(81 days)
Dimension Vista" APOAI Flex® reagent cartridge: The APOAI method is an in vitro diagnostic test for the quantitative determination of apolipoprotein A-1 in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein A-I aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Dimension Vista™ APOB Flex® reagent cartridge: The APOB method is an in vitro diagnostic test for the quantitative determination of apolipoprotein B in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotien B aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Dimension Vista" Apolipoprotein Calibrator: The APO CAL is an in vitro diagnostic product for the calibration of the apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) methods on the Dimension Vista® System.
Dimension Vista™ Apolipoprotein Control: APO CON is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) on the Dimension Vista® System.
Dimension Vista™ APOAI and APOB Flex® reagent cartridges: 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" Apolipoprotein Calibrator: APO CAL is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.
Dimension Vista™ Apolipoprotein Control: APO CON is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.
The provided 510(k) summary describes the acceptance criteria and a study demonstrating the performance of the Dimension Vista™ APOAI and APOB Flex® reagent cartridges.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Dimension Vista™ APOAI and APOB assays are implicitly defined by their comparison to legally marketed predicate devices, specifically the Dade Behring N Antisera to Human Apo A-1 and Apo B assays on the BN ProSpec® System. The study aims to demonstrate "correlation and equivalent performance," and the reported objective metrics are high correlation coefficients (close to 1), slopes close to 1, and intercepts close to 0.
| Assay | Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| APOAI | Correlation Coefficient | High (e.g., >0.97) | 0.997 |
| APOAI | Slope | Close to 1 (e.g., 0.9-1.1) | 1.007 |
| APOAI | Intercept | Close to 0 (e.g., -0.1 to 0.1) | -0.038 |
| APOB | Correlation Coefficient | High (e.g., >0.97) | 0.995 |
| APOB | Slope | Close to 1 (e.g., 0.9-1.1) | 1.011 |
| APOB | Intercept | Close to 0 (e.g., -0.1 to 0.1) | -0.004 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For APOAI: 72
- For APOB: 77
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) summary for a submission to the US FDA from a German manufacturer, it's likely the samples were collected and analyzed to support the submission, but specific details are not provided. The samples tested were human serum.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The ground truth for this diagnostic device is established by the results produced by a legally marketed predicate device (the Dade Behring N Antisera assays on the BN ProSpec® System), not by human expert interpretation. The study is a method comparison study comparing a new device to an existing one.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth is established by a predicate device, not by expert consensus requiring adjudication.
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. This is a laboratory diagnostic device (an in vitro diagnostic test for apolipoproteins), not an AI-powered image analysis or clinical decision support tool involving human readers/interpreters. Therefore, MRMC studies and AI assistance effect sizes are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The study directly compares the performance of the new device (Dimension Vista™ APOAI and APOB assays) against the predicate device, operating independently. There is no human intervention mentioned as part of the primary measurement process for the device itself during the comparison.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for this method comparison study is the results obtained from the legally marketed predicate device: Dade Behring N Antisera to Human Apo A-1 and Apo B assays on the BN ProSpec® System. This is considered a "reference method" comparison in the context of IVD submissions, rather than a true "ground truth" derived from an absolute standard like pathology or long-term outcomes data, which would be typical for validating clinical efficacy.
8. The Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. This is typical for in vitro diagnostic device submissions like this. The assays are based on established immunochemical principles, and the development process would involve internal optimization and validation, but not a "training set" in the machine learning sense to establish the core algorithm. The data presented is for validation testing.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described or relevant in the context of this 510(k) submission for an IVD reagent cartridge, the method for establishing its ground truth is not applicable and not provided.
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.