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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 the addition of the antimicrobial agent cefuroxime at concentrations of 0.125-4 µg/mL to Streptococcus ID/AST or AST only Phoenix panels. Cefuroxime 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 antimicrobial agent.

Active In Vitro and in Clinical Infections Against:

Streptococcus pneumoniae Streptococcus pyogenes (and other streptococci)

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. For testing Streptococcus species 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-S Broth used for performing AST tests only. .
• BD Phoenix AST-S 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 The I nooms parel to a couler anisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. For each isolate, an inoculation equivalent to a 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. indicator for the detection of erganism go as well as bacterial turbidity are used in the determination Mrasurements of enanges to T 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℃. 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, R or N (susceptible, intermediate, resistant or not susceptible).

The provided text describes the 510(k) summary for the BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent cefuroxime. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the statement that the system has demonstrated "substantially equivalent performance" when compared to the CLSI reference broth microdilution method and the FDA Draft guidance document. Specifically, the performance was assessed by Essential Agreement (EA) and Category Agreement (CA). While explicit numerical acceptance criteria for EA and CA are not stated, the study concludes substantial equivalence, indicating these metrics met the required thresholds.

Note: The provided Table 1 is severely corrupted with non-sensical text and numbers, making it impossible to extract the specific numerical values for Essential Agreement and Category Agreement. However, the text explicitly states the conclusions that the studies demonstrated substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The exact number of clinical, stock, and challenge isolates tested is not explicitly stated in the provided text. It mentions "Clinical, stock and challenge isolates were tested."
• Data Provenance: The isolates were tested "across multiple geographically diverse sites across the United States." This indicates prospective data collection for the clinical studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The reference method for comparison (CLSI reference broth microdilution method) is mentioned, but details on the human component of ground truth determination are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document. The performance was assessed by comparing Phoenix System results to CLSI reference method results. The process for resolving discrepancies or establishing the "ground truth" for the reference method itself is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed as described in the typical sense for imaging devices. This device is an automated microbiology system. The comparison was between the automated system's output and a reference laboratory method (CLSI broth microdilution), not between human readers with and without AI assistance.

6. Standalone Performance

Yes, a standalone performance evaluation was done. The entire study describes the performance of the algorithm only (BD Phoenix™ Automated Microbiology System) in determining antimicrobial susceptibility without a human-in-the-loop for interpretive decisions once the system generates results. The system automatically takes readings and interprets them to give MIC values and category interpretations.

7. Type of Ground Truth Used

The ground truth used for the clinical studies was the CLSI reference broth microdilution method. For challenge isolates, results were compared "to the expected results," implying a predefined or known ground truth for those specific strains.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. The description focuses on the evaluation (test) phase to demonstrate substantial equivalence, rather than a development or training phase for the algorithm.

9. How Ground Truth for the Training Set Was Established

As no explicit training set is described, information on how its ground truth was established is not available in the provided text.

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