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510(k) Data Aggregation
(447 days)
The PRODIGY iConnect 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, forearm, upper arm, palm, calf or thigh. The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The PRODIGY iConnect 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 PRODIGY iConnect Blood Glucose Monitoring System 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).
PRODIGY No Coding Blood Glucose Test Strips are intended for use with the PRODIGY iConnect blood glucose meter to measure the concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm. upper arm, palm, calf or thigh for self-testing at home. They are for testing outside the body (in vitro diagnostic use only). Do not use them for diagnosis of, or screening for diabetes or for testing on neonates. PRODIGY No Coding Blood Glucose Test Strips are used as an aid to monitor the effectiveness of diabetes control.
The system is intended for use at home for single patient use. It should not be used for the diagnosis of diabetes or for the testing of newborns. It consists of three main components, i.e., iConnect blood glucose meter, PRODIGY No Coding Blood Glucose Test Strips and 2 levels of Prodigy control solutions (Level 1 & Level 2). The physical components of the meter are Housing, PCBA, LCD and Ear phone jack. The PRODIGY No Coding Blood Glucose Test Strips are not coded. The device has the function of alternative sites testing at Finger, Palm, Forearm, Upper arm, Calf and Thigh.
The system has the ability of physically connecting to mobile devices for the purpose of obtaining blood glucose determination via a mobile APP.
The PRODIGY iConnect Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Meter User Guide, Quick Reference Guide, Logbook, and Warranty Card. The PRODIGY iConnect Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Meter User Guide, Quick Reference Guide, Logbook, Warranty Card, Prodigy Lancing Device, Prodigy Lancets, PRODIGY No Coding Blood Glucose Test Strips, and PRODIGY Control Solution.
Here's a breakdown of the acceptance criteria and the study information for the PRODIGY iConnect Blood Glucose Monitoring System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Robustness | Individual bias of test results compared with YSI mean: < 10 mg/dL at glucose concentrations < 75 mg/dL; < ± 10% at glucose concentrations ≥ 75 mg/dL after 3,650 cleaning/disinfection cycles. | Individual bias of the test results compared with YSI mean were less than 10 mg/dL at glucose concentrations < 75 mg/dL and less than ± 10% at glucose concentrations ≥ 75 mg/dL. The test results met acceptance criteria. |
| Precision (Within-run & Between-run) | Pooled Standard Deviation < 5.0 mg/dL at glucose concentration < 100 mg/dL; Pooled Coefficient of Variation < 5.0% at glucose concentration ≥ 100 mg/dL, compared to YSI reference standards over ten days. | Pooled Standard Deviation less than 5.0 mg/dL at glucose concentration < 100 mg/dL, and pooled Coefficient of Variation less than 5.0% at glucose concentration ≥ 100 mg/dL for within runs and between runs compared to the YSI reference standards over the course of ten days. The test results met the acceptance criteria. |
| Linearity | Correlation coefficient > 0.95. 100% of individual glucose results bias within ±10% within the measuring range of 20 to 600 mg/dL. | Correlation coefficient is greater than 0.95 (Lot I: 0.9997, Lot II: 0.9998, Lot III: 0.9999). 100% of the bias of individual glucose results fallen within ±10%. The linearity of measurement is acceptable between 20 to 600 mg/dL. The test results met the acceptance criteria. |
| System Accuracy | For glucose concentrations < 75 mg/dL: ≥95% of results within ±15 mg/dL. For glucose concentrations ≥ 75 mg/dL: ≥95% of results within ±20%. | For glucose concentrations < 75 mg/dL: ≥96.9% of tests for which the differences fell within ±15 mg/dL (Finger: 100%, Palm: 100%, Forearm: 100%, Upper Arm: 100%, Calf: 100%, Thigh: 100%). For glucose concentrations ≥ 75 mg/dL: 100% within 20% (Finger: 100%, Palm: 100%, Forearm: 100%, Upper Arm: 100%, Calf: 100%, Thigh: 100%). The test results met the acceptance criteria. |
