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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℃ +/- 1℃, 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 tetracycline, at concentrations of 0.25 to 16 µg/ml (7-Dilution MIC Sequence), 0.5 – 8 µg/ml (5-Dilution BP Sequence), and 2 - 8 ug/ml (3-Dilution BP Dilution Sequence), for all Staphylococcus species and Enterococcus species to the test panel.

The Gram-positive organisms which may be used for tetracycline susceptibility testing in this panel are: Staphylococcus aureus, Streptococcus faecalis (Enterococcus faecalis)

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 a breakdown of the acceptance criteria and study details for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Tetracycline, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a number, but the study used "fresh and stock Efficacy isolates" and "stock Challenge strains."
   • Data Provenance: Not specified (e.g., country of origin). The study was an "external validation."

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The reference standard was a "frozen Reference Panel" and "Expected Results," which implies a gold standard established by expert consensus or predefined criteria, but the specific individuals are not detailed.

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

   • Adjudication Method: Not specified. The comparison was directly between the MicroScan® panel's results and the "frozen Reference panel" and "Expected Results."

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:

   • MRMC Study: No, this was not an MRMC study. This device is an automated antimicrobial susceptibility testing (AST) system, not an AI-assisted diagnostic imaging tool with human interpretation.

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

   • Standalone Performance: Yes, the device's performance was evaluated independently against the reference standard. While the system can be read visually for AST, the primary evaluation detailed here is for the automated system ("read by the MicroScan® Instrumentation"). The "read by determining the lowest antimicrobial concentration showing inhibition of growth" implies an automated or semi-automated reading process for the MIC.

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

   • Ground Truth Type: "Frozen Reference Panel" and "Expected Results." This suggests a highly standardized and validated reference method for antimicrobial susceptibility testing, commonly considered a gold standard in microbiology, likely established by expert consensus guidelines and previous validation studies of the reference method itself.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This device is a diagnostic test kit based on established biochemical principles and does not involve machine learning or a "training set" in the conventional AI sense.

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

   • Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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