(71 days)
The Cholesterol test system is useful in monitoring LDL and HDL cholesterol levels. Patients at risk include males over 45 years and females over 55 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who smoke. Depending on a patients' number of risk factors, treatment can be medication or diet restrictions.
Not Found
This is a medical device approval letter from the FDA in 1998, which predates the widespread use of AI in medical devices and the structured reporting of AI-specific performance metrics. Therefore, the document does not contain the information requested regarding a study that proves the device meets AI acceptance criteria. The device described, "REP Cholesterol Profile Template" and "REP Vis Cholesterol", are likely in vitro diagnostic devices, and their "performance" would refer to analytical performance characteristics (e.g., accuracy, precision) as measured in a lab setting, not AI algorithm performance.
Here's why the requested information cannot be extracted:
- No AI Component: The document refers to a "Cholesterol test system." In 1998, this would undoubtedly be a physical diagnostic kit or instrument, not an AI software algorithm.
- Approval Date: The letter is dated May 1, 1998. AI in medical devices, particularly for diagnostic imaging or risk prediction, was not a common or recognized field requiring specific "AI acceptance criteria" or "AI a test sets" at this time.
- Focus of the Letter: The letter is a 510(k) clearance, indicating "substantial equivalence" to predicate devices. This process primarily focuses on intended use, technological characteristics, and safety and effectiveness data (often analytical performance for IVDs) to demonstrate equivalence to a device already legally marketed, rather than novel AI performance evaluation.
Therefore, I cannot provide the requested information in the specified format because the provided document is not relevant to AI-powered medical devices or their specific performance criteria.
§ 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.