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The skyla Hi Hemoglobin A1c System, consisting of the skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA Ic %) in venous and finger-stick capillary whole blood.

The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus.

This system is intended for clinical laboratory and point-of-care use.

This test is not for screening or diagnosis of diabetes.

The skyla Hi Analyzer is a portable and compact system, and was designed with skyla Hi Hemoglobin A1c Reagent Kit for on-site quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in human blood.

The provided document describes the FDA 510(k) clearance for the Skyla Hi Hemoglobin A1c System. This is an in-vitro diagnostic device that measures glycated hemoglobin (HbA1c %) in blood for monitoring long-term glycemic control in persons previously diagnosed with diabetes mellitus.

Therefore, the acceptance criteria and study detailed below relate to the analytical and clinical performance of this diagnostic device, not an AI/ML-based device. The concepts of "experts establish ground truth," "adjudication," "multi-reader multi-case," and "standalone algorithm performance" are not directly applicable in the context of an in-vitro diagnostic device clearance, as these are typically used for imaging or AI/ML-driven diagnostic aids.

However, I can extract and present the performance data and study design details relevant to this type of device based on the provided text.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for an in-vitro diagnostic device typically involve precision (reproducibility and repeatability) and method comparison (accuracy against a reference method). The reported device performance is demonstrated through studies detailed in the "Discussion of Non-Clinical Tests Performed" and "Discussion of Clinical Tests Performed" sections.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

• Patient 1 (Mean 5.04%): 0.095 SD (1.9% CV)
• Patient 2 (Mean 5.56%): 0.110 SD (2.0% CV)
• Patient 3 (Mean 6.54%): 0.135 SD (2.1% CV)
• Patient 4 (Mean 7.96%): 0.198 SD (2.5% CV)
• Patient 5 (Mean 12.10%): 0.292 SD (2.4% CV)
• Control 1 (Mean 5.20%): 0.130 SD (2.5% CV)
• Control 2 (Mean 9.69%): 0.260 SD (2.7% CV)
• Calibrator 1 (Mean 13.58%): 0.138 SD (1.0% CV) |
  | Linearity | Demonstrated linearity across the claimed measuring range. | Evaluated (mentioned as "Evaluations included linearity"), but specific results/range are not provided in the summary. |
  | Method Comparison (Accuracy/Correlation) | Demonstrated strong correlation and agreement with a legally marketed comparator device or a recognized reference method. (Typically assessed via regression analysis, bias analysis, or Bland-Altman plots with acceptable limits). | Against Bio-Rad VARIANT II Hemoglobin testing system:
• Venous Whole Blood: y = 0.9945x + 0.0779
• Finger-stick Capillary Blood: y = 0.9993x + 0.0589
  (Conclusion: "comparable to comparative device whole blood testing results.") |
  | Interference | Demonstrated that common interfering substances do not significantly impact results. | Evaluated (mentioned as "Evaluations included interference"), but specific results/substances are not provided in the summary. |
  | Sample Volume | Demonstrated consistent performance across acceptable sample volume ranges. | Evaluated (mentioned as "Evaluations included sample volume"), but specific results/ranges are not provided in the summary. |
  | Hematocrit | Demonstrated consistent performance across a range of hematocrit levels. | Evaluated (mentioned as "Evaluations included hematocrit"), but specific results/ranges are not provided in the summary. |

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Precision Test Set:

     • Total samples: 8 different samples (5 patient samples, 2 control samples, 1 calibrator).
     • Total runs/measurements: For each sample, 80 measurements were performed at each of the 3 sites, totaling 240 measurements per sample type. This is broken down into within-run, between-run, and between-day components.
     • Provenance: Not explicitly stated, but typically these are controlled laboratory studies using patient samples, control materials, and calibrators. The presence of "Site 1, Site 2, Site 3" indicates a multi-site study. It is likely prospective collection for study purposes. Country of origin for data is not specified.

   • Method Comparison Test Set (POC User Performance Study):

     • Total samples: A total of 243 samples were analyzed.
     • Provenance: The study was performed in "POC sites by intended operators," suggesting a prospective clinical study environment. The samples included both venous whole blood and finger-stick capillary samples. Country of origin for data is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable in the context of an in-vitro diagnostic device like an HbA1c assay. The "ground truth" for HbA1c measurements is established by a reference method, not by expert consensus or interpretations. In this case, the Bio-Rad VARIANT II Hemoglobin testing system served as the comparator/reference method for the method comparison study.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation of complex data (e.g., medical images) where there can be inter-reader variability. For an HbA1c assay, the output is a quantitative numerical value, and the comparison is direct to a reference method result.

4. 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 not an AI/ML-assisted diagnostic device, and there are no "human readers" interpreting images or similar data. The study is evaluating the analytical and clinical performance of a laboratory/point-of-care instrument.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. While the device (Skyla Hi Hemoglobin A1c System) operates independently to produce a numerical result, the concept of "standalone algorithm performance" typically applies to AI/ML systems generating an output that would then be presented to a human for review/decision. Here, the device is the analytical system. Its performance is demonstrated directly by the precision and method comparison studies.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the method comparison study was the results obtained from a legally marketed predicate device/reference method, specifically the Bio-Rad VARIANT II Hemoglobin testing system. The performance is assessed by correlating the results of the new device with this established method. For precision studies, there isn't a "ground truth" in the same sense; rather, the "true value" is approximated by the mean of many measurements, and variability around that mean is assessed.

7. The sample size for the training set:

   • This refers to the development of the device itself (e.g., calibration, reagent formulation, software algorithms). The document does not specify a "training set" size in the way it would for an AI/ML model. The device's internal algorithms and calibration are developed through internal R&D processes and validated with various studies (e.g., linearity, calibrator assignments), which are generally proprietary and not detailed in a 510(k) summary beyond their successful completion.

8. How the ground truth for the training set was established:

   • Not explicitly mentioned in the context of "training data" for an AI/ML model. For an in-vitro diagnostic device, the "training" (development and calibration) would involve using reference materials, calibrators traceable to international standards (if applicable for HbA1c, e.g., IFCC), and characterized patient samples, with their values established by highly accurate methods or external reference laboratories.

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