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The SASTM Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection of Rotavirus antigens in feces as an aid in the diagnosis of acute gastroenteritis caused by rotavirus infection. This test is for professional use only.

rapid, membrane-based immunogold assay

This is a K990842, clearance letter for SAS™ Rota Test from the FDA. This document does not contain the detailed study information regarding acceptance criteria and device performance. It primarily serves as a notification of the FDA's decision regarding substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications based on the provided text.

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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).

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.

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The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
For use to detect the presence of rotavirus in stool specimens from patients with loose stools, diarrhea, gastroenteritis, or suspected to be infected with rotavirus.

The ImmunoCard STAT! Rotavirus assay system is a membrane based immunogold assay for rotavirus. Each kit contains the following components: ImmunoCard STAT! Rotavirus devices(30), Positive Control (1.8ml), Sample Diluent (10.5ml), Transfer Pipets (30). In brief, 1/15 diluted stool enters the sample application pad and migrates through the conjugate pad. Monoclonal antibody (conjugated to colloidal gold particles) contained in the pad is dissolved in the specimen and travels onto the nitrocellulose membrane. The nitrocellulose membrane contains two "capture" zones. The first holds polyclonal antibody to rotavirus, and the second has polyclonal anti-mouse IgG. The first zone serves as the test line, indicating the presence of rotavirus. The second zone acts as a procedural control and verifies that the sample has migrated sufficiently into the device to permit a valid test result to be read in the first (test) zone. The final absorbent pad acts as a reservoir and draws the sample through the test strip.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Performance vs Electron Microscopy": {
      "Acceptance Criteria": "Not explicitly stated as numerical criteria, but implied to be comparable to predicate devices.",
      "Sensitivity": "93.1%",
      "Specificity": "95.8%",
      "Correlation": "94.4%"
    },
    "Performance vs Premier Rotaclone (Predicate Device)": {
      "Acceptance Criteria": "Not explicitly stated as numerical criteria, but implied demonstration of substantial equivalence.",
      "Sensitivity": "97.7%",
      "Specificity": "100.0%",
      "Correlation": "98.8%"
    },
    "Sensitivity Limits": {
      "Acceptance Criteria": "Not explicitly stated as numerical criteria.",
      "Reported Performance": "Approximately 1.8-3.7 x 10^6 viral particles."
    },
    "Reproducibility": {
      "Acceptance Criteria": "Not explicitly stated as numerical criteria.",
      "Reported Performance": "100% on controls, negative and moderate positive stools, and 96% on low positive stools."
    },
    "Cross-Reactivity": {
      "Acceptance Criteria": "No false positive or false negative results with a panel of bacteria and viruses.",
      "Reported Performance": "Met the criteria: gave no false positive or false negative results."
    },
    "Interfering Substances": {
      "Acceptance Criteria": "Barium sulfate should not have an effect. High levels of blood may affect flow, potentially causing an occasional invalid result.",
      "Reported Performance": "No effect from barium sulfate. High levels (≥33%) of blood could affect flow, resulting in an occasional invalid test result (consistent with criteria)."
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The sample size for the clinical test set is not explicitly stated in the provided text. The data provenance (country of origin, retrospective or prospective) is also not specified.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable/Not specified. The ground truth for the core performance evaluation was established using Electron Microscopy and a predicate device (Premier Rotaclone), not necessarily human expert consensus for individual case adjudication.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable/Not specified. The performance was referenced against Electron Microscopy and a predicate device, not human adjudication of a test set.",
  "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": "Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool for human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, the device performance metrics (sensitivity, specificity, correlation) are presented as standalone performance evaluations against Electron Microscopy and a predicate device, indicating algorithm-only performance.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The primary ground truth used for performance comparison was **Electron Microscopy**. A second comparison was also made against the **Premier Rotaclone** predicate device.",
  "8. The sample size for the training set": "Not applicable. For this type of in vitro diagnostic device (immunoassay), there isn't typically a 'training set' in the machine learning sense. The device's capture and detection antibodies are developed and optimized through laboratory work, not by 'training' on a dataset.",
  "9. How the ground truth for the training set was established": "Not applicable, as there is no traditional 'training set' for this immunoassay device."
}

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The Trinity Biotech Rotavirus EIA kit is intended for the detection of rotavirus antigen in human fecal specimens and is used as an aid in the diagnosis of acute gastroenteritis caused by rotavirus in children and infants. The performance characteristic was not determined in the elderly population.

Not Found

I cannot fulfill this request. The provided text is a regulatory document from the FDA regarding a medical device, the "Trinity Biotech's Rotavirus EIA". It is a clearance letter for a 510(k) submission and discusses substantial equivalence, regulatory classifications, and general controls.

The document does not contain any information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria (beyond stating that the device is substantially equivalent to a predicate).
• Sample sizes for test sets or training sets.
• Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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The VIDAS Rotavirus (RTV) Assay detects the presence of rotavirus antigen in stool specimens.

The VIDAS RTV Assay detects the presence of rotavirus antigen in stool specimens. Assay specificity is conferred by the use of two antibodies. The rotavirus antigen is captured on the SPR by a polyclonal anti-rotavirus VP6 antibody, and the detector antibody conjugate is composed of a mouse monoclonal anti-rotavirus VP6 antibody.

Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the VIDAS Rotavirus Assay:

Acceptance Criteria and Study Details for the VIDAS Rotavirus Assay

This submission describes the VIDAS Rotavirus Assay, a diagnostic device for detecting rotavirus antigen in stool specimens. The primary study presented here is a standalone performance evaluation comparing the VIDAS RTV Assay to a commercially available EIA, with discrepancies resolved by a second EIA and electron microscopy (EM).

1. Table of Acceptance Criteria and Reported Device Performance

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