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The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The GLUCOCARD Shine Express 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 GLUCOCARD Shine Blood Glucose Test Strips are for use with the GLUCOCARD Shine Express Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

The GLUCOCARD Shine Connex Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The GLUCOCARD Shine Connex 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 GLUCOCARD Shine Blood Glucose Test Strips are for use with the GLUCOCARD Shine Connex Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

The GLUCOCARD Shine Connex Blood Glucose Monitoring System consist of a hand held GLUCOCARD Shine Connex Blood Glucose Meter, GLUCOCARD Shine Blood Glucose Test Strip, and GLUCOCARD Shine Glucose Control Solution. The GLUCOCARD Shine Express Blood Glucose Monitoring System consist of a hand held GLUCOCARD Shine Express Blood Glucose Meter, GLUCOCARD Shine Blood Glucose Test Strip, and GLUCOCARD Shine Glucose Control Solution. The two candidate test systems are derived from the same design platform as their predicate device, CareSens N Premier Blood Glucose Monitoring System/CareSens N Premier BT Blood Glucose Monitoring System (K170614). The candidate devices are modified versions of the predicate device to suit the market needs for test systems with Bluetooth and talking features. The GLUCOCARD Shine Connex Blood Glucose Meter is a Bluetooth meter, similar to the CareSens N Premier BT Blood Glucose Meter, whereas the GLUCOCARD Shine Express Blood Glucose Meter is enabled with a talking feature (English and Spanish).

Both candidate devices are used with the GLUCOCARD Shine Blood Glucose Test Strip and GLUCOCARD Shine Glucose Control Solution, which are the same in chemical composition, fundamental scientific technology, intended use and operating principle as with the components of the predicate device, cleared in K170614. The only difference between the test strip & control solution of the candidate device and the ones of the predicate device is the brand name.

This is a medical device application for two blood glucose monitoring systems, GLUCOCARD Shine Connex and GLUCOCARD Shine Express. As such, the acceptance criteria are based on established performance standards for blood glucose meters, primarily ISO 15197:2013 or equivalent.

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1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for accuracy or precision, nor does it provide specific numerical performance results for the new devices. However, it does refer to "pre-determined Pass/Fail criteria" and concludes that the device passed "all of the tests."

For blood glucose monitoring systems, a common standard for accuracy is ISO 15197:2013, which typically requires:

• For glucose concentrations < 100 mg/dL: 95% of results must be within ±15 mg/dL of the reference method.
• For glucose concentrations ≥ 100 mg/dL: 95% of results must be within ±15% of the reference method.

Given that this is a 510(k) submission and the device is deemed substantially equivalent, it implies that the device met similar, if not identical, criteria to its predicate device (CareSens N Premier BGMS/CareSens N Premier BT BGMS, K170614), which would have needed to meet such standards.

Inferred Table:

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

The document does not explicitly state the sample size for the clinical or analytical test set used for performance evaluation of the GLUCOCARD Shine Connex or GLUCOCARD Shine Express. It only mentions:

• "Verification, validation and testing activities were conducted to establish the performance, functionality and liabilities of the modified devices."
• "The device passed all of the tests based on pre-determined Pass/Fail criteria."

Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is typically not applicable for blood glucose monitoring systems. The "ground truth" for blood glucose measurements is established by a highly accurate laboratory reference method (e.g., YSI analyzer), not by expert consensus. Therefore, no "experts" in the human reviewer sense are used for establishing the ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable for blood glucose monitoring systems. The ground truth is determined by an objective, quantitative laboratory reference method, not by human adjudication of images or clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. Blood glucose monitoring systems are standalone diagnostic devices and do not involve human "readers" interpreting results in a way that would necessitate an MRMC study or AI assistance. The device directly provides a numerical glucose value.

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

Yes, the performance evaluation performed for this device is a standalone performance assessment. Blood glucose meters are designed to provide a direct, quantitative glucose measurement without human interpretation or intervention in the measurement process itself. The "device performance" mentioned refers to the accuracy and precision of the meter and test strip system in autonomously measuring glucose.

7. The Type of Ground Truth Used

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method known for its high accuracy and precision, such as a YSI glucose analyzer, measuring glucose in plasma or whole blood. The document doesn't explicitly name the reference method used but this is the standard practice.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device performance studies. Blood glucose monitoring systems are not typically developed using machine learning models that require distinct training sets for their primary measurement function. Their performance is validated through analytical and clinical studies.

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

As explained in point 8, a "training set" in the machine learning sense is not applicable here. The ground truth for the validation of the device's accuracy would be established by the laboratory reference method, as described in point 7.

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