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510(k) Data Aggregation
(52 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, Enterococcus, and Streptococcus.
This premarket notification is for additional organism groups and Amoxicillin-clavulanate (0.5/0.25 – 32/16 µg/mL), Ampicillin-sulbactam (0.5/0.25-32/16 µg/mL), and Ticarcillin (1-128 µg/mL), on the BD Phoenix Automated Microbiology System.
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 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 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. Phoenix panels are inoculated with a specified organism density and placed into the instrument.
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, or resistant).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is assessed using Essential Agreement (EA) and Category Agreement (CA) when compared to the CLSI reference broth microdilution method. The document refers to the FDA Draft Guidance Document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, February 5, 2003" for defining acceptance criteria. While specific numerical acceptance criteria (e.g., minimum percentage for EA or CA) are not explicitly stated in the provided text, the phrase "substantially equivalent performance" implicitly indicates that the reported values must meet or exceed a predefined threshold set by the FDA guidance.
| Performance Metric | Acceptance Criteria (Implied by FDA Guidance) | Reported Device Performance (Amoxicillin-clavulanate) | Reported Device Performance (Ampicillin-sulbactam) | Reported Device Performance (Ticarcillin) |
|---|---|---|---|---|
| Essential Agreement (EA) | "Substantially equivalent performance" (as per FDA guidance) | 96.7% | 97.2% | 94.7% |
| Category Agreement (CA) | "Substantially equivalent performance" (as per FDA guidance) | 90.9% | 87.5% | 92.7% |
| Intra-site Reproducibility | Greater than 90% | > 90% (for each antimicrobial agent) | > 90% (for each antimicrobial agent) | > 90% (for each antimicrobial agent) |
| Inter-site Reproducibility | Greater than 95% | > 95% (for each antimicrobial agent) | > 95% (for each antimicrobial agent) | > 95% (for each antimicrobial agent) |
2. Sample Size Used for the Test Set and Data Provenance
The test set included clinical, stock, and challenge isolates.
- Amoxicillin-clavulanate: 2249 isolates
- Ampicillin-sulbactam: 1305 isolates
- Ticarcillin: 2882 isolates
The data provenance is described as "across multiple geographically diverse sites across the United States." The study involved prospective collection as it describes testing isolates with the Phoenix system and comparing them to reference methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing the ground truth. It refers to the CLSI reference broth microdilution method as the ground truth, which is a standardized laboratory procedure, not an expert consensus in the human-in-the-loop sense.
4. Adjudication Method for the Test Set
No explicit adjudication method (like 2+1 or 3+1) is mentioned. The comparison is made directly between the BD Phoenix System results and the results obtained from the CLSI reference broth microdilution method (for clinical isolates) or "expected results" (for challenge isolates). This implies a direct comparison rather than an adjudicated consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance?
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an automated system for antimicrobial susceptibility testing, not an imaging device requiring human interpretation, so the concept of human readers improving with or without AI assistance does not apply in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The entire study for Essential Agreement (EA) and Category Agreement (CA) directly compares the automated Phoenix System's results against the reference method. The "Clinical Studies" section clearly states: "Phoenix System results for clinical isolates were compared to the results obtained from the CLSI reference broth microdilution method." This is a direct comparison of the automated system's performance without human intervention in the interpretation phase for these metrics.
7. The Type of Ground Truth Used
The primary type of ground truth used was the CLSI reference broth microdilution method. For "challenge" isolates, "expected results" were used, which would also be based on established laboratory testing standards.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for any training set. This is common for older 510(k) submissions, especially for systems where the "algorithm" is based on established biochemical reactions and growth curves rather than machine learning models that require explicit training datasets.
9. How the Ground Truth for the Training Set Was Established
As no training set information is provided, how its ground truth was established is not discussed in this document. The system's performance is evaluated against the CLSI reference method as the gold standard for AST.
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