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The Clever Choice Voice+ S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice Voice + S Blood Glucose Monitoring System is to be used by a single person and should not be shared. The Clever Choice Voice+ S 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 Clever Choice Voice+ S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady- state times (when glucose is not changing rapidly). The Clever Choice Blood Glucose Test +S Test Strips are for use with the Clever Choice Voice+ S Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice Voice+ S meters and Clever Choice +S Test Strips.

The Clever Choice Voice+ M Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice Voice + M Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. The Clever Choice + M Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady – state times (when glucose is not changing rapidly). The Clever Choice Blood Glucose +M Test Strips are for use with the Clever Choice Voice+ M Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice Voice+ M meters and Clever Choice +M Test Strips. Only auto-disabling, single use lancing devices may be used with this device.

The Clever Choice+ S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice+ S Blood Glucose Monitoring System is to be used by a single person and should not be shared. The Clever Choice+ S 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 Clever Choice+ S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady- state times (when glucose is not changing rapidly). The Clever Choice +S Blood Glucose Test Strips are for use with the Clever Choice+ S Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice+ S meters and Clever Choice +S Test Strips.

The Clever Choice Voice+ M Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice+ M Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. The Clever Choice Voice+ M Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady – state times (when glucose is not changing rapidly). The Clever Choice Blood +M Glucose Test Strips are for use with the Clever Choice+ M Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice+ M meters and Clever Choice +M Test Strips. Only auto-disabling, single use lancing devices may be used with this device.

Clever Choice Voice+ S Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, single use test strips, and the control solutions.

Clever Choice Voice+ M Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, multi use test strips, and the control solutions.

The four blood Glucose Monitoring system models are all based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. All of them use the same technological characteristics for testing with their predicate device. The appearance is different from their predicate device. The new Blood Glucose Monitoring Systems have a function of ejecting the used test strip, which is also different from their predicate device.

The provided 510(k) summary for the Simple Diagnostics Clever Choice Blood Glucose Monitoring Systems states that performance testing was conducted according to ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. However, the summary does not provide a detailed table of acceptance criteria or the specific reported device performance values against those criteria. It also lacks detailed information about the study design that would allow for a complete description of the elements requested in the prompt (sample sizes, expert qualifications, etc.).

Based on typical requirements for blood glucose monitoring systems and the information provided, here's an attempt to answer the questions, noting where information is missing:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states compliance with ISO 15197. This standard specifies accuracy criteria for blood glucose meters. Typical criteria for ISO 15197 are:

Note: The 510(k) summary only states that "Non-clinical test and clinical testing was done according to the above standard." It does not present the actual numerical results demonstrating this compliance for the Clever Choice systems. It implicitly states that the new devices were found to be substantially equivalent to the predicate device, which would imply they meet similar performance standards.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated in the provided document.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, clinical testing for ISO 15197 typically involves prospective collection of capillary blood samples from human subjects.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. For blood glucose monitoring systems, the "ground truth" (reference method) is usually established by a laboratory analyzer using a highly accurate method (e.g., YSI analyzer, hexokinase method), not by human experts. The operators performing the tests would be healthcare professionals or trained individuals.

4. Adjudication method for the test set:

• Given that blood glucose measurements typically rely on a reference laboratory method rather than qualitative expert interpretation, an adjudication method in the traditional sense (e.g., 2+1, 3+1 for image analysis) is not applicable. The reference method provides a definitive numerical value.

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 device is a blood glucose monitoring system, which directly measures glucose levels. It is not an AI-powered diagnostic imaging or interpretation system that would involve "human readers" or AI assistance in that context. Its performance is evaluated against a reference laboratory method.

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

• Yes, in essence. Blood glucose meters operate in a standalone manner. The device itself (meter and test strip) performs the measurement and displays the result. While a human initiates the test and reads the result, the core "algorithm" (the electrochemical reaction and conversion to a glucose value) functions without human intervention in the measurement process. The performance against the reference method (as per ISO 15197) is a standalone performance evaluation.

7. The type of ground truth used:

• Reference Laboratory Method: For blood glucose monitoring systems, the ground truth is established by a highly accurate laboratory analyzer (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer, or a method traceable to an international reference standard like the hexokinase method). This is considered an objective, high-accuracy measurement.

8. The sample size for the training set:

• Not applicable/Not provided. For a traditional electrochemical biosensor like this, there isn't a "training set" in the machine learning sense. The device's calibration and performance characteristics are determined by its physical and chemical design, manufacturing processes, and quality control. Initial characterization and chemical stability studies would be performed during development, but it's not a "training set" for an algorithm.

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

• Not applicable/Not provided. As there is no "training set" in the AI or machine learning sense for this type of device, the concept of establishing ground truth for a training set does not apply. The device's core functionality relies on established electrochemical principles, not a learnable algorithm.

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