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The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive bacteria. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/ - 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the reformulated antimicrobial Vancomycin at concentrations of 0.25 to 64 ug/ml to the test panel.

The gram-positive organisms which may be used for Vancomycin susceptibility testing in this panel are:

Enterococci (e.g., Enterococcus faecalis)

Staphylococci. including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillinresistant strains)

MicroScan Dried Gram-Positive 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-positive bacteria.

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. For accurate detection of vancomycin resistance with enterococcus species, panels were incubated to 24 hours.

The provided text describes the acceptance criteria and study for the MicroScan Dried Gram-Positive MIC/Combo Panels with Vancomycin.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation, and "Efficacy, Challenge and Reproducibility isolates" for reproducibility testing. However, the exact number of isolates (sample size) for the test set is not explicitly stated.
• Data Provenance: The text does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective, though the description of the "external evaluation" and "Challenge strains" suggests a prospective testing methodology.

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

This information is not provided in the given text. The ground truth was established by comparison with a "CLSI frozen Reference Panel," but there's no mention of human experts defining this ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given text. The comparison was made against a CLSI frozen Reference Panel, implying a direct comparison rather than an adjudication process involving multiple human readers.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is an in vitro diagnostic for antimicrobial susceptibility testing, not an AI-assisted diagnostic device for human readers. Therefore, the concept of human reader improvement with or without AI assistance is not applicable here.

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

Yes, a standalone performance study was done. The device (MicroScan Dried Gram-Positive MIC/Combo Panel) "demonstrated substantially equivalent performance when compared with an CLSI frozen Reference Panel." This comparison assesses the algorithm/device's performance in determining MIC values independently. The panel can be read visually or with MicroScan instrumentation, indicating both a potential human-in-the-loop and a standalone (instrument-read) performance. The performance metric of 99.4% Essential Agreement relates to the panel's direct performance.

7. The Type of Ground Truth Used

The ground truth used was a CLSI frozen Reference Panel. This panel's results are considered the gold standard for comparison in antimicrobial susceptibility testing for the purpose of this submission.

8. The Sample Size for the Training Set

This information is not provided in the given text. The document describes the testing and comparison with a reference panel, but does not detail a separate "training set" for the device, as it is a panel design for inherent chemical and biological interactions, not a machine learning algorithm that requires explicit training data in the same way.

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

Since a training set (in the context of machine learning) is not explicitly mentioned or clearly applicable to this type of device (a chemical/biological testing panel), the method for establishing its ground truth is not provided. The "ground truth" reference (CLSI frozen Reference Panel) is used for evaluation of the device's performance.

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