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510(k) Data Aggregation
(74 days)
MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN
The intended use of this panel is for determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of Haemophilus spp.
After incubation in a non-CO2 incubator for 20 - 24 hours, the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.
The two-fold dilutions of AMPICILLIN in the panel range from 0.015 to 16 mcg/ml for testing Haemophilus spp.
Microdilution Minimum Inhibitory Concentration (MIC) Panels
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dade MicroScan Inc. MicroScan® MICroSTREP plus™ Panel - Ampicillin:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric / Requirement | Reported Device Performance |
|---|---|---|
| Performance | Overall Essential Agreement with NCCLS frozen Reference | 91.5% |
| Reproducibility | Acceptable results (implied by statement "Reproducibility testing demonstrated acceptable results") | Acceptable results |
| Quality Control | Acceptable results (implied by statement "Quality Control testing demonstrated acceptable results") | Acceptable results |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a single number. The study used "fresh and stock Efficacy isolates and stock Challenge strains of Haemophilus spp." The total number of isolates tested is not provided in this summary.
- Data Provenance: Not explicitly stated, but it was an "external evaluation." The country of origin is not mentioned, and it is a prospective evaluation aimed at confirming performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Adjudication Method: Not specified.
4. Adjudication Method for the Test Set:
- The document does not specify any adjudication method (e.g., 2+1, 3+1).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This device is a diagnostic panel for susceptibility testing, not an imaging or interpretive device that typically involves human readers. The comparison was between the device and a reference method.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study. The device, a microdilution panel, directly outputs a Minimum Inhibitory Concentration (MIC) value, which is then compared to a reference standard. There isn't an "algorithm only" in the sense of a software-based AI, but rather the performance of the physical test panel itself determining the MIC. Human technicians would "read" the panel, but the performance evaluation is of the panel's result against the reference.
7. The Type of Ground Truth Used:
- The ground truth used was an NCCLS frozen Reference, which serves as the gold standard for antimicrobial susceptibility testing.
8. The Sample Size for the Training Set:
- The document does not mention a "training set" as this is not an AI/machine learning device that requires training data in that sense. The device's performance is evaluated against a reference standard in a verification study.
9. How the Ground Truth for the Training Set was Established:
- Not applicable as there is no "training set" in the context of this device's development or evaluation as described. The "ground truth" for the evaluation set was the NCCLS frozen Reference.
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