(68 days)
Dimension Vista™ MALB Flex® reagent cartridge: The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine on the Dimension Vista™ System. Measurement of albumin aids in the diagnosis of kidney and intestinal disease.
Dimension Vista™ Protein 3 Calibrator: Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method on the Dimension Vista™ System.
Dimension Vista™ Protein 3 Control: Protein 3 Control is an assayed intralaboratory quality control for the assessment of precision and analytical bias in determination of Microalbumin (MALB) on the Dimension Vista™ System.
Dimension Vista™ MALB Flex® reagent cartridge: Proteins contained in human urine 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 albumin in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 3 Calibrator: PROT3 CAL is a lyophilized, polygeline based (with urinary proteins of human origin) product containing Albumin.
Dimension Vista™ Protein 3 Control: PROT3 CON is a lyophilized, polygeline and albumin based product containing albumin of human origin.
Here's a breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a method comparison study between the Dimension Vista™ MALB Flex® reagent cartridge and a predicate device (Dade Behring N Antiserum to Human Albumin assay on the BN ProSpec® System). The acceptance criteria are implicitly based on the regression analysis results to demonstrate substantial equivalence.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Dimension Vista™ MALB vs. Predicate) |
|---|---|---|
| Method Comparison | Regression analysis demonstrating substantial equivalence to the predicate device. The values of the slope, intercept, and correlation coefficient should indicate good agreement. | Slope: 0.922 |
| y-intercept: 2.1292 | ||
| r value: 0.9996 |
Note: The document only provides the regression analysis results as the performance characteristics. Explicit acceptance criteria (e.g., "slope within X range," "intercept within Y range," "r-value > Z") are not explicitly stated in the provided text. The regulatory body's approval of substantial equivalence (K061990) implies these results met their internal criteria for equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The number of urine samples used was 100.
- Data Provenance: The text does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "evaluating urine samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (method comparison for an in vitro diagnostic device for quantitative determination of albumin) does not typically involve expert readers or establishing ground truth through expert consensus. The "ground truth" in this context is established by the results from the legally marketed predicate device (Dade Behring N Antiserum to Human Albumin assay on the BN ProSpec® System).
4. Adjudication Method for the Test Set
Not applicable. As this is a method comparison study for an in vitro diagnostic device, there is no expert adjudication process in the way it would be applied for image-based diagnostics. The comparison is against the established results of a predicate device.
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 not an AI-assisted diagnostic device, nor is it an MRMC study. It is a comparison of an in vitro diagnostic reagent and system to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the Dimension Vista™ MALB assay system itself, which is a standalone automated in vitro diagnostic system. The study evaluates its performance independently, by comparing its results to a predicate device. It is not an AI algorithm, but a quantitative biochemical assay.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the quantitative determination of albumin in human urine by the legally marketed predicate device, the Dade Behring N Antiserum to Human Albumin assay on the BN ProSpec® System.
8. The Sample Size for the Training Set
Not applicable. This device is an in vitro diagnostic reagent system, not a machine learning or AI model that requires a training set in the conventional sense. The "training" for such systems involves calibration and quality control, but not in the context of a dataset for model development.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, this is not an AI/ML device requiring a training set with established ground truth. The calibration and control materials (Dimension Vista™ Protein 3 Calibrator and Control) have known concentrations of albumin to ensure the system's accuracy and precision during routine use.
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.