(47 days)
The VITEK® Gram Positive Susceptibility Test is intended to be used with the VITEK® System 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 agalactiae, and S. pneumoniae. VITEK® Gram Positive Ertapenem is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Streptococcus agalactiae. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
The VITEK GPS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. After the card is inoculated with a standardized organism suspension, it is placed in the Reader/Incubator of the VITEK System. Organism growth inside the card is optically monitored throughout the 6-15 hour incubation cycle. MIC results are automatically calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.
Here's an analysis of the provided text regarding the VITEK® Gram Positive Ertapenem device's acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|---|
| Overall Category Agreement | Not explicitly stated | 99.3% Overall Category Agreement |
| Reproducibility | Not explicitly stated | Acceptable results |
| Quality Control | Not explicitly stated | Acceptable results |
Note: The document references the "FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued Feb. 5, 2003" for defining substantial equivalence, which would contain the specific acceptance criteria for AST systems. However, these specific numerical criteria are not enumerated within the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the test set. It mentions:
- Test Set Description: "external evaluations were designed to confirm the VITEK Gram Positive Ertapenem by comparing its performance with the NCCLS agar dilution reference method."
- Data Provenance: The external evaluations were conducted with "fresh and stock clinical isolates and stock challenge strains." This implies the data is likely a mix of retrospective (stock clinical isolates) and potentially prospective (fresh clinical isolates) data. The country of origin is not specified but is implicitly within the scope of FDA approval requirements, suggesting data from the US or international data meeting US standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not mention the use of experts to establish the ground truth for the test set. Instead, it states that the device's performance was compared to the "NCCLS reference agar dilution method," which is a laboratory-based, objective reference standard for antimicrobial susceptibility testing.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as the ground truth was established by the "NCCLS reference agar dilution method," not human interpretation requiring adjudication.
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 device is an automated antimicrobial susceptibility test system, not an imaging or diagnostic device that typically involves human readers. The comparison is between the automated system and a reference lab method.
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® Gram Positive Ertapenem system is an automated device designed to calculate MIC results and interpretive categories without human intervention once the card is inoculated and placed in the system. Its performance was directly compared to the NCCLS reference method.
7. The Type of Ground Truth Used
The type of ground truth used was the NCCLS reference agar dilution method. This is an established microbiological laboratory gold standard for determining antimicrobial susceptibility, providing objective minimum inhibitory concentration (MIC) values.
8. The Sample Size for the Training Set
The document does not explicitly state the sample size used for any 'training set.' For a device like VITEK, which measures growth patterns against known antibiotic concentrations, the "training" (calibration and validation) would typically involve extensive testing against known strains and reference methods during its development. The provided text only describes the clinical evaluation or test set performance.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" is mentioned, the method for establishing its ground truth is also not detailed. However, based on the nature of antimicrobial susceptibility testing, any developmental or 'training' data would have had its ground truth established using standard reference methods like the NCCLS agar dilution method or similar, highly controlled laboratory techniques to ensure accurate MIC determination for algorithm development and calibration.
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”