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The MTS (MIC Test Strip) Gentamicin 0.016-256 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined 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.

MTS Gentamicin at concentrations of 0.016-256 uq/mL should be interpreted at 16-20 hours of incubation.

MTS Gentamicin can be used to determine the MIC of gentamicin aqainst the following bacteria. Gentamicin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:

• Gram-negative bacteria Citrobacter freundii Citrobacter koseri Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens

MTS consists of specialized paper impregnated with a pre-defined 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 letter and the Indications for Use statement for the MTS Gentamicin 0.016-256 ug/mL device, which is an antimicrobial susceptibility test. This type of device is for determining the minimum inhibitory concentration (MIC) of an antimicrobial agent against bacteria.

Based on the document, I can provide information on acceptance criteria and device performance from the perspective of an antimicrobial susceptibility test, but not a device that utilizes AI or human-in-the-loop performance, as those concepts are not applicable to this product.

Here's the breakdown of the information that can be extracted or reasonably inferred, and where the document is silent on aspects requested in the prompt:

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

The document does not explicitly present a table of acceptance criteria and reported device performance in the manner typically found in a clinical study report for an AI/ML device. However, for antimicrobial susceptibility tests like this, the "acceptance criteria" are generally based on the agreement rates with a reference method (e.g., broth microdilution) and the performance against established quality control (QC) ranges for specific organisms. The "reported device performance" would be these agreement rates and successful QC results.

Given the nature of the device, the following would be the high-level performance expectations:

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set (i.e., the number of bacterial isolates tested). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). For such devices, clinical performance data would typically involve testing a large and diverse collection of clinical isolates, often from multiple geographical locations and collected prospectively or retrospectively from clinical laboratories.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document. For antimicrobial susceptibility testing, the concept of "experts" establishing ground truth in the way it's used for AI/ML image interpretation is not relevant. The "ground truth" (or reference method) for MIC determination is typically established by carefully performed and validated laboratory methods, most commonly broth microdilution, followed by interpretation based on established clinical breakpoints set by organizations like CLSI or FDA.

4. Adjudication method for the test set

This information is not applicable and not provided in the document. As stated above, the "ground truth" is determined by a reference laboratory method, not by human adjudication of interpretations.

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

This is not applicable as the device is an antimicrobial susceptibility test strip, not an AI-assisted diagnostic device requiring human interpretation. Therefore, no MRMC study or effect size related to AI assistance would be performed or reported for this device.

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

This is not applicable. The device is a physical test strip that is manually read. There is no algorithm involved in its direct operation or interpretation for a standalone evaluation. The "human-in-the-loop" aspect exists in the manual reading of the inhibition zone and subsequent interpretation based on breakpoints.

7. The type of ground truth used

The type of ground truth used for evaluating this device would be the Minimum Inhibitory Concentration (MIC) values determined by a reference method, most commonly broth microdilution, which is considered the gold standard for antimicrobial susceptibility testing. Clinical breakpoints (Susceptible, Intermediate, Resistant categories) are then applied to these MICs.

8. The sample size for the training set

The concept of a "training set" is not applicable to this device, as it is a physical diagnostic test, not an AI/ML model that requires training data.

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

Not applicable, as there is no training set for this type of device.

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