(38 days)
Dimension Vista™ A1AT Flex® reagent cartridge:
The A1AT method is an in vitro diagnostic test for the quantitative determination of a - antitrypsin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of a-antitrypsin aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema.
Dimension Vista™ Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the a1antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 1 Control L. M and H
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.
Dimension Vista" A1AT Flex® reagent cartridge
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing a1antitrypsin (A1AT). C3 complement, C4 complement, immunoglobulin A (IGA). immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
Dimension Vista" Protein 1 Control L. M and H
Protein 1 Control L, M and H are multi-analyte, liguid, human serum based products containing a1-antitrypsin (A1AT), C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista" A1AT Flex® reagent cartridge:
Acceptance Criteria and Device Performance Study
The submission focuses on establishing substantial equivalence for the Dimension Vista™ A1AT Flex® reagent cartridge by comparing its performance to a legally marketed predicate device, the Dade Behring N Antisera to Human α1-Antitrypsin assay on the BN ProSpec® System. The primary method used to demonstrate this is a method comparison study.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence in this context are typically demonstrated through strong correlation and agreement between the new device and the predicate device. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient, maximum allowable bias) are not directly stated as "acceptance criteria" in the provided document, they are implied by the reported results and the conclusion of equivalence.
For the purpose of this analysis, I will infer the performance metrics from the Method Comparison Study as the "reported device performance," which implicitly met the internal or regulatory acceptance thresholds for demonstrating equivalence.
| Performance Metric | Implied Acceptance Criteria (Typically Good Correlation) | Reported Device Performance |
|---|---|---|
| Sample Size (n) | Sufficient for statistical significance | 139 |
| Slope | Close to 1.0 | 1.000 |
| Intercept (g/L) | Close to 0.0 | 0.070 |
| Correlation Coefficient (r) | Close to 1.0 (ideally > 0.97 for method comparison in analytical assays) | 0.996 |
| Concentration Range | Representative of clinical use | 0.23 g/L to 4.71 g/L (for α1-antitrypsin in human serum and plasma) |
Conclusion from document: "These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human α-Antitrypsin assay and the Dimension Vista™ A1AT assay."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 139 samples.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "evaluating serum and plasma samples." Given the nature of a 510(k) submission for an in vitro diagnostic, these samples would typically come from human subjects, either collected retrospectively or prospectively for the purpose of the study. Without further information, we cannot definitively classify the provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission for an in vitro diagnostic (IVD) assay typically relies on a "predicate device" as the gold standard or reference for comparison, rather than expert consensus on individual cases. The "ground truth" for the test set is established by the results obtained from the predicate device (Dade Behring N Antisera to Human α1-Antitrypsin assay on the BN ProSpec® System). Therefore, there were no human "experts" establishing a ground truth in the traditional sense of clinical diagnosis or interpretation for this specific method comparison.
4. Adjudication Method
As the "ground truth" or reference method is another automated IVD assay, there is no adjudication method described or necessary in the sense of resolving discrepancies between human readers or interpretations. The comparison is between two quantitative analytical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is relevant for diagnostic imaging devices or other tests that involve human interpretation and reader variability. For an automated in vitro diagnostic assay like the Dimension Vista™ A1AT Flex® reagent cartridge, the performance is assessed by analytical comparison to a predicate method, not by comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was implicitly done. The "Method Comparison Study" directly evaluates the performance of the Dimension Vista™ A1AT assay (the new device, effectively "standalone" in its measurement capability) against a predicate device. The reported slope, intercept, and correlation coefficient are standard metrics for evaluating the analytical performance of an IVD assay by itself when compared to a reference method, without human intervention in the measurement process itself.
7. Type of Ground Truth Used
The ground truth used for the comparison was the results obtained from a legally marketed predicate in vitro diagnostic assay (Dade Behring N Antisera to Human α1-Antitrypsin assay on the BN ProSpec® System). This is a common and accepted method for establishing equivalence for new IVD assays.
8. Sample Size for the Training Set
This information is not provided. The document describes a "Method Comparison Study" for the new device against a predicate. For IVD assays, there wasn't a separate "training set" in the context of machine learning, and the study doesn't mention how the assay itself (e.g., reagent formulation, instrument parameters) was developed or optimized. The 139 samples were used for the performance evaluation, not to "train" an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" or a machine learning component for this traditional IVD reagent cartridge, this question is not applicable in the context of the provided document. The assay's analytical principles are based on known immunochemical reactions, and its calibration would be established using calibrators with known concentrations (as mentioned for the Dimension Vista™ Protein 1 Calibrator), not through a "training set" and ground truth in the AI sense.
§ 866.5130
Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.(b)
Classification. Class II (performance standards).