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VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 Gram Positive Meropenem for Streptococcus pneumoniae is a quantitative 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 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has 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 antibiotic contained on the card.

Here's an analysis of the provided information regarding the acceptance criteria and study for the VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for antimicrobial susceptibility testing systems are defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems (Issued Feb. 5, 2003). While the precise numerical targets for "acceptable performance" of Essential Agreement and Category Agreement are not explicitly stated within the provided text, the document indicates that the device met these criteria. However, for a complete understanding, one would typically refer to that FDA guidance document. Based on the provided text, we can infer the reported performance metrics.

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

• Sample Size for Test Set: The exact number of isolates used in the external evaluation is not explicitly stated. The text mentions "fresh and stock clinical isolates and stock challenge strains."
• Data Provenance: The study was an "external evaluation." The country of origin is not specified, but bioMérieux, Inc. is based in Hazelwood, MO, USA. The isolates included "fresh and stock clinical isolates," indicating a mix of prospective (fresh) and retrospective (stock) clinical data, alongside "stock challenge strains."

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

This information is not provided in the text. The ground truth was established by the CLSI broth microdilution reference method, which is a standardized laboratory procedure, not typically an expert consensus reading.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was established by a laboratory reference method (CLSI broth microdilution), not by human expert interpretation that would require an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of an automated device against a reference method, not on human-in-the-loop performance or the effect of AI assistance on human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was a standalone performance study. The VITEK® 2 system (an automated device/algorithm) was evaluated independently against the CLSI broth microdilution reference method.

7. The Type of Ground Truth Used

The ground truth used was the CLSI broth microdilution reference method. This is a laboratory standard for determining the minimum inhibitory concentration (MIC) of antimicrobials.

8. The Sample Size for the Training Set

The text does not provide information regarding a separate "training set" or its sample size. The description pertains to a validation study (external evaluation) for a device that already exists. Device development often involves internal validation and optimization, but those details are not part of this 510(k) submission summary.

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

As no training set is described, information on how its ground truth was established is not provided.

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