(60 days)
The "Wiener lab. Amilasa 405 cinética" test system is a quantitative in vitro diagnostic device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas)
Kinetic method. The principle is based on the following reaction system: alpha amylase 10 CNPG 3 -> 9 CNP + 1 CNPG 2 + G 3 + G CNPG 3 (2-Chloro-4-Nitrophenyl-alpha-D-Maltotrioside) CNP can be detected spectrophotometrically at 405 nm.
The provided text does not contain detailed acceptance criteria for the "Wiener Lab. Amilasa 405 Cinética" test system. It presents performance characteristics of the Wiener Lab. system and compares them to two predicate devices (GENZYME DIRECT AMYLASE and TRACE AMYLASE DST).
However, I can extract the reported performance characteristics of the Wiener Lab. device that would typically be part of acceptance criteria for such a device, and detail the lack of information regarding the study design and acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Not explicitly stated, but typical for medical devices) | Reported Wiener Lab. AMILASA 405 CINETICA Performance |
|---|---|---|
| Intended Use | Quantitative determination of amylase in human sera, plasma, and urine for diagnosis and treatment of pancreatitis. | Quantitative determination of amylase in human sera, plasma, and urine for diagnosis and treatment of pancreatitis. |
| Test Principle | Kinetic method based on specific enzymatic reaction and spectrophotometric detection at 405 nm. | Kinetic method using CNPG3 substrate, detected spectrophotometrically at 405 nm. |
| Reagent Stability | Unopened: Stable until expiration date at 2-8°C. Prepared: Stable for specified duration at given temperature. | Unopened: Stable until expiration date at 2-8°C. Prepared: 15 days at room temperature or 60 days at 2-10°C. |
| Working Temperature Range | Defined operating temperature(s). | 25 - 37°C |
| Wavelength of Reading | 405 nm | 405 nm |
| Linearity | Defined range where results are proportional to concentration. | 1000 U/l |
| Minimum Detection Limit | Lowest concentration detectable with reasonable analytical precision. | 4.7 U/l (real) |
| Expected Values (Serum) | Reference range for healthy individuals. | Until 125 U/l (at 37°C) |
| Expected Values (Urine) | Reference range for healthy individuals. | Until 680 U/l (Random urine) |
| Intra-assay Precision (Normal Control) | Acceptable Coefficient of Variation (CV). | CV = 3.48 % |
| Intra-assay Precision (Abnormal Control) | Acceptable Coefficient of Variation (CV). | CV = 1.51 % |
| Inter-assay Precision (Normal Control) | Acceptable Coefficient of Variation (CV). | CV = 5.53 % |
| Inter-assay Precision (Abnormal Control) | Acceptable Coefficient of Variation (CV). | CV = 1.95 % |
Note: The document states "The following table illustrates the similarities and differences" when comparing the new device to predicate devices. It presents characteristics and their values for both devices, implying these are the performance metrics assessed for substantial equivalence. However, explicit numerical acceptance criteria (e.g., "Linearity must be >= 1000 U/l") are not provided, nor is a direct statement like "The device meets the following acceptance criteria: ...". The "reported device performance" in the table above is the "WIENER LAB. Test System" column from the provided tables.
2. Sample size used for the test set and the data provenance
The document does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information about experts used for ground truth or their qualifications. The device is an in vitro diagnostic (IVD) test, where ground truth is typically established through reference methods or clinical diagnosis, not expert image interpretation.
4. Adjudication method for the test set
The document does not provide any information about an adjudication method for a test set. This concept is usually relevant for studies involving human interpretation (e.g., radiology reads), which is not the primary focus for an IVD kit's performance evaluation as described here.
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 section is not applicable as the document describes an in vitro diagnostic test for amylase activity, not an AI-assisted diagnostic tool that involves human readers interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document describes the performance of the device itself as a standalone diagnostic test. It does not refer to an "algorithm" in the context of AI, but rather the chemical reagents and kinetic method. The performance characteristics listed (precision, linearity, detection limit, expected values) are indeed standalone performance metrics for this IVD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used to evaluate the device's performance characteristics. For an amylase assay, ground truth during development and validation would typically involve:
- Reference methods: Comparing results to established, highly accurate (though often more complex or expensive) amylase measurement methods.
- Known concentration samples: Using samples with accurately determined amylase concentrations (e.g., spiked samples, commutable reference materials).
- Clinically characterized samples: Samples from patients with confirmed pancreatitis or healthy individuals, where the clinical diagnosis serves as the 'truth' regarding the expected range or elevated levels.
8. The sample size for the training set
The document does not provide any information about a "training set." This term is typically used in machine learning or AI development. For an IVD device like this, the equivalent would be the samples used during the development and optimization phases. No sample sizes for these phases are reported.
9. How the ground truth for the training set was established
As there is no mention of a training set, there is no information on how its ground truth was established.
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.