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The ReliOn™ Premier Classic Blood Glucose Monitoring System consists of the The ReliOn™ Premier Classic Blood Glucose Meter and the ReliOn™ Premier Blood Glucose Test Strips. The ReliOn™ Premier Classic Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternate sites such as the forearm, palm, thigh, and calf. Alternate site testing should be used only during steady-state blood glucose conditions. The ReliOn™ Premier Classic Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The ReliOn™ Premier Classic Blood Glucose Monitoring System consists of the The ReliOn™ Premier Classic Blood Glucose Meter and the ReliOn™ Premier Blood Glucose Test Strips.

Here's a breakdown of the acceptance criteria and study information for the ReliOn™ Premier Classic Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only touches upon the regulatory approval and indications for use. It does not include a table explicitly stating acceptance criteria or detailed performance results against those criteria. Clinical performance data, often presented in tables conforming to ISO standards (e.g., ISO 15197 for blood glucose monitoring systems), would typically be found in the full 510(k) submission but are not present in this summary.

To illustrate what such a table would look like for a blood glucose monitoring system, I'll describe typical acceptance criteria based on ISO 15197 (a common standard for such devices), and then indicate that the provided document does not contain the performance data.

Hypothetical Table (Based on typical ISO 15197 standards; performance data not in document):

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

The provided document does not contain any information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). This information would typically be detailed in the study report itself.

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

The provided document does not contain any information regarding the number or qualifications of experts used to establish the ground truth. For blood glucose monitors, the "ground truth" (reference method) is typically established using a high-precision laboratory analyzer, not usually by human experts in the same way as, for example, diagnostic imaging.

4. Adjudication Method for the Test Set

As the "ground truth" for blood glucose monitors is typically an objective measurement from a laboratory reference method, an adjudication method (like 2+1, 3+1 consensus) for the test set is generally not applicable or mentioned in the context of device accuracy for this type of product.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

MRMC comparative effectiveness studies are typically performed for diagnostic imaging devices where human interpretation is a key component and the AI's role is to assist human readers. For a blood glucose monitoring system like the ReliOn™ Premier Classic, which is a standalone measurement device, an MRMC study is not relevant or applicable, and therefore, no information is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The ReliOn™ Premier Classic Blood Glucose Monitoring System is a standalone device. Its performance, as designed and intended, is the "algorithm only" or system-only performance without a human-in-the-loop directly interpreting the result for diagnostic purposes (the human reads the result and takes action, but doesn't "interpret" it in the way a radiologist interprets an image). Therefore, the accuracy and precision studies performed for such a device would inherently be standalone performance studies.

7. The Type of Ground Truth Used

For a blood glucose monitoring system, the ground truth is typically established by measurements from a laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer or similar) which is considered highly accurate and precise. The provided document does not explicitly state the type of ground truth used, but this is the standard practice for such devices.

8. The Sample Size for the Training Set

The provided document does not contain any information regarding the sample size for a training set. Blood glucose meters do not typically involve "training" a machine learning algorithm in the same way modern AI algorithms do. Their calibration and algorithms are developed based on extensive characterization using chemical and electrical engineering principles, and clinical/analytical validation. If there were "training data" for a calibration curve, it would be part of the device's inherent design and manufacturing process, rather than a separate "training set" in the AI sense.

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

As noted above, the concept of a "training set" and establishing ground truth for it, in the context of machine learning, is not explicitly applicable to a traditional blood glucose monitoring system. The device's calibration and measurement principles are based on established electrochemical reactions and sensor design, validated against laboratory reference methods.

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