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The microdot 9 Home Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use only), by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended for "single patient-home use" only and should not be shared. It should be used only for testing fresh capillary whole blood samples from a fingerstick or palm for glucose (sugar). Alternate site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus.

The system consists of the microdot® Home Blood Glucose meter, microdot® Home Test Strips and microdot® Control solutions.

microdot® Home Test Strips

The microdot® Home Test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick or palm.

The microdot® Home Blood Glucose Monitoring System consists of the microdot® Home Blood Glucose Meter, microdote Home Test Strips, microdot Control Solutions and a commercially available (510(k) cleared) lancing device and lancets. A clear cap is provided with the lancing device for alternate site testing on the palm. microdote Home Blood Glucose Monitoring System is for a single patient use only. The meter and lancing device must not be shared with anyone.

microdot® Home is an auto code system. The meter turns on upon insertion of the strip, a blood sample from the finger or palm is applied to the test strip and after 10 seconds, the plasma glucose result is displayed on the screen in mg/dL only.

microdot Home Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system, microdot® Xtra Blood Glucose Monitoring System. It relies on quantitative electrochemical biosensor technology to measure current generated on disposable test strips.

The strip remains unchanged since the last submission approval, microdot® Xtra Blood Glucose Monitoring System (K083273). The Test Strip manufacturing and performance characteristics are unchanged. The test strips are designed to quantitatively measure glucose in fresh capillary blood from the fingertip by persons with diabetes.

The microdot® Home Blood Glucose Monitoring System device received 510(k) clearance (K102383) in 2012. The submission focused on adding palm testing as an alternate site for an existing product.

Here's an analysis of the acceptance criteria and the study that supports it:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for glucose monitoring systems for self-testing are generally defined by ISO 15197. The document explicitly references ISO15197:2003: in vitro diagnostic test systems - requirements for blood-glucose monitoring systems for self testing in managing diabetes mellitus (Section 8: User Performance). While the exact acceptance criteria thresholds from ISO15197:2003 are not explicitly listed in the 510(k) summary, the performance data is presented in a way that suggests alignment with such standards, using percentage agreement within specific glucose ranges and mg/dL deviations.

The performance is reported against a reference method, likely YSI (Yellow Springs Instrument), which is a common laboratory reference for glucose measurement.

| Sites tested | Performance for glucose levels

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microdot® Xtra Blood Glucose Monitoring System is intended for self testing of qlucose in capillary whole blood from a fingerstick by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus.

microdot® Xtra Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities.

microdot® Xtra Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities.

microdot® Control solutions are intended for use with microdot® Xtra Blood Glucose Meter and microdot® Xtra Test Strips as a quality control check to verify the accuracy of the blood glucose test results.

The microdot® Xtra Blood Glucose Monitoring System consists of the microdot® Xtra Blood Glucose Meter, microdot® Xtra Test Strips, microdot® Control Solutions and a commercially available (510(k) cleared) lancing device and lancets.

The microdot® Xtra Blood Glucose Monitoring System is intended for invitro diagnostic use and for the quantitative measurement of glucose in fresh capillary whole blood. The modified device ie microdor® Xtra Blood Glucose Monitoring System, and its predicate device, microdot® Blood Glucose Monitoring System are intended for use by persons with diabetes or by healthcare professionals in home settings or healthcare facilities.

The modified microdot® Xtra Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system. The microdot® Xtra Blood Glucose Monitoring System relies on quantitative electrochemical biosensor technology to measure current generated on disposable test strips.

The strip remains unchanged since the last submission approval, microdot® Blood Glucose Monitoring System (K070524). The Test Strip manufacturing and performance characteristics are unchanged. The test strips are designed to quantitatively measure glucose in fresh capillary blood from the fingertip by persons with diabetes or by healthcare professional in home or healthcare facilities. Both the predicate strips, microdor® Test Strips (K070524) and the microdot® Xtra Test Strips use the reagent qlucose dehydrogenase with nicotinamide-adenine dinucleotide as co-factor.

The predicate meter uses lot specific calibration code number marked on the strip vial label. The specific code number on the strip vial label allows the meter to convert electrical current into glucose readings via the embedded software in the meter. The user calibrates their meter each time they open a new vial of strips.

Each lot of strips is calibrated to give plasma equivalent glucose readings. The meter is turned on by strip insertion, the user applies a drop of blood or control solution to the test strip and the meter starts the measurement. After 10 seconds, the meter displays the glucose concentration and time and date on the LCD display.

