Search Results
Found 1 results
510(k) Data Aggregation
(207 days)
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 ($<3%$) are generally considered good for hemoglobin measurement.
| Performance Characteristic | Acceptance Criteria (Inferred / Implied) | Reported Device Performance |
|---|---|---|
| Linearity | Device should be linear across its operational range. | Linear range of 5 to 24 g/dL. |
| Precision (Non-Clinical) | Low %CV values, indicating reproducibility. | Level 1: %CV for Total Hb not explicitly provided (table unreadable). Level 2: %CV for Total Hb not explicitly provided (table unreadable). Level 3: %CV for Total Hb not explicitly provided (table unreadable). |
| Precision (Clinical - Site 1) | Low %CV values across different Hb levels. | Level 1 (5.6 g/dL): 1.0% CV Level 2 (11.1 g/dL): 2.1% CV Level 3 (14.3 g/dL): 2.0% CV |
| Precision (Clinical - Site 2) | Low %CV values across different Hb levels. | Level 1 (5.3 g/dL): 0.8% CV Level 2 (10.7 g/dL): 2.8% CV Level 3 (13.7 g/dL): 1.4% CV |
| Precision (Clinical - Site 3) | Low %CV values across different Hb levels. | Level 1 (5.4 g/dL): 1.2% CV Level 2 (10.8 g/dL): 3.0% CV Level 3 (14.1 g/dL): 2.3% CV |
| Accuracy (Capillary vs. HiCN) | High correlation (r ≈ 1), Slope ≈ 1, y-intercept ≈ 0. | n=177, Min=9.5 g/dL, Max=18.0 g/dL, Slope=1.02, y-intercept=0.13, "r"=0.97 |
| Accuracy (Venous vs. HiCN) | High correlation (r ≈ 1), Slope ≈ 1, y-intercept ≈ 0. | n=224, Min=5.1 g/dL, Max=23.5 g/dL, Slope=1.04, y-intercept=-0.42, "r"=0.99 |
| Interference | No significant interference from common substances at specified concentrations. | Not affected by listed interferents at specified concentrations (Acetaminophen, etc.). |
Note: The precision summary table for the 20-day in-house precision test is largely unreadable in the provided text. Therefore, specific %CV values for that section cannot be extracted.
2. Sample Size Used for the Test Set and Data Provenance
- Linearity Study Test Set: 11 samples. Data provenance is implied to be in-house (non-clinical).
- 20-day In-house Precision Test Set: 80 per level (for 3 levels), totaling 240 measurements. Data provenance is in-house (non-clinical).
- Clinical Precision Study Test Set: 30 measurements per level per site, for 3 sites and 3 levels (total of 270 measurements). Data provenance is from "three external POL-type sites" (Physician's Office Laboratory), indicating prospective clinical data from human samples, likely from the US or a similar regulatory jurisdiction given the FDA submission.
- Clinical Accuracy Study Test Set:
- Capillary vs. HiCN: 177 patient samples.
- Venous vs. HiCN: 224 patient samples.
Data provenance is from "three US clinical sites," indicating prospective clinical data from human samples within the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. The Avie™ Total Hb Test System is an in vitro diagnostic (IVD) device that measures a quantitative biomarker (total hemoglobin). The "ground truth" for such devices is established by a reference method (HemoCue® 201+, hemiglobincyanide [HiCN]) rather than through expert consensus or interpretation of images/data by human experts.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth is established by a reference laboratory method (HiCN) and the predicate device (HemoCue® 201+), not by subjective expert assessment requiring adjudication.
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. This type of study typically applies to imaging or diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the AI's impact on human performance.
- The Avie™ Total Hb Test System is an automated IVD device that provides a quantitative result. Its performance is compared to a reference method, not to human reader interpretations. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done. The entire study, particularly the accuracy and precision sections, evaluates the Avie™ Total Hb Test System (device and strips) as an algorithm/system in measuring hemoglobin. The resulting numerical values (e.g., slope, intercept, 'r' value, %CV) represent the device's standalone performance compared to the reference method. There is no human interpretation component integrated into the device's core measurement process that would make it "human-in-the-loop" in the artificial intelligence sense.
7. The Type of Ground Truth Used
The ground truth used for the accuracy studies was:
- Reference Method: Hemiglobincyanide (HiCN) method (CLSI reference method, CLSI Doc H15-A3).
8. The Sample Size for the Training Set
The document does not explicitly describe a training set in the context of machine learning or AI algorithm development. The Avie™ Total Hb Test System is described as utilizing "general chemistry reactions" and "photometric measurement." It is a traditional IVD device, not an AI/ML-driven one. Therefore, the concept of a "training set" for an AI model is not applicable here. The device is factory-calibrated based on the HiCN method.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" in the AI/ML sense is not applicable. The device is factory calibrated against the HiCN method. This calibration process establishes the internal parameters and algorithms of the device to accurately convert photometric measurements into hemoglobin concentrations, using the HiCN method as the standard for correctness.
Ask a specific question about this device
Page 1 of 1