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The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorhoeae). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The purpose of this 510(k) is specifically for the ceftolozane/tazobactam MTS at concentrations of 0.016/4 - 256/4 mcg/mL.

Ceftolozane/azobactam has been shown to be active against the following bacteria, both clinically and in vitro according to the FDA label:

Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The provided text is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the "Liofilchem MIC Test Strip (MTS) - Ceftolozane/tazobactam." It does not contain the detailed information required to answer your questions about acceptance criteria for an AI/ML device study.

Specifically, the document pertains to an in vitro diagnostic device (MTS) used for antimicrobial susceptibility testing, which involves manual reading procedures and overnight incubation. It's a standard microbiological test, not an AI/ML powered device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML model. It's about substantial equivalence to a predicate device for a manual test strip.
2. Sample sizes used for the test set and the data provenance: Not applicable to an AI/ML study description in this document.
3. Number of experts used to establish the ground truth...: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. The device involves manual reading, not AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For this device, ground truth would be established by standard microbiological methods (e.g., broth microdilution reference method) to determine the true MIC value, but the details of such a comparative study are not in this letter.
8. The sample size for the training set: Not applicable, as this is not an AI/ML training dataset.
9. How the ground truth for the training set was established: Not applicable.

The document discusses the "Indications for Use" for the test strip and lists bacteria against which the antibiotic combination (ceftolozane/tazobactam) has shown activity "both clinically and in vitro according to the FDA label." This refers to the established efficacy of the drug, not the performance metrics of an AI/ML diagnostic alongside a reader.

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