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To determine gram-positive bacterial susceptibility to the antimicrobial agent Synercid.

Organisms with indications for testing include:

FROM THE INDICATION FOR USE SECTION OF THE MANUFACTURER'S PACKAGE INSERT (7-14-99)

Methicillin-susceptible Staphylococcus aureus Vancomycin resistant Enterococcus faecium Streptococcus pyogenes (Gp.A)

FROM THE MICROBIOLOGY SECTION OF THE MANUFACTURER'S PACKAGE INSERT (7-14-99).

Streptococcus agalactiae (Gp.B) Methicillin-resistant Staphylococcus aureus Staphylococcus epidermidis

The MicroScan® Dried Gram-Positive MIC/Combo Panels with Synercid are not intended for use with Streptococcus pneumoniae and viridans streptococci.

Microdilution Minimum Inhibitory Concentration (MIC) Panel

Here's a breakdown of the acceptance criteria and study details based on the provided text:

Acceptance Criteria and Device Performance

Note: The specific numerical thresholds for "acceptable" reproducibility and Quality Control performance are not provided in the document.

Study Details

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

   • The study used "fresh and stock Efficacy isolates and stock Challenge strains" for external evaluations.
   • The exact sample size (number of isolates/strains) is not specified.
   • The provenance is not explicitly stated (e.g., country of origin) but the study was an "external evaluation," implying independent data collection. The data is retrospective, as "stock isolates" and "stock challenge strains" were used.

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

   • Not applicable/Not mentioned. The ground truth was established by comparison to a "NCCLS frozen Synercid Reference panel," which is a standardized method, not human expert consensus.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. The comparison was against a reference panel, not requiring human adjudication of discrepancies.

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) panel, which is a laboratory device, not an AI-based diagnostic tool for human readers.

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

   • Yes, this was a standalone performance study of the device (MicroScan® Dried Gram-Positive MIC/Combo Panels with Synercid). Its performance was compared directly to a "NCCLS frozen Synercid Reference panel." The "human-in-the-loop" aspect would involve the lab technician performing the test, but the evaluation is of the device's output accuracy against a reference.

6. The type of ground truth used:

   • Reference Standard: The ground truth was established by an "NCCLS frozen Synercid Reference panel." This is a recognized and standardized reference method for antimicrobial susceptibility testing.

7. The sample size for the training set:

   • Not applicable. This device is a diagnostic testing panel, not an AI model that requires a training set in the conventional sense. The "training" of such a device is in its manufacturing and calibration process, not through a data-driven model training phase.

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

   • Not applicable, as there is no training set in the context of an AI model. The device's design and manufacturing rely on established microbiological and chemical principles, with performance validated against reference standards.

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