(48 days)
The Wiener lab. Uricostat enzimático AA Líquida. test system is a quantitative in vitro diagnostic device intended to be used in the determination of uric acid in human sera and heparinized plasmas on both manual and automated systems. Measurements of serum uric acid, are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients under treatment with cytotoxic drugs.
End point method. The principle is based on the following reaction system: UOD Uric Acid + 2 H2O + O2- -> Allantoin + H2O2 + CO2 POD 2 H2O2 + 4-AP + 3,5-SDH ------------------------------------------------------------------------------------------------------------------------------------------------------ The amount of uric acid is determined by measuring the absorbance of this pigment. UOD: Uricase; POD: Peroxidase; 4-AP: 4-Aminophenazone; 3,5-DHS: 3,5-dichlorohydroxybenzenesulfonic acid, sodium salt.
The provided document describes the Wiener lab. Uricostat enzimático AA Líquida, an in vitro diagnostic device for determining uric acid levels. The document primarily focuses on establishing substantial equivalence to a predicate device rather than providing a detailed study demonstrating device performance in the context of clinical acceptance criteria typical for AI/ML-based medical devices.
Therefore, the requested information elements related to AI/ML device testing (such as ground truth, expert adjudication, MRMC studies, training set details) are not applicable or available in this document. The information provided outlines the analytical performance of the device.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document serves as a 510(k) summary, which establishes substantial equivalence to a predicate device. The performance claims are primarily based on equivalence to the predicate and analytical performance. Explicit "acceptance criteria" for clinical utility in the context of a new AI/ML device are not stated, but rather, performance metrics compared to the predicate device are presented.
| Acceptance Criteria (Implied for Analytical Performance) | Reported Device Performance (Uricostat enzimático AA Líquida) |
|---|---|
| Intended Use | Enzymatic method for the determination of uric acid in serum or plasma. |
| Test Principle | End point method using Uricase and Peroxidase reactions, measuring absorbance of red quinonimine. |
| Reagents | Standard: uric acid. |
| Reagent 1: Good buffer - DHS. | |
| Reagent 2: Good buffer. Reagents can be used separately or as Monoreagent (4 parts Reagent 1 + 1 part Reagent 2). | |
| Preparation of Working Reagent | Reagents may be used separately or as Monoreagent, mixing 4 parts of Reagent 1 + 1 part of Reagent 2. (Predicate required dissolution of an enzyme vial in a buffer bottle). |
| Stability of Final Color | (Not specified for new device, predicate was 30 minutes. Implied similar or better.) |
| Wavelength of Reading | 505 nm in spectrophotometer or 490-530 nm in photocolorimeter with green filter. |
| Calibration | Single point. |
| Linearity | 20 mg/dl (This value represents the upper limit of linearity). |
| Within-run precision (CV) | Normal Level Serum: CV = 2.21% |
| High Level Serum: CV = 1.32% | |
| Run-to-run precision (CV) | Normal Level Serum: CV = 2.86% |
| High Level Serum: CV = 1.90% |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the precision and linearity studies, nor does it provide details on the provenance of the samples (e.g., country of origin, retrospective or prospective). This information is typically found in detailed validation reports, not in a 510(k) summary focused on substantial equivalence.
3. 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. This device is a quantitative in vitro diagnostic test for measuring uric acid, not an AI/ML device requiring expert interpretation of complex data for ground truth establishment. Its performance is evaluated against reference methods or established analytical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device requiring human adjudication of ground truth.
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 device is an analytical test that measures a biochemical parameter, not a system that assists human readers in interpreting images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the inherent performance of the Uricostat enzimático AA Líquida test system itself. The precision and linearity data represent the standalone analytical performance of the device without human intervention in the result generation (though human operators would perform the assay).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an in vitro diagnostic device like this, "ground truth" would typically refer to:
- Reference materials: Control sera with known concentrations of uric acid.
- Reference methods: Comparison with a gold standard analytical method for uric acid measurement.
- Known concentrations: Spiking samples with known amounts of uric acid for linearity studies.
The document implicitly uses these types of "ground truth" for its analytical performance claims (e.g., "Normal Control," "Abnormal Control," "Normal Level Serum," "High Level Serum" for precision, and implied known concentrations for linearity).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set in that context. The development of the reagents and assay would have involved optimization, but not "training data" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
§ 862.1775 Uric acid test system.
(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.