Search Results

For in vitro diagnostic use only. The extendSURE™ lyophilized hemoglobin A1c linearity controls are intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories.

The extendSURE™ Lyophilized Hemoglobin A1c Linearity Controls comprises one vial each of 5 equally spaced levels of HbA1c control, 1 vial of reconstitution fluid and a product information sheet. The product is provided in a lyophilized form and each vial is reconstituted with 0.25 mL of reconstitution fluid (0.09% sodium azide) prior to use.

Here's a summary of the acceptance criteria and the study details for the extendSURE™ Lyophilized Hemoglobin A1c Linearity Controls, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of typical AI/ML device validation where a distinct, prospectively collected, or independently curated dataset is used to evaluate the final performance of an algorithm against ground truth.

Instead, the performance characteristics are related to stability studies, which involve testing the device itself over time on various laboratory instruments.

• Sample Size: The document does not specify the number of individual control vials or measurements used in the stability studies. It simply mentions "Stability studies...were performed."
• Data Provenance: The studies were conducted by Canterbury Scientific Ltd. It's an internal study presumably performed in New Zealand based on the company's location. The data is retrospective in the sense that the stability studies were completed and then reported for the 510(k) submission.

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

Not applicable. This device is a linearity control, not an AI/ML algorithm that generates a diagnostic output requiring expert interpretation for ground truth. The "ground truth" here is the chemical stability and performance of the control material itself when measured by laboratory instruments. The "truth" is established by the known concentration ranges of HbA1c in the control material and its linearity when tested on specific instruments.

4. Adjudication Method for the Test Set

Not applicable, for the same reasons as above.

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 not an AI/ML diagnostic aid. It is a quality control material.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating the performance of the linearity controls is:

• Analytical Performance: The inherent chemical stability of the HbA1c levels within the control material over time and under various storage conditions.
• Instrument Measurements: The ability of the control material to demonstrate linearity when measured by established and validated laboratory instruments (e.g., Bayer DCA 2000, BioRad Variant Classic). The "truth" is whether the measured values on these instruments fall within expected ranges and demonstrate
  linearity across the specified range.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable, for the same reasons as above. The "ground truth" for the linearity controls themselves is established during their manufacturing process, where specific concentrations of HbA1c are formulated, and then confirmed through extensive stability and performance testing against known analytical methods on various laboratory platforms.

Ask a specific question about this device