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The Avie™ Total Hb Test System is for the quantitative measurement of total hemoglobin in whole blood (capillary or venous EDTA,K2). The test system is designed for point-of-care use in primary care settings. The test system is for professional in vitro diagnostic use only.

The Avie™ Total Hb Test System is a point of care (POC) IVD system that utilizes general chemistry reactions to quantify total hemoglobin in fresh capillary blood and venous blood. The test system includes a small instrument (Reader) and disposable reagent strips- the strips are packaged in a reusable canister with desiccant, similar to the packaging of routine urine test strips. The concentration of total hemoglobin is calculated photometrically and is based on the optical intensity of the reaction within the quantitative area of the test strip. The calibration of the Avie™ Total Hb Test is traceable to the same high-order reference method as the HemoCue (hemiglobincyanide [HiCN].

Here's an analysis of the acceptance criteria and study details for the Avie™ Total Hb Test System based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for each performance metric (e.g., "Slope must be between 0.98 and 1.02"). Instead, it reports the results of the performed studies, implying that these results were considered acceptable for demonstrating substantial equivalence to the predicate device.

However, we can infer performance goals based on the reported values and the comparison to the HiCN method (a high-order reference method). The reported "r" values (correlation coefficients) close to 1.0 indicate a strong correlation, and slopes near 1.0 with y-intercepts near 0 indicate good agreement with the reference method. Precision %CV values in the low single digits ($

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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:

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.

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The Avie A1C test is a point of care system that quantitatively measures % A1C (glycated hemoglobin) in capillary or venous whole blood samples. The test is for prescription use and physician-directed home use to monitor glycemic control in patients with diabetes mellitus. The device cannot be used in patients with hemoglobinopathies of HbF, HbC, and HbD.

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This document is a 510(k) clearance letter from the FDA for the Avie A1C Test System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain the acceptance criteria or a study proving that the device meets such criteria.

The letter primarily focuses on:

• Confirming the device's substantial equivalence.
• Stating its regulatory classification (Class II).
• Outlining general controls and other FDA regulations the manufacturer must comply with.
• Providing contact information for various FDA offices.
• Including an "Indications for Use" statement for the device.

Therefore, based solely on the provided text, I cannot answer the requested questions about acceptance criteria and the study proving the device meets those criteria.

The requested information (acceptance criteria, device performance table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) would typically be found in the detailed premarket notification (510(k) submission) itself, or in supporting performance study reports, not in the final clearance letter.

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The Avie™ Alc test is a point of care system that quantitatively measures %A1C (glycated hemoglobin) in capillary or venous whole blood samples. The test is for prescription use and physician-directed home use to monitor glycemic control in people with diabetes mellitus. The device cannot be used in patients with hemoglobinopathies of HbF, HbC, and HbD.

The Avie A1C test system is for the quantitative measurement of %A1C in fingerstick whole blood at the point-of-care (Professional or Physician Directed Home Use). The system consists of a small instrument ("Reader), a single-use diluent solution vial, single-use reagent test cartridges, and control levels I and II solutions. To perform one test, the Reader is turned on by the push of a button on its top surface, and a self-check (optics and software) is performed automatically. If a malfunction is detected, the Reader displays an error message on the LCD display. When the LCD display denotes "Ready" a test cartridge is inserted into an unambiguous slot in the reader. About four uL of whole blood is delivered into a vial containing wash solution or diluent, via a transfer pipette, and the vial is inverted five times for mixing. At the instruction of the reader (LCD read-out), three drops of blood mixture are applied to a well in the cartridge: the reactions then proceed automatically. There are no further procedural steps, and results in %A1C are displayed on the reader's LCD screen in approximately three minutes. The concentration of A1C is expressed as a percentage of the total hemoglobin as follows: %HBA1C = (HBA1C ÷ TOTAL HB) ×100

Here's an analysis of the acceptance criteria and study information for the Avie™ A1C Test System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Study Test Set:
  • Approximately 150 subjects for the main clinical study (professional vs. self-testing analysis).
  • 109 subjects for the combined professional vs. self-testing sensitivity study.
  • 42 subjects for the untrained operator study.
  • 60 subjects for the comparison against the A1C Now+ predicate.
  • 60 subjects for the comparison of venous to capillary samples.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data. It mentions "four sites" and "three sites" for the clinical studies and "NGSP laboratory in Columbia. MO" for ground truth testing. This suggests the studies were likely conducted within the United States. The studies are described as clinical studies, implying they are prospective as participants actively performed tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The ground truth for the test set was established by sending collected venous blood samples to an NGSP laboratory in Columbia, MO.
• The document does not specify the number of experts (e.g., lab technicians, certified professionals) within the NGSP laboratory who processed and analyzed these samples.
• The qualifications of these experts are implied by the NGSP (National Glycohemoglobin Standardization Program) certification, which signifies adherence to standardization and quality control for HbA1c testing. Specific individual qualifications (e.g., years of experience as a clinical chemist) are not provided.

4. Adjudication Method for the Test Set

• The document does not describe an explicit "adjudication method" in the context of expert consensus for image or diagnostic interpretation typically found in AI/ML device studies.
• Instead, the ground truth was derived from a single, standardized laboratory method performed by an NGSP-certified laboratory. The device's performance was then compared to this reference standard. Therefore, there was no multi-reader adjudication process as such.

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

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with or without AI assistance.
• This device (Avie™ A1C Test System) is a diagnostic instrument for quantitative measurement of A1C, not an AI or imaging diagnostic aid that assists human readers.
• The studies involved comparing the device's readings to laboratory reference methods and evaluating performance by professional and self-testing users, and trained vs. untrained operators, but not human interpretation aided by AI.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

• Yes, the primary evaluation of the Avie™ A1C Test System's performance (its "algorithm only") was done in a standalone manner against the NGSP reference method. The "Professional" and "Self" testing studies reflect the device's performance when used by different types of operators (humans-in-the-loop), but still measure the device's output against the ground truth.
• The regression statistics (e.g., "Avie = 0.95 (NGSP) + 0.004 r = 0.94") directly reflect the standalone performance of the device's measurement compared to the reference.

7. The Type of Ground Truth Used

• The ground truth used was laboratory reference measurements of %A1C from venous blood samples, performed by an NGSP-certified laboratory. This is a highly standardized and accepted method for determining HbA1c levels.

8. The Sample Size for the Training Set

• The document does not provide information regarding a separate training set. This is typical for a diagnostic device like the Avie™ A1C Test System, which is based on a fixed immunoassay methodology rather than a machine learning or AI model that requires explicit training data. The device is likely calibrated at the factory.

9. How the Ground Truth for the Training Set Was Established

• As there's no mention of a traditional "training set" for an AI/ML model, the concept of establishing ground truth for it is not applicable here. The device's calibration would be established by the manufacturer using a separate, internal process traceable to NGSP standards, but this is distinct from an AI model's training data.

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