(94 days)
Dimension Vista™ IGE Flex® reagent cartridge: The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.
Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), 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 C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.
Dimension Vista™ IGE 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 C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), 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, liquid, human serum based products containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
This submission describes the Dimension Vista™ IGE Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator, and Dimension Vista™ Protein 1 Control L, M, and H for the quantitative determination of Immunoglobulin E (IgE). The study aimed to demonstrate equivalent performance to a legally marketed predicate device.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for correlation coefficient, slope, or intercept. Instead, it implies that a strong correlation and "equivalent performance" between the new device and the predicate device would be considered acceptable. The reported performance is a regression analysis of the method comparison study.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation (r) | Strong correlation to predicate (e.g., close to 1) | 0.999 |
| Slope (m) | Close to 1 (indicating proportional agreement) | 1.041 |
| Intercept (b) | Close to 0 (indicating negligible systematic bias) | 0.151 |
Note: The document states, "These studies demonstrate correlation and equivalent performance between the Dade Behring N Latex IgE mono assay and the Dimension Vista " IGE assay." This statement, along with the high correlation coefficient, suggests the reported performance met the unstated equivalence criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 120 serum and plasma samples.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the samples were human serum and plasma. It doesn't specify if the data was retrospective or prospective, but method comparison studies are typically prospective or use banked retrospective samples to evaluate the new device against a predicate. Given the typical nature of device validation, it's likely these were distinct samples collected for the purpose of the comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of in vitro diagnostic device (IVD) for quantitative measurement does not typically rely on "expert consensus" for ground truth in the same way an imaging or diagnostic AI model would.
- Ground Truth Establishment: The "ground truth" for the test set was established by running the samples on the predicate device, the Dade Behring N Latex IgE mono assay on the BN ProSpec® System.
- Number and Qualifications of Experts: Not applicable in the context of this type of quantitative IVD comparison. The performance of the predicate device serves as the reference, which has its own established accuracy and precision validated through previous studies.
4. Adjudication Method for the Test Set
Not applicable. The comparison involves quantitative measurements from two different analytical systems, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This submission pertains to an in vitro diagnostic device for quantitative IgE measurement, which does not involve human readers interpreting cases or AI assistance in a diagnostic workflow. Therefore, an MRMC study is not relevant.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, in essence. The method comparison study directly evaluated the Dimension Vista™ IGE assay (algorithm/device only) against the predicate device. The output is a numerical value, and there is no human-in-the-loop interpretation or intervention in generating this primary result.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this comparison study was the quantitative IgE values obtained from the predicate device: the Dade Behring N Latex IgE mono assay on the BN ProSpec® System. This is a form of comparative reference measurement, where the established method (predicate) serves as the benchmark.
8. The Sample Size for the Training Set
- Sample Size for Training Set: The document does not explicitly mention a "training set" in the context of machine learning. For IVDs, the development and calibration of the assay (reagents, calibrators, controls) are typically done through extensive internal studies (which would involve numerous samples for optimization, calibration curve generation, and verification of analytical performance characteristics like linearity, precision, etc.) before the final method comparison study. The 120 samples discussed in the method comparison are best considered a validation/test set for the final, developed assay.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Since a "training set" in the machine learning sense isn't explicitly described, the concept of ground truth for training would relate to the development and calibration of the assay itself. This would involve:
- Reference materials: Using internationally recognized IgE reference materials or purified IgE standards with known concentrations for calibrating the assay and defining the optimal reagent formulation and reaction conditions.
- Known samples: Running samples with previously established IgE concentrations (e.g., from other validated methods) to confirm the assay's ability to accurately measure them.
- Analytical studies: Performing studies to establish linearity, limit of detection, precision, and other analytical performance characteristics, where "ground truth" is defined by the expected behavior of the assay with controlled samples.
The document focuses on the final validation of the Dimension Vista™ IGE assay against a predicate, rather than the developmental steps involving "training."
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).