(412 days)
To determine bacterial antimicrobial agent susceptibility. For use with aerobic non-enterococcal streptococci including S. pneumoniae. The MicroScan® MICroSTREP plus™ Panel is used to determine antimicrobial susceptibility of aerobic non-enterococcal streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20-24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial AMOXICILLIN at concentrations of 0.008 - 16 mcg/ML to the test panel. The organisms which may be used for AMOXICILLIN susceptibility testing in this panel are; Streptococcus pneumoniae.
Microdilution Minimum Inhibitory Concentration (MIC) Panels. MicroScan® MICroSTREP plus™ Panel - Amoxicillin.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Dade Behring MicroScan® MICroSTREP plus™ Panel - Amoxicillin:
The provided document describes the submission and FDA clearance for the Dade Behring MicroScan® MICroSTREP plus™ Panel, specifically for the addition of Amoxicillin. The core of the study is a comparison between the new device and a predicate device (NCCLS Frozen Reference Panels) to demonstrate "substantial equivalence."
Acceptance Criteria and Reported Device Performance
The document states that the acceptance criterion for the device's performance is "acceptable Essential Agreement performance" when compared to the frozen Reference panel. While specific numerical targets for Essential Agreement are not explicitly stated within the provided text, the FDA's "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991) is referenced as the guiding document for defining acceptable performance. For reproducibility testing, the criterion was "acceptable reproducibility and precision." Similarly, for Quality Control, the criterion was "acceptable results."
| Acceptance Criteria Category | Specific Metric (as implied or referenced) | Acceptance Criterion | Reported Device Performance |
|---|---|---|---|
| Comparative Performance | Essential Agreement (vs. NCCLS Frozen Reference Panels) | "acceptable Essential Agreement performance" as defined by FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991) | Demonstrated "acceptable Essential Agreement performance" |
| Reproducibility | Reproducibility and Precision | "acceptable reproducibility and precision" | Demonstrated "acceptable reproducibility and precision" |
| Quality Control | N/A (General QC standards) | "acceptable results" | Demonstrated "acceptable results" |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated with a numerical value. The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for the external evaluation.
- Data Provenance: Not explicitly stated, though the manufacturer is based in West Sacramento, CA, suggesting the study was likely conducted in the US. The isolates themselves could have varied origins.
- Retrospective or Prospective: Not explicitly stated. Given the use of "fresh and stock Efficacy isolates and stock Challenge strains," it likely involved elements of both, with "fresh" isolates suggesting prospective collection and "stock" isolates being retrospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The ground truth was established by comparison to NCCLS Frozen Reference Panels, which themselves represent a gold standard for susceptibility testing, implying expert-derived methodologies.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not explicitly stated. The comparison is against a "Reference panel," which generally serves as the definitive result rather than requiring further human adjudication for discrepancies between methods.
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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:
- MRMC Study: No, an MRMC study was not performed. This device is an in-vitro diagnostic (IVD) antimicrobial susceptibility test, not an AI-assisted diagnostic imaging device that typically involves human readers interpreting cases. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in essence, the "external evaluation" against the NCCLS Frozen Reference Panel is a standalone performance assessment of the new MicroScan panel. It assesses the panel's ability to accurately determine MIC values and susceptibility categories independently, without human interpretation influencing the primary measurement of MIC. However, it's important to note that the instruction states "read visually according to the Package Insert," implying a human reading step for the MicroScan panel. The "standalone" here refers to the algorithm's performance in the context of generating the MIC, not necessarily a fully automated system from specimen to result without any human interaction.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth was established by NCCLS Frozen Reference Panels. These panels are considered the gold standard for antimicrobial susceptibility testing, representing a highly standardized and validated method, effectively serving as an expert-derived and experimentally confirmed ground truth.
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The sample size for the training set:
- Sample Size for Training Set: The document does not explicitly mention a "training set" or its size in the context of machine learning. This device predates widespread AI/ML applications in IVD. The data cited ("fresh and stock Efficacy isolates and stock Challenge strains") appears to be for the evaluation/test of the device's performance, not for training a model.
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How the ground truth for the training set was established:
- How Ground Truth for Training Set was Established: Not applicable, as a distinct training set (in the ML sense) is not described or implied for this device. The development of the MicroScan panel itself would have relied on established microbiological principles and validation methods to ensure its accuracy against known microbial responses, which informally serve as "ground truth" for its design.
§ 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).