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The BD PhoenixTM 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-Enteropacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.

This premarket notification is to demonstrate the ability to detect vancomycin resistant Staphylococcus qureus (VRSA) with the antimicrobial agent vancomycin at concentrations of 0.5-32 µg/mL (K030677, April 1, 2003) and Gram positive ID/AST or AST only Phoenix panels. Vancomycin 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.

Active In Vitro and in Clinical Infections Against:
Staphylococcus species
Enterococcus species

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 ● or 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).

This 510(k) summary describes the BD Phoenix™ Automated Microbiology System for Vancomycin (0.5-32 µg/mL) – Detection of VRSA.

Here's an analysis of the provided text to fulfill your request:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a numerical target format. However, it defines performance metrics (Essential Agreement and Category Agreement) and implicitly, substantial equivalence to the reference method (CLSI broth microdilution) as the overarching acceptance criterion.

Note: The provided "Table 1" is corrupted and unreadable. The text mentions "Table 1 summarizes the performance for the isolates tested in this study and included in the 510(k) premarket notification (K030677, April 1, 2003) for vancomycin and Gram-positive organisms and the Phoenix System." Without the actual data from the table, precise numerical performance for EA and CA cannot be extracted from this document directly. The conclusion, however, states that "The data collected from the substantial equivalence studies demonstrate that testing on the BD Phoenix™ Automated Microbiology System with this antimicrobial agent is substantially equivalent..."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as a single number for the entire test set. The document refers to "Clinical, stock and challenge isolates."
• Data Provenance: "across multiple geographically diverse sites across the United States."
• Retrospective/Prospective: Not explicitly stated, but "Clinical isolates were tested" often implies a prospective collection, while "stock and challenge isolates" are typically retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The ground truth method (CLSI reference broth microdilution) is a standardized laboratory procedure, not typically established by individual experts for each case in the same way an imaging study's ground truth might be.

4. Adjudication method for the test set:

This information is not provided in the document. For AST systems, the "adjudication" is inherent in the comparison to the CLSI reference method, which is a gold standard. There isn't typically an expert panel adjudicating discordant results in the same way as an imaging study.

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, an MRMC comparative effectiveness study was not performed. This device is an automated system for in vitro antimicrobial susceptibility testing, not a diagnostic imaging AI requiring human reader interaction or assistance. Therefore, there's no concept of "human readers improve with AI vs without AI assistance" 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 BD Phoenix™ Automated Microbiology System is an automated device, meaning its performance is evaluated as a standalone system (algorithm only) without direct human intervention in the interpretation process of each individual test result beyond initial setup and quality control. The comparison to the CLSI reference broth microdilution method is a standalone vs. standalone comparison.

7. The type of ground truth used:

The ground truth used was the CLSI reference broth microdilution method. This is considered the gold standard for antimicrobial susceptibility testing. For challenge isolates, "expected results" were used, which would also be derived from reference methods or known phenotypic/genotypic characteristics.

8. The sample size for the training set:

The document does not provide specific information about a dedicated "training set" sample size. For such in vitro diagnostic devices, the development typically involves analytical studies and internal validation, but the concept of a distinct 'training set' and 'test set' as used in machine learning models isn't directly applicable or explicitly detailed here. The "clinical, stock, and challenge isolates" described are primarily for the evaluation/test phase for regulatory submission.

9. How the ground truth for the training set was established:

Since a distinct "training set" with established ground truth is not explicitly mentioned or detailed in the document, this specific question cannot be answered from the provided text. If an implicit "training" occurred during the device's development, the ground truth would have been established using standard microbiological techniques, likely including the CLSI reference broth microdilution method or other validated methods.

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