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The Smartest™ Glucowise Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.

It is not intended for the diagnosis or screening for diabetes mellitus.

The Smartest™ Glucowise Blood Glucose Monitoring System has the same intended use as previously cleared for the Smartest™ SuperCheck I Blood Glucose Monitoring System (K091815).

The Smartest™ Glucowise Blood Glucose Monitoring System has done a cleaning and disinfection validation test to comply with "Letter to Manufacturers of Blood Glucose Monitoring Systems Listed with the FDA" dated September, 30th, 2010.

For single patient use

Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S

The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise Blood Glucose Monitoring System Model 1 6267-S is intended to be used by a single person and should not be shared.

The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S 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 Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Smartest™ Glucowise Test Strips are for use with the Smartest™ Glucowise Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm.

The Smartest™ Glucowise Control Solutions are for use with the Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S as a quality control check to verify that the meter and test strips are working together properly.

For multiple patient use

Smartest™ Glucowise MULTI Blood Glucose Monitoring System, Model 6267-M

The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancets.

The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Smartest™ Glucowise MULTI Test Strips are for use with the Smartest™ Glucowise MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm.

The Smartest™ Glucowise MULTI Control Solutions are for use with the Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M as a quality control check to verify that the meter and test strips are working together properly.

The Smartest™ Glucowise Blood Glucose Monitoring System (Model 6267-S, 6267-M) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use. The data download functionality is optionally available and sold separately.

To perform a test, a glucose test strip is inserted into the top of the device. When a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured.

The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.

Here's an analysis of the provided text regarding the Smartest™ Glucowise Blood Glucose Monitoring System, focusing on acceptance criteria, performance, and study details.

Important Note: The provided text is a 510(k) summary for a Special 510(k) submission. A Special 510(k) is used when a modification to an already cleared device does not significantly alter its safety or effectiveness. In this case, the modification was the removal of a "talking feature." Therefore, the submission primarily focuses on demonstrating that this change does not negatively impact the device's original performance, rather than conducting a full de novo performance study for the original device. This means much of the detailed performance data and study specifics (like sample sizes for training/test sets, expert qualifications, etc.) for the glucose measurement function itself are likely contained within the predicate device's (K091815) original submission, which is not included here. This document leverages the previous clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) and the primary modification is the removal of a talking feature, the document does not explicitly state new, specific acceptance criteria for glucose measurement performance. Instead, it asserts that the device's performance remains equivalent to the predicate device (Smartest™ SuperCheck 1, K091815), which was already cleared by the FDA.

Therefore, the "reported device performance" is essentially that the Smartest™ Glucowise system retains the performance characteristics of the Smartest™ SuperCheck 1, as the modification (removing the talking feature) is stated to "not affect the intended use of the device, and it will not significantly affect safety or effectiveness."

To understand the actual numerical acceptance criteria for glucose measurement accuracy, one would need to refer to the original K091815 submission for the predicate device.

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

The provided document does not specify a sample size for a test set related to the glucose measurement accuracy for the Smartest™ Glucowise device. This is because the submission is a "Special 510(k)" relying on the equivalence to a previously cleared device where only a non-performance-affecting modification (removal of a talking feature) was made.

The document states: "Biotest Medical Corp. has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device... meet the design input requirements." This suggests internal testing was done to confirm the removal of the talking feature did not inadvertently introduce new risks or affect existing functionalities. However, no details on test set sizes or data provenance for these specific "verification and validation activities" are provided in the summary.

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

This information is not provided in the document. For a glucose monitoring system, "ground truth" for blood glucose levels is typically established using laboratory reference methods (e.g., YSI glucose analyzer), not expert consensus in the traditional sense of medical imaging or diagnosis. Since this is a Special 510(k), explicit details on expert involvement (beyond internal validation engineers) are not expected for this specific modification.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are typically relevant for studies where human interpretation of data (e.g., medical images) is involved and multiple experts' opinions need to be reconciled. For a blood glucose meter, the "ground truth" is typically a quantitative laboratory measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done for this submission. MRMC studies are generally applicable to interpretive tasks where human readers' performance is being evaluated, often with and without AI assistance. This device is a blood glucose meter, which provides a quantitative reading, not an interpretive one involving human readers for diagnosis.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This document does not describe a standalone performance study in the context of an "algorithm only" as typically discussed for AI/ML devices. The device is a standalone glucose measurement system. Its performance is evaluated by comparing its readings to a reference method, not by assessing an algorithm's performance in isolation from the hardware.

The entire device is the "standalone" measurement system, and its performance for glucose measurement would have been established and cleared in the predicate device's submission (K091815). The current submission leverages that prior clearance.

7. Type of Ground Truth Used

Based on the nature of a blood glucose monitoring system, the ground truth for glucose measurements would typically be established using a laboratory reference method (e.g., YSI glucose analyzer) that provides highly accurate and precise glucose concentration values. This document does not explicitly state the ground truth method, but it is implied by the "quantitative measurement of glucose."

8. Sample Size for the Training Set

This information is not provided in the document. The device is a traditional electrochemical blood glucose meter, not a machine learning model that requires a "training set" in the common understanding of AI/ML. Its operational parameters are determined through calibration and manufacturing processes, not by training on a large dataset in the AI sense.

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

As noted above, the concept of a "training set" as it applies to AI/ML devices is not relevant here. The device uses established chemical principles to measure glucose. Therefore, there is no "ground truth for the training set" to be established in the context of machine learning.

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