(85 days)
The AlCNow multi-use test provides quantitative measurement of the percent of glycated hemoglobin (%HbAIc, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.
The A1CNow+ tests provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used to monitor glycemic control in people with diabetes. A1cNow+ consists of 1) a semi-disposable plastic-encased device (the monitor), 2) a plastic cartridge enclosing dry reagent strips, and 3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge. When testing with A1CNow+, an unmeasured whole blood mixture (diluted) is directly applied to the sample port, and the results are displayed in numeric form on the Monitor's liquid crystal display after 5 minutes.
The provided text describes a 510(k) submission for a device modification (AlcNow® Multi-Use) and does not contain detailed acceptance criteria and performance data in a tabular format typically found in clinical study reports. It broadly states that the device is "safe and effective" and "substantially equivalent" to its predicate.
Based on the provided document, here's what can be extracted and what information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific numerical acceptance criteria or detailed performance metrics. It generally states that "The performance was assessed in two separate clinical validation studies. The studies showed that changes to the hemolysate kit and product stability had no negative impact on product safety and efficacy."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set(s) or the data provenance (e.g., country of origin, retrospective/prospective nature). It only mentions "two separate clinical validation studies."
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)
The document does not provide information on the number or qualifications of experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication methods used for the test set.
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 device (A1CNow®) is a diagnostic assay for measuring glycated hemoglobin, not an AI-assisted imaging device or one involving "human readers" in the context of MRMC studies typical for image-based diagnostic aids. Therefore, an MRMC comparative effectiveness study, as described, is not applicable or mentioned for this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The A1CNow® device is an automated in vitro diagnostic device. Its performance is inherently "standalone" in that it directly measures %A1C from a blood sample. The "studies showed that changes to the hemolysate kit and product stability had no negative impact on product safety and efficacy" implies standalone performance evaluation of the device's accuracy and reliability. However, the document does not explicitly use the term "standalone performance study" in the context of algorithm-only performance. It notes that the product is "safe and effective in the hands of lay users and healthcare professionals," suggesting evaluation of its overall use, not just the technical core.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an A1C measurement device, the "ground truth" would typically be established by a reference method for A1C measurement (e.g., HPLC methods that are traceable to the DCCT reference method) in a clinical laboratory. The document does not explicitly state how the ground truth was established, but this is the standard approach for such assays.
8. The sample size for the training set
The document does not mention the concept of a "training set" as it would apply to machine learning algorithms. This device is a biochemical assay, not an AI/ML-based diagnostic. Therefore, information on a "training set" is not relevant or provided.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for an AI/ML model, this information is not applicable or provided.
Summary of what is available vs. missing:
The provided text serves as a 510(k) summary for a device modification, focusing on establishing substantial equivalence. It describes the device, its intended use, and states that performance was assessed through clinical validation studies, concluding "no negative impact on product safety and efficacy" and "substantially equivalent." However, it lacks the detailed quantitative performance metrics, sample sizes, ground truth methodologies, and specific study designs that would typically constitute a comprehensive report of acceptance criteria and proven performance for a clinical study.
§ 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).