(93 days)
VITEK® 2 Gram Positive Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus species. VITEK 2 Gram Positive 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 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.
VITEK® 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test designed for antimicrobial susceptibility testing of Staphylococcus species. A positive ICR test is indicative of inducible MLS, resistance, which confers resistance to macrolides, lincosamides, and type B inducible MLS, resistance, which confers resistance to macrolides, and VITEK® 2 Co laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK 2 AST 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 bacterial isolate to be tested is diluted to a standardized concentration in 0.45% - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System belomatically 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 over a delined pend of the (up to To Tronice). It the interpretive category result for each antibiotic contained on the card.
{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": "Acceptable performance when compared with the CLSI Disk Approximation Test reference method.",
"Reported Device Performance": "99.3% overall Category Agreement."
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": {
"Sample Size": "Not specified, but states 'fresh and stock clinical isolates and stock challenge strains'.",
"Data provenance": "External evaluation (implying clinical samples), prospective for fresh isolates and retrospective for stock isolates."
},
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable, as ground truth was established by the CLSI Disk Approximation Test reference method, not human experts.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable, as ground truth was established by the CLSI Disk Approximation Test reference method, not human adjudication.",
"5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "No MRMC comparative effectiveness study was done. This is a standalone diagnostic device comparison to a reference method, not an AI assistance tool for human readers.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, a standalone comparison of the VITEK 2 System to the CLSI Disk Approximation Test reference method was performed.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "CLSI Disk Approximation Test reference method.",
"8. The sample size for the training set": "Not specified, as this device likely uses a rule-based or predefined algorithm rather than a machine learning model that requires a training set in the conventional sense. The 'training' would be the development and validation against CLSI standards.",
"9. How the ground truth for the training set was established": "Not applicable for a training set in the context of typical machine learning. The device's performance was validated against the CLSI Disk Approximation Test reference method."
}
§ 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.”