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510(k) Data Aggregation
(72 days)
WIENER LAB COLINESTERASA AA
The WIENER LAB. Colinesterasa AA test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens, on both manual and automated systems. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).
Kinetic Method. The principle is based on the following reaction system: Cholinesterase Butyrylthiocholine + H2O -> Thiocholine + Butyrate Thiocholine + DTNB -> 2-Nitro-5-Mercapto-benzoate The cholinesterase activity is determined by measuring the rate of absorbance change at 405 nm. DTNB: 5,5'-Dithiobis-2-Nitrobenzoic Acid. ChE: serum or plasma cholinesterase.
Here's a breakdown of the acceptance criteria and study information for the "Wiener lab. Colinesterasa AA" device, based on the provided text:
Device: Wiener lab. Colinesterasa AA (Cholinesterase test system)
Predicate Device: SIGMA DIAGNOSTICS Cholinesterase (BTC) (Cat. 421-10)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as separate targets, but rather are implied by direct comparison to the predicate device. The study's goal was to demonstrate "substantial equivalence" to the predicate, meaning the performance of the Wiener lab. Colinesterasa AA device should be comparable to or better than the SIGMA DIAGNOSTICS Cholinesterase (BTC) system.
| Performance Characteristic | Acceptance Criteria (Implied - comparable to predicate) | Reported Device Performance (Wiener lab. Colinesterasa AA) | Predicate Device Performance (SIGMA DIAGNOSTICS Cholinesterase (BTC)) |
|---|---|---|---|
| Intended Use | Quantitative, kinetic determination of cholinesterase activity in serum/plasma | Quantitative in vitro diagnostic for cholinesterase in human specimens (manual & automated) | Quantitative, kinetic determination of cholinesterase activity in serum |
| Test Principle | Kinetic method, absorbance change at 405 nm | Kinetic method, absorbance change at 405 nm | Kinetic method, absorbance change at 405 nm |
| Wavelength of Reading | 405 nm | 405 nm | 405 nm |
| Linearity | Comparable to 13000 U/l or better | 17000 U/l | 13000 U/l for a Sample/Reagent Ratio 1:300 |
| Within-run precision (Normal Level Serum) | Comparable to 2.0% CV or better | CV = 1.41% | CV = 2.0% |
| Within-run precision (High Level Serum) | Comparable to 1.8% CV or better | CV = 0.97% | CV = 1.8% |
| Total precision (Normal Level Serum) | Comparable to 4.2% CV or better | CV = 2.00% | CV = 4.2% |
| Total precision (High Level Serum) | Comparable to 2.6% CV or better | CV = 1.97% | CV = 2.6% |
| Expected Values | Provide relevant reference ranges | Children, men & women >40: 5500-13400 U/l (37°C); Women 16-39 (non-pregnant, non-OC): 4400-11700 U/l (37°C); Women 18-41 (pregnant or OC): 3800-9500 U/l (37°C) | 3200-7700 U/l at 30°C |
Note on Acceptance Criteria: The document explicitly states the objective is to demonstrate "substantial equivalence" to the predicate device. Therefore, the "acceptance criteria" are implied to be achieving comparable or improved performance across the listed metrics. The reported device performance generally demonstrates better performance (e.g., higher linearity, lower CVs for precision) than the predicate device, which supports the claim of substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size for the test set used to generate the reported performance data (linearity, precision, expected values).
The data provenance is not explicitly stated. However, given that "Wiener Laboratorios S.A.I.C." is located in Rosario, Argentina, it is reasonable to infer that the studies were likely conducted in Argentina or involved samples from that region. The study type (retrospective or prospective) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of in vitro diagnostic device for chemical analysis. Ground truth for enzyme activity measurements is established through the analytical performance of the device (e.g., linearity, precision, accuracy against known standards or validated methods), not through expert consensus on qualitative interpretation. The "ground truth" here is the actual cholinesterase activity in the samples, measured by the device and compared for consistency and accuracy.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used for qualitative or interpretive assessments (e.g., diagnostic imaging, pathology slides) where there might be inter-reader variability. This is not applicable to the quantitative measurement of an enzyme activity by an in vitro diagnostic device.
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
This is not applicable. The device is an in vitro diagnostic for quantitative chemical analysis, not an AI-powered diagnostic imaging or qualitative assessment tool that involves human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable in the context of an "algorithm only" device as typically understood for AI or image analysis. The "Wiener lab. Colinesterasa AA" system is a chemical reagent-based assay. Its performance is inherent to the chemical reactions and subsequent spectrophotometric measurement, whether operated manually or on an automated system. Its operation is analogous to a standalone diagnostic test in that the result is directly generated by the system, requiring human intervention primarily for sample handling, instrument setup, and interpretation of the numerical result against reference ranges.
7. The Type of Ground Truth Used
The ground truth used for performance validation (linearity, precision, expected values) would typically be:
- For Linearity: Known concentrations of cholinesterase, or samples whose concentrations have been established by a gold-standard reference method.
- For Precision: Repeated measurements on control materials or patient samples where consistent readings are expected.
- For Expected Values: Data collected from a statistically significant healthy population (reference ranges) as well as patient populations with known cholinesterase inhibition disorders. The provided "Expected values" table serves as a reference range established through clinical studies.
8. The Sample Size for the Training Set
This is not applicable as the device is a chemical reagent-based analytical system, not a machine learning model that requires a "training set" in the conventional sense. The "training" for such a system involves formulation optimization and calibration, which doesn't typically involve a "training set" of patient data as understood in AI/ML.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
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