The microdot® Xtra Blood Glucose Monitoring System is pre-programmed with a predetermined code number, thus removing the requirement to load a code number specific to the strip vial.

The provided document is a 510(k) summary for the microdot® Xtra Blood Glucose Monitoring System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information typically found in a full submission that would include acceptance criteria, specific performance data from studies, ground truth establishment, sample sizes for test and training sets, or expert involvement.

Therefore, I can only provide information based on what is present in the document and explicitly state what is missing.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document does not explicitly state specific acceptance criteria (e.g., specific accuracy ranges, precision limits, or clinical metrics) for the device's performance. The submission asserts "substantial equivalence" to a predicate device, implying that its performance should be comparable, but no quantitative targets are given in this summary.
• Reported Device Performance: The document does not include any reported quantitative device performance data from a study. It only states that the device is "substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system."

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

• Sample Size for Test Set: Not specified in this 510(k) summary.
• Data Provenance: Not specified in this 510(k) summary. The document mentions the applicant is "Cambridge Sensors Limited" in the "United Kingdom," but does not explicitly state the origin of any test data.

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

• This information is not provided in the 510(k) summary. For blood glucose meters, "ground truth" is typically established by laboratory reference methods, not by expert consensus on images.

4. Adjudication method for the test set

• This information is not provided in the 510(k) summary. Given the nature of a blood glucose meter, expert adjudication as seen in image analysis is generally not applicable. Ground truth for blood glucose is usually determined by established laboratory reference methods.

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

• A MRMC comparative effectiveness study is not applicable and was not done for this device. This device is a standalone blood glucose meter, not an AI-assisted diagnostic tool that interprets medical images for human readers.

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

• Yes, the device operates as a standalone system. The microdot® Xtra Blood Glucose Monitoring System is an electrochemical biosensor designed to measure glucose directly from fresh capillary whole blood. Its output (glucose concentration) is a direct result of the chemical reaction and electronic measurement without human interpretation or algorithm assistance during the measurement process itself. The user applies the blood and the meter displays the result.

7. The type of ground truth used

• The document implies that the ground truth for glucose measurements would be established using a laboratory reference method (such as a YSI glucose analyzer, which is common for blood glucose meter validation). The device is calibrated to "Plasma equivalent" values, which are derived from such reference methods. However, the specific reference method used is not explicitly stated in this summary.

8. The sample size for the training set

• Not applicable / Not specified. Blood glucose meters typically do not have a "training set" in the sense that AI algorithms do. Their performance is based on the inherent physical and chemical properties of the electrochemical biosensor and its calibration. While there's internal calibration data used by the manufacturer, it's not a "training set" in the context of machine learning.

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

• Not applicable / Not specified. As mentioned above, the concept of a "training set" and its associated ground truth establishment methods (like expert consensus, pathology, etc.) does not directly apply to the development and validation of a traditional electrochemical blood glucose meter described in this document. The device's calibration refers to ensuring its readings align with established laboratory reference methods for glucose.

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microdot Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.

microdot Blood Glucose Meter The microdot Blood Glucose Meter is intended for the quantitative measurement r fromlers in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.

microdot Test Strips The microdot Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by o grassowith diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.

microdot Control solutions miorodot oontrol solutions are intended for use with microdot Blood Glucose Meter and microdot Test Strips as a quality control check to verify the accuracy of the blood glucose test results.

The microdot® Blood Glucose System is comprised of the microdot® Meter, Test Strips, & three controls. The test strip is inserted into the device, a drop of blood is added to the strip, and a glucose result is presented in 10 seconds.

The test principle is based on electrochemical biosensor technology. Glucose dehydrogenase converts to glucose to gluconolactone, with reduction of NAD to NADH. Re-oxidation of the mediator by the meter induces a micro current to flow, and the size of the micro current is directly proportional to the amount of glucose in the blood. The micro current is detected in of the blood glucose concentration.

The provided document describes the microdot® Blood Glucose Monitoring System and its performance studies. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for accuracy in the same way modern regulatory submissions do (e.g., ISO 15197:2013). However, it reports on several performance metrics that demonstrate its equivalence to a predicate device and its overall functionality. Given the context of the comparison to the predicate device and the non-clinical and clinical study results, the implied acceptance criterion for accuracy is a strong correlation with a reference method and acceptable bias within a specified hematocrit range.

• Lot 1: slope = 0.93, r = 0.996
• Lot 2: slope = 0.94, r = 0.996 |
  | Precision (Within-run CV%) | Low coefficient of variation (CV%) at various glucose concentrations. Specific criteria not defined, but generally

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