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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 Cefotaxime at concentrations of 0.015 to 8 mcg/ml to the test panel. The organisms which may be used for Cefotaxime susceptibility testing in this panel are: Streptococcus pyogenes (Group A beta-hemolytic streptococci), Streptococcus agalactiae (Group B streptococci), Streptococcus pneumoniae (formerly Diplococcus pneumoniae).

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. 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.

Here's a breakdown of the acceptance criteria and study information for the MicroScan® MICroSTREP plus™ Panel, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: The document indicates that "external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the exact sample size for the test set is not explicitly stated. The data provenance is not specified regarding country of origin, but it is clear that the data relates to a pre-market submission, implying prospective testing for the device's validation.

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 was established by comparing performance to an "NCCLS frozen Reference panel," which implies a standardized method rather than expert consensus on individual cases.

3. Adjudication method for the test set: Not applicable, as the comparison was against a standardized reference panel (NCCLS frozen Reference panel) rather than individual case adjudication.

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: Not applicable. This study evaluates the performance of an in vitro diagnostic device against a reference method, not an AI system assisting human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device operates as a standalone system (microdilution panels read visually). The performance described is its standalone performance against a reference standard. There is no "algorithm only" component in the sense of a software-based AI algorithm. The device, after incubation, is "read visually" as per the package insert.

6. The type of ground truth used: The ground truth was established by an "NCCLS frozen Reference panel." This is a standardized, recognized reference method for antimicrobial susceptibility testing, which serves as the gold standard for comparison in this context.

7. The sample size for the training set: This information is not provided. The document focuses on the validation study (test set) of the device against a reference standard. The concept of a "training set" in the context of machine learning or AI is not directly applicable here, as it's a traditional in vitro diagnostic device.

8. How the ground truth for the training set was established: Not applicable, as no training set (in the machine learning sense) is mentioned or implied for this traditional in vitro diagnostic device. The device's mechanism involves chemical reactions and visual interpretation, not an algorithm that learns from a training set.

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