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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 cocci. After inoculation, panels are incubated for 16 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

The MicroScan Inducible Clindamycin test is intended to detect inducible clindamycin resistance in staphylococci in a broth microdilution system. The ICd test applies to isolates that are erythromycin resistant or intermediate and clindamycin susceptible or intermediate.

This particular submission is for the addition of the Inducible Clindamycin test, consisting of 4 mcg/ml of erythromycin and 0.5 mcg/ml of clindamycin, to the test panel.

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 cocci.

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 antiryicrobial concentration showing inhibition of growth.

Here's a breakdown of the acceptance criteria and the study details for the MicroScan Dried Gram-Positive MIC/Combo Panels with the Inducible Clindamycin test, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a number. The study mentions "fresh and stock Efficacy isolates and stock Challenge strains."
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study was an "external design validation (Clinical Trial)". It's a prospective evaluation for efficacy isolates and stock challenge strains.

2. 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 document. The ground truth method, CLSI D-zone disk diffusion test, is a standardized laboratory test, not an expert consensus for each case.

3. Adjudication method for the test set:

   • This information is not provided. Given that the comparative method is the CLSI D-zone disk diffusion test, it's unlikely that a human adjudication method in the typical sense (like 2+1, 3+1 for imaging) was used. The CLSI D-zone disk diffusion test itself serves as the reference standard.

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, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) test for antimicrobial susceptibility, not an imaging AI device that assists human readers.

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

   • Yes, the study assesses the "standalone" performance of the MicroScan Inducible Clindamycin test against the CLSI D-zone disk diffusion test. While the test involves laboratory procedures performed by humans, the performance metrics (Categorical Agreement, Sensitivity, Specificity) are for the device's output itself, not its assistance to a human interpreter. The text mentions it can be "read either visually or with MicroScan instrumentation."

6. The type of ground truth used:

   • The ground truth used was the CLSI D-zone disk diffusion test. This is a recognized standard laboratory method for detecting inducible clindamycin resistance. For challenge strains, "Expected Results determined prior to the evaluation" also served as ground truth.

7. The sample size for the training set:

   • This information is not provided. The document describes a validation study, not the development process. Given this is an IVD microbiology test, there might not be a "training set" in the machine learning sense, but rather development and internal validation data that isn't detailed in this summary.

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

   • Since the training set sample size is not provided, the method for establishing its ground truth is also not provided.

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