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The MSC Lipid Control is intended for use as an assayed quality control material to monitor the ongoing precision of clinical laboratory systems for the following analytes: High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), Total Cholesterol (CHOL), Triglycerides (TRIG), Apolipoprotein AI (Apo AI), and Apolipoprotein B (Apo B), on instruments listed in the value sheet.

The MSC Lipid Control is a human serum based liquid quality control containing stabilized HDL-C, LDL-C, CHOL, TRIG, Apo AI, and Apo B of human origin.

The provided text describes a 510(k) summary for the "MSC Lipid Control" device, which is a quality control material. It details the device's intended use and substantial equivalence to predicate devices. However, the text does not contain information about acceptance criteria, a specific study design to prove device performance against acceptance criteria, or any details related to AI/algorithm performance.

Therefore, I cannot fulfill your request for the following sections based on the provided input:

1. A table of acceptance criteria and the reported device performance (Not provided in the text)
2. Sample sized used for the test set and the data provenance (Not applicable, as this is a quality control material, not an AI/diagnostic device with a test set in that context. The text also does not provide details on specific testing methodology for establishing equivalence beyond general statements.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable/provided)
4. Adjudication method (Not applicable/provided)
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, as this is not an AI/diagnostic device)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable, as this is not an AI/algorithm)
7. The type of ground truth used (Not applicable/provided)
8. The sample size for the training set (Not applicable, as this is not an AI/algorithm)
9. How the ground truth for the training set was established (Not applicable, as this is not an AI/algorithm)

The provided documentation is for a Class I medical device (quality control material), whose approval is based on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than explicit acceptance criteria demonstrated through a detailed clinical or performance study as would be expected for a diagnostic or AI-driven device. The equivalence for this type of device is typically established through analytical performance (e.g., stability, homogeneity, assigned values) relative to the predicate, but specific details of such studies are not provided in this 510(k) summary. The summary states that "the performance of MSC Lipid Control is substantially equivalent in form and function to the predicate devices for its stated intended use." This is the general "proof" for this type of submission.

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The MSC Lipid Control is intended for use as an assayed control material to monitor the ongoing precision of clinical laboratory analysis for Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol. This material is intended for use on automated, semi-automated, and manual clinical chemistry analyzer systems.

The MSC Lipid Control is a human serum based liquid control containing stabilized Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol of human origin.

The provided text is a 510(k) summary for a medical device called "MSC Lipid Control," which is a quality control material for clinical laboratory analysis of lipids. It does not contain any information regarding acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or the type of ground truth used for AI-driven devices.

This document describes a traditional medical device (a control material) and its substantial equivalence to a predicate device, rather than a novel device requiring extensive performance studies with AI or human readers. Therefore, the requested information elements are not applicable to the provided context.

Ask a specific question about this device