(62 days)
For in vitro diagnostic use only. VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentrations.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 19 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of HDL and LDL cholesterol using VITROS dHDL and dLDL Reagents.
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 5.1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5.1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
- The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products dLDL Reagent, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS dLDL assay.
- The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have there own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5.1 FS Chemistry System premarket notification (K031924).
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
The provided text describes the acceptance criteria and study for the VITROS Chemistry Products dLDL Reagent and Performance Verifiers. However, it is a 510(k) summary for an in vitro diagnostic device (IVD), which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about de novo clinical studies often associated with AI/ML devices or complex medical devices. Therefore, some of the information requested, especially regarding AI/ML-specific metrics like MRMC studies, sample sizes for AI training sets, ground truth establishment for training, and expert qualifications/adjudication for test sets, is not applicable or not present in this type of document.
Here's the available information extracted and organized according to your prompt:
1. Table of acceptance criteria and the reported device performance
For the VITROS dLDL Reagent (new device) compared to the Polymedco Lipi+Plus Direct LDL assay (predicate device):
| Characteristic | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate) | Reported Device Performance (VITROS dLDL) |
|---|---|---|
| Correlation with Predicate | Strong linear correlation and high correlation coefficient | VITROS dLDL = 1.031 x X - 3.81 (mg/dL), with a correlation coefficient of 0.9908 |
| Reportable Range | Consistent with predicate's intended use | 30 - 350 mg/dL |
| Specimen Pretreatment | None Required (Homogeneous assay) | None Required (Homogeneous assay) |
| Basic Principle | Elimination enzymatic test | Elimination enzymatic test |
| Reagents | Liquid ready to use | Liquid ready to use |
| Instrumentation | (Not an acceptance criterion for the reagent itself, but specified as the intended platform) | VITROS 5,1 FS Chemistry System |
| Sample Type | Serum and Plasma | Serum and Plasma (heparin) |
| Reaction Steps | Step 1: Elimination, Step 2: Measurement | Step 1: Elimination, Step 2: Measurement |
| Incubation Temperature | 37 °C | 37 °C |
| Additional Studies (Summarized) | Acceptable precision, specificity, linearity, and expected values | Studies performed to determine precision, specificity, linearity, and expected values (results summarized in Instructions for Use, not detailed here) |
For the VITROS Chemistry Products Performance Verifiers I and II (new device) compared to the VITROS Chemistry Products Performance Verifiers (predicate device):
| Characteristic | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate) | Reported Device Performance (VITROS dLDL) |
|---|---|---|
| Intended Use | Monitor performance on VITROS Chemistry Systems | Monitor performance on VITROS Chemistry Systems (New additional intended use: to monitor performance of LDL Cholesterol on the VITROS 5,1 FS Chemistry System) - Note: The "new additional intended use" is a difference, but typically deemed acceptable if performance is still substantially equivalent. |
| Matrix of Performance Verifiers | Base matrix of freeze-dried human serum with added enzymes, electrolytes, stabilizers, preservatives, and other organic analytes | Base matrix of freeze-dried human serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. |
| Performance Verifier Levels | Low and High | Low and High |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states that equivalence was demonstrated using "patient samples" but does not specify the number of samples used for the correlation study or other performance studies (precision, specificity, linearity).
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data is described as using "commercially available reagents along with patient samples", suggesting data from clinical laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is an IVD device measuring a biochemical analyte. The "ground truth" for the test set is established by the predicate device's measurement (Polymedco Lipi+Plus Direct LDL assay). Therefore, the concept of "experts" to establish ground truth in the sense of image interpretation or diagnostic adjudication is not applicable here. The analytical measurement of the predicate device serves as the reference.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for an IVD device measuring a biochemical analyte against a predicate assay.
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 in vitro diagnostic assay, not an AI/ML diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone performance evaluations of the VITROS Chemistry Products dLDL Reagent and Performance Verifiers. The device measures LDL cholesterol directly and its performance is assessed analytically, independent of human interpretation or an operator-in-the-loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The primary ground truth for the correlation study of the VITROS dLDL assay is the measurement obtained from the predicate device, the Polymedco Lipi+Plus Direct LDL assay, on the Dade Dimension clinical chemistry analyzer. For other performance characteristics (precision, linearity), the "ground truth" would be defined by standard laboratory reference methods or expected values.
8. The sample size for the training set
This document describes a traditional IVD. The concept of a distinct "training set" for an AI/ML algorithm is not applicable here. The reagents and assay development follow established chemical and enzymatic principles, and their performance is subsequently validated using patient samples.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm.
§ 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.