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The MicroScan® Dried Gram Negative Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and screening for suspected ESBL production in E. coli, Klebsiella spp and P. mirabilis.

The MicroScan® ESBL plus Dried ESBL Confirmation Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in E. coli, Klebsiella spp and P. mirabilis.

After inoculation, panels are incubated for a minimum of 16 hours at 35℃ in a non-CO2 incubator, and read visually, according to the Package Insert.

This particular submission is for the addition of P. mirabilis to the intended use of the antimicrobics: cefpodoxime (0.015-64 µgml), ceftazidime (0.5-128 µg/ml) and cefotaxime (0.5-128 ug/ml) for ESBL screening, and for the antimicrobics ceftazidime (0.5-128 µg/ml), ceftazidime/clavulanic acid (0.12/4-32/4 µg/ml), cefotaxime (0.5-128 ug/ml) and cefotaxime/clavulanic acid (0.12/4-32/4 µg/ml) for ESBL confirmation.

The Gram Negative organisms which may be used for screening of suspected of ESBL production in this panel are:
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Proteus mirabilis

The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are:
Escherichia coli
Klebsiella oxvioca
Klebsiella pneumoniae
Proteus mirabilis

MicroScan® Dried Gram Negative MIC/Combo Panels are designed for use in determining quanfitative and/or qualitative antimicrobial agent susceptibility for Gram Negative organisms and screening for suspected ESBL production in E. coli, Klebsiella spp., and P. mirabilis.

MicroScan® ESBL plus ESBL Confirmation Panel is designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility for Gram Negative organisms and confirmation of ESBL production in E. coli, Klebsiella spp., and P. mirabilis.

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 at 35 °C for a minimum of 16 hours. the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.

Here's a breakdown of the acceptance criteria and study information for the MicroScan® Dried Gram Negative MIC/Combo Panels, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "both fresh and stock isolates and stock challenge strains" were used, but does not specify the exact sample size for the test set.

• Data Provenance: The document does not explicitly state the country of origin. The study appears to be retrospective as it compares panel results against established reference methods (CLSI frozen Reference result or molecular characterization result).

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

The document does not specify the number of experts or their qualifications used to establish the ground truth. It refers to CLSI document M100-S16 and molecular characterization results as the ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving multiple readers. The comparison is between the device's results and a single reference ground truth (CLSI or molecular characterization).

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study focuses on the device's performance against a reference standard, not its impact on human reader performance.

6. Standalone (Algorithm Only) Performance Study

Yes, the study describes standalone performance of the device. The "dried Test panel antimicrobial agents demonstrated an overall Agreement of > 90% for both screen and confirmation" when compared against reference methods, indicating the device itself was evaluated. There is no mention of a human-in-the-loop component for the performance evaluation described.

7. Type of Ground Truth Used

The ground truth used was:

• CLSI frozen Reference result
• Molecular characterization result (Challenge)

8. Sample Size for the Training Set

The document does not specify a separate training set sample size. The study describes "Efficacy and Challenge studies" and "Design Validation studies," but these appear to be primarily for performance evaluation against the established ground truth rather than a distinct training phase for an algorithm. This device is a pre-formed panel, not a software algorithm that would typically require a training set in the modern sense.

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

As no distinct training set is described for an algorithm, the method for establishing ground truth for a training set is not applicable in this context. The document focuses on demonstrating the device's performance against established reference standards (CLSI and molecular characterization).

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