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This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol (uE¿) in human serum on the Bayer Immuno 1™ system. Measurements of uE, are used in evaluating fetal well-being by monitoring the level of the hormone derived from fetal-placental circulation.

This diagnostic method is not intended for use on any other system.

This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol in human serum on the Bayer Immuno 1 System.

Here's an analysis of the provided text regarding the Bayer Immuno 1™ Unconjugated Estriol method, focusing on acceptance criteria and study details:

Device: Bayer Immuno 1™ System Unconjugated Estriol Assay

Predicate Device: Diagnostic Products Corporation (DPC) Coat-a-Count® Free Estriol RIA method

1. Acceptance Criteria and Reported Device Performance

The document presents performance data for the Bayer Immuno 1™ uEstriol method and compares it to the predicate DPC Coat-a-Count® Free Estriol RIA method. While explicit acceptance criteria (e.g., "must be less than X," "must be greater than Y") are not formally listed as such in the provided text, the implied acceptance criteria are that the new device's performance is comparable to or better than the predicate device across various metrics, demonstrating substantial equivalence.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

*Note on Specificity: For some compounds (e.g., Estriol-3-sulfate, Estriol-3-(β-D-glucuronide), Estradiol), the Bayer Immuno 1™ shows a higher cross-reactivity percentage than the DPC method. However, without explicit acceptance limits, and given that these values are still relatively low (mostly <2%), they are likely considered acceptable in the context of substantial equivalence, particularly if they do not significantly impact the intended use or if the overall profile is favorable. The DPC method did not report 16a-Hydroxyestrone, so direct comparison is not possible for that compound.

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

• Sample Size for Method Comparison (Regression Equation): n = 249 (samples were compared between Immuno 1 uE3 Assay and DPC Coat-a-Count Free Estriol RIA).

• Sample Size for Precision (within-run & total): n = 20 samples measured over 10 days for each concentration level.

• Sample Size for Specificity (Cross-Reactants): Cross-reactants were "spiked into Normal Human Serum Pools." The number of individual samples within these pools or the number of pools tested isn't specified, but it implies a controlled experiment using pooled human serum.

• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It presents laboratory performance data. Given it's a submission to the FDA, it would typically be derived from studies conducted in a controlled lab environment, likely from a prospective study design to evaluate the new device. The phrase "Normal Human Serum Pools" suggests controlled sample procurement.

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

This document describes the performance characteristics of an in vitro diagnostic assay for measuring unconjugated estriol. For such assays, "ground truth" is typically established by:

• Reference Methods: Comparison to a legally marketed predicate device (as done here with the DPC RIA method) is a common way to establish agreement and "truth" in terms of clinical utility relative to existing methods.
• Analytical Standards: Known concentrations of analytes (e.g., purified unconjugated estriol) are used to calibrate the assay and determine its accuracy, linearity, and precision.

Therefore, the concept of "experts establishing ground truth" in the sense of clinical specialists reviewing cases (like radiologists for imaging studies) is not directly applicable here. The "ground truth" in this context is the accuracy and reliability of the measurement itself, validated against established analytical principles and a predicate device.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving subjective interpretation of data (e.g., imaging, pathology slides) by multiple human experts.

Since this is an analytical performance study for an in vitro diagnostic assay, there is no adjudication method described or relevant in this context. The comparisons are quantitative measurements between the new device and the predicate device, or between multiple runs of the same device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

MRMC studies are relevant for evaluating the impact of AI systems, particularly in diagnostic imaging or pathology, on the performance of human readers. This document describes an in vitro diagnostic assay for measuring a specific hormone level in serum, which is an automated, quantitative measurement. It does not involve human "readers" interpreting output in a comparative effectiveness setting.

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

Yes, the provided study assesses standalone performance.

The Bayer Immuno 1™ Unconjugated Estriol method is an automated in vitro diagnostic system, meaning it operates as an "algorithm only" (or rather, an automated instrument and reagent system) without human interpretation as part of its core function, other than loading samples and reviewing results. The reported precision, method comparison, and specificity data all represent the standalone analytical performance of the device.

7. The Type of Ground Truth Used

The "ground truth" for this study is established by:

• Comparison to a Legally Marketed Predicate Device: The DPC Coat-a-Count® Free Estriol RIA method served as the reference for method comparison, implying its accepted performance defines the "ground truth" for clinical utility in that context.
• Analytical Standards/Known Concentrations: For precision and specificity, the ground truth is based on known concentrations of unconjugated estriol and other compounds used in spiked samples and controls. This ensures the device accurately measures what it's supposed to measure and doesn't react significantly with other substances.

In essence, the ground truth is analytical accuracy and precision relative to established methods and known chemical standards, rather than expert consensus on a clinical outcome or pathology.

8. The Sample Size for the Training Set

This document describes a pre-market submission for a medical device (an in vitro diagnostic assay). The concept of a "training set" is primarily associated with machine learning or AI models. This device is a traditional analytical instrument system.

Therefore, there is no "training set" in the machine learning sense for this type of device. The system's "training" involves its chemical and mechanical design, calibration procedures using known standards, and validation processes described in the performance studies.

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

As noted above, the concept of a "training set" and associated "ground truth" in the machine learning context does not apply to this traditional in vitro diagnostic assay.

Instead, the device's accuracy and reliability are ensured through:

• Calibration: Using reference materials with defined, known concentrations of unconjugated estriol.
• Quality Control: Regular testing with control samples to ensure the assay is performing within expected parameters.
• Development and Validation: Extensive lab testing during the device's development to optimize its chemical reactions, optical/detection system, and software algorithms to accurately quantify unconjugated estriol. These processes inherently rely on established chemical and physiological principles and analytical standards.

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