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The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma, cerebrospinal fluid (CSF) and urine 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), a ;- 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], Immunoglobulin G (IGG-C) [cerebrospinal fluid] and Immunoglobulin G (IGG-U) (urine), Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G Subclass 2 (IGG2), Immunoglobulin G Subclass 3 (IGG3), Immunoglobulin G Subclass 4 (IGG4), lmmunoglobulin 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 α Microglobulin (A1MIC), specialty Albumin (sALB), Immunoglobulin G (IGG -C), Immunoglobulin G (IGG-U)** and Microalbumin (MALB). * For Cerebrospinal fluid (CSF) ** For urine

Dimension Vista® System Immunoglobulin G Flex® reagent cartridge: Proteins contained in human body fluids from 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 document is a 510(k) premarket notification for in vitro diagnostic devices, namely the Dimension Vista® System IGG Flex® reagent cartridge, Protein 1 Calibrator, and Protein 3 Control. It states that these devices are substantially equivalent to legally marketed predicate devices. This type of submission does not typically include detailed studies with acceptance criteria and device performance in the format of a clinical trial for an AI/ML medical device. Instead, it focuses on demonstrating analytical performance (e.g., correlation, precision, analytical bias) for a laboratory diagnostic system.

Therefore, the requested information about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and how ground truth was established is not present in the provided text.

The document primarily makes claims of substantial equivalence to predicate devices based on intended use and analytical studies, rather than reporting on a clinical effectiveness study with defined acceptance criteria for diagnostic accuracy, sensitivity, or specificity in the way an AI/ML device might.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided. The document states that "studies included in this submission demonstrate correlation to and equivalent performance between the predicate Beckman Coulter IMMAGE® Immunochemistry System Urine Immunoglobulin G for urine sample matrix and the predicate N Antisera to Human Immunoglobulins (IgG IgA, and IgM) on the BN ProSpec® System for the addition of a pre-reaction step to the Dimension Vista® IGG-C assay."

This indicates that correlation and equivalent performance were the acceptance criteria, but the specific metrics (e.g., correlation coefficient thresholds, mean difference limits) and the resultant device performance values are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Not provided. The summary mentions "studies" but does not give details about the sample sizes of patients or samples used in these studies, nor their country of origin or whether they were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable/Provided. For an in vitro diagnostic device measuring immunoglobulin G, the "ground truth" would typically be established by a reference method or known concentrations of analytes in control materials, not by expert interpretation of images or clinical data. Therefore, the concept of "experts" in this context is not relevant.

4. Adjudication Method for the Test Set

Not applicable/Provided. Adjudication methods (e.g., 2+1) are usually relevant for human expert interpretation and resolving discrepancies, which is not pertinent to the analytical performance of an in vitro diagnostic assay.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. MRMC studies are associated with diagnostic imaging or other interpretive tasks where multiple human readers assess cases. This is an IVD device for quantitative measurement, so an MRMC study would not be applicable.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, implicitly. The device is an in vitro diagnostic system designed to quantitatively measure Immunoglobulin G. Its performance is inherently "standalone" in that it processes samples and produces numerical results without human interpretive input into the measurement itself. The "correlation" and "equivalent performance" mentioned would be standalone analytical performance. However, specific metrics are not provided.

7. The Type of Ground Truth Used

Implicitly, reference methods or known concentrations. For an IVD device, the ground truth for performance studies is typically established by:

• Comparison to a legally marketed predicate device (as stated in the conclusion).
• Known concentrations of analytes in control samples or calibrators.
• Reference methods that are considered the gold standard for measuring the analyte.
  The document states "correlation to and equivalent performance between the predicate...", suggesting the predicate device's results serve as the ground truth reference for comparison.

8. The Sample Size for the Training Set

Not applicable/Provided. This device is an analytical instrument and reagents, not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The "training set" concept is not relevant here.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Provided. As mentioned, the concept of a "training set" with established ground truth is not applicable for this type of IVD device.

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The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure immunoglobulin G (IgG) in serum and plasma.

The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgG by its polyclonal antibodies.a IgG from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 nm. The increase in turbidity is proportional to the concentration of IgG and it is calculated from a five point calibration curve.

Here's a breakdown of the acceptance criteria and the study information for the IGG Flex™ Reagent Cartridge, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 111 clinical patient samples.
• Data Provenance: The text does not explicitly state the country of origin. It indicates "clinical patient samples," suggesting real-world patient data. The study is retrospective in nature, as it involves comparing the new device's measurements on existing "clinical patient samples" to a legally marketed predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For in vitro diagnostic (IVD) devices like this, the "ground truth" is typically established by measurements from a well-characterized, legally marketed predicate device, rather than direct expert interpretation of raw data. The predicate device's results serve as the reference.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the study design is a direct comparison to a predicate device, not an interpretation-based task requiring expert adjudication. The comparison method involved running the same samples on both devices and analyzing the statistical correlation of the quantitative results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for imaging devices where human readers interpret diagnostic images. The IGG Flex™ is an in vitro diagnostic reagent and system, and its performance is assessed through quantitative agreement (correlation) with a predicate device, not by human reader interpretation. Therefore, there is no effect size of how much human readers improve with AI vs without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in effect, a standalone performance study was done. The IGG Flex™ Reagent Cartridge, as an in vitro diagnostic assay on the Dimension® clinical chemistry system, operates as a standalone automated system. The reported performance (correlation, slope, intercept) reflects the direct output of this system compared to the predicate device, without direct human intervention in the result generation or interpretation for the comparison study itself. While humans operate the instruments, the "performance" here refers to the analytical capabilities of the assay and instrument combination.

7. The Type of Ground Truth Used

The "ground truth" for the comparative study was established by the measurements obtained from the legally marketed predicate device: the Beckman Array® Immunoglobulin G Method. The comparison was directly between the quantitative results of the IGG Flex™ system and the Beckman Array® system for the same patient samples.

8. The Sample Size for the Training Set

The document does not provide information about a specific "training set" or "training set sample size" for the IGG Flex™ reagent. This is typical for IVD assays. The development of such assays involves analytical validation, calibration, and optimization, which would use various samples, but these are not usually referred to as a "training set" in the same way machine learning algorithms are. The reported study focuses on clinical validation/comparison.

9. How the Ground Truth for the Training Set Was Established

Since no specific "training set" is mentioned in the context of algorithm development (as it's not an AI/ML device), the concept of establishing ground truth for a training set in that sense is not applicable here. The ground truth for the reported study (comparison to predicate) was the Beckman Array® Immunoglobulin G Method results, as explained in point 7. For the initial development and calibration of the IGG Flex™ assay itself, ground truth would have been established through a combination of analytical methods, reference materials, and established laboratory practices to ensure accurate IgG quantification.

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