(91 days)
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8 micrograms/mL)
MicroScan Dried Gram-Neqative MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the Beckman Coulter MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam:
The document describes the Beckman Coulter MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8µg/mL), a device intended for determining antimicrobial agent susceptibility. The device is classified as Class II and operates by rehydrating dried antimicrobial agent dilutions with a standardized suspension of the organism, incubating for 16-20 hours, and then reading the minimum inhibitory concentration (MIC).
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the device's performance is "Essential Agreement" when compared to a CLSI frozen Reference Panel. While a specific numerical target for Essential Agreement is not explicitly stated as an "acceptance criterion" in a table format, the document clearly states that the device "demonstrated substantially equivalent performance" and "acceptable performance with an overall Essential Agreement of 98.3%." This implies that the observed 98.3% Essential Agreement met the internal or regulatory threshold for acceptability.
| Acceptance Criteria | Reported Device Performance (Meropenem/Vaborbactam) |
|---|---|
| Essential Agreement | 98.3% |
Note: The document also mentions "acceptable reproducibility and precision" for inoculum and instrument testing (using Turbidity or Prompt® inoculum methods and autoSCAN-4 or WalkAway systems), and "acceptable results" for Quality Control testing for meropenem/vaborbactam. While these are important aspects of device performance, the primary comparative performance metric explicitly stated against a reference panel is Essential Agreement.
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Description: The external evaluations were conducted with "fresh, recent and stock Efficacy isolates and stock Challenge strains."
- Sample Size: The exact sample size for the test set (number of isolates or strains) is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin of the data. The data appears to be prospective in the sense that the evaluations were designed to confirm acceptability of the proposed panel, rather than analyzing existing archived data.
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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 text. The ground truth is established by a "CLSI frozen Reference panel," which implies a standardized laboratory method, not expert interpretation.
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Adjudication method for the test set:
- This information is not applicable/provided. The method relies on a single, standardized reference panel (CLSI frozen Reference Panel) for comparison, not a multi-reader adjudication process.
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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 done. This device is an Antimicrobial Susceptibility Test (AST) system, which determines the MIC of an antibiotic against bacteria, not an AI-powered diagnostic imaging or interpretation tool for human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device essentially functions as a standalone algorithm/system in its primary determination of MICs. While human operators are involved in setting up the test and reading the results (or loading into an automated reader), the "performance" described (Essential Agreement) is that of the device itself in comparison to a reference standard, not a human-in-the-loop scenario. There's no AI component mentioned as an 'algorithm'.
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The type of ground truth used:
- The ground truth used for comparison is a CLSI frozen Reference Panel. This represents a standardized, established laboratory method for determining antimicrobial susceptibility, considered the gold standard for comparison in AST device evaluations.
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The sample size for the training set:
- This information is not provided in the text. The concept of a "training set" typically applies to machine learning or AI models. This document describes a traditional in-vitro diagnostic device, and while there would have been internal development data, it's not described in terms of "training sets" as it would be for an AI device.
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How the ground truth for the training set was established:
- This information is not provided and is likely not applicable in the context of this type of device and its evaluation as described. The ground truth for comparative evaluation was the CLSI frozen Reference Panel.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).