(127 days)
For the quantitative determination of low and density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. HDL/LDL-Advance Calibrator is used to calibrate HDL Cholesterol and LDL Cholesterol Assays in serum. HDL is high density lipoprotein and LDL is a low density lipoprotein.
Not Found
The provided document is a 510(k) clearance letter for an in vitro diagnostic device, specifically the "HDL/LDL-ADVANCE Calibrator, Cat. No. SE-278". This type of document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance study results that would include detailed acceptance criteria tables, sample sizes for test/training sets, expert consensus details, or MRMC studies.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and comparative effectiveness studies is not available in the provided document.
The document states that the device is a calibrator used to calibrate HDL Cholesterol and LDL Cholesterol assays. Calibrators are reference materials used to establish the relationship between a measurement signal and the concentration of an analyte. The primary evidence for their performance often revolves around their traceability to certified reference materials, their stability, and their ability to produce accurate and precise results when used with their intended assays, rather than diagnostic accuracy metrics like sensitivity or specificity.
To address your specific points based on the limited information available in this type of document:
- A table of acceptance criteria and the reported device performance: Not available. The document is a clearance letter, not a detailed study report.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a calibrator and not available.
- Adjudication method for the test set: Not applicable for a calibrator and not available.
- 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 an in vitro diagnostic calibrator, not an AI-based diagnostic tool for human image interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: For a calibrator, "ground truth" would typically refer to the assigned values of HDL and LDL in the calibrator material, which are established through a robust metrological process, often traceable to higher-order reference methods or materials, not expert consensus on pathology or outcomes data. This specific information detail is not in the document.
- The sample size for the training set: Not applicable. This is a calibrator, not a machine learning algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.