(191 days)
For in vitro diagnostic use only. VITROS Chemistry Products dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5, I FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. 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.
The VITROS dHDL assay is performed using the VITROS Chemistry Products dHDL Slide and the VITROS Chemistry Products Calibrator Kit 25 on the VITROS Chemistry Systems. The VITROS dHDL Slide is a multi-layered analytical element coated on a polyester support. The method is based on a non-HDL precipitation method followed by an enzymatic detection. All reactions necessary for a single quantitative measurement of HDLC take place within the multi-layered analytical element of a VITROS Chemistry Products dHDL Slide. A drop of sample fluid is metered onto the slide and a reaction occurs which ultimately generates a colored dye. The density of dye formed is proportional to the HDL Cholesterol concentration present in the sample and is measured by reflectance spectrophotometry.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of clinical performance metrics like sensitivity, specificity, or reader studies for an AI device.
This document describes a Special 510(k) submission for a modification to an existing in vitro diagnostic (IVD) device, the VITROS Chemistry Products dHDL Slide, used to measure HDL cholesterol. The modification primarily involves a reduction in the physical size of the slide and consequently a reduction in the reagents per slide and the sample volume required per test, without changing the fundamental technology or intended use.
Therefore, the requested information elements related to AI device performance evaluation (e.g., sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.
The "study" conducted for this submission would have focused on demonstrating that despite the physical changes, the modified device performs equivalently to the predicate (unmodified) device in terms of analytical performance. This would typically involve analytical studies like method comparison, precision, linearity, and interference testing, not clinical performance studies as would be conducted for a new AI-powered diagnostic.
Here's what can be extracted and inferred from the document regarding the device and its evaluation:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Inferred from a Special 510(k) for device modification): The primary acceptance criterion for this type of submission is demonstrating substantial equivalence to the predicate device. This means the modified device must perform comparably to the predicate device for its intended use, with no new questions of safety or effectiveness raised. Specifically, for an IVD, this generally means analytical performance (e.g., accuracy, precision, linearity, measuring range) should be equivalent. The document indicates that the concentration of ingredients per slide has changed, but the concentration of ingredients in the assay reaction remains the same, which is key to maintaining performance.
- Reported Device Performance: The document provides a summary stating: "The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products dHDL Slides (modified) for use with human serum and plasma is substantially equivalent to the predicate (unmodified VITROS dHDL Slide) and is safe and effective for the stated intended use." This statement is the ultimate "reported performance" in the context of a 510(k) submission, confirming that the device meets the regulatory standard of substantial equivalence. Specific analytical performance metrics (e.g., bias, correlation coefficients between modified and predicate device results) are not detailed in this summary but would have been part of the full 510(k) submission to demonstrate equivalence.
2. Sample size used for the test set and the data provenance:
* Not applicable / Not explicitly stated in this summary. This document is a summary of a Special 510(k), which focuses on modifications to an existing device. The "test set" in this context refers to samples used for analytical verification and validation (e.g., method comparison, precision studies), not a clinical test set for AI performance. The details of these analytical studies (number of samples, study design) are not included in this summary document.
* Data Provenance: Not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. This is an in vitro diagnostic device for quantitative measurement of HDL cholesterol. The "ground truth" for such a device is established by qualified laboratory methods (e.g., CDC reference methods, other validated clinical laboratory analyzers) or reference materials, not by human expert interpretation of images or other subjective data. Human experts are typically involved in interpreting the results in a clinical context, but not in establishing the "ground truth" for the device's measurement performance itself.
4. Adjudication method for the test set:
* Not applicable. See point 3.
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 device is an automated in vitro diagnostic assay, not an AI-powered image analysis or diagnostic support system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable. This is an automated laboratory test, not an AI algorithm. Its performance is inherently "standalone" in the sense that it provides a quantitative result without human subjective interpretation of an image or pattern.
7. The type of ground truth used:
* Inferred: For an IVD measuring HDL cholesterol, the ground truth for establishing analytical performance typically comes from:
* Reference methods: Comparability to established, validated reference methods (e.g., CDC-certified reference methods for lipid measurements).
* Certified reference materials: Materials with known, traceable concentrations of the analyte.
* Standard clinical laboratory analyzers: Comparison to existing, cleared devices in a method comparison study.
8. The sample size for the training set:
* Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established:
* Not applicable. This is not a machine learning or AI device.
§ 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.