(69 days)
The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista System for: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), B2-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG) [serum/plasma] and Immunoglobulin G (IGG-C) [cerebrospinal fluid], Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G Subclass 2 (IGG2), Immunoglobulin G Subclass 3 (IGG3), Immunoglobulin G Subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF).
PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of a1-Microglobulin (A1MIC), specialty Albumin (sALB), Immunoglobulin G (IGG -C) and Microalbumin (MALB). * For Cerebrospinal fluid (CSF)
Dimension Vista® System Immunoglobulin G 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® System Protein 1 Calibrator: PROT1 CAL is a multi-analyte, liquid human serum based product containing: α₁-Acid Glycoprotein, α₁-Antitrypsin, β₂-Microglobulin, C3 Complement, C4 Complement, Ceruloplasmin, Haptoglobin, Hemopexin, Homocysteine, Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin G Subclass 1, Immunoglobulin G Subclass 2, Immunoglobulin G Subclass 3, Immunoglobulin G Subclass 4, Immunoglobulin M, Prealbumin, Retinol Binding Protein, soluble Transferrin Receptor, Transferrin.
Dimension Vista® System Protein 3 Control: PROT3 CON is a multi-analyte, lyophilized, polygeline and rabbit albumin based product containing: a -Microglobulin, Immunoglobulin G, Albumin.
The provided text is a 510(k) summary for the Dimension Vista® System Immunoglobulin G Flex® Reagent Cartridge, Dimension Vista® System Protein 1 Calibrator, and Dimension Vista® System Protein 3 Control. This document primarily focuses on demonstrating substantial equivalence to previously cleared devices for adding Cerebrospinal Fluid (CSF) as a sample matrix for IgG measurement. It does not contain specific acceptance criteria, performance data, or details of a comprehensive study as typically requested for AI/ML device evaluations.
Therefore, many of the requested items (sample size, data provenance, expert qualifications, adjudication methods, MRMC study, training set details) are not applicable or not available in this type of submission. This 510(k) is for an in-vitro diagnostic (IVD) test, which typically has different evaluation criteria and reporting compared to AI/ML devices for image analysis or other diagnostic tasks involving human readers.
However, I can extract the information that is present and indicate where information is missing based on the context of the document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative table format or report performance against such criteria. Instead, it states that "The studies included in this submission demonstrate correlation to and equivalent performance between the predicate N Antisera to Human IGG for CSF sample matrix." This implies that the performance (likely accuracy, precision, and linearity for CSF samples) was deemed equivalent to the predicate, but the specific numerical values for performance or acceptance criteria are not provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in quantitative terms. | "studies included in this submission demonstrate correlation to and equivalent performance between the predicate N Antisera to Human IGG for CSF sample matrix." |
| Implicitly, the performance for the expanded indications (CSF) must be equivalent to the predicate device. | Performance data for the CSF matrix extension is not provided in this summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. Given the nature of a 510(k) summary for an IVD test, such detailed study design specifics are often contained in the full 510(k) submission and not in the public summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable for this type of IVD device. The "ground truth" for a quantitative IVD test like this would typically involve reference methods, calibrator values, and quality control materials, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for this type of IVD device. Adjudication methods are typically used in studies involving human readers or AI output where there can be discretionary interpretation.
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 information is not applicable for this type of IVD device. This is a laboratory diagnostic test for quantitative measurement of a marker, not an AI-assisted diagnostic tool for human readers interpreting images or complex data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an AI/ML algorithm. This device is an automated IVD test system. Its standalone performance is inherent to its function, but it's not an "algorithm only" in the way an AI model is, as it relies on reagent chemistry and instrument mechanics. The summary implies "standalone" performance was demonstrated through "correlation" and "equivalent performance" studies against a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a quantitative diagnostic assay of Immunoglobulin G in CSF, the ground truth would be established by:
- Reference methods: Highly accurate and precise laboratory methods (e.g., nephelometry, turbidimetry, or potentially a gold standard method if available) used to determine true concentrations in samples.
- Calibrators: Materials with known, assigned concentrations of the analyte (IgG) used to establish the measurement curve of the assay. The Dimension Vista® System Protein 1 Calibrator is mentioned for this purpose.
- Quality Control materials: Materials with known, assigned ranges of analyte concentration used to monitor the assay's performance and ensure accuracy and precision. The Dimension Vista® System Protein 3 Control is mentioned for this purpose.
The summary itself does not detail how the ground truth for the specific 'studies' was established, but these are the general principles for such assays.
8. The sample size for the training set
This information is not applicable for this type of IVD device. The Dimension Vista® system and its reagents are based on established immunochemical principles (light scattering) and are calibrated, not "trained" in the machine learning sense. There is no training set in the context of AI/ML.
9. How the ground truth for the training set was established
This information is not applicable for this type of IVD device, as there is no "training set" in the AI/ML sense. Calibration is performed using materials with established concentrations (as outlined in point 7).
§ 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).