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The VITEK® 2 Compact System is intended to be used with VITEK® 2 AST Cards for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae and S. pneumoniae. It is intended for use as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

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 AST card. The cards are filled with a vacuum filling process, sealed and placed into the reader/incubator. The VITEK 2 Compact monitors growth based on attenuation of light measured by an optical scanner over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MC value Our pleation of the interpretive category result for each antibiotic contained on the VITEK 2 AST Card.

Here's a breakdown of the acceptance criteria and study information for the VITEK® 2 Compact, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated as a number. The text mentions "External evaluations were conducted with a test set of challenge, reproducibility and quality control for both gram-negative and gram-positive organisms."
• Data Provenance: Not explicitly stated (e.g., country of origin). The study was described as "External evaluations," suggesting it was conducted outside of bioMérieux's direct control. The filing is with the US FDA, so it's likely relevant to the US regulatory context.
• Retrospective/Prospective: Not explicitly stated. The nature of the "challenge, reproducibility and quality control" testing suggests it was prospective, conducted specifically to evaluate the new device.

3. Number of Experts and Qualifications for Ground Truth

Not explicitly stated. The ground truth for comparative performance in this context is the results obtained from the predicate device, the VITEK® 2 System. There is no mention of human experts establishing ground truth for individual cases outside of the predicate device's output.

4. Adjudication Method for the Test Set

Not applicable in the human expert sense. The "ground truth" for comparison was the performance of the predicate VITEK® 2 System itself. The performance data presented (e.g., % agreement) directly compares the new device's output to the predicate's output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not a study involving human readers or interpretation of medical images or other data where AI would assist human readers. It's an automated antimicrobial susceptibility testing device, comparing its automated results to those of a predicate automated device.

6. Standalone Performance

Yes. The study evaluates the performance of the VITEK® 2 Compact device on its own, comparing its output directly to the predicate device. This is by nature a standalone performance assessment. The device generates "the MIC value and the interpretive category result for each antibiotic."

7. Type of Ground Truth Used

The ground truth used for comparison was the results obtained from the predicate device (VITEK® 2 System). The text states: "The VITEK® 2 Compact demonstrated substantially equivalent performance when compared to the VITEK® 2 System."

8. Sample Size for the Training Set

Not applicable/not provided. This device is not described as using machine learning or needing a "training set" in the conventional AI sense. It's an automated system based on established microbiological principles (attenuation of light over time to determine growth and MIC).

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

Not applicable. As noted above, this device does not appear to utilize a training set in the AI machine learning context. Its operation is based on an optical scanner monitoring growth and calculating values, essentially mimicking the doubling dilution technique.

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