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510(k) Data Aggregation
(42 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.
This premarket notification is for the addition of the antimicrobial agent meropenem at concentrations of 0.0313-2 µg/mL to Streptococcus ID/AST or AST only Phoenix panels. Meropenem 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 (excluding penicillin-resistant strains) Viridans group 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 containing dried reagents. Organisms for susceptibility testing must be a pure culture and containing driver organisme or 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 deterative of 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℃. 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 a breakdown 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 is an Antimicrobial Susceptibility Test (AST) system. The acceptance criteria are based on Essential Agreement (EA) and Category Agreement (CA) with a CLSI reference broth microdilution method.
Acceptance Criteria (Required Performance) | Reported Device Performance (Meropenem 0.0313-2 µg/mL for Streptococcal Organisms) |
---|---|
Essential Agreement (EA) %: Not explicitly stated as a minimum percentage but implied to be high for "substantially equivalent performance." | 97.2% (n=1935) |
Category Agreement (CA) %: Not explicitly stated as a minimum percentage but implied to be high for "substantially equivalent performance." | 95.3% (n=1935) |
Intra-site Reproducibility: Greater than 90% | Greater than 90% (for this antimicrobial agent) |
Inter-site Reproducibility: Greater than 95% | Greater than 95% (for this antimicrobial agent) |
Overall Reproducibility (Accuracy section): 95% or greater within ± 1 dilution | 95% or greater within ± 1 dilution |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Clinical Studies): The table for Essential Agreement (EA) and Category Agreement (CA) shows n=1935 for the "Antimicrobial" (Meropenem) for streptococcal organisms. This represents the number of isolates tested.
- Data Provenance: "Clinical, stock and challenge isolates were tested across multiple geographically diverse sites." This indicates a mix of retrospective (stock and challenge) and prospective (clinical) data from various geographical locations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth. The ground truth method, CLSI reference broth microdilution, is a standardized laboratory procedure, not typically relying on expert consultation for each case's outcome.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for disagreements. The comparison is made against a standardized "CLSI reference broth microdilution method." Discrepancies would likely be investigated for technical or procedural errors, rather than expert adjudication in the traditional sense of medical image interpretation.
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
No, an MRMC comparative effectiveness study was not done. This study focuses on the performance of an automated microbiology system (BD Phoenix) against a reference standard (CLSI broth microdilution), not on human reader performance with or without AI assistance. The device is a standalone diagnostic tool, not an AI-assisted diagnostic aid for human readers in the context of these types of studies.
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 describes the performance of the "BD Phoenix Automate Microbiology System" (the device/algorithm) in isolation, compared to the CLSI reference method. The results (EA, CA) are for the device's output without direct human interpretation influencing the final MIC or category.
7. The Type of Ground Truth Used
The type of ground truth used is the CLSI reference broth microdilution method. This is a laboratory-based, standardized, and highly accepted method for determining antimicrobial susceptibility.
8. The Sample Size for the Training Set
The document does not provide information on the training set size. This is common for this type of 510(k) submission, as the focus is on the validation performance of the final device against a reference method. The device's underlying "algorithm" (how it interprets readings) would have been developed and "trained" prior to this validation.
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for the training set was established, nor does it describe the training process. This information is typically proprietary to the manufacturer and not required for 510(k) submissions focusing on validation against established standards. However, it can be inferred that similar CLSI reference methods or other established laboratory techniques would have been used during the development and calibration of the system.
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