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OPUS Ethanol is an in vitro diagnostic thin film-based, fluorescence inhibition test for the quantitative measurement of ethanol in human serum or plasma as an aid in the diagnosis and treatment of alcohol intoxication and poisoning. OPUS Ethanol is intended for use with the OPUS analyzers.

OPUS Ethanol is a set of in vitro diagnostic reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ethanol in human serum or plasma. Assay range is 10-300 mg/dl.

Kanzoll Behring Diagnostics Inc. OPUS® Ethanol 510(k) Notification

Here's an analysis of the provided Kanzoll document, focusing on acceptance criteria and the study proving the device meets them:

Missing Information Disclaimer:

It's important to note that the provided document is a 510(k) summary, which often provides a high-level overview. Consequently, some details typically found in a full study report (like acceptance criteria for precision and accuracy, detailed ground truth establishment for training, or explicit statements about standalone performance and MRMC studies) may not be explicitly stated or fully detailed. In such cases, I will infer based on common medical device submission practices or mark as "Not explicitly stated."

1. Table of Acceptance Criteria and Reported Device Performance

Note: Acceptance criteria for precision and accuracy are not explicitly stated in the provided summary. The reported performance is presented as the study result.

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

• Sample Size for Precision:
  • Intra-assay: 3 levels of control material, 20 replicates each. (Total 60 measurements)
  • Inter-assay: 3 levels of control material, duplicate measurements over 5 days. (Total 30 measurements)
• Sample Size for Accuracy (Recovery): 4 dilutions of an elevated patient sample, assayed in duplicate. (Total 8 measurements)
• Sample Size for Accuracy (Correlation): 50 serum samples.
• Data Provenance: Not explicitly stated (e.g., specific country, demographic details). "Normal human serum poor" and "elevated Bone AP patient sample" are mentioned, suggesting human biological samples. The study appears to be retrospective as it's testing pre-existing samples or control materials.

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

• Not Applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement of ethanol. The "ground truth" for such devices is typically established through analytical methods with known concentrations (e.g., spiked samples, reference materials, or a legally marketed predicate device). It does not involve expert readers establishing ground truth as in imaging or diagnostic pathology AI.
• The "ground truth" for the correlation study was established by comparing to a "commercially available immunoassay" (the Abbott TDx/TDxFLx REA Ethanol assay, as implied by the substantial equivalence claim).

4. Adjudication Method for the Test Set

• Not Applicable. As an IVD device measuring a chemical analyte, expert adjudication methods (like 2+1 or 3+1) are not relevant here. The comparison is against established analytical methods/predicate devices.

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

• Not Applicable.
  • The OPUS Ethanol device is a laboratory instrument/reagent system for quantitative measurement. It does not involve human "readers" interpreting images or clinical data in the same way an AI-powered diagnostic imaging tool would. Therefore, an MRMC study is not relevant to its evaluation.
  • The study focuses on the analytical performance characteristics of the device itself (precision, accuracy) when processing samples.

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

• Yes, this is a standalone study.
  • The performance characteristics (precision, recovery, correlation) reported are for the OPUS Ethanol system operating independently. There is no mention of human-in-the-loop assistance influencing the reported measurements. The device provides a quantitative measurement directly.

7. The Type of Ground Truth Used

• For Precision: Based on control materials with established (or internally validated) target ethanol concentrations.
• For Accuracy (Recovery): Created by dilutions of an elevated patient sample into a normal human serum pool. This implies a known expected concentration after dilution.
• For Accuracy (Correlation): Measurements from a legally marketed predicate device, the Abbott TDx/TDxFLx REA Ethanol assay. This is a common method for IVD studies to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable / Not explicitly stated for 'training'.
  • The OPUS Ethanol device is an immunoassay system, not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. It relies on chemical reactions and optical detection, not a learned model from a dataset.
  • Therefore, the concept of a training set as understood in AI/ML is not relevant here. The manufacturing and calibration process of the reagents and instrument would be analogous to "training" in a broad sense, but not with a separate data set as described for AI.

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

• Not Applicable. (See explanation in point 8).
  • The "ground truth" for the calibration of the instrument would be established through a six-level calibrator system (as mentioned in point 6, comparing it to the predicate). These calibrators are solutions with precisely known concentrations of ethanol, used to create a standard curve.

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