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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 penicillin at concentrations of 0.0156-32 ug/mL to Streptococcus ID/AST or AST only Phoenix panels. Penicillin has been shown to be active in viro 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:

Beta hemolytic streptococci group ACG Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae (per drug package insert- streptococci groups A, C, G, H, L and M and pneumococci)

Active In Vitro Against:

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 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 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. 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, R or N (susceptible, intermediate, resistant or not susceptible).

Here's an analysis of the provided text to extract the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System for Penicillin.

Acceptance Criteria and Device Performance Study for BD Phoenix™ Automated Microbiology System (Penicillin)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state numerical acceptance criteria (e.g., "Essential Agreement must be ≥ 90%"). However, it does state the overall intra-site reproducibility and overall inter-site reproducibility as key performance metrics. The goal of the study was to demonstrate Substantial Equivalence to the CLSI reference broth microdilution method based on Essential Agreement (EA) and Category Agreement (CA).

Note on EA and CA: The provided text indicates that Table 1 summarizes the performance for the isolates tested in this study, including EA and CA. However, the table itself is corrupted and unreadable, preventing the extraction of specific numerical values for EA and CA. The conclusion states that the data 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 Data Provenance

• Test Set Sample Size: Not explicitly stated as a single number. The study utilized "clinical, stock, and challenge isolates."
• Data Provenance:
  • Country of Origin: "multiple geographically diverse sites across the United States."
  • Retrospective or Prospective: Not explicitly stated. However, the nature of "clinical isolates" usually implies prospective collection during the study period, while "stock and challenge isolates" are typically existing, characterized strains.

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

Not provided in the document. The ground truth method is specified, but not the human experts involved in its establishment.

4. Adjudication Method for the Test Set

Not applicable. The ground truth method (CLSI reference broth microdilution) is a standardized laboratory method, not typically requiring expert adjudication in the same way an image analysis might.

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

Not applicable. This is an automated microbiology system that performs in vitro antimicrobial susceptibility testing. It is not an AI-assisted diagnostic tool for human readers, but rather an automated system designed to replace or augment manual laboratory methods.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this was a standalone performance study. The BD Phoenix™ Automated Microbiology System is an automated device designed to generate results (ID, MIC values, and category interpretations) without direct human interpretation in the results generation phase. Its performance was compared against a reference method (CLSI broth microdilution), which is a form of standalone evaluation.

7. The Type of Ground Truth Used

• For Clinical Isolates: The ground truth was established by the CLSI reference broth microdilution method (AST panels prepared according to CLSI M7).
• For Challenge Set Isolates: The ground truth was based on "expected results." This typically refers to pre-determined, highly characterized results for control strains.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of an automated system (BD Phoenix™) that utilizes a defined methodology (broth microdilution with redox indicator). It is not an AI/Machine Learning model that undergoes a distinct "training phase" on a dataset, then a "testing phase." The "system" itself is the product, and its performance is evaluated against a gold standard.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there isn't a traditional "training set" in the context of an AI/ML model. The device's internal algorithms and parameters would have been developed and refined over time by the manufacturer, likely using historical data and expert knowledge, but this isn't described in terms of a specific "training set" and associated ground truth in this submission.

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