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The MicroScan Synergies plus" Gram-Negative 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-Negative bacilli (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.

This particular submission is for the antimicrobial Moxifloxacin on the Synergies plus™ Gram-Negative MIC/Combo Panels.

The Gram-Negative organisms which may be used for Moxifloxacin susceptibility testing in this panel are:

Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis

MicroScan rapID/S plus ™ Gram-Negative 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 MicroScan rapID/S plus ™ Gram-Negative MIC/Combo Panels are read on the WalkAway® SI System or equivalent (upgraded WalkAway 40 or WalkAway® 96 instruments).

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. rapID/S plus ™ panels are inoculated and rehydrated with a standardized suspension of the organism and incubated at 35°C in the WalkAway® SI System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 528 isolates
   • Data Provenance: Not explicitly stated regarding country of origin. The test set consisted of "fresh and stock Efficacy isolates and stock Challenge strains." It is likely retrospective given the use of stock and challenge strains.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The ground truth was established by an "NCCLS frozen Reference Panel." This implies a standardized laboratory method rather than expert interpretation of individual cases. Therefore, the concept of "experts" in the traditional sense (e.g., radiologists) doesn't apply directly here. The NCCLS (now CLSI) standards are developed by committees of experts in microbiology.

3. Adjudication method for the test set:

   • The method was a comparison to an "NCCLS frozen Reference Panel." This acts as the gold standard, so no additional adjudication (like 2+1, 3+1) was necessary for the test set results themselves.

4. 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. This study is for an automated antimicrobial susceptibility system, not an AI-assisted diagnostic imaging device for human interpretation. Therefore, an MRMC study is not applicable.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes. The device (MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel read on the WalkAway® SI System) operates as a standalone system. The results presented (Essential Agreement and Categorical Agreement) represent the performance of the device without human interpretation affecting the MIC determination. Human interaction would typically be involved in setting up the panels, but the reading and interpretation of the MIC are automated by the instrument.

6. The type of ground truth used:

   • Reference method (NCCLS frozen Reference Panel). This is a highly standardized laboratory method considered the gold standard for antimicrobial susceptibility testing.

7. The sample size for the training set:

   • Not explicitly stated in the provided text. The document describes the external evaluation which acts as the validation/test set. Details about the training set size for the underlying algorithm (if any, as this is an older device that likely relies on established biochemical reactions rather than deep learning) are not provided.

8. How the ground truth for the training set was established:

   • Not explicitly stated. Given the nature of the device (antimicrobial susceptibility testing), it's highly probable that any implicit "training" or calibration of the system (e.g., interpreting growth patterns in wells) would be based on comparison to established reference methods (like those defined by NCCLS/CLSI) and a wide range of known isolates with confirmed resistance/susceptibility profiles.

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