(84 days)
The IGG1 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 1 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 1 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
The IGG2 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 2 in human serum. heparinized plasma and EDTA plasma on the Dimension Vista" System. Measurements of immunoglobulin G subclass 2 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
The IGG3 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 3 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System. Measurements of immunoglobulin G subclass 3 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
The IGG4 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 4 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista" System. Measurements of immunoglobulin G subclass 4 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findinas.
Dimension Vista® IGG 1-2 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 standard of known concentration.
Dimension Vista® IGG 3-4 Flex® reagent cartridge: Antibodies as well as polystyrene particles coated with antibodies specific to human IGG3 or IGG4 are aggregated when mixed with samples containing IGG3 or IGG4. These aggregates 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista® IGG Subclass assays:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as 'acceptance criteria' in the document. Instead, the study aims to demonstrate substantial equivalence to legally marketed predicate devices through method comparison. The performance is reported as the results of the regression analysis comparing the new device to the predicate device.
| Test | Performance Metric | Acceptance Criteria (Implied for Substantial Equivalence via Method Comparison) | Reported Device Performance |
|---|---|---|---|
| Dimension Vista® IGG1 | Slope | Close to 1.00 | 1.002 |
| Intercept (g/L) | Close to 0 | -0.165 | |
| Correlation Coefficient | Close to 1.00 | 0.994 | |
| Dimension Vista® IGG2 | Not explicitly detailed in provided text, but implied to be similar to IGG1 against its specific predicate. | 1.002 (from the "Method Comparison Study" table, though it's confusingly placed and listed with IGG1's n of 129, indicating it might be a general header for the IGG assays rather than specific data for IGG2 at that point.) Self-correction: The "Method Comparison Study" table has 'Dimension Vista® IGG1' and 'Dimension Vista® IGG2' but the 'n' for IGG2 is missing, and 'Slope', 'Intercept', and 'Correlation Coefficient' data are also not present for IGG2 in that specific table segment for the Siemens N Antisera comparison. The document states "The Dimension Vista® IGG 1 and 2 assays were compared to N Antiserum to Human IgG Subclasses 1 and 2 on the BN ProSpec® System." The table provided only shows data for IGG1 for this comparison. Therefore, I cannot extract IGG2 performance from the provided text for this comparison. | |
| Dimension Vista® IGG3 | Slope | Close to 1.00 | 1.047 |
| Intercept (g/L) | Close to 0 | -0.002 | |
| Correlation Coefficient | Close to 1.00 | 0.993 | |
| Dimension Vista® IGG4 | Slope | Close to 1.00 | 1.020 |
| Intercept (g/L) | Close to 0 | -0.009 | |
| Correlation Coefficient | Close to 1.00 | 0.996 |
Note on IGG2 data: The provided text has a gap in reporting the specific method comparison results (Slope, Intercept, Correlation Coefficient) for Dimension Vista® IGG2. While it states it was compared, the table only shows IGG1's results against the N Antiserum.
2. Sample Size Used for the Test Set and Data Provenance
- Dimension Vista® IGG1: The test set used a sample size (n) of 129 (human serum/plasma samples, as described in the device's intended use).
- Dimension Vista® IGG3: The test set used a sample size (n) of 142 (human serum/plasma samples).
- Dimension Vista® IGG4: The test set used a sample size (n) of 150 (human serum/plasma samples).
- Data Provenance: The document does not specify the country of origin of the data. It does not explicitly state if the data was retrospective or prospective, although method comparison studies usually involve prospectively collected samples or a mixed approach of existing and newly collected samples for spanning the measuring range.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to in vitro diagnostic (IVD) devices like the one described. The "ground truth" in this context is the measurement obtained from the legally marketed predicate device (Siemens N Antisera to Human IgG Subclasses 1 and 2, and Siemens N Latex IgG3 and 4 assays run on the BN ProSpec® System). These are established diagnostic assays, and their results are treated as the reference for comparison, not requiring expert consensus for individual sample values.
4. Adjudication Method for the Test Set
Not applicable. For IVD devices comparing to a predicate, the predicate device's result is the reference point, not an adjudicated "ground truth" derived from human experts.
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
Not applicable. This is an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that involves human readers/interpreters in the decision-making process. The device performs quantitative measurements directly.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The method comparison described (new device vs. predicate device) assesses the performance of the Dimension Vista® IGG Subclass assays as standalone devices. The results are quantitative measurements, not dependent on human interpretation of the assay's output for diagnosis, though clinicians interpret the quantitative results in conjunction with other findings.
7. The Type of Ground Truth Used
The "ground truth" for the method comparison studies was the results obtained from the legally marketed predicate devices:
- Siemens N Antisera to Human IgG Subclasses 1 and 2 (for IGG1 and IGG2)
- Siemens N Latex IgG3 and 4 (for IGG3 and IGG4)
These predicate devices were run on the BN ProSpec® System.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" or its sample size. For an IVD device submission, the focus is typically on verification and validation studies (like method comparison) using clinical samples, rather than a separate "training set" in the context of machine learning algorithms. The development and internal optimization of the assay might involve various samples, but these are generally considered part of the development phase leading up to the formal validation studies.
9. How the Ground Truth for the Training Set was Established
As no training set is explicitly mentioned or detailed in the document in the context of algorithm development, this question is not applicable. The performance characteristics are evaluated against established predicate methods.
§ 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).