Search Results
Found 1 results
510(k) Data Aggregation
(59 days)
VIDAS ROTAVIRUS (RTV) ASSAY
The VIDAS Rotavirus (RTV) Assay is for the qualitative detection of rotavirus antigen in stool specimens. It is intended as an aid in the diagnosis of acute nonbacterial gastroenteritis.
The VIDAS Rotavirus (RTV) Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS (Vitek ImmunoDiagnositic Assay System) instrument. All assay steps and the assay temperature are controlled by the instrument.
The VIDAS Rotavirus Assay contains a pipette tip-like disposable device, the Solid Phase Receptacle (SPR), a Reagent Strip, 1 Bottle of Standard, 1 Bottle of Positive Control, and 1 Bottle of Negative Control. The Kit contains a sufficient number of SPR's and Strips to perform 60 Tests.
The SPR serves as the solid phase, as well as, the pipettor for the assay. The SPR is coated with rabbit anti-rotavirus antibodies. The Strip contains the reagents necessary to perform the assay, as well as, a sample well for placement of the specimen. Each RTV Assay requires one RTV Reagent Strip and one RTV SPR.
The provided document is a 510(k) summary for the VIDAS Rotavirus (RTV) Assay, dated August 1, 1997. It describes the device, its intended use, and provides a synopsis of test methods and results. However, it does not explicitly state "acceptance criteria" in a table format with corresponding reported performance for each criterion. It also does not describe a "study that proves the device meets the acceptance criteria" in the format of a modern AI/ML device study.
Based on the available information, here's a structured response interpreting the provided text in the context of your request for acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not provide explicit acceptance criteria. Instead, it presents performance characteristics without pre-defined thresholds. The performance is reported in comparison to other methods (commercial EIA assays and Electron Microscopy, EM).
| Performance Characteristic | Reported Performance (vs. EIA 1) | Reported Performance (vs. EIA 2) | Reported Performance (vs. Electron Microscopy) |
|---|---|---|---|
| False Positive Results | 8 false positives, relative specificity of 95.8%, overall agreement of 94.6% | 8 false positives, relative specificity of 95.7%, overall agreement of 92.4% | No false positive samples, overall agreement of 97.0% |
| False Negative Results | 9 false negatives, sensitivity of 92.7%, overall agreement of 94.6% | 16 false negatives, relative sensitivity of 87.8%, overall agreement of 92.4% | 3 false negatives, sensitivity of 95.7%, overall agreement of 97.0% |
| Discrepant Samples | Overall agreement of all samples (after EM resolution of 13 discrepant samples from EIA studies): 94.8% | - | - |
| Equivocal Results | 5 equivocal results | - | - |
| Invalid Results | No invalid results | - | - |
| Cross-reactivity and Interference | No cross-reactivity or interference observed with approximately 50 microorganisms. | - | - |
| Precision (Intra-assay) | Coefficients of variation of less than 10% | - | - |
| Precision (Inter-assay) | Coefficients of variation of less than 10% | - | - |
| Limit of Detection | Approx. 3.16 x 10² VP/mL in formed stool; 6.28 x 10² VP/mL in semisolid stool; 1.44 x 10⁵ VP/mL in liquid stool (quantitated via EM) | - | - |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the total sample size for the test set or the country of origin of the data. It mentions "studies comparing the VIDAS RTV Assay to one commercially available EIA" and "a second EIA," as well as "a study comparing VIDAS RTV Assay to Electron Microscopy." The number of false positives/negatives, sensitivities, and specificities are provided, implying a certain number of positive and negative samples were included in these comparisons. For example, for the "one commercially available EIA" comparison, 8 false positives and 9 false negatives are mentioned, with an overall agreement of 94.6%. This indicates a total number of samples that can be calculated, but the exact total is not explicitly provided. The studies appear to be retrospective, utilizing collected samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The ground truth seems to have been established by comparing the VIDAS RTV Assay to "commercially available EIAs" and "Electron Microscopy." There is no mention of human experts (e.g., radiologists, lab technicians) adjudicating results for the ground truth.
4. Adjudication method for the test set
The document describes an adjudication process for 13 discrepant samples from the VIDAS vs. EIA studies. These 13 samples were "further tested with EM." Of these, 4 resolved positive and 4 resolved negative in agreement with VIDAS RTV. Three specimens that were VIDAS positive and EIA negative were confirmed negative by EM. One specimen that was VIDAS negative and EIA positive was confirmed positive by EM. One discrepant result was not tested. This suggests a form of 2-way comparison (VIDAS vs. EIA) with a third, more definitive method (EM) for resolving discrepancies.
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
No such study is mentioned or implied. The device is a diagnostic assay, an automated enzyme-linked fluorescent immunoassay (ELFA), not an AI-assisted interpretation system for human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone performance evaluations of the VIDAS RTV Assay. The device is an automated system (ELFA performed in a VIDAS instrument) that provides a qualitative result (detection of rotavirus antigen), without direct human-in-the-loop interpretation of the assay's output for diagnosis. The performance metrics (sensitivity, specificity, agreement) are calculated based on the assay's results compared to reference methods.
7. The type of ground truth used
The ground truth for evaluating the VIDAS RTV Assay's performance was established using:
- Other commercially available Enzyme Immunoassays (EIAs): This served as a comparative ground truth for initial performance assessment.
- Electron Microscopy (EM): This was used as a more definitive ground truth, especially for resolving discrepant results between the VIDAS assay and the other EIAs, and also for direct comparison to the VIDAS assay for sensitivity and specificity. EM is considered a highly reliable method for visualizing viral particles.
- Quantitated rotavirus antigen via EM: Used to determine the Limit of Detection, where EM was the method to quantitate the reference rotavirus antigen concentrations.
8. The sample size for the training set
The document does not provide any information about a training set. This is typical for diagnostic assays developed prior to the widespread application of machine learning/AI workflows. The assay's parameters would have been optimized through laboratory development and validation, rather than "training" on a specific dataset in the AI sense.
9. How the ground truth for the training set was established
As there is no mention of a training set in the context of machine learning, this question is not directly applicable to the document provided. The assay's development and validation would have involved establishing its operational characteristics and analytical performance using known positive and negative controls and characterized samples, but not a "training set" with ground truth in the AI/ML context.
Ask a specific question about this device
Page 1 of 1