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510(k) Data Aggregation
(264 days)
VITEK® 2 Gram Negative Ciprofloxacin is designed for antimicrobial susceptibility testing of Gram negative bacilli and 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. VITEK® 2 Gram Negative Ciprofloxacin is a quantitative test. Ciprofloxacin has been shown to be active against most strains of the microorganisms listed below. according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections Citrobacter freundii Citrobacter koseri (diversus) Enterobacter cloacae Escherichia coli Klebsiella pneumonia Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Salmonella typhi Serratia marcescens Shigella sonnei
In vitro data available but clinical significance is unknown Enterobacter aerogenes Klebsiella oxytoca Salmonella enteritidis
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, Staphylococus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.
The antimicrobial presented in VITEK® 2 AST-GN Cards is 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, 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 antimicrobial contained on the card.
Here's a breakdown of the acceptance criteria and the study details for the VITEK® 2 AST-GN Ciprofloxacin device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the statement, "VITEK® 2 AST-GN Ciprofloxacin demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009)." The document does not explicitly state numerical acceptance criteria, but rather reports the device's performance against the reference method.
| Performance Metric | Acceptance Criteria (Implied by FDA Guidance) | Reported Device Performance |
|---|---|---|
| Overall Essential Agreement | Substantially Equivalent (as per FDA Guidance) | 97.1% |
| Overall Category Agreement | Substantially Equivalent (as per FDA Guidance) | 97.1% |
| Reproducibility | Acceptable (as per FDA Guidance) | Acceptable Results |
| Quality Control | Acceptable (as per FDA Guidance) | Acceptable Results |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains." However, it does not provide the specific sample size (number of isolates) for the test set. The data provenance is described as "clinical isolates," implying a retrospective nature, and "challenge strains," which are laboratory-derived. The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications to establish the ground truth.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss any effect size of AI assistance on human readers. This device is an automated antimicrobial susceptibility system, not a human-interpreted diagnostic imaging tool.
6. Standalone Performance
Yes, a standalone performance study was done. The "external evaluation" comparing the VITEK® 2 AST-GN Ciprofloxacin to the CLSI broth microdilution reference method represents the standalone performance of the algorithm/device. The VITEK® 2 system is described as automated.
7. Type of Ground Truth Used
The ground truth used was the CLSI broth microdilution reference method. This is considered a gold standard for determining Minimum Inhibitory Concentrations (MICs) of antimicrobial agents.
8. Sample Size for the Training Set
The document does not provide a sample size for a training set. Automated AST systems typically rely on pre-established algorithms derived from extensive microbiology knowledge and data, rather than a distinct "training set" in the machine learning sense described here. The study focuses on validation against a reference method.
9. How the Ground Truth for the Training Set Was Established
Since there is no explicitly mentioned "training set" in the context of machine learning, the document does not describe how ground truth for a training set was established. The "ground truth" referenced for the performance evaluation is the CLSI broth microdilution reference method.
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