the panels where they are continuously incubated at a nominal temperature of 35°C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S. I, or R (sensitive, intermediate, and resistant).
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format, but it implies them through the "Essential Agreement (EA)" and "Category Agreement (CA)" metrics. For intra- and inter-site reproducibility, the acceptance criteria are implicitly greater than 90% and greater than 95%, respectively.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intra-site Reproducibility (Moxifloxacin, Gram-negative) | > 90% | > 90% |
| Inter-site Reproducibility (Moxifloxacin, Gram-negative) | > 95% | > 95% |
| Essential Agreement (EA) | Not explicitly stated | Summarized in Table 1 (Table 1 is incomplete in the provided text, but states "1000" for "Moxitloxacın" which implies good performance.) |
| Category Agreement (CA) | Not explicitly stated | Summarized in Table 1 (Table 1 is incomplete in the provided text, but states "1000" for "Moxitloxacın" which implies good performance.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Type of Isolates: Clinical, stock, and challenge isolates.
- Provenance: Across multiple geographically diverse sites across the United States.
- Retrospective/Prospective: Not explicitly stated, but the mention of "clinical isolates" being compared to "reference broth microdilution method" suggests these were likely prospective or at least collected for this specific study. "Stock and challenge isolates" are by nature pre-defined.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The ground truth for clinical isolates was established by the "NCCLS reference broth microdilution method," which is a standardized laboratory method, not reliant on individual human experts in the same way as, for example, a radiologist's interpretation. For "challenge set isolates," performance was compared to "expected results," implying predefined ground truth based on known characteristics of those isolates.
4. Adjudication Method for the Test Set:
This information is not applicable as the ground truth was established by comparing to a reference method (NCCLS broth microdilution) or expected results for challenge isolates, not through human expert consensus needing adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This was not a MRMC comparative effectiveness study involving human readers with and without AI assistance. The study assessed the performance of an automated microbiology system (BD Phoenix) against a reference laboratory method (NCCLS broth microdilution). It did not evaluate human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone study was performed. The entire evaluation focuses on the performance of the "BD Phoenix™ Automated Microbiology System" (an algorithm/automated device) at determining antimicrobial susceptibility. Its results are compared directly to the NCCLS reference method, without human intervention in the interpretation phase being evaluated.
7. The Type of Ground Truth Used:
- For Clinical Isolates: The ground truth was established by the NCCLS reference broth microdilution method. This is an established laboratory standard method.
- For Challenge Set Isolates: The ground truth was based on "expected results," implying pre-defined, known results for these specific isolates, often used to test the limits or specific characteristics of a system.
8. The Sample Size for the Training Set:
The document does not specify a training set size. This is a premarket notification for an existing system (BD Phoenix) with the addition of a new antimicrobial agent (Moxifloxacin). The "clinical studies" described are likely validation/test sets, not a training set in the machine learning sense. The system itself was likely developed and "trained" (in a broader engineering sense) prior to this specific submission.
9. How the Ground Truth for the Training Set Was Established:
As no specific training set is outlined in this document for the addition of Moxifloxacin, the method for establishing ground truth for any underlying training of the overall BD Phoenix system is not provided.
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