(197 days)
In vitro diagnostic method for the quantitative measurement of Hemoglobin A1c in human whole blood on the Olympus system analyzers. Measurements obtained through this method can be used for monitoring the long-term care of people with diabetes.
Olympus HbA1c Reagent Test System (Reagent, Calibrator & Control, Hemoglobin Denaturant)
This looks like a 510(k) summary for an Olympus HbA1c Reagent Test System. Unfortunately, the provided text does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement.
The document is a letter from the FDA confirming clearance of the device due to substantial equivalence to a predicate device. It states the device name, regulation number, and indications for use. It does not include the actual study data or the specific acceptance criteria used for clearance.
To answer your questions, I would need to see the full 510(k) submission, specifically the sections detailing the performance studies.
Therefore, for your current input, I can only provide the following:
1. A table of acceptance criteria and the reported device performance:
- Not provided in the given text. This information would typically be in a separate section of the 510(k) submission, detailing analytical and clinical performance studies.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided in the given text.
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):
- Not applicable/provided in the given text. For an in vitro diagnostic (IVD) like an HbA1c test, "ground truth" is typically established by reference methods or validated laboratory assays, not by expert interpretation in the same way as imaging studies. No information on experts is present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/provided in the given text. Adjudication methods like 2+1 are common in imaging studies where human interpretation is involved. For a quantitative IVD, the "truth" is usually a numerical value from a reference method.
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:
- Not applicable. This device is an in vitro diagnostic reagent system, not an AI-assisted diagnostic tool that aids human readers in interpreting images or other complex data. MRMC studies are not relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an automated reagent-based test system, not an AI algorithm. Its performance is inherently "standalone" in the sense that it provides a quantitative result without human interpretive input beyond sample handling and instrument operation. The concept of "human-in-the-loop" as it applies to AI/CAD devices is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided in the given text. For an HbA1c test, the ground truth would typically be established by a recognized reference method for HbA1c (e.g., NGSP-certified methods).
8. The sample size for the training set:
- Not applicable/provided in the given text. This is a reagent test system, not a machine learning algorithm that requires a "training set" in the conventional AI sense. Calibration and validation are part of its development, but not "training" like an AI model.
9. How the ground truth for the training set was established:
- Not applicable/provided in the given text. (See point 8).
§ 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).