(56 days)
The HDLC Precipitating Reagent is to be used in the separation of HDL from other serum lipoproteins to provide valuable information for the prediction of coronary heart disease when used in conjunction with total cholesterol and triglyceride determinations.
Not Found
This communication is an FDA 510(k) clearance letter for the HDLC Precipitating Reagent. It does not contain the detailed study information generally associated with acceptance criteria and device performance evaluation. The letter indicates that the device has been found substantially equivalent to a predicate device, which means its safety and effectiveness have been deemed comparable to a previously cleared device. However, the letter itself does not provide the specific data from the studies that supported this determination.
Therefore, most of the requested information cannot be extracted from this document alone. For a comprehensive answer, information from the original 510(k) submission (K982539) would be required.
Based only on the provided text, here's what can be inferred or stated as missing:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document is a clearance letter, not a performance report. It states the device is "substantially equivalent" but does not detail the specific performance metrics or acceptance criteria used in the underlying studies.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. This information is part of the original 510(k) submission, not the clearance letter.
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)
- Cannot be extracted. This information would be found in the detailed study protocol and results of the 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. This information would typically be described in the study design section of the 510(k) submission.
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 / Cannot be extracted. This is a reagent (HDLC Precipitating Reagent) used in a clinical laboratory setting, not an AI-assisted diagnostic imaging device. Therefore, MRMC studies and "human readers improve with AI" metrics are not relevant to this type of product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Cannot be extracted. This is a laboratory reagent. The concept of "standalone algorithm performance" without human-in-the-loop is not relevant here. The device's performance would be measured by its accuracy in separating HDL from other lipoproteins, which then informs a diagnostic interpretation by a clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be extracted. For a precipitating reagent, the "ground truth" would likely involve comparison against established reference methods or highly accurate analytical techniques for lipoprotein separation and quantification. However, this detail is not in the clearance letter.
8. The sample size for the training set
- Not applicable / Cannot be extracted. A "training set" is typically associated with machine learning or AI models. This is a chemical reagent, so this concept does not apply in the same way. Performance studies would involve method validation, accuracy, precision, and interference studies.
9. How the ground truth for the training set was established
- Not applicable / Cannot be extracted. See explanation for #8.
§ 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.