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The ADVIA IMS® Digoxin method is for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. Measurements obtained are used as an aid in the diagnosis of digoxin overdose and in monitoring therapeutic levels of digoxin to ensure appropriate therapy.

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AI/ML Overview

The Bayer ADVIA IMS® Digoxin assay is intended for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. This product is used as an aid in diagnosing digoxin overdose and monitoring therapeutic levels of digoxin for appropriate therapy.

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. However, the study aims to demonstrate substantial equivalence to the predicate device, the Immuno 1 Digoxin Assay. Therefore, the "reported device performance" is compared directly against the predicate device's performance, implying that performance comparable to or better than the predicate is the de facto acceptance criterion.

Performance Characteristic	Acceptance Criteria (Implied: Comparable to Immuno 1)	Reported Device Performance (ADVIA IMS)	Predicate Device Performance (Immuno 1)
Imprecision (Total CV%)	Comparable to or better than Immuno 1	Level 0.75 ng/mL: 6.0%	Level 0.7 ng/mL: 8.2%
		Level 1.9 ng/mL: 5.9%	Level 2.2 ng/mL: 4.2%
		Level 3.3 ng/mL: 3.8%	Level 3.4 ng/mL: 3.6%
Correlation (vs. Immuno 1)	Strong correlation (R-value close to 1)	Regression: Y=1.017X+0.055	N/A (Immuno 1 is the comparison)
	Low Syx	Syx: 0.265 ng/mL	N/A
	R-value close to 1	R: 0.985	N/A
Interference (Bilirubin)	% Deviation within acceptable limits (likely < ±10%)	3.6%, 0.7%, 6.2%	Not specified
Interference (Triglycerides)	% Deviation within acceptable limits (likely < ±10%)	-1.7%, 0.1%, 3.0%	Not specified
Interference (Hemoglobin)	% Deviation within acceptable limits (likely < ±10%)	-4.0%, -6.9%, -3.6%	Not specified
Analytical Range	Similar to Immuno 1	0.04 - 6 ng/mL	Not explicitly stated for Immuno 1, but "Minimum Detectable Concentration" is 0.04 ng/mL
Minimum Detectable Concentration	Similar to Immuno 1	0.04 ng/mL	0.04 ng/mL

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

Correlation Study (test set):
- Sample Size: 72 serum specimens.
- Data Provenance: Not explicitly stated, but clinical specimens are typically derived from human subjects. The document does not specify country of origin or whether the data was retrospective or prospective.
Imprecision Study: The sample size isn't explicitly stated as a number of individual patient samples, but rather as "levels" (0.75, 1.9, 3.3 ng/mL). Imprecision studies typically involve multiple replicates of samples at different concentrations. The data provenance is not specified.
Interference Study: The sample size for each interferant condition is not explicitly stated. It involves spiked concentrations, implying controlled laboratory conditions rather than patient samples. Data provenance is not specified.

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

This is a submission for an in vitro diagnostic (IVD) assay, not an AI/imaging device that requires expert review for ground truth.
The "ground truth" for this type of device is established by the reference method or predicate device results. In this case, the Immuno 1 Digoxin Assay serves as the comparison system (X) for the correlation study, establishing the "ground truth" against which the ADVIA IMS device (Y) is evaluated.
No human experts are mentioned as establishing ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. This is an IVD assay, and the "ground truth" (reference measurement) does not require expert adjudication in the way an imaging study or clinical diagnosis might. The results from the Immuno 1 assay are taken as the comparative standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, particularly in imaging, where human readers interact with the AI. This submission is for an IVD assay, which is an automated chemical analysis, not an AI or imaging device involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance data presented (imprecision, correlation, interference) reflects the standalone performance of the ADVIA IMS Digoxin Assay. As an IVD assay, it operates as an "algorithm only" or automated system without human intervention in the measurement process itself, beyond sample loading and general operation.

7. The Type of Ground Truth Used

The ground truth (or more accurately, the reference method/comparison method) used for evaluating the ADVIA IMS Digoxin Assay in the correlation study was the Immuno 1 Digoxin Assay. This is a predicate device which is already legally marketed and presumed to provide accurate measurements of digoxin in human serum.
For imprecision and interference, the "ground truth" is based on the known concentrations of controls or spiked samples.

8. The Sample Size for the Training Set

This document is a 510(k) summary for an IVD assay, which is based on chemical reactions rather than machine learning or AI models that require "training sets." Therefore, the concept of a training set as understood in AI/ML is not applicable here.

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

Not applicable, as there is no "training set" in the context of an IVD assay's development described here.

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