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The TRU LEGIONELLA® assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of Legionella serogroup 1 infection. A negative result does not preclude infection with Legionella pneumophila serogroup 1. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.

The TRU LEGIONELLA® assay is an in vitro, rapid, lateral-flow immunoassay.

This is a letter acknowledging the receipt of a 510(k) premarket notification for a medical device called "Legionella. Spp., Elisa." While it indicates that the device has been found substantially equivalent to a predicate device, this document does not contain the detailed study information, acceptance criteria, or performance data that you requested.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the FDA has evaluated the submission and deemed the device safe and effective for its stated indications based on comparisons to a legally marketed predicate. However, the supporting data and studies are part of the original 510(k) submission and are not publicly detailed in this acknowledgment letter.

Therefore, I cannot extract the requested information from the provided text. To obtain that level of detail, you would typically need to review the actual 510(k) summary and supporting documentation submitted by Meridian Bioscience, Inc. to the FDA, which is usually found in a separate, more comprehensive public document associated with the 510(k) number (K163273).

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The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. It is designed to test specimens from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of Legionella pneumophila serogroup 1 infection. A negative result does not preclude infection with Legionella pneumophila serogroup 1. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.

The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. The assay consists of Test Strips containing anti-Legionella pneumophila serogroup 1 as the capture antibody, Containing anti-Legionella pneumophila serogroup 1 as the detection antibody, Sample Diluent/Negative Control, and Positive Control.

The provided text describes the performance of the TRU Legionella assay, an in vitro rapid lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. The study aims to demonstrate substantial equivalence to a predicate device, the BinaxNOW® Legionella Urinary Antigen test.

Here's an analysis based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages for positive or negative agreement. Instead, it presents the performance of the TRU Legionella assay in comparison to the predicate device, the BinaxNOW® Legionella test, and demonstrates high correlation. The overall performance metrics serve as the reported device performance.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 428 qualified patient samples.
• Data Provenance:
  • Country of Origin: Southeastern regions of the United States and the Netherlands.
  • Retrospective/Prospective: The US clinical trial sites evaluated both retrospective frozen samples and prospectively collected samples. The retrospective samples were those previously submitted for Legionella testing. The site in the Netherlands evaluated 220 frozen samples from a well-characterized repository.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the clinical study was established by comparison to the Binax NOW® Legionella Urinary Antigen test (predicate device). The document does not describe the use of independent experts to establish ground truth for this comparison study, as it's a comparative effectiveness study against a legally marketed device. The predicate device itself serves as the reference standard for "truth" in this context.

For the samples from the Netherlands, they were "chosen from a well characterized repository of urine samples collected from patients with confirmed Legionnaires Disease as well as negative specimens from patients suspected of infection by Legionella," implying an existing clinical diagnosis. However, the exact number and qualifications of experts involved in the initial confirmation of these Legionnaires' Disease cases are not specified in this document.

4. Adjudication Method for the Test Set

Not applicable. The study is a direct comparison of the TRU Legionella assay's results against the BinaxNOW® Legionella test. There is no mention of an adjudication method involving multiple readers or experts to resolve discrepancies between the two tests. The BinaxNOW® result is treated as the reference.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed to assess human reader improvement with AI assistance. This document describes the performance of an in vitro diagnostic (IVD) rapid immunoassay, not an AI-powered diagnostic imaging or interpretation tool. The test is visually read by a single operator, and the comparison is between the new device and a predicate device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this is effectively a standalone performance study. The TRU Legionella assay is an in vitro rapid lateral-flow immunoassay designed for direct visual interpretation of results. Its performance is measured independently against the predicate device without human-in-the-loop assistance for the assay itself (beyond the visual reading as intended).

7. Type of Ground Truth Used

The primary ground truth used for the clinical performance comparison was the results from the predicate device, BinaxNOW® Legionella Urinary Antigen test. For the samples from the Netherlands, the repository samples were "from patients with confirmed Legionnaires Disease," suggesting clinical diagnosis/outcomes data for positive cases, and "negative specimens from patients suspected of infection by Legionella" for negative cases.

8. Sample Size for the Training Set

The document does not explicitly describe a separate "training set" in the context of machine learning or AI development. This is a traditional IVD device. The analytical studies (sensitivity, interference, cross-reactivity, strain reactivity) involve testing numerous laboratory-prepared specimens, but these are for analytical validation rather than AI model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is a traditional IVD device and not an AI-based system involving a training set in the machine learning sense. The analytical studies establishing limits of detection, interference, and cross-reactivity use known concentrations of L. pneumophila strains or other substances, which are internally controlled ground truths established through laboratory methods.

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