| Hematocrit Evaluation | Individual difference of blood glucose measurements compared with individual YSI mean fall within ±15% from HCT 20% to 60%. % bias difference on mean value of blood glucose measurements fall within 8% compared with mean of blood glucose measurements in HCT 40% from HCT 20% to 60%. | All of the individual difference of the blood glucose measurements compared with individual YSI mean fall within ±15% from HCT 20% to 60%. Also, % bias difference on mean value of the blood glucose measurements fall within 8% compared with the mean of blood glucose measurements in HCT 40% from HCT 20% to 60%. The test results met the acceptance criteria. |
| Interference Study | Bias of mean test results within the listed ranges ≤ 10% compared with the YSI mean measurements. The concentration limits of all interfering substances higher than therapeutic or physiological levels. | Bias of mean test results within the range listed above were ≤ 10% compared with the YSI mean measurements. No obvious interference was observed in the interfering substance at neither therapeutic nor physiological levels at three blood glucose levels. The test results met the acceptance criteria. |
| Operation Condition | Confirmed operation within temperature range of 4 - 40 °C and relative humidity range of 10~85%. | The study confirmed the operation conditions for the temperature range of 4 - 40 °C (39.2 - 104 °F), and the relative humidity range of 10~85%. |
| Sample Volume | Test values of volumes between 0.7 and 1.5 uL fall within acceptable criteria. Requires at least 0.7 uL of blood sample. | The test values of volumes between 0.7 and 1.5 uL were fall within acceptable criteria. It's required at least 0.7 uL of blood sample. The test results met the acceptance criteria. |
| Virucide Evaluation | Complete inactivation of Hepatitis B Virus at specified dilutions on case & lens coupons within 2 minutes contact time using PDI SUPER SANI-CLOTH germicidal disposable wipes. | PDI SUPER SANI-CLOTH germicidal disposable wipes (EPA Reg. No. 9480-4) within 2 minutes contact time can completely inactivate the Hepatitis B Virus at undiluted (HBsAg: 7857.9 IU/mL), 10X, 100X and 1000X virus dilution on the Case & Lens coupons. |
| Altitude Study | Individual results fall within ± 10% at altitude below 11,161 feet (3,402 meters). | The individual results fall within ± 10% at the altitude below 11,161 feet (3,402 meters). The results met the acceptance criteria. So it shows no significant effects on PRODIGY iConnect Blood Glucose Monitoring System at the altitudes below 11,161 feet (3,402 meters). |
| Mechanical Resistance | Meters can withstand vibration and drop testing required by ISO 15197:2013, IEC 60068-2-64:1993, and IEC 61010-1:2010. | All studies showed the meters could stand the vibration and drop testing required in ISO 15197:2013, IEC 60068-2-64:1993 and IEC 61010-1: 2010. |
| Shelf-Life Study | Unused test strips stable for 25 months; 96 days for opened vials. | The unused test strips were stable for 25 months and 96 days for opened vials. The shelf-life of PRODIGY Blood Glucose Test Strip is claimed as 24 months for unopened strips vials and 90 days for opened strips vials. All data met the acceptance criteria. |
| Software V&V | Device performs as intended based on Software Design Specifications, hazards mitigated. | All software documentation prepared and submitted, tested against specifications. Device Hazard Analysis completed and risk control implemented. Testing results support all software specifications met acceptance criteria of each module and interaction of processes. V&V with HTC and Apple platforms demonstrated safety and effectiveness. |
| Electrical Safety | Complies with IEC 60601-1: 2005, IEC 61010-1:2010, IEC 61010-2-101:2002, FCC 47 CFR Part 15 Subpart B/Oct. 2013 and CISPR 22/1997 (Class B Limit). | The device with Apple or HTC platform passed all the electrical safety testing according to national & international standards including IEC 60601-1: 2005, IEC 61010-1:2010, IEC 61010-2-101:2002, FCC 47 CFR Part 15 Subpart B/Oct. 2013 and CISPR 22/1997 (Class B Limit). |
