(18 days)
The cassette COBAS Integra LDL-Cholesterol plus 2nd Generation contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentration in serum and plasma.
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.
The LDL-Cholesterol plus 2nd Generation test principle is based on the selective micellary solubilization of LDL-cholesterol by a nonionic detergent and the interaction of a sugar compound and lipoproteins. The inclusion of a sugar compound and a detergent in the enzymatic method for cholesterol determination (cholesterol esterase cholesterol oxidase coupling reaction) enables the selective determination of LDL-cholesterol. The color intensity of the blue quinoneimine dye formed is directly proportional to the LDL-Cholesterol concentration. It is determined by measuring the increase in absorbance at 583 nm.
The provided text is a 510(k) summary for a medical device called "LDL-Cholesterol plus 2nd Generation". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data for the currently submitted device.
Therefore, I cannot extract all the requested information, specifically regarding detailed acceptance criteria, reported device performance (with numerical metrics), sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance. The document primarily asserts equivalence based on shared principles, intended use, and formulation.
However, I can extract information related to the intended use and indications for use, which are foundational to what the device is designed to do, and the type of ground truth suggested by its purpose.
Here's what can be inferred or directly stated from the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (Roche/Hitachi LDL-Cholesterol plus 2nd generation assay, K974733), stating that the proposed device has "the same intended use and indication for use, the same scientific principle, the same formulation and similar application parameters" as the predicate device. It does not present specific acceptance criteria or performance data for the new device's evaluation against those criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary.
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 information is not provided in the 510(k) summary. This type of detail is typically associated with studies involving human interpretation or subjective assessments, which is not the primary focus for an in-vitro diagnostic reagent system aiming for quantitative measurement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary.
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
An MRMC study is not applicable and therefore, not done. This device is an in-vitro diagnostic reagent system for quantitative determination of LDL-Cholesterol, not an AI-assisted diagnostic tool requiring human interpretation comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone diagnostic reagent system for quantitative determination. The performance mentioned in the summary is inherent to the reagent system and its application on the COBAS Integra systems, which intrinsically operates without human-in-the-loop during the analytical process. There's no separate "algorithm only" performance reported in the context of interpretation, as it's a direct measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the device's function, the ground truth would inherently be quantitative reference methods or established laboratory standards for LDL-Cholesterol measurement. The intention is to accurately measure LDL-Cholesterol concentration. This would typically involve comparison to a gold standard method for cholesterol determination or certified reference materials.
8. The sample size for the training set
This information is not provided in the 510(k) summary. For a diagnostic reagent, "training set" might refer to samples used during reagent development and optimization, but specific sizes are not reported here.
9. How the ground truth for the training set was established
This information is not provided in the 510(k) summary. Similar to the above, it would involve comparison to established methods for LDL-Cholesterol measurement during the development phase.
§ 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.