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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. gonorrhoeae ). 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 (MC) in ye/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The indications for use of this 510(k) is specifically for the Ceftazidime MTS at concentrations of 0.016 - 256.0 ug/mL interpreted after 16-20 hours of incubation.

The non-fastidious bacteria that have been shown to be active both clinically and in vitro against Ceftazidime according to the FDA label are:

Citrobacter species Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis Proteus vulgaris 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 (MC) in ye/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The provided text describes a 510(k) premarket notification for a medical device called "Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0μg/mL". This device is an antimicrobial susceptibility test. However, the document provided does not contain the detailed study information required to answer all parts of your request. It mainly describes the regulatory approval process and the indications for use of the device.

Therefore, I can only provide limited information based on the text.

Here's what I can extract:

1. A table of acceptance criteria and the reported device performance

   • The document does not provide a table of acceptance criteria or reported device performance for this specific device. This information would typically be found in the detailed study report submitted as part of the 510(k), which is not included here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • This information is not present in the provided text.

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)

   • This information is not present in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • This information is not present in the provided text.

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

   • The Liofilchem MIC Test Strip (MTS) is a manual reading device, not an AI-assisted device. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable, and this information is not present.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • This device involves manual reading, so it's not a standalone algorithm. This information is not present.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • For antimicrobial susceptibility tests, the "ground truth" often refers to a reference method (e.g., broth microdilution or agar dilution) against which the test strip's results are compared. The document states "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 µg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures." It does not explicitly state the specific reference method used for ground truth comparison in validation studies.

8. The sample size for the training set

   • This information is not present in the provided text. As a manual test strip, it generally doesn't involve a "training set" in the machine learning sense.

9. How the ground truth for the training set was established

   • This information is not present in the provided text. Again, the concept of a "training set" with established ground truth is typically associated with AI/machine learning models, which this device is not.

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