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The MicroScan® Synergies plus™ 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 enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial clindamycin, at concentrations of 0.03 to 8 ug/ml Long Dilution Sequence and 0.12 - 2 ug/ml 5-Dilution Breakpoint Sequence, for Staphylococcus spp., to the test panel.

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

• Staphylococcus aureus (penicillinase and non-penicillinase producing strains) ●
• . Staphylococcus epidermidis (penicllinase and non-penicillinase producing strains)

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, 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 enterococci and staphylococci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water. buffer, or minute concentrations of broth, to concentrations bridging the range of clinical interest. Panels are rehydrated with Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, or equivalent, for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with clindamycin:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not explicitly stated regarding the exact number of efficacy isolates and challenge strains. It mentions "fresh and stock Efficacy isolates and stock Challenge strains". The country of origin of the data is not specified. The study appears to be prospective as it's an external validation conducted to confirm acceptability.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The "Expected Results" for challenge strains likely imply an expert consensus or established laboratory standards, but the number and qualifications of experts are not provided.

3. Adjudication method for the test set: Not explicitly stated for establishing "Expected Results" for challenge strains or reconciling discrepancies. However, the comparison is against a "frozen Reference Panel" and "Expected Results," suggesting a predefined ground truth or 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. This study is for an antimicrobial susceptibility testing (AST) system, not an AI-assisted diagnostic imaging device. It focuses on the accuracy and reproducibility of the device itself rather than human reader performance with or without AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in effect. The device (MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel) operates as a standalone system, determining MIC values. While it requires human inoculation, the reading and interpretation of the MIC are performed by the WalkAway® SI instrument (or equivalent), or can be read visually for AST portions. The "Essential Agreement" evaluation directly assesses the device's performance against the reference, without human interpretation variability being the primary focus of the performance metric.

6. The type of ground truth used:

   • Frozen Reference Panel: This serves as a primary ground truth for the "Long Dilution Sequence" comparison, likely representing a gold standard for MIC determination.
   • Expected Results: For the Challenge strains, "Expected Results" were determined prior to evaluation, which usually implies that the MIC values for these strains were previously established through rigorous testing and expert consensus using a reference method.

7. The sample size for the training set: Not applicable and not mentioned. This is a traditional in vitro diagnostic device, not a machine learning or AI-based system that typically utilizes training sets in the same manner. The "frozen Reference Panel" and "Expected Results" are used for validation, not as a training set for an algorithm.

8. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set in the context of an algorithmic or AI model.

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