(55 days)
Dimension Vista® IgA Flex® Reagent Cartridge: The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma by means of nephelometry on the Dimension Vista System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Dimension Vista® IGM Flex® reagent cartridge: The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma by means of nephelometry on the Dimension Vista" System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Dimension Vista® IGA 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 respective protein in the sample. The result is evaluated by comparison with a calibrator of known concentration.
Dimension Vista® IGM 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.
The provided document describes the 510(k) summary for the Dimension Vista® IGA and IGM Flex® reagent cartridges. These devices are in vitro diagnostic tests for the quantitative measurement of Immunoglobulin A and Immunoglobulin M in human serum and heparinized plasma. The study presented here is a method comparison study to demonstrate substantial equivalence to previously marketed devices, rather than establishing direct acceptance criteria for a new clinical outcome.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The study aims to demonstrate substantial equivalence to predicate devices. The acceptance criteria for method comparison studies typically involve statistical measures such as slope, intercept, and correlation coefficient, demonstrating a strong agreement between the new device and the predicate. While explicit numerical acceptance criteria (e.g., "slope must be between X and Y") are not directly stated as "acceptance criteria" in this summary, the reported regression analysis results serve as the performance data to support equivalence.
| Metric | Acceptance Criteria (Implied for Substantial Equivalence via Regression Analysis) | Dimension Vista® IGA Performance | Dimension Vista® IGM Performance |
|---|---|---|---|
| Slope (95% CI) | Close to 1.000 for strong agreement | 1.000 (1.000, 1.000) | 1.023 (0.967, 1.122) |
| Intercept (95% CI) | Close to 0.000 for strong agreement | 0.000 (0.000, 0.000) | 0.004 (-0.004, 0.008) |
| Correlation Coefficient (r) | Close to 1.000 for strong agreement | 0.992 | 0.989 |
| Correlation Coefficient (r²) | Close to 1.000 for strong agreement | 0.983 | 0.979 |
Interpretation of Performance:
- For the IgA assay, the slope of 1.000, intercept of 0.000, and very high correlation coefficients (r=0.992, r²=0.983) indicate excellent agreement with the predicate device (N Antiserum to Human IgA on the BN ProSpec® System) within the tested low-end range.
- For the IgM assay, the slope of 1.023 (95% CI includes 1.000), intercept of 0.004 (95% CI includes 0.000), and high correlation coefficients (r=0.989, r²=0.979) also demonstrate strong agreement with the predicate device (N Antiserum to Human IgM on the BN ProSpec® System) within the tested low-end range.
2. Sample Size Used for the Test Set and Data Provenance
- Dimension Vista® IGA: 28 serum samples.
- Dimension Vista® IGM: 26 serum samples.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "serum samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This study is a method comparison against a predicate device, not a diagnostic accuracy study where human experts establish ground truth. The "ground truth" in this context is the measurement obtained from the legally marketed predicate device (Siemens N Antisera to Human IgA and IgM on the BN ProSpec® System). Therefore, no human experts were used to establish ground truth for the test set in the traditional sense of clinical decision-making.
4. Adjudication Method for the Test Set
Not applicable. This was a method comparison study between a new device and a predicate device, not a study involving human readers or adjudicated outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is an in vitro diagnostic device comparison, not an evaluation of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this study represents a "standalone" performance evaluation in that it assesses the analytical performance of the new device (Dimension Vista® IGA/IGM assays) independent of human interpretation or intervention beyond the standard laboratory procedures for running the tests. The performance is compared directly against another automated assay (the predicate device). However, it's important to differentiate this from "standalone AI algorithm performance" in the context of image analysis, for example. Here, "standalone" refers to the device's analytical performance on its own.
7. The Type of Ground Truth Used
The ground truth for this method comparison study was established by the measurements obtained from the legally marketed predicate devices:
- Siemens N Antisera to Human IgA on the BN ProSpec® System.
- Siemens N Antisera to Human IgM on the BN ProSpec® System.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or algorithm development. This is a traditional IVD device comparison study, not an AI/ML-driven device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/ML algorithm in this context.
§ 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).