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TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasopharyngeal swab samples in symptomatic patients. This test is not intended for the detection of influenza C viruses. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens.

This is an FDA 510(k) clearance letter for the TRU FLU device, not a study report. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.

However, I can extract the following:

1. Trade/Device Name and Regulation:

• Trade/Device Name: TRU FLU
• Regulation Number: 21 CFR 866.3330
• Regulation Name: Influenza virus serological reagents

2. Intended Use and Type of Test:

• TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasopharyngeal swab samples in symptomatic patients.
• The test is not intended for the detection of influenza C viruses.
• Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay.
• Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Regarding your specific points:

• 1. A table of acceptance criteria and the reported device performance: This document does not contain this information. A 510(k) clearance letter acknowledges substantial equivalence to a predicate device, but the detailed performance data and acceptance criteria are typically found in the 510(k) summary or the full submission, not in the clearance letter itself.
• 2. Sample sized used for the test set and the data provenance: Not available in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available in this document.
• 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: This device is an immunochromatographic assay, not an AI-powered diagnostic device, so an MRMC study with AI assistance would not be applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a manual rapid diagnostic test, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): The document only states that "Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay," implying that these methods would likely serve as the ground truth in performance studies. However, the specific ground truth used for the clearance study is not detailed here.
• 8. The sample size for the training set: Not available in this document, and likely not applicable in the same way as an AI algorithm (though training for test development and validation would have occurred).
• 9. How the ground truth for the training set was established: Not available in this document.

To obtain the detailed information you are looking for, you would need to access the full 510(k) summary and potentially the performance data included in the submission, which are typically available through the FDA website or by request.

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TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples in symptomatic patients. The test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other clinical management decisions.

TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement. The document primarily consists of an FDA 510(k) clearance letter for the TRU FLU device, stating that it is substantially equivalent to legally marketed predicate devices and outlining regulatory requirements. It also includes the official "Indications for Use" statement for the device. Therefore, I cannot fulfill your request based on the provided input.

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TRU FLU is a rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples from symptomatic patients. The test is not intended for the detection of influenza C viruses A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other clinical management decisions.

TRU FLU is a single use immunoassay that consists of a Conjugate Tube, a Test Strip, and Sample Diluent. The Conjugate Tube contains a lyophilized bead of colloidal gold-linked monoclonal antibodies to influenza A and influenza B (detector antibodies). The Test Strip carries a nitrocellulose membrane with dried capture antibodies at separate lines for influenza B. The Test Strip holder caps the Conjugate Tube during testing and subsequent disposal to reduce exposure to potential pathogens.

The conjugate bead is first rehydrated in the Conjugate Tube with Sample Diluent, prior to the addition of patient specimen. The contents are mixed before the Test Strip is added. As the test is incubated at 20-25 C. influenza A or influenza B antigens, if present in the diluted sample, bind to the corresponding monoclonal antibody-colloidal gold conjugate as the sample moves up the Test Strip. The influenza A capture monoclonal antibody is bound to the Test Strip at the test-FLU A position of the device. When it binds the antigen-influenza A antibody-colloidal gold complex, it yields a visible pink-red line. Similarly, the influenza B capture monoclonal antibody bound to the assay membrane at the test-FLU B position will result in a pink-red line when it captures antibody-colloidal gold complexes. When no antigen is present, no complexes are formed and no pink-red line will appear at either the test FLU A or the test FLU B position of the Test Strip. An internal control line helps determine whether adequate flow has occurred through the Test Strip during a test run. A visible pink-red line at the Control position of the Test Strip should be present each time a specimen or control is tested. If no pink-red control line is seen, the test is considered invalid.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: TRU FLU (Rapid, qualitative lateral-flow immunoassay for the detection of Influenza A and B antigens)

Indications for Use: Rapid, qualitative, lateral-flow immunochromatographic assay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples from symptomatic patients. Not intended for detection of influenza C viruses. Negative results are presumptive and should be confirmed by cell culture; they should not be the sole basis for treatment or clinical management.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "Sensitivity must be >= 90%"). However, based on the performance evaluation and the 510(k) clearance, the implied acceptance criteria are that the device demonstrates substantial equivalence to the reference method (tissue culture) and the predicate device (Binax NOW Influenza A&B) in terms of sensitivity and specificity for both Influenza A and B across different sample types and patient demographics.

Here's the summarized reported device performance against the "Gold Standard" (Tissue Culture):

(Note: "N/A" in the table above for 95% CI when only 1 positive sample existed implies the CI was not calculable or meaningful for such a small n, which is a limitation of some individual site data, not the overall study.)

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Total Samples: 697 prospectively collected fresh samples + 63 frozen samples = 760 samples (after excluding 1 invalid tissue culture result from the 697 prospective samples for sensitivity/specificity calculations).
  • Fresh Samples: 697 samples (366 wash/aspirate, 320 swab, 11 not defined).
  • Frozen Samples: 63 samples (all wash/aspirate).
• Data Provenance:
  • Country of Origin: United States. The study states "Nine independent laboratories (in different geographic regions of the US) and the manufacturer participated in the study."
  • Retrospective or Prospective: Primarily prospective. "The test plan was designed to evaluate the performance of prospectively collected fresh and frozen samples from the 2006-7 season." The document also mentions "prospectively collected fresh and 63 frozen samples were tested." Tissue culture on frozen samples was performed at the time of collection.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified. The ground truth (tissue culture) was performed at "each laboratory's established internal method." It does not explicitly state that experts established a consensus ground truth for the device evaluation; rather, a standard laboratory method was employed.
• Qualifications of Experts: Not specified. It's assumed that standard certified laboratory personnel performed the tissue culture, but specific qualifications (e.g., "clinical microbiologist with X years of experience") are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (like 2+1 or 3+1) for resolving discrepancies between the TRU FLU results and the tissue culture results. The tissue culture results appear to have been used directly as the reference standard without further expert adjudication mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of the TRU FLU device against a gold standard (tissue culture) and compares it to a predicate device, not on assessing human reader improvement with or without AI assistance. The device in question is a rapid diagnostic test, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

Yes, a standalone study was performed. The entire clinical performance evaluation section describes the algorithm's (TRU FLU device's) performance without human intervention, specifically comparing its results against the tissue culture gold standard. The device requires no instruments and is read directly by a user. The sensitivity and specificity values reported are representative of the device's standalone performance.

7. Type of Ground Truth Used

The type of ground truth used was tissue culture isolation. The document explicitly states: "Tissue culture isolation remains the gold standard for the detection of influenza, yet the procedure can take 7 days to complete". It further confirms: "Trial sites were instructed to test samples in parallel by tissue culture (standard reference), TRU FLU and the predicate device, NOW Influenza A&B. Tissue culture (reference method) was performed by the site using the site's method."

8. Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its sample size. This is common for traditional in-vitro diagnostic devices (like lateral-flow immunoassays) where the "training" analogous to machine learning models is typically the biochemical assay design and optimization, followed by verification and validation, rather than a distinct data-driven training phase on labeled data. The study described focuses on clinical validation of the final device.

9. How Ground Truth for the Training Set Was Established

As no separate "training set" is mentioned (see point 8), the document does not describe how ground truth for such a set was established. The clinical evaluation sets (fresh and frozen samples) used tissue culture as the ground truth, as detailed in point 7.

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