(24 days)
The MAS™ Lipid Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many lipid determinations. Include MAS™ Lipid Control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
The DADE® Lipid Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many lipid determinations. Include DADE® Lipid Control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
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The provided document is a 510(k) premarket notification letter from the FDA for a quality control material (MAS™ Lipid Control and DADE® Lipid Control). This type of regulatory submission is for an in-vitro diagnostic device and does not involve studies related to AI algorithms, image analysis, or human-in-the-loop performance. Therefore, most of the requested information (acceptance criteria for device performance studies, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.
The document primarily focuses on the substantial equivalence determination for a quality control material, which means it compares the device to a legally marketed predicate device to ensure it performs as intended for monitoring assay conditions in lipid determinations.
Let's address what information can be gleaned from the document based on the context of a quality control material:
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A table of acceptance criteria and the reported device performance:
- This document is "Indications for Use" form, which states the intended use of the device. It does not provide specific acceptance criteria or performance data for the device itself. For quality control materials, acceptance criteria would typically involve demonstrating consistency and stability of the control material over its shelf life, and its ability to produce expected results when run on specified assay systems within predefined ranges. However, these specific criteria and their demonstration are not detailed in this public 510(k) summary letter. The letter only states that the device is intended "for monitoring assay conditions" and that "assay values are provided for the specific systems listed" (though not listed in this document). The "user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument."
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable to this document. The 510(k) letter does not describe a clinical study or a test set in the context of an AI device. For quality control materials, the "test set" would be the internal testing done by the manufacturer to establish the stability and assigned values of the control material, typically not disclosed in this level of detail in a 510(k) summary.
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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):
- Not applicable. This is not an AI or image-based diagnostic device where expert ground truth as described would be established.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a quality control material.
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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 a quality control material, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document pertains to a physical quality control material, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a quality control material, the "ground truth" would be the assigned lot values for various analytes, established through extensive testing by the manufacturer using reference methods or established clinical analyzers. This process is not detailed in the provided document.
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The sample size for the training set:
- Not applicable to this document, as it is not an AI/ML device.
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How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a regulatory approval letter for a quality control material, and as such, it does not contain the information requested in your prompt, which is tailored for AI-based diagnostic devices.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.