(206 days)
INTENDED USE
The Lifestream Cholesterol Monitor is a professional-use, point-of-care in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples, used with the Privalink Software accessory to provide personalized health related information
INDICATIONS FOR USE
Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and with personalized health related information, aid in the management of patients undergoing therapy with lipid lowering drugs.
The measurement range for the Cholestron is 150 - 300 mg/dL.
Prescription Use
Not Found
This document is a 510(k) clearance letter from the FDA for a software accessory to a cholesterol monitor, not a study report or clinical trial. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, and ground truth establishment is not present in the provided text.
However, based on the information that is present, here's what can be inferred or explicitly stated:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance for the Privalink Software Accessory itself. The 510(k) process is primarily about demonstrating substantial equivalence to a predicate device, not necessarily proving new performance against specific criteria.
The only performance-related information mentioned is the measurement range for the Lifestream Cholesterol Monitor: 150 - 300 mg/dL. This is a functional specification of the main device, not the software accessory, and it's presented as an operational range rather than a performance target met through a study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The letter focuses on the regulatory clearance based on substantial equivalence, not on the details of a specific performance study for the software accessory.
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The Privalink Software Accessory is described as providing "personalized health related information," which suggests it might assist in interpretation, but there's no mention of a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. Given its role as an "accessory" to a cholesterol monitor for personalized health information, it's unlikely to have been evaluated as a standalone diagnostic algorithm in the same way an AI-powered image analysis tool might be.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary based on available information:
The provided document is a regulatory clearance letter, not a detailed study report. It confirms the FDA's finding of "substantial equivalence" for the Privalink Software Accessory to a legally marketed predicate device. This implies that the performance for the purpose of regulatory clearance was demonstrated through comparison to an existing device rather than through a de novo clinical study with specific acceptance criteria and detailed performance metrics as would be expected for a novel diagnostic algorithm.
The only quantitative information related to performance is the measurement range of the Lifestream Cholesterol Monitor from 150 - 300 mg/dL, which is the device the software accessory works with. Details about the software accessory's specific performance (e.g., accuracy of personalized health information, impact on user interpretation) are not included in this letter.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.