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The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.

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Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA IMS Uric Acid method, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary directly presents performance data for the ADVIA IMS Uric Acid method and compares it to a predicate device (ADVIA 1650 Uric Acid) and/or a comparison system (CDC Uricase). While explicit "acceptance criteria" are not stated as defined thresholds (e.g., "CV must be less than X%"), the reported performance demonstrates "substantial equivalence" to the predicate, implying that these levels of performance were acceptable for clearance.

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

The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

• Imprecision Study (Serum): The "Level (mg/dL)" values suggest multiple measurements were taken at three different concentrations, but the exact number of replicates or individual samples is not provided.
• Imprecision Study (Urine): Similar to serum, the exact number of replicates or individual samples is not provided.
• Correlation Studies:
  • Serum vs. CDC Uricase: N = 117
  • Serum vs. Advia 1650: N = 100
  • Plasma (Y) vs. Serum (X) with Advia 1650: N = 54
  • Urine vs. CDC Uricase: N = 10
  • Urine vs. Advia 1650: N = 63
• Interfering Substances: The Uric Acid Conc. (mg/dL) values suggest testing at specific concentrations, but the number of samples for each interferent is not provided.

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

This information is not provided in the 510(k) summary. For in vitro diagnostic devices like this, "ground truth" is typically established by reference methods or validated comparative systems (e.g., CDC Uricase), rather than by human expert consensus or pathology review in the same way it would be for an imaging-based AI device.

4. Adjudication Method for the Test Set

This is not applicable for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI devices that assist human diagnosticians (e.g., CAD systems for radiology). The ADVIA IMS Uric Acid method is a standalone laboratory instrument for quantitative measurement, not an AI assisting human readers.

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

Yes, the studies presented are standalone performance studies of the ADVIA IMS Uric Acid method. The device measures uric acid levels automatically; there is no "human-in-the-loop" once the sample is loaded and the test initiated. The performance metrics (imprecision, correlation, interference) directly reflect the algorithm's and instrument's capabilities.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the test set was established using:

• Reference Methods: The "CDC Uricase" method is cited as a comparison system for correlation studies in both serum and urine. This is a highly accurate and standardized reference method for uric acid measurement.
• Predicate Device/Comparative System: The "Advia 1650" (the predicate device) was used as a comparison system for imprecision, correlation, and for comparing plasma vs. serum. This indicates that the performance of the new device was benchmarked against an already legally marketed and accepted method.

8. The Sample Size for the Training Set

This is not applicable in the context of this device. The ADVIA IMS Uric Acid method is an enzymatic assay based on established biochemical principles, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is characterized through analytical validation studies using patient samples and quality controls, which are the "test sets" described above.

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

As mentioned above, this is not applicable because the device does not employ machine learning or AI that would necessitate a "training set" with ground truth established through, for example, expert annotation. The device's underlying chemistry and optical detection principles are well-understood and do not require iterative training.

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