(219 days)
This in vitro diagnostic method is intended to quantitatively measure Hemoglobin Alc (HbA1c) and Total Hemoglobin (Thb) in human blood on the Technicon RA family/opeRA instrument systems. Measurements obtained through this procedure can be used for monitoring the long-term care of persons with diabetes.
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The provided text describes the performance of the Technicon RA®/opeRA™ Systems Hemoglobin A1c/Total Hemoglobin assays in comparison to a predicate device (Ames DCA 2000® Hemoglobin method for HbA1c) and a reference method (NCCLS Reference Method for Total Hemoglobin).
Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that the provided text doesn't explicitly state "acceptance criteria" as pass/fail thresholds. Instead, it presents a comparison of the new device's performance against either a predicate device or a reference method. The implicit acceptance criteria are that the new device's performance should be comparable or within an acceptable range of these established methods.
Hemoglobin A1c (%)
| Metric | Acceptance Criteria (Predicate: Ames DCA 2000® Hemoglobin method) | Technicon RA®/opeRA™ Systems HbA1c Performance | Notes |
|---|---|---|---|
| Precision | Comparison presented at different mean % levels. | ||
| Mean % (low) | 5.2 (Total CV: 3.5-5.6%) | 5.7 (Total CV: 3.1%) | Technicon RA/opeRA shows slightly better precision (lower CV). |
| Mean % (mid) | 8.2 (Total CV: 2.4-4.9%) | 8.9 (Total CV: 2.6%) | Technicon RA/opeRA shows slightly better precision (lower CV). |
| Mean % (high) | 12.0 (Total CV: 3.3-4.9%) | 11.6 (Total CV: 2.0%) | Technicon RA/opeRA shows better precision (lower CV). |
| Analytical Range | 2.5 - 14.0% | 2.5 - 18% | Technicon RA/opeRA offers a wider analytical range. |
| Correlation | y = 1.09 x -0.39, n = 154, r = 0.99, Syx = 0.36 (where x = DCA 2000) | y = RA/opeRA, x = DCA 2000 (No explicit equation for RA/opeRA alone) | The correlation parameters are given for the RA/opeRA system when compared to DCA 2000, indicating strong correlation (r=0.99). |
| Expected Values | 4.5 - 5.7% | 4.4 - 6.0 % | The expected value ranges are very similar, indicating clinical agreement. |
Total Hemoglobin (g/dL)
| Metric | Acceptance Criteria (Reference: NCCLS Reference Method, Thb Document H15 - A2) | Technicon RA®/opeRA™ Systems Thb Performance | Notes |
|---|---|---|---|
| Precision | Not explicitly stated; presumably the NCCLS method provides a benchmark. | Comparison presented at different mean g/dL levels. | |
| Mean g/dL (low) | N/A | 10.6 (Within-Run CV: 0.6%) | Low within-run CV, indicating good precision. |
| Mean g/dL (mid) | N/A | 15.3 (Within-Run CV: 0.7%) | Low within-run CV, indicating good precision. |
| Mean g/dL (high) | N/A | 18.6 (Within-Run CV: 0.9%) | Low within-run CV, indicating good precision. |
| Analytical Range | Not explicitly stated. | 7 - 23 g/dL | Wide analytical range. |
| Correlation | Implied good correlation based on the NCCLS standard. | y = 0.96 x + 0.13, n = 50, r = 0.988, Syx = 0.65 (where x = NCCLS method) | Strong correlation (r = 0.988) with the NCCLS reference method. Syx (standard error of the estimate) is low. |
| Expected Values | Not explicitly stated. | 12.3 - 17.9 g/dL | Consistent with general expected Hemoglobin ranges. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- HbA1c Correlation Test Set Sample Size: n = 154
- Total Hemoglobin Correlation Test Set Sample Size: n = 50
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
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)
This section is not applicable to this type of device (in vitro diagnostic assay). Ground truth for these assays is established through comparison to a well-characterized predicate device or an internationally recognized reference method, not by human expert consensus or interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., medical imaging, pathology slides where experts might disagree). For in vitro diagnostic assays, the "adjudication" is inherent in the analytical measurement and comparison to an established method.
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 section is not applicable. This is an in vitro diagnostic device for quantitative measurement, not an AI or software device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, this is effectively a standalone performance study. The reported data demonstrates the analytical performance of the Technicon RA®/opeRA™ Systems assays (the "algorithm/device only") in measuring HbA1c and Total Hemoglobin, independent of human interpretation or assistance during the measurement process. The results directly reflect the device's ability to produce quantitative values.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Hemoglobin A1c: The ground truth for comparative purposes was established by the Ames DCA 2000® Hemoglobin method, which was a previously FDA-cleared device regarded as substantially equivalent.
- For Total Hemoglobin: The ground truth for comparative purposes was established by the NCCLS Reference Method, Thb Document H15 - A2. This is a recognized scientific reference standard for Total Hemoglobin measurement.
8. The sample size for the training set
The document does not explicitly mention a training set sample size. This type of assay development typically involves assay optimization and validation rather than a distinct "training set" in the machine learning sense. The provided data likely represents validation or performance characterization studies.
9. How the ground truth for the training set was established
As there's no explicitly mentioned "training set" in the context of machine learning, this question is not applicable. Instead, the development of such assays involves rigorous analytical testing, standardization against known materials, and comparison to established methods to ensure accuracy and precision. The "ground truth" during development would be traceable to chemical standards, certified reference materials, and accepted analytical techniques.
§ 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).