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The Sigma Diagnostics INFINITY™ BUN Reagent is intended for the in vitro quantitative, diagnostic determination of Urea (or Urea Nitrogen) in human serum, plasma or urine on both automated and manual systems.

The Sigma Diagnostics INFINITY™ BUN Reagent is a device intended to measure urea nitrogen (an end product of nitrogen metabolism) in serum, plasma or urine. Measurements obtained by the device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Sigma Diagnostics INFINITY™ BUN Reagent is intended for the in vitro quantitative, diagnostic determination of Urea (or Urea Nitrogen) in human serum, plasma or urine on both automated and manual systems.

The enzyme methodology employed in this reagent is based on the reaction first described by Talke and Schubert. To shorten and simplify the assay, the calculations are based on the discovery of Tiffany, et al. that urea concentration is proportional to absorbance change over a fixed time interval.

The series of reactions involved in the assay system is as follows:

1. Urea is hydrolyzed in the presence of water and urease to produce ammonia and carbon dioxide.
   Urea + H2O _ Urease _ 2NH3 + CO2
2. In the presence of glutamate dehydrogenase (GLDH) and reduced nicotinamide adenine dinucleotide (NADH), the ammonia combines with a-ketoglutarate (a-KG) to produce L-glutamate.
   NH3 + a-KG + NADH __ GLDH ___ L-Glutamate + NAD

INFINITY BUN reagent has the convenience of being a single vial reagent and also incorporates a patented dynamic stabilization process which regenerates NADH from NAD (oxidized NADH), thereby increasing the shelf life of the reagent.

The provided text describes a 510(k) summary for the INFINITY™ BUN Reagent, an in vitro diagnostic device. The primary goal of this submission is to demonstrate substantial equivalence to a predicate device, not to establish new acceptance criteria or perform a de novo study the way an AI/ML product might. Therefore, many of the requested categories (like MRMC study, sample sizes for training/test sets, expert qualifications for ground truth, and adjudication methods) are not applicable or not explicitly detailed in this type of submission for a chemical reagent.

Here's a breakdown of the information provided in relation to your request, with an emphasis on what is present and what is absent:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are primarily based on demonstrating substantial equivalence to a previously cleared predicate device. This is typically shown through correlation studies.

Study Information

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Sample Size (Test Set): N=126 plasma samples were used for the correlation study.
   • Data Provenance: Not specified (e.g., country of origin). The nature of the samples (plasma) suggests they are biological samples, likely collected for clinical testing, though whether they were retrospective or prospectively collected is not stated.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • Not Applicable: For a chemical reagent, "ground truth" is typically established by the reference method or the predicate device's measurement. There are no "experts" in the sense of human interpretation like radiologists for this type of device. The ground truth for the correlation study would be the results obtained by the predicate device (Sigma Diagnostics BUN Reagent, Procedure No. 67).

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Not Applicable: Adjudication methods are relevant for subjective interpretations (e.g., image analysis by multiple readers). For a quantitative chemical assay, the comparison is directly between the numerical results of the new device and the predicate device, not an adjudicated interpretation.

4. 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 (IVD) reagent, not an AI/ML device that assists human readers. Therefore, an MRMC study is not relevant.

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

   • This refers to an "algorithm only" performance. For this IVD reagent, the performance is standalone in the sense that the device itself performs the measurement. There isn't an "algorithm" in the modern AI sense, but rather a chemical reaction and spectrophotometric reading that yields a quantitative result. The correlation study directly assesses this standalone performance against a predicate.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Ground Truth Type: The "ground truth" for the correlation study was the quantitative measurement obtained from the predicate device (Sigma Diagnostics BUN Reagent, Procedure No. 67). This is a direct comparative measurement rather than an expert consensus or pathology result.

7. The sample size for the training set

   • Not Applicable / Not Provided: This is a chemical reagent, not an AI/ML model that requires "training data." The device's performance is inherent in its chemical formulation and reaction kinetics.

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

   • Not Applicable / Not Provided: As there is no "training set" for this type of device, this question is not relevant.

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