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510(k) Data Aggregation
(184 days)
The S-Test Hemoglobin A1c Reagent is intended for the quantitative determination of percent Hemoglobin A1c concentration in EDTA whole blood using the S40 Clinical Analyzer. Measurement of glycosylated hemoglobin is used for monitoring the long-term glycemic control of individuals with diabetes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Hemoglobin A1c (HbA1c) reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of %HbA1c concentration in EDTA whole blood. This method is based on a colorimetric assay for total hemoglobin and an enzymatic assay for HbA1c.
Acceptance Criteria and Study Details for S-Test HbA1c Reagent Cartridge (K091711)
This document describes the acceptance criteria and supporting study details for the S-Test HbA1c Reagent cartridge, as presented in the 510(k) summary K091711.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the precision and accuracy data presented in the 510(k) summary. Given this is a diagnostic assay for a quantitative measure, the acceptance criteria are generally focused on demonstrating acceptable levels of precision and linearity/correlation with a comparative method.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Precision | ||
| Within-run CV | ≤ X% (typical clinical range) | 0.9 to 1.1% (3 HbA1c levels, 20 days, lab) 0.5 to 1.8% (3 POL sites, 5 days) |
| Total CV | ≤ Y% (typical clinical range) | 1.2 to 1.5% (3 HbA1c levels, 20 days, lab) 0.7 to 3.2% (3 POL sites, 5 days) |
| Accuracy | ||
| Correlation | Correlation coefficient $\ge$ 0.95 | 0.982 (110 samples, lab) 0.988 to 0.996 (3 POL sites) |
| Slope | 0.95 to 1.05 | Confidence Interval: 0.988 to 1.062 (lab) Confidence Interval: 0.957 to 1.065 (3 POL sites) |
| Intercept | Close to 0 (e.g., -0.5 to 0.5) | Confidence Interval: -0.48 to 0.02 (lab) Confidence Interval: -0.64 to 0.16 (3 POL sites) |
| Standard Error of Estimate | Clinically acceptable (e.g., < 0.5%) | 0.39 (110 samples, lab) 0.18 to 0.31 (3 POL sites) |
Note: The specific numerical acceptance criteria (e.g., maximum CV values, exact correlation coefficients) are not explicitly stated as "acceptance criteria" in the summary. However, the reported device performance is presented as evidence of meeting acceptable standards for a diagnostic device of this type, benchmarked against predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size (Accuracy Study): 110 EDTA whole blood samples.
- Data Provenance: The summary does not explicitly state the country of origin. It indicates studies conducted "in a correlation study" (presumably at the manufacturer's site or a central lab) and also "at three separate Physician Office Laboratory (POL) sites." The nature of the studies (correlation, precision over time) suggests retrospective and prospective components (e.g., samples collected and then tested, or runs performed over several days).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for this device (S-Test HbA1c) is established by a "comparative method" or "predicate device" which is itself a legally marketed and validated assay for HbA1c. Therefore, there are no human experts establishing a subjective "ground truth" (e.g., like a radiologist reading an image). The ground truth is the numerical result provided by the established comparative method.
4. Adjudication method for the test set
Not applicable. Since the ground truth is established by a quantitative comparative method, there is no need for expert 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
Not applicable. This is a standalone in vitro diagnostic assay, not an AI-assisted interpretation device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done for the S-Test HbA1c Reagent cartridge used with the S40 Clinical Analyzer. The reported precision and accuracy data reflect the performance of the device itself (reagent + analyzer) in measuring HbA1c concentrations without human interpretive input. The "comparative method" used for accuracy also represents a standalone, established laboratory technique.
7. The type of ground truth used
The ground truth used for the accuracy studies was the quantitative result obtained from a comparative method (likely a legally marketed and established HbA1c assay, potentially the predicate device mentioned earlier or another accepted reference method) run on the same patient samples.
8. The sample size for the training set
Not applicable. This is a chemical/enzymatic assay system, not a machine learning or AI-based device that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. (See #8).
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