(153 days)
The Aina HbA1c Monitoring System 2 consists of the Aina 2 Automated HbA1c Device, Aina HbA1c Test Kits, mobile device, and the Aina Mobile Application. It is intended to be used for quantitative measurement of % HbA1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood. It is intended for in-vitro diagnostic use by healthcare professionals in a laboratory environment to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not in the diagnosis of or screening for diabetes or for use on neonates.
The system consists of the Aina 2 Automated HbA1c Device for sample processing that connects to a smartphone via Bluetooth, the Aina Device for optical test strip readout, Aina HbA1c Test Kits which contain all the reagents necessary for running each HbA1c test, and the Aina Mobile Application. The Aina Device is a reflectance-based colorimetric sensor device that connects to the mobile device through the audio jack. The smartphone runs the Aina Mobile Application, which is software that allows for user interaction and illustrates the step-by-step testing process on its touchscreen. The Aina Mobile Application software is responsible for analyzing the optical signals measured by and transferred to it by the Aina Device, including applying analysis algorithms to compute the HbA1c reading. In addition, the Aina Mobile Application controls the functioning of the Aina 2 Automated HbA1c Device by sending it commands via Bluetooth. Streck A1c-Cellular control solutions can be used for regular quality control checking of the system.
Here's an analysis of the acceptance criteria and study details for the Aina HbA1c Monitoring System 2, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail thresholds. However, it does present performance data from various studies. Based on the data provided, the implied acceptance criteria would be that the device demonstrates comparable performance to established methods and exhibits suitable analytical performance characteristics.
| Performance Metric (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|
| Measuring Range | 4.4-13.4% HbA1c (Compared to predicate: 4-15% HbA1c) |
| Total Hemoglobin Range | 7.2-20 g/dL (Compared to predicate: 6-20 g/dL) |
| Repeatability (Blood Samples) | Normal (5.4% HbA1c): Total SD 0.2%, CV 4.2% |
| Elevated (6.1% HbA1c): Total SD 0.2%, CV 3.7% | |
| High (11.1% HbA1c): Total SD 0.4%, CV 3.2% | |
| Repeatability (Control Solutions) | Level 1 (5.9% HbA1c): Total SD 0.22%, CV 3.7% |
| Level 2 (13.4% HbA1c): Total SD 0.38%, CV 2.8% | |
| Linearity/Assay Reportable Range | Linear range from 4.4% to 13.4% HbA1c. |
| Linear regression: y(%HbA1c) = 1.01x - 0.08; R=0.998 | |
| Interfering Substances | No significant interference observed for various endogenous and exogenous substances (e.g., Bilirubin, Triglycerides, Cholesterol, Glucose, Drugs, Hemoglobin C, D, E, S, A2). |
| WARNING: Significant negative interference from Hemoglobin F (HbF). | |
| Specimen Stability | Whole blood samples stable for up to 10 days when stored at 2 to 8°C. |
| Clinical Accuracy (Regression Analysis vs. Tosoh G8) | Passing-Bablok: Slope 1.0 (95% CI: 0.9792 - 1.041), y-Intercept -0.20 (95% CI: -0.4929 - 0.0377) |
| Weighted Deming: Slope 1.003 (95% CI: 0.9679 - 1.038), y-Intercept -0.1924 (95% CI: -0.4465 - 0.0618) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Clinical Accuracy): n=132 (for regression analysis) fresh prospective venous whole blood samples.
- Data Provenance: Samples collected from study participants at three (3) clinical sites. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a company based in Boston, MA, suggesting the clinical sites were likely in the United States. The study design was prospective (fresh samples).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The ground truth for the clinical accuracy study was established using the Tosoh G8 reference method. This is an automated laboratory analyzer, considered a high-performance liquid chromatography (HPLC) system, which is a widely accepted reference method for HbA1c measurement.
- No human "experts" were used to establish the ground truth in terms of reading images or diagnosing. The ground truth was based on the measurement from a validated reference instrument.
4. Adjudication Method for the Test Set:
- This is not applicable as the ground truth was established by an automated reference method (Tosoh G8) rather than human experts requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic (IVD) measurement system, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers improving with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Yes, the performance studies described are for the "Aina HbA1c Monitoring System 2" acting as a standalone device. While healthcare professionals operate the device, the reported performance metrics (repeatability, linearity, clinical accuracy) are of the device as a measurement system. The "Aina Mobile Application" applies analysis algorithms to compute the HbA1c reading, which is the core of its "standalone" algorithmic performance.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- The ground truth for the clinical accuracy study was established using a validated reference laboratory method: the Tosoh G8 for HbA1c measurement. This is considered a highly accurate and standardized method.
8. The Sample Size for the Training Set:
- The document does not provide information on the sample size used for the training set. This is a common omission in 510(k) summaries for IVD devices, as the focus is typically on the analytical and clinical validation of the final product, rather than the deep learning model's training specifics. It does mention the "Aina Mobile Application software is responsible for analyzing the optical signals measured by and transferred to it by the Aina Device, including applying analysis algorithms to compute the HbA1c reading," implying there are algorithms that would have been developed and potentially "trained," but no training data specifics are given.
9. How the Ground Truth for the Training Set Was Established:
- Since no information about a dedicated training set is provided, the method for establishing its ground truth is also not detailed. Assuming standard IVD development, any internal optimization or calibration (which might be analogous to "training") would typically use samples characterized by a reference method similar to, or the same as, the one used for the clinical validation (e.g., Tosoh G8 or other established HbA1c reference methods).
§ 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).