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The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic non-entercoccal streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert.

This particular submission is for the addition of the antimicrobial Vancomycin at concentrations of 0.03 - 16 mcg/ml to the test panel.

The organisms which may be used for Vancomycin susceptibility testing in this panel are; Aerobic non-enterococcal streptococci, including Streptococcus pneumoniae.

Microdilution Minimum Inhibitory Concentration (MIC) Panels

Here's an analysis of the provided text to extract the acceptance criteria and study details:

Acceptance Criteria and Device Performance for MicroScan® MICroSTREP plus™ Panel (Vancomycin)

1. Acceptance Criteria and Reported Device Performance

Note: The specific numerical threshold for "acceptable performance" for Essential Agreement is not explicitly stated in the provided text, but the reported 99% was deemed acceptable.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of the number of isolates or tests. The study refers to "fresh and stock Efficacy isolates and stock Challenge strains" for external evaluation.
• Data Provenance: Not explicitly stated. The study was an "external evaluation," but the country of origin or whether it was retrospective/prospective is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Ground Truth Method: The ground truth was established by comparison with an NCCLS frozen Reference Panel. This implies a standardized reference method, but not necessarily human expert consensus for each individual case.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable/not described. The study used an NCCLS frozen Reference Panel as the comparator, which serves as the "truth standard" rather than relying on multiple human readers and an adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This type of study is not relevant for an antimicrobial susceptibility testing device like the MicroScan® MICroSTREP plus™ Panel, which directly measures MIC values and compares them to a reference method, not human interpretation.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Standalone Study Done: Yes. The performance data (99% Essential Agreement, acceptable reproducibility, and QC results) directly represent the standalone performance of the MicroScan® MICroSTREP plus™ Panel in determining Vancomycin susceptibility, as it is a device designed to provide a direct readout.

7. Type of Ground Truth Used

• Ground Truth Type: A reference standard, specifically an NCCLS frozen Reference Panel. This panel provides established, standardized minimum inhibitory concentration (MIC) values for comparison.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified. The document primarily describes the validation (test set) for the new Vancomycin addition, not the original development/training of the panel itself.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not specified. The document focuses on the validation of the Vancomycin component against a reference panel, not the initial development or training ground truth for the core device technology.

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