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The MicroScan® Dried 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. 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 addition of the antimicrobial gemifloxacin at concentrations of 0.002 to 16 mcg/ml to the test panel.

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

Klebsiella pneumoniae
Klebsiella oxytoca
Proteus vulgaris

MicroScan® Dried Gram-Negative MIC/Combo Panels are designed for solid media of rapidly growing and of qualitative 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 used to determine minimum inhibitory concentrations (MICs) and research concentrations. The panels are inoculated with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration showing inhibition of growth.

The provided text describes the 510(k) submission for the MicroScan® Dried Gram-Negative MIC/Combo Panels with the addition of gemifloxacin. It focuses on demonstrating substantial equivalence to a predicate device for determining antimicrobial agent susceptibility.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The text mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for external evaluation, but does not specify the exact number of isolates or strains (sample size).
• Data Provenance: The text does not specify the country of origin. The study appears to be prospective in nature, as it describes "external evaluation" and "reproducibility testing" specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not specify the number or qualifications of experts used to establish the ground truth. It states that "Expected Results determined prior to the evaluation" were used for comparison. The ground truth is effectively the performance of the NCCLS frozen Reference Panel.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe an adjudication method for the test set. The comparison is made against "Expected Results determined prior to the evaluation" which are established by the NCCLS frozen Reference Panel.

5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a device for determining antimicrobial susceptibility, not for image interpretation or human-in-the-loop assistance. The device can be read visually, but the study focuses on the device's performance against a reference method, not an improvement in human reading.

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

The study described is essentially a standalone performance evaluation of the MicroScan® Dried Gram-Negative MIC/Combo Panels with gemifloxacin. While the panels can be read visually, the evaluation focuses on the device's ability to produce accurate MIC results compared to a reference method, regardless of the reading method (visual or MicroScan instrumentation, like WalkAway®). The "algorithm" here is the system's ability to determine the MIC.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was the results obtained from an NCCLS frozen Reference Panel. This is a recognized standard method for antimicrobial susceptibility testing. The text refers to these as "Expected Results determined prior to the evaluation."

8. The sample size for the training set

The document does not mention a training set or its sample size. This type of device (antimicrobial susceptibility panel) is not typically developed using machine learning models that require distinct training and test sets in the same way an AI diagnostic algorithm would. The development involves established microbiological methods and reagents.

9. How the ground truth for the training set was established

As there is no explicit mention of a training set in the context of machine learning, this question is not applicable based on the provided text. The "ground truth" (NCCLS frozen Reference Panel results) is used for comparison in the evaluation, which serves as the "test set" in this context.

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