(24 days)
The InView™ multi-use test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called InView™, a glycosylated hemoglobin assay. It does not contain the specific details about acceptance criteria or the study that proves the device meets those criteria. My analysis of the given text is as follows:
-
A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The document is a regulatory clearance letter, not a detailed study report.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided document.
-
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 present in the provided document.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided document.
-
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 device is a quantitative assay for glycated hemoglobin, not an imaging device or an AI diagnostic tool that human readers would use in conjunction with. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not applicable and not mentioned.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The InView™ is described as a "multi-use test" for measuring %HbA1c levels. It is presented as a standalone device ("algorithm only" equivalent for an in-vitro diagnostic) in the sense that it provides a quantitative measurement. The FDA clearance confirms its performance for "home use and professional use for monitoring glycemic control in people with diabetes." This implies a standalone performance without a human-in-the-loop interacting with an AI algorithm for diagnosis. However, specific performance metrics are not given.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present in the provided document. For a quantitative assay like HbA1c, the ground truth would typically be established by a reference method or a highly accurate laboratory assay.
-
The sample size for the training set: This information is not present in the provided document.
-
How the ground truth for the training set was established: This information is not present in the provided document.
Summary: The provided FDA 510(k) clearance letter confirms that the InView™ glycated hemoglobin assay is substantially equivalent to legally marketed predicate devices. It states the intended use as quantitative measurement of %HbA1c for home and professional use in monitoring glycemic control. However, this document does not contain the detailed technical or clinical study data (such as acceptance criteria, sample sizes, ground truth establishment, or performance metrics) that would typically be found in the 510(k) submission itself or a comprehensive study report. The letter is a regulatory approval, not a scientific publication of study results.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).