(94 days)
For in vitro diagnostic use only. VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.
For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 25 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of HDL cholesterol using VITROS Chemistry Products dHDL Slides.
For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers I and II are assayed controls used to monitor performance on VITROS Chemistry Systems.
The VITROS Chemistry Systems are fully automated clinical chemistry analyzers intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid).
The system is comprised of four main elements:
- The VITROS Chemistry System - instrumentation, which provides automated use of the chemistry reagents.
- The VITROS Chemistry Products MicroSlides range of products, in this case the VITROS Chemistry Products dHDL Slides, VITROS Chemistry Products Calibrator Kit 25 and VITROS Chemistry Products Performance Verifier I and II which are combined by the VITROS Chemistry Systems to perform the VITROS dHDL Slide assay.
- The VITROS Chemistry Products MicroTip range of liquid reagent products that are formulated for use only on the VITROS 5,1 FS Chemistry System.
- Common reagents used by multiple assays on the VITROS Chemistry Systems, in this case VITROS Chemistry Products 7% BSA.
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
The provided document is a 510(k) summary for in-vitro diagnostic devices (VITROS Chemistry Products dHDL Slides, Calibrator Kit 25, and Performance Verifiers I and II) and therefore does not include the detailed acceptance criteria and study information typically found for AI/ML-driven medical devices. The document focuses on demonstrating substantial equivalence to a predicate device.
However, I can extract the information provided regarding the comparison study.
Here's a breakdown of the available information based on your request categories:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the way an AI/ML study would (e.g., target specificity, sensitivity thresholds). Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is reported as a correlation between the new device and the predicate device.
| Metric (New Device vs. Predicate Device) | Reported Value |
|---|---|
| Linear Regression Coefficient (slope) | 0.953 |
| Linear Regression Intercept | -0.64 mg/dL |
| Correlation Coefficient (r) | 0.996 |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document states that "patient samples" were used, but the specific number is not provided.
- Data Provenance: Not specified (e.g., country of origin).
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is an in-vitro diagnostic device measuring HDL cholesterol. The "ground truth" would be established by reference methods or comparison to the predicate device, not by expert interpretation of images or other subjective data. No experts for ground truth establishment are mentioned.
4. Adjudication method for the test set:
Not applicable for this type of device. The comparison is between quantitative measurements from two different analytical systems.
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 AI-assisted diagnostic tool that would involve human readers interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a standalone in-vitro diagnostic assay. Its performance is evaluated intrinsically and through comparison to the predicate device. It operates without human-in-the-loop performance in the interpretative sense of AI.
7. The type of ground truth used:
The "ground truth" for this study is essentially the quantitative measurement of HDL cholesterol obtained from the predicate device, the AHDL Flex® reagent cartridge for use with the Dade Behring Dimension® analyzer. The study aims to show that the new device's measurements are highly correlated with those of the predicate device.
8. The sample size for the training set:
The document describes a comparison study, not a machine learning study with distinct training and test sets in the typical sense. Therefore, "training set" is not applicable in this context. The study utilized patient samples for the correlation analysis.
9. How the ground truth for the training set was established:
Not applicable, as there's no "training set" in the context of an ML model. The comparison is against the predicate device's measurements.
§ 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.