(65 days)
For in vitro diagnostic use:
System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.
This 510(k) application is for System U3/Gentamicin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 g/ml, Intermediate 8 µg/ml and Resistant ≥ 16 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.
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This document is a 510(k) clearance letter from the FDA for a device called "System U3™ for Gentamicin." It doesn't contain information about acceptance criteria or a dedicated study proving the device meets said criteria in the way a clinical trial report would.
However, based on the provided text, we can infer some aspects relevant to its regulatory acceptance and what would be expected for such a device. Since this is a 510(k) submission, the primary criterion for acceptance is substantial equivalence to a legally marketed predicate device.
Here's an analysis of what can be gleaned, and where information is missing for a complete answer:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance (Inferred/Expected) |
---|---|
Substantial Equivalence: Device performs as safely and effectively as a predicate device for its intended use. | "Determined the device is substantially equivalent" to legally marketed predicate devices. (Stated in the letter) |
Accuracy of Susceptibility Categorization: Correctly determine susceptibility categories (Susceptible, Intermediate, Resistant) based on MIC breakpoints. | The System U3™ for Gentamicin is for susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 µg/ml, Intermediate 8 µg/ml, and Resistant ≥ 16 µg/ml. (Implied that the device achieves this in comparison to a predicate, as per substantial equivalence). The specific accuracy percentages are not provided here. |
Reproducibility/Reliability: Consistent results when tested under similar conditions. | Not explicitly stated in this letter, but would be a standard part of any validation study for such a device. |
Intended Use: For in vitro diagnostic use, for antimicrobial susceptibility testing of non-fastidious Gram negative and Gram positive aerobic bacteria (e.g., Enterobacteriaceae, Pseudomonas, Staphylococcus, Enterococcus species). | The device's indications for use are exactly as described in the acceptance criteria. |
Compliance with MIC Breakpoints: Adherence to established MIC breakpoints for Gentamicin. | "based on the MIC breakpoints of Susceptible ≤ 4 µg/ml, Intermediate 8 µg/ml and Resistant ≥ 16 µg/ml". (Stated in the indications for use). |
Note: The FDA 510(k) clearance letter confirms that the device has met the criteria for substantial equivalence, allowing it to be marketed. However, it does not detail the specific study results that led to this conclusion. Those details would be in the original 510(k) submission file, which is not provided here.
Based on the provided text, the following information is either not present or cannot be definitively extracted:
- 2. Sample size used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- 4. Adjudication method for the test set: Not mentioned.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable/mentioned for this type of in vitro diagnostic device (antibiotic susceptibility testing). MRMC studies are usually for imaging diagnostics where human interpretation is a significant factor.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "System U3" is a qualitative technique, not an "algorithm" in the modern AI sense. It determines susceptibility categories, likely through a standardized method that is inherently standalone in its result generation, even if a human reads the final result. However, the exact performance metrics of such a standalone component are not detailed here.
- 7. The type of ground truth used: Not explicitly stated, but for antimicrobial susceptibility testing devices, the "ground truth" is typically established by reference methods (e.g., broth microdilution or agar dilution as described by CLSI guidelines), which are considered the gold standard for determining MIC values.
- 8. The sample size for the training set: Not applicable and not mentioned. This device is not described as an AI/ML algorithm that requires a training set in the contemporary sense. It's an established qualitative technique.
- 9. How the ground truth for the training set was established: Not applicable and not mentioned.
In summary, the provided document is a regulatory clearance letter, not a detailed study report. It confirms the device's market approval based on the FDA's assessment of the 510(k) submission, which would have contained the underlying performance data and justification for substantial equivalence.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).