| EMC | Complies with IEC 60601-1-2:2007, IEC 61326-1:2012, IEC 61326-2-6:2005, CISPR 11:2009 +A1:2010 Class B, IEC 61000-4-2:2008, IEC 61000-4-3:2010, IEC 61000-4-8:2009 for radiated emissions, electrostatic discharge, radio-frequency electromagnetic immunity, and power frequency magnetic field immunity. | The PRODIGY iConnect Blood Glucose Monitoring System with Apple or HTC platform has been tested and successfully met all of the relevant sections (Radiated Emissions, Electrostatic Discharge Immunity Test, Radiated Radio-Frequency Electromagnetic Immunity, and Power Frequency Magnetic Field Immunity Test to complies to all standards including IEC 60601-1-2:2007: Electromagnetic Compatibility, IEC 61326-1:2012, IEC 61326-2-6:2005, Emission: CISPR 11:2009 +A1:2010, Class B, Immunity: IEC 61000-4-2:2008, IEC 61000-4-3:2010, IEC 61000-4-8:2009. |
2. Sample Size Used for the Test Set and Data Provenance
- System Accuracy Evaluation (Lay Persons Study): 350 lay persons.
- Data Provenance: The document does not explicitly state the country of origin. It indicates "internal test results" and a study involving "lay persons," but no geographical specifics are provided. It does not mention whether it was retrospective or prospective. It is implied to be prospective for the lay persons study.
- Precision Evaluation: Tested over the blood glucose concentration range of 20-600 mg/dL and Control Levels 1 and 2 over the course of ten days. (Specific number of samples/runs not detailed, but standard deviations/CVs derived).
- Linearity Evaluation: Not specified exact number of samples, but used different lots of test strips (Lot I, Lot II, Lot III).
- Hematocrit Evaluation: Evaluated over an HCT range of 20-60%.
- Interference Study: "Ten meters and three lots of test strips were used for this study." Samples were venous blood spiked with various substances at three glucose levels (60, 120, 250 mg/dL).
- Robustness Evaluation: Ten iConnect meters for vibration and drop tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly mention the use of experts to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method as external expert review for ground truth was not explicitly stated. The ground truth was established by a reference method (YSI).
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.
This device is a blood glucose monitoring system, not an imaging device requiring human "readers" or AI assistance in interpretation in the context of MRMC studies common in radiology or pathology. Therefore, an MRMC comparative effectiveness study of human readers with/without AI assistance was not performed or applicable in the way described. The device is for direct quantitative measurement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
Yes, the studies performed (Precision, Linearity, System Accuracy, Hematocrit, Interference, etc.) evaluate the standalone performance of the PRODIGY iConnect Blood Glucose Monitoring System. The device directly measures glucose concentration without human interpretation of its output that would significantly alter the result. The software verification and validation also represent standalone algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for accuracy studies (System Accuracy, Precision, Linearity, Hematocrit, Interference) was established using a YSI reference standard (specifically, implies the YSI 2300 Glucose Analyzer, which is a common and highly accurate laboratory reference method for glucose measurement).
8. The sample size for the training set
The document does not specify a separate "training set" sample size. For medical devices, particularly for quantitative measurement systems, "training" in the machine learning sense is often not distinct in the same way as for AI image analysis. Instead, the devices are designed and then validated against established standards. The development and internal testing phases would involve data, but it's not typically compartmentalized as a "training set" in regulatory submissions for this type of device.
9. How the ground truth for the training set was established
As there's no explicitly defined "training set" in the context of machine learning, the establishment of ground truth for general device development and calibration would similarly rely on highly accurate laboratory reference methods like the YSI and adherence to standards (e.g., ISO 15197).
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