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VITEK® 2 Streptococcus Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Streptococcus agalactiae and Streptococcus pyogenes. VITEK® 2 Streptococcus Inducible Clindamycin Resistance is a qualitative test. It is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and yeast.

The antimicrobial presented in VITEK® 2 AST-ST Cards are in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seas and places the card into the incubator/reader. The VITE variet a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.

Acceptance Criteria and Device Performance Study for VITEK® 2 Streptococcus Inducible Clindamycin Resistance

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not explicitly state the exact numerical sample size for the test set. It mentions "fresh and stock clinical isolates, as well as a set of challenge strains" were used in an external evaluation.
• Data Provenance: The data used for the study was from "fresh and stock clinical isolates, as well as a set of challenge strains." The document does not specify the country of origin, but it is implied to be clinical isolates, likely from the United States given the FDA submission. The study involved both prospective (fresh clinical isolates) and retrospective (stock clinical isolates) elements.

3. Number, Qualifications, and Adjudication Method of Experts for Ground Truth

• The document does not specify the number of experts used to establish the ground truth or their qualifications.
• The document does not specify the adjudication method used.

4. MRMC Comparative Effectiveness Study

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed (or at least not reported in this summary). This device is an automated antimicrobial susceptibility test system, not an AI system designed to assist human readers in interpretation.

5. Standalone Performance Study

• A standalone performance study was performed. The "VITEK® 2 Streptococcus Inducible Clindamycin Resistance" system itself was evaluated for its performance against the CLSI Interpretive Criteria. The reported 99.2% overall category agreement is a measure of the algorithm's standalone performance.

6. Type of Ground Truth Used

• The ground truth used was the CLSI Interpretive Criteria. This refers to established guidelines and standards from the Clinical and Laboratory Standards Institute for interpreting antimicrobial susceptibility test results. The reference method involved incubation at 24 hours.

7. Sample Size for Training Set

• The document does not specify the sample size used for the training set.

8. How Ground Truth for Training Set Was Established

• The document does not specify how the ground truth for the training set was established. However, given the nature of AST systems, the training data would typically also be based on established reference methods and interpretive criteria, likely CLSI or similar.

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