(64 days)
The Olympus LDL Cholesterol Test System contains LDL Cholesterol Reagent, LDL Cholesterol Calibrator, and Assayed HDL/L/L/L Cholesterol Control materials intended for use on the Olympus Family of Clinical Chemistry Analyzers for the quantitative determination of LDL Cholesterol concentrations in human serum and plasma.
The Olympus LDL Cholesterol Calibrator is a lyophilized human serum intended to provide an LDL concentration of known value for use in calibration of the Olympus LDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers.
The Olympus HDL/LDL Cholesterol Control consists of lyophilized human sera. These assayed control sera a designed to monitor the recovery and precision of the Olympus LDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers.
LDL Cholesterol levels play a causal role in the development of coronary artery disease and is used for the measurement of the LDL Cholesterol concentration in serum and plasma.
Not Found
This FDA 510(k) clearance document for the Olympus LDL Cholesterol Test System does not contain the detailed information required to fill out the table and answer all the questions about acceptance criteria and the study proving device performance as it pertains to an AI/ML device.
This document is for an in vitro diagnostic device (a chemistry analyzer for determining LDL Cholesterol levels), not an AI/ML device. Therefore, many of the questions regarding AI-specific evaluation metrics (like expert readers, adjudication, MRMC studies, training sets, etc.) are not applicable here.
However, I can extract information relevant to the type of device and its intended use, which might be analogous to what would be expected for a diagnostic device.
Here's what I can provide based on the given document:
Device Type: In Vitro Diagnostic (IVD) - Specifically, a Lipoprotein Test System and Calibrator for quantitative determination of LDL Cholesterol.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria or reported performance metrics in a tabular format. For IVD devices like this, typical performance metrics would include:
- Accuracy/Bias: Comparison to a reference method (e.g., CDC reference method for cholesterol).
- Precision/Reproducibility: Within-run, between-run, and total precision (CV% or SD).
- Linearity/Measuring Range: The range over which the device accurately measures concentrations.
- Interference: Lack of significant interference from common substances in serum/plasma.
- Stability: Reagent and calibrator stability.
- Method Comparison: Correlation and agreement with a predicate device.
Since these specific details are not in the provided clearance letter, I cannot populate a table.
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 FDA clearance letter. The letter explicitly states that the device is "substantially equivalent" to predicate devices, implying that the manufacturer submitted data, but the specifics of the study design (sample size, data provenance) are not part of this summary document.
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 not applicable in the context of an IVD device for quantitative chemical measurement. Ground truth for chemical analytes is typically established by certified reference materials or highly accurate reference methods, not by expert human interpretation in the way it is for image-based diagnostics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for a quantitative IVD device. Adjudication methods are typically used for qualitative or expert-interpreted diagnostic tasks (e.g., radiology, pathology).
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 is not applicable as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is an automated chemistry analyzer, not an AI algorithm. Its performance is inherently "standalone" in the sense that it provides a quantitative result without human subjective interpretation of the primary measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a quantitative IVD device like this, the ground truth would typically be established by reference methods or certified reference materials (e.g., from organizations like the CDC or NIST) for LDL Cholesterol, rather than expert consensus, pathology, or outcomes data. The document does not specify which reference method was used.
8. The sample size for the training set
This information is not provided and is not typically relevant for the type of IVD device described. While a manufacturer would develop and validate the reagent and analyzer, the concept of a "training set" in the machine learning sense does not apply directly to this chemistry-based measurement system.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
§ 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.