(100 days)
The A1c 2.2 Plus Automated Glycohemoglobin Analyzer is a high pressure liquid chromatography system intended for IN VITRO DIAGNOSTIC USE ONLY. Glycosylated hemoglobin measurements obtained by this device are used in the management and treatment of diabetes.
The A1c 2.2 Plus Automated Glycohemoglobin Analyzer is a high pressure liquid chromatography system.
The provided document is a 510(k) premarket notification approval letter for the A1c 2.2 Plus Automated Glycohemoglobin Analyzer. This device is an in vitro diagnostic (IVD) device used for measuring glycosylated hemoglobin in the management and treatment of diabetes.
The document does not contain the detailed information required to answer your request about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications as it pertains to a study proving the device meets acceptance criteria. The letter is an FDA approval, stating that the device is substantially equivalent to legally marketed predicate devices, and grants permission to market the device. It does not include the specifics of the performance studies themselves, which would typically be found in the 510(k) summary or full submission.
Therefore, I cannot provide the requested information based on the given text.
To be clear:
- A table of acceptance criteria and the reported device performance: Not present in the provided document.
- Sample sized used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not present.
- Adjudication method for the test set: Not present.
- 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. This is an automated analyzer, not an AI-assisted diagnostic tool requiring human reader involvement.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is described as an "Automated Glycohemoglobin Analyzer," implying a standalone, automated performance. However, details of the study are not provided.
- The type of ground truth used: Not explicitly stated, but for a device measuring glycosylated hemoglobin, the ground truth would typically be reference methods of glycosylated hemoglobin measurement, or clinical outcome data. Details are not in the provided text.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
§ 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).