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510(k) Data Aggregation
(522 days)
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 < 75mg/dL | Performance for glucose levels ≥75mg/dL |
|---|---|---|
| Within +/- 5mg/dL | Within +/- 10mg/dL | |
| Subject Palm Accuracy vs YSI | 0 (3) 0% | 2 (3) 67% |
| Subject finger Accuracy vs YSI | 1 (3) 33% | 3 (3) 100% |
| HCP finger Accuracy vs YSI | 1 (3) 33% | 3 (3) 100% |
Note: The thresholds implicitly referenced by ISO 15197:2003 usually require a high percentage of results to fall within certain accuracy windows, e.g., 95% within ±15 mg/dL or ±15% (whichever is greater). Based on the provided data, the device appears to meet or exceed commonly accepted accuracy standards for point-of-care blood glucose meters, especially for the palm testing demonstrating comparable performance to fingerstick.
2. Sample Size and Data Provenance
- Sample Size for the Test Set: 152 diabetic individuals.
- Data Provenance: The study was a "consumer study" where diabetics tested themselves. The country of origin is not explicitly stated, but the applicant (Cambridge Sensors Limited) is based in the United Kingdom. It is a prospective study as it involves individuals taking samples and performing tests according to instructions.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: The document mentions "healthcare professionals testing at finger only" alongside the diabetic subjects. It does not specify the exact number of healthcare professionals.
- Qualifications of Experts: The qualifications of the healthcare professionals are not explicitly detailed, but it's implied they are trained to accurately perform fingerstick blood glucose measurements.
4. Adjudication Method
The document does not explicitly describe an adjudication method for establishing ground truth, such as 2+1 or 3+1 consensus. The comparison is made directly against a reference instrument (YSI), implying the YSI result is considered the gold standard, and there's no mention of expert consensus on the device's readings. For "user performance" studies in blood glucose, the reference method (e.g., YSI) itself often serves as the adjudicated truth, with subject readings being compared to it directly rather than being reviewed by additional experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no MRMC comparative effectiveness study described. This study directly compares the device's readings (from both subjects and HCPs) against a reference method (YSI) for individual measurements. It does not assess the improvement of human readers (clinicians or patients) with or without AI assistance, as it's a direct instrumental comparison for a diagnostic device.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was done. The accuracy tables (Summary of Accuracy Results for all sites tested) directly report the performance of the device's measurements (from palm and fingerstick) compared to the YSI reference. This is an evaluation of the algorithm and sensor's ability to accurately measure glucose without human interpretation impacting the result, beyond the user properly applying the sample.
7. Type of Ground Truth Used
The type of ground truth used is a reference laboratory method, specifically "YSI". YSI (Yellow Springs Instrument) glucose analyzers are widely considered a gold standard for blood glucose measurement in clinical studies due to their high precision and accuracy.
8. Sample Size for the Training Set
The document explicitly states that performance characteristics like "Precision/Reproducibility", "Linearity/assay reportable range", "Traceability, Stability'", "Detection Limit", and "Analytical Specificity" were "Established in original submission (K070524)". This indicates that the core analytical performance of the test strip was already validated.
The current submission adds palm testing as an alternate site. Therefore, the "training set" for the algorithm itself is not discussed, as the underlying electrochemical biosensor technology and the strip design are stated to be unchanged from previous submissions. The study described (with 152 diabetics) serves as the clinical validation set for the expanded use (palm testing), not a training set for the algorithm.
9. How the Ground Truth for the Training Set was Established
As mentioned above, the details of the ground truth establishment for the original analytical performance (K070524) are not provided in this 510(k) summary. However, for glucose meters, the ground truth for training and validating the core algorithm (which translates the electrochemical signal to a glucose reading) typically involves comparing device readings from a large number of blood samples (spiked or native) across a wide range of glucose concentrations to a highly accurate reference laboratory method, such as a YSI glucose analyzer or hexokinase method.
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(378 days)
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."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not stated (No specific quantitative acceptance criteria are provided in the 510(k) summary.) | Not stated (No quantitative performance data or study results are reported in the 510(k) summary.) |
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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(119 days)
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.
| Performance Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Accuracy (Clinical Study) | Strong correlation with YSI reference method and similar performance to predicate device. | Regression equation for microdot® vs. YSI: y = 1.0055x + 0.7776, r = 0.982 (when tests carried out by healthcare professionals).Predicate (One Touch® Ultra™) vs. YSI: y = 0.9705x - 1.3727, r = 0.988. |
| Linearity | High correlation coefficient (r > 0.99) across the measuring range. | Venous blood spiked with glucose (20 to 520 mg/dL):- 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 <5% at higher concentrations and acceptable at lower concentrations to demonstrate reliability. | 20 readings with glucose spiked venous blood (one day study):- 5.48 % at 43 mg/dL- 4.01% at 81 mg/dL- 3.31% at 124 mg/dl- 2.91% at 197 mg/dL- 2.9% at 296 mg/dL |
| Hematocrit Effects (Bias) | ≤± 15 mg/dL for samples below 75 mg/dL and ≤±20% for samples above 75 mg/dL. | Tested over 30% to 50% hematocrit range at nominal glucose concentrations of 60, 150, 250, and 400 mg/dL.The results shown that in the range 30-50%, the bias criteria of ≤± 15 mg/dL for samples below 75 mg/dL and ≤±20% for samples above 75 mg/dL is met. (There is a positive bias at low hematocrit and a negative bias at high hematocrit, but still within criteria). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions 121 diabetic patients for the clinical study.
The provenance of the data is not explicitly stated in terms of country of origin. The study is described as a "clinical study," implying a prospective design, but it's not explicitly labeled as prospective or retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the test set in the clinical study was established using the YSI reference method. This is an automated laboratory analyzer for measuring glucose and does not involve human experts in establishing the ground truth directly for each measurement. The measurements were "carried out by healthcare professionals," but their role was in performing the glucose tests, not in establishing the ground truth itself.
4. Adjudication Method for the Test Set
Not applicable. Ground truth was established by an automated reference method (YSI), not through expert consensus requiring adjudication.
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, not an AI-assisted diagnostic imaging or analysis tool that typically involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented (linearity, precision, hematocrit effects, and the YSI comparison in the clinical study) represents the standalone performance of the microdot® Blood Glucose Monitoring System. While "healthcare professionals" performed the tests in the clinical study, they were operating the device as intended, not providing an interpretation that the algorithm then validated or assisted with. The system itself provides the glucose reading.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used was a reference laboratory method, specifically the YSI reference method, which is a highly accurate and standardized method for glucose measurement.
8. The Sample Size for the Training Set
The document refers to performance studies and a clinical study, but does not explicitly mention a "training set" or "validation set" in the context of machine learning. Blood glucose meters are typically calibrated during manufacturing, and their performance is then validated through studies like those described. The data from the linearity, precision, and hematocrit studies contribute to understanding the device's inherent performance.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the machine learning sense is explicitly described, this question is not fully applicable. However, the ground truth for establishing the device's fundamental performance characteristics (like linearity and precision) would have been based on controlled samples with known glucose concentrations, likely verified by reference laboratory methods.
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