(53 days)
Skin cholesterol as measured by PREVU* POC can be used as part of risk assessment for coronary heart disease in persons with a history of myocardial infarction and/or in persons suspected of having significant multi-vessel coronary artery disease (>50% stenosis in >1 vessel as diagnosed by coronary angiography) where further diagnostic evaluation is being considered. Test results, when considered in conjunction with clinical evaluation, blood cholesterol tests and other risk factors identified for coronary artery disease, will aid the physician in focusing diagnostic and patient management options.
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This document (K062092) is a 510(k) clearance letter from the FDA for the PREVU* POC Skin Sterol Test, indicating substantial equivalence to a legally marketed predicate device. It is important to note that this document does not contain information about specific acceptance criteria, study data proving the device meets those criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. This often involves comparing device features, intended use, and performance characteristics (which would be provided by the manufacturer in their 510(k) submission). However, the clearance letter provided here is merely the FDA's decision, not the full submission with detailed internal study data.
Therefore,Based on the provided FDA 510(k) clearance letter for the PREVU* POC Skin Sterol Test (K062092), the following information cannot be extracted:
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Table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. The letter acknowledges the device's substantial equivalence but does not detail the specific performance metrics or acceptance criteria used in the manufacturer's submission.
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Sample size used for the test set and the data provenance: This information is not included in the FDA clearance letter. The letter does not describe the studies conducted by the manufacturer, nor the characteristics of the data used in those studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the FDA clearance letter.
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Adjudication method for the test set: This information is not provided in the FDA clearance letter.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: This information is not relevant to the clearance of a diagnostic test like the PREVU* POC Skin Sterol Test, which is not an AI-assisted diagnostic. Furthermore, the letter does not mention such a study.
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If a standalone performance study was done: While a performance study would have been part of the manufacturer's 510(k) submission, the details of such a study (including whether it was a "standalone" algorithm performance study, which typically refers to AI/algorithm-only performance) are not included in this FDA clearance letter.
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The type of ground truth used: This information is not provided in the FDA clearance letter.
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The sample size for the training set: As with the test set, information about training data for any model used in the device is not present in this FDA clearance letter.
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How the ground truth for the training set was established: This information is not provided in the FDA clearance letter.
In summary, the provided document is a regulatory clearance notice and does not contain the detailed technical or clinical study data that would address the requested points. The FDA's decision of substantial equivalence indicates that they reviewed the manufacturer's submitted data and determined it met the requirements for marketing, but the specifics of those data are not part of this public clearance letter.
§ 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.