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The "Wiener lab. Bilirrubina directa AA" test system is a quantitative in vitro diagnostic device intended to be used in the determination of direct bilirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver. hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

Direct bilirubin is measured using a stable dichlorophenyldiazonium salt (DPD) to form a red azocompound in an acid solution, with maximal O.D. at 546 nm. The amount of direct bilirubin is determined by measuring the absorbance of this pigment.

The provided text describes a 510(k) summary for the "WIENER LAB. BILIRRUBINA DIRECTA AA" test system, which is a quantitative in vitro diagnostic device for determining direct bilirubin in human sera and heparinized plasmas. The summary claims substantial equivalence to a predicate device, the DMA Direct Bilirubin Plus test system.

The document does not describe an acceptance criteria study in the way one would typically find for a medical device that uses algorithms or AI. This is a traditional in vitro diagnostic device (IVD) based on chemical reactions and spectrophotometric measurements, not an AI/ML powered device. Therefore, many of the requested categories in the prompt are not applicable.

However, I can extract the performance characteristics that serve as the "acceptance criteria" for chemical assays, by comparing them to a predicate device for demonstrating substantial equivalence. The "study" proving the device meets these criteria is an internal validation performed by Wiener Laboratorios S.A.I.C. for submission to the FDA.

Here is the information based on the provided text, with explanations for non-applicable categories:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by claiming substantial equivalence to the predicate device (DMA Direct Bilirubin Plus test system). The "reported device performance" are the values for the Wiener Lab. system.

Note on Differences: While the predicate device had a stated "Within-run precision (Normal Level Serum)" of CV=<1%, the Wiener Lab device reported 4.03%. Similarly, the predicate's "Total-run precision (Normal Serum Control)" was 8.8% while Wiener Lab reported 5.09%. For "High Level Serum" and "Abnormal Serum Control", the Wiener Lab device shows better precision. The FDA found these differences acceptable for substantial equivalence.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for the precision studies (within-run and total-run). It only provides the coefficient of variation (CV) results. The data provenance is internal validation conducted by Wiener Laboratorios S.A.I.C., an Argentinian company. The studies are implicitly prospective as they were performed to validate the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is an in vitro diagnostic (IVD) chemical assay, not an imaging or diagnostic AI device requiring expert interpretation for ground truth. The "ground truth" for this type of device is the actual concentration of bilirubin in a sample, typically determined by reference methods or validated controls, not by expert consensus.

4. Adjudication method for the test set

Not applicable. See point 3.

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 IVD chemical assay, not a device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, in a sense. The performance metrics (linearity, precision, etc.) are inherent to the chemical reagents and instrument's ability, independent of human interpretation of the results for the measurement itself. The "standalone" performance here refers to the analytical performance of the assay.

7. The type of ground truth used

For chemical assays like this, the ground truth is established by:

• Known concentrations: Using reference materials or calibrators with accurately determined bilirubin concentrations.
• Comparison to reference methods: Comparing results to a gold standard laboratory method if available.
• Quality control materials: Using commercial quality control sera with established target values.

The document does not explicitly state the specific methods used for ground truth determination, but these are standard practices for IVDs.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The performance is based on the chemical formulation and instrumentation.

9. How the ground truth for the training set was established

Not applicable. See point 8.

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