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The Assay Kit is indicated LFS Lipogel for the electrophoretic separation of lipoproteins in a gradient polyacrylamide gel. That is, the LFS Lipogel Assay Kit is an in vitro diagnostic device intended to test human plasma or serum for lipoproteins and their subfractions.

The LFS Lipogel Assay Kit utilizes a gel electrophoresis method for separating lipoproteins. The principle of electrophoresis is based upon the fact that lipoproteins, when placed in an electrical field, will migrate toward one of the electrode poles. The lipids in human plasma are bound to protein and circulate throughout the body as complexes known as lipoproteins. Routine electrophoresis separates lipoprotein complexes into four generally distinct, well-resolved fractions or zones. lach fraction is composed of one or more individual lipoproteins. From the fastest migrating to the slowest, these fractions have been b designated alpha a 2 lipoproteins (high density lipoproteins - HDL), pre-beta lipoproteins (very low density lipoproteins - VLDL), beta lipoproteins (low density lipoproteins -LDL) , , , and chylomicrons.

The resulting pattern may be visually interpreted or quantified. After electrophoresis, the lipoproteins in the gel are immobilized in a fixative solution. The lipoprotein pattern is visualized by staining the qel lipid-specific stain. with a With the use of densitometer, the relative percentage of each lipoprotein fraction can be determined.

The LFS Lipogel Assay Kit is a complete system containing the reagents, gels, and hardware necessary to perform electrophoretic separation of lipoproteins.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LFS Lipogel Assay Kit:

The provided text is a 510(k) summary for a medical device (LFS Lipogel Assay Kit) seeking substantial equivalence to existing devices. As such, it does not contain a detailed description of acceptance criteria or a comprehensive study plan with the level of detail requested in the prompt. It focuses on demonstrating substantial equivalence rather than fulfilling specific, detailed performance benchmarks. Therefore, many of the requested fields cannot be fully populated from the given information.

However, I can extract and infer what information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a structured table. Instead, it describes performance testing conducted to characterize the device and demonstrate substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document mentions "Performance testing was conducted," but it does not provide any details about the number of samples, patients, or runs used in this testing.
• Data Provenance: Not explicitly stated, but generally for 510(k) submissions, internal testing by the manufacturer (Zaxis, Inc.) is common. The text mentions testing "between laboratories," implying data from at least one other lab was involved, but details are absent. It does not indicate retrospective or prospective data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable/Not specified. This device is an in-vitro diagnostic (IVD) for laboratory use. The "ground truth" for lipoprotein separation is established through the chemical and physical properties of the assay itself and comparison to established methods (predicate devices). It's not a device relying on expert interpretation of complex images or signals in the same way an AI diagnostic would.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified. Given the nature of an IVD for lipoprotein separation, adjudication by human experts in the way described (e.g., 2+1) is not typically performed for performance studies. The results are typically quantitative or semi-quantitative and assessed against laboratory standards or predicate device results.

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

• MRMC Study: No. This device is an electrophoretic gel and reagents for lipoprotein separation, not an AI-powered diagnostic that assists human readers.
• Effect Size with AI Assistance: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable in the context of AI. However, the kit itself, when used in a lab, functions primarily as a "standalone" system in that it performs the separation. The "interpretation" can be visual or densitometric. The document states: "The resulting pattern may be visually interpreted or quantified. With the use of densitometer, the relative percentage of each lipoprotein fraction can be determined." This indicates either visual interpretation by a lab technician or automated quantification via a densitometer. The performance testing would be on the device's ability to produce these patterns accurately and reproducibly.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this type of IVD device is typically established by:
  • Reference Methods: Comparison to established, clinically validated methods for lipoprotein separation (the predicate devices serve as this de facto reference for the substantial equivalence claim).
  • Known Samples: Using control samples with known lipoprotein profiles.
  • Chemical/Physical Principles: The intrinsic accuracy of the electrophoretic method itself, based on well-understood scientific principles.
  • The document implies comparison to the "Helena Laboratories' Titan Gel-Lipoprotein Electrophoresis System" served as the primary comparative basis for demonstrating equivalence.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. This is not an AI/machine learning device; therefore, there is no "training set" in the conventional sense. The device is a chemical and mechanical system.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI model.

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