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This in vitro diagnostic method is intended to quantitatively measure deoxypyridinoline (DPD) in human urine on the Bayer Immuno 1™ system. Measurements obtained by this device are used as an indicator of bone resorption. Results obtained using the Bayer Immuno 1 system Deoxypyridinoline method are generally expressed as a ratio to urine creatinine (nM DPD/mM creatinine), and should be interpreted in conjunction with all other available clinical and diagnostic results. The urine creatinine result (mmol/L) must be entered from an off-system standard laboratory analysis.

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

The IMMUNO 1 DPD assay is a heterogeneous competitive immunoassay format.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Method Comparison: 341 human urine samples.
• Sample Size for Imprecision: 3 controls, assayed in duplicate for 20 runs (40 assays total).
• Sample Size for Recovery: 11 urine samples.
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It refers to "human urine samples," which could imply prospective collection for validation, but this is not confirmed.

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

The document does not describe the use of experts to establish ground truth for the test set. Instead, the "ground truth" for method comparison and recovery studies is based on quantitative analytical results from the predicate device (Pyrilinks®-D method) or known spiked concentrations.

4. Adjudication Method for the Test Set

Not applicable. This device validation focuses on analytical performance characteristics (sensitivity, imprecision, correlation with a predicate device, recovery) rather than subjective assessments requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or interpretation device. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are essentially standalone performance evaluations of the IMMUNO 1 DPD assay. The reported metrics (sensitivity, imprecision, method comparison, and recovery) are specific to the device's analytical capabilities without human interpretative input beyond operating the system and entering creatinine results.

7. The Type of Ground Truth Used

• For Method Comparison: The "ground truth" was the quantitative results obtained from the predicate device, Pyrilinks®-D method. This is a comparative study of two analytical methods.
• For Recovery: The "ground truth" was the known concentration of DPD spiked into urine samples.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a traditional in vitro diagnostic device, not an AI/ML-based system. Therefore, the concept of a training set as understood in AI development is not applicable here.

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

Not applicable, as there is no mention of a training set for an AI/ML model for this traditional in vitro diagnostic device.

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