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To determine bacterial antimicrobial agent susceptibility. The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 – 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Penicillin at concentrations of 0.015 to 16 mcg/ml to the test panel. The organisms which may be used for Penicillin susceptibility testing in this panel are: Streptococcus pneumoniae, Streptococci (Groups A, C, G, H, L and M).

The MicroScan® MICroSTREP plus™ is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. 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 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.

The MicroScan® MICroSTREP plus™ Panel is intended to determine bacterial susceptibility to Penicillin by measuring the Minimum Inhibitory Concentration (MIC) for aerobic streptococci, including Streptococcus pneumoniae.

Here's a breakdown of the acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance:

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

The study used "fresh and stock Efficacy isolates and stock Challenge strains" for external evaluation. The exact sample size is not specified in the provided text. The data provenance is not explicitly stated in terms of country of origin, but the product and regulatory body are US-based, suggesting the data is likely from the US. The study involved both "fresh" isolates (prospective) and "stock" isolates/strains (retrospective).

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

The document does not specify the number of experts or their qualifications involved in establishing the ground truth. It states that the performance was compared against an "NCCLS frozen Reference Panel." This implies the reference panel itself serves as the ground truth, and its creation would have involved standardized methods overseen by experts, though these details are not provided here.

4. Adjudication Method for the Test Set:

Not applicable. The comparison was made against a standardized "NCCLS frozen Reference Panel," which implicitly serves as an objective reference, rather than requiring expert adjudication of individual results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The device is for laboratory testing, not for human interpretation of medical images or other subjective inputs. Performance is compared against a reference panel.

6. If a Standalone Performance Study was Done:

Yes, a standalone performance study was done. The MicroScan® MICroSTREP plus™ Panel's performance was evaluated independently by comparing its results against an NCCLS frozen Reference Panel for Penicillin susceptibility.

7. Type of Ground Truth Used:

The ground truth used was a standardized NCCLS frozen Reference Panel. This panel provides a scientifically established and accepted reference for antimicrobial susceptibility testing.

8. Sample Size for the Training Set:

The document does not mention a separate "training set" for the device. The device is a diagnostic panel that directly performs the test, not an algorithm that requires training data in the AI sense.

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

Not applicable, as there is no mention of a training set for this type of device. The device's performance is intrinsically linked to its chemical and biological design, and its "calibration" or validation is done by comparison to a recognized gold standard (the NCCLS reference panel).

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