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The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration, and the verification of reportable range for the glucose analyte.

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is an in-vitro diagnostic device consisting of sets of 5 levels of liquid, linearity material and additives in human based serum. The product contains the following analyte: glucose. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

Here's a breakdown of the acceptance criteria and study information for the Audit® MicroControls™ Linearity DROP LQ Blood Glucose device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides acceptance criteria for stability claims rather than performance metrics like sensitivity or specificity.

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

• The document mentions that multiple measurements were taken for the analyte at each level during value assignment and stability studies. However, specific sample sizes for a "test set" (e.g., number of unique samples or runs for a formal validation study) are not explicitly provided.
• Data Provenance: The studies were conducted internally by Aalto Scientific, Ltd. The data is retrospective for the completed accelerated stability study and real-time open vial stability, and prospective for the ongoing real-time shelf-life study. The country of origin of the data is not explicitly stated but can be inferred as the USA, where Aalto Scientific, Ltd. is located.

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

• This information is not applicable in the context of this device. The device is a quality control material used to verify the linearity, calibration, and reportable range of blood glucose measurement systems. The "ground truth" for this type of device is established through analytical value assignment based on measurements performed on a reference instrument, not through human expert interpretation of results.
• The document states: "Analyte value assignment for Level A through Level E was performed on Roche Cobas for the blood glucose analyte using the corresponding reagent. The analyte was measured multiple times. The mean value of the analyte was used to establish a target concentration value at each level."

4. Adjudication Method for the Test Set

• Not applicable. As the device is a quality control material and "ground truth" is established through analytical measurement, there is no human-based adjudication process for a test set in the conventional sense. The "adjudication" is inherent in the analytical measurement and statistical determination of mean values.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging AI) where human readers are making diagnoses. The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is a quality control material for analytical instruments, not an interpretative device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a control material, not an algorithm. Therefore, "standalone performance" in the context of an algorithm's accuracy without human intervention is not relevant. Its performance is measured by its stability and its ability to produce expected values when analyzed by a blood glucose measurement system.

7. The Type of Ground Truth Used

• The ground truth (or target values) for the device's glucose levels was established through analytical measurement on a reference instrument (Roche Cobas c501) with multiple measurements and calculation of the mean value. This is essentially an instrument-based reference value rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not explicitly stated and not directly applicable as this is a physical control material, not an AI/ML algorithm. The concept of a "training set" is typically used for machine learning models. For this device, the equivalent would be the data used for the "value assignment" to establish its target concentrations. The document mentions "The analyte was measured multiple times" for value assignment, but a specific number is not given.

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

• As explained in Point 7, the "ground truth" (target values) for the device's five levels (A-E) was established through repeated analytical measurements of the glucose analyte on a Roche Cobas c501 instrument. The mean of these multiple measurements was used to define the target concentration value for each level. Raw materials are subject to internal quality control.

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