(23 days)
The AlcNow™ test provides quantitative measurement of the percent of glycated hemoglobin (% HbA1c) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.
Not Found
Here's an analysis of the provided text regarding the A1cNow™ device, focusing on the requested information about acceptance criteria and the supporting study:
The provided text only contains the FDA 510(k) clearance letter for the A1cNow™ device, along with its statement of intended use. It does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in the 510(k) summary or the actual study report. The FDA letter merely states that the device was deemed substantially equivalent to legally marketed predicate devices.
Therefore, for most of your requested points, the information is not available in the provided document.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The FDA letter indicates the device was found substantially equivalent, implying it met certain criteria, but the specific criteria and performance values are not listed. | Not provided in the document. The FDA letter doesn't include performance metrics like accuracy, precision, or comparison to a reference method. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available in the document.
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 available in the document. For a glycated hemoglobin assay, "ground truth" would typically be established by a reference method (e.g., HPLC) rather than human experts interpreting images, but the specifics are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the document. This concept is more applicable to studies involving human interpretation (like imaging studies) rather than a quantitative assay.
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 and not available in the document. The A1cNow™ is a quantitative assay, not an AI-assisted diagnostic imaging device that involves human readers in the traditional MRMC sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not available in the document. The A1cNow™ is a diagnostic assay, where "standalone performance" generally refers to the device's accuracy and precision using laboratory methods, which would have been part of the substantial equivalence submission but are not detailed here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available in the document. For a blood test like HbA1c, the "ground truth" would likely be a highly accurate reference method (e.g., HPLC) for measuring glycated hemoglobin.
8. The sample size for the training set
- Not applicable/Not available in the document. This device is a quantitative assay, typically calibrated according to established laboratory procedures using calibrators and controls, rather than "trained" in the machine learning sense with a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not available in the document. As above, the concept of a training set and its ground truth in the machine learning context does not directly apply to this type of device. Calibration would be performed using materials with known values derived from reference methods.
In summary, the provided FDA clearance letter and statement of intended use confirm the FDA's decision to clear the A1cNow™ device for marketing based on substantial equivalence. However, it does not provide the detailed study results, specific acceptance criteria, or the methodology of the studies that supported this clearance. To find that information, one would typically need to consult the 510(k) summary document filed with the FDA, which is usually publicly available through the FDA device database.
§ 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).