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The IMMULITE® 2000 Digoxin assay is for in vitro diagnostic use with the IMMULITE® 2000 Analyzer -- for the quantitative measurement of digoxin in serum or heparinized plasma, as an aid in monitoring the therapeutic administration of this cardioglycoside, while avoiding toxicity.

IMMULITE® 2000 Digoxin is a solid phase, chemiluminescent enzyme-labeled competitive immunoassay for use with the IMMULITE® 2000 Automated Analyzer. The solid phase is a polystyrene bead coated with a monoclonal murine anti-digoxin antibody. The patient sample and alkaline phosphatase-conjugated digoxin are simultaneously introduced into the Reaction Tube containing the bead, and incubated for approximately 30 minutes at 37 degrees C with intermittent agitation. During this time, digoxin in the sample competes with the enzyme-fairched digoxin for a limited number of antibody binding sites on the bead. Unbound enzyme conjugate is then removed by a centrifugal wash, after which substrate is added and the Reaction Tube is incubated for a further 5 minutes. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is inversely proportional to the concentration of digoxin in the sample.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in terms of predefined thresholds for performance metrics. Instead, it demonstrates performance equivalence to a predicate device. The performance is presented as a method comparison, and the acceptance is implied by the FDA's granting of substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 97 samples
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a common omission in older 510(k) summaries for in-vitro diagnostics where the focus is on analytical performance, not clinical data from specific populations. It's safe to assume the samples were collected specifically for this method comparison study.

3. Number of Experts and Qualifications for Ground Truth

This type of study (method comparison for an in-vitro diagnostic device) does not typically involve human experts establishing ground truth in the way an imaging algorithm might. The "ground truth" for this test set is the measurement provided by the established, commercially available predicate device (IMMULITE® Digoxin).

4. Adjudication Method for the Test Set

Not applicable. As described above, this is a direct comparison to a reference method, not an expert-based adjudication process.

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

No, an MRMC comparative effectiveness study was not done. This device is an automated in-vitro diagnostic assay, not an imaging or diagnostic aid that involves human readers.

6. Standalone Performance Study

Yes, a standalone study was performed. The "Method Comparison" section directly evaluates the IMMULITE® 2000 Digoxin's performance against a predicate device using analytical samples. This is an assessment of the algorithm/device itself without human-in-the-loop interaction for interpretation.

7. Type of Ground Truth Used

The ground truth used was the results from a legally marketed predicate device (IMMULITE® Digoxin). This is a common and accepted method for demonstrating substantial equivalence for new in-vitro diagnostic devices.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or its size. For this type of competitive immunoassay, training would typically refer to the internal development and calibration of the assay. The 97 samples mentioned are for the method comparison (often considered a validation or test set), not an explicitly stated training set for an AI/algorithm.

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

Not applicable/not explicitly stated as a distinct "training set" with established ground truth in the same way an AI model would have. The "training" in the context of an immunoassay development involves optimizing reagent concentrations, reaction conditions, and calibration procedures to achieve desired analytical performance characteristics. The "ground truth" for calibration would be provided by purified digoxin standards of known concentrations.

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