(610 days)
The Avie™ A1C System test is a point of care system that quantitatively measures % A1C (glycated hemoglobin) in capillary and venous whole blood. The Avie™ A1C System consists of the Avie™ A1C System Reader, Avie™ A1C System Test Cartridge and Avie™ A1C System Diluent. The test is for physician directed prescription home use and professional use to monitor glycemic control in patients with diabetes mellitus. Single use, auto-disabling lancing devices are to be used in the professional setting. The device cannot be used in patients with hemoglobinopathies of Hemoglobin C and Hemoglobin D.
The Avie A1C Test is a point of care system that utilizes a Reader and disposable test cartridges to measure %A1C in whole blood samples. Whole blood from either capillary of venous is directly applied to the sample port of a test cartridge. Insertion of the test cartridge into the reader automatically prompts the operator to add diluent. Addition of diluent lyses the red bloods cell which allows both the A1C and total hemoglobin analytes to be measured. The test completes in less than three (3) minutes. Both the A1C and Total Hemoglobin (Total Hb) analytes are measured using its own distinct wavelength. Hemoglobin from the lyzed blood is converted to met-hemoglobin and is read at 420 nm. The concentration of hemoglobin is directly proportional to the intensity of met-hemoglobin concentration. For A1C the lysed blood is mixed with anti-hemoglobin antibodies conjugated to colored microparticles. After a predetermined time the microparticle mixture is automatically released onto a reagent strip where the reacted and unreacted microparticle species are separated and read optically. The final displayed result is expressed as; %A1C = (A1C = Total Hb)×100. MEC Dynamics, Corp. calibrates the Avie™ A1C System using National Glycohemoglobin Standardization Program (NGSP) certified laboratory value assigned blood samples. Lot specific information is transferred to the Avie™ AIC Reader via radio frequency identification (RFID).
Here's a breakdown of the acceptance criteria and the study information for the Avie™ A1C System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state formal "acceptance criteria" in a numerical or target performance format (e.g., "accuracy must be > 95%"). However, it does report on performance metrics that would typically be used to assess the device's suitability. Based on the "Brief Description of Nonclinical Data" and "Brief Description of Clinical Data" sections, here's an interpretation of relevant performance characteristics:
| Performance Metric | Acceptance Criteria (Implied/Derived) | Reported Device Performance |
|---|---|---|
| Precision | %CV within 5% at normal and abnormal levels | Within 5% CV at each of two levels (normal and abnormal %A1C) |
| Linearity | Linear over the intended measurement range | Linear between 5 and 14 %A1C |
| Interference | Insensitive to high physiological levels of common interferents and therapeutic drug levels; sensitive to certain hemoglobin variants | Insensitive to high physiological levels of triglyceride and bilirubin, high therapeutic levels of various over-the-counter pharmaceuticals, and hemoglobin levels ranging from approximately 9 g/dL to 20 g/dL. May report unreliable results if high levels of Hemoglobin D, Hemoglobin C, or other hemoglobin variants are present. |
| NGSP Traceability | Certified traceability to NGSP standards | NGSP issued a certificate of traceability granting manufacturer certification to MEC Dynamics, Corporation. |
| User Capillary Blood Regression (Non-Professional vs. NGSP) | Strong correlation and close agreement to NGSP reference method | y = 0.976 (NGSP) + 0.151, r = 0.987 (174 subjects) |
| User Capillary Blood Regression (Professional vs. NGSP) | Strong correlation and close agreement to NGSP reference method | y = 0.973 (NGSP) + 0.172, r = 0.988 (174 subjects) |
| User Capillary Blood Regression (Non-Professional vs. Professional) | Strong correlation and close agreement between user types | y = 0.998 (Professional Users) + 0.019, r = 0.984 (169 sample pairs) |
| Professional Venous Blood Regression (Professional vs. NGSP) | Strong correlation and close agreement to NGSP reference method | y = 0.972 (NGSP) + 0.210, r = 0.993 (279 whole blood samples) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- For non-professional user capillary results: 174 subjects
- For professional user capillary results: 174 subjects
- For comparison between professional and non-professional capillary users: 169 capillary sample pairs
- For professional user venous results: 279 whole blood samples
- Data Provenance: The document does not explicitly state the country of origin for the data. It mentions "Clinical studies were conducted across four sites" and "Venous blood was collected and sent to the NGSP laboratory in Columbia, MO," indicating the clinical data was likely collected in the United States and sent to a US-based reference lab. The data is prospective as it describes studies being conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The ground truth for the clinical studies (determination of %A1C values) was established by the National Glycohemoglobin Standardization Program (NGSP) laboratory in Columbia, MO.
- The number and specific qualifications of individual experts at the NGSP laboratory are not detailed in the provided text, but the NGSP provides "certified laboratory value assigned blood samples" and "a certificate of traceability," implying a high level of expertise and standardized methodology.
4. Adjudication Method for the Test Set
- The document implies that the NGSP laboratory results serve as the definitive ground truth for comparison. There is no mention of an adjudication method for the test set data between multiple readers or methods other than the direct comparison of the Avie™ A1C system's results against the NGSP reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, an MRMC comparative effectiveness study was not explicitly described in the provided text. The study compares the device's performance against a reference method (NGSP) and also compares professional vs. non-professional users of the device itself. It does not assess the improvement of human readers with AI vs. without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone performance assessment was done. The Avie™ A1C System is a point-of-care device that directly measures %A1C. The clinical studies compare the device's output (whether operated by a professional or non-professional) directly against the NGSP reference standard. This is a standalone assessment of the device's measurement capabilities. The "algorithm" in this context refers to the internal workings of the device to produce the %A1C result.
7. The Type of Ground Truth Used
- The primary ground truth used was NGSP certified laboratory values, which represent a standardized and highly accurate reference method for glycated hemoglobin (A1C) measurement. This is a form of expert consensus on a standardized analytical method.
8. The Sample Size for the Training Set
- The document does not specify a sample size for a training set. The described studies are performance evaluations (clinical and non-clinical) of the device. The device itself is calibrated using "NGSP certified laboratory value assigned blood samples," and lot-specific information is transferred via RFID. This suggests that the device's internal algorithms and calibrations are established via a robust process, but specific "training set" details are not provided for a machine learning context.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, the document states: "MEC Dynamics, Corp. calibrates the Avie™ A1C System using National Glycohemoglobin Standardization Program (NGSP) certified laboratory value assigned blood samples." This indicates the ground truth for calibration (which can be considered analogous to "training" in a broad sense for a medical device) is established by using NGSP-certified reference materials with known, highly accurate %A1C values.
§ 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).