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510(k) Data Aggregation
(481 days)
The Prodigy Choice 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, palm, upper-arm, calf or thigh. The Prodigy Choice Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Prodigy Choice 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 Choice 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).
The Prodigy Choice Test Strips are for use with the Prodigy Choice Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, palm, upper-arm, calf or thigh.
The Prodigy Choice Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The Prodigy Choice Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The Prodigy Choice Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution. The Prodigy No Coding Test Strips utilize the enzyme glucose oxidase, which is derived from recombinant protein derived from the fungus Aspergillus niger.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Prodigy Choice Blood Glucose Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in a quantitative table format. It refers to compliance with ISO and NCCLS standards but doesn't detail the specific performance thresholds required by those standards, nor does it present the device's performance against them directly within the summary.
Here's a table based on the information that is available:
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Compliance with ISO 15197 | Tested and complies |
| Compliance with NCCLS EP9-A | Tested and complies |
| Compliance with NCCLS SP5-A | Tested and complies |
| Compliance with ISO 14971 | Tested and complies |
| Label Comprehension | Tested with Human Factor Study and complies |
| Usability | Tested with Human Factor Study and complies |
Note: Since specific numerical acceptance criteria and direct performance metrics are not provided in the 510(k) summary, this table relies on the general statement that the device "was tested to the required standards" and "complies." Detailed performance data would typically be found in the actual test reports submitted to the FDA, which are not part of this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size for the test set used in the performance testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. For a blood glucose monitoring system, the "ground truth" would typically refer to a reference laboratory instrument's measurement of glucose in blood samples.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is typically relevant for interpretative devices (e.g., imaging AI). For a blood glucose meter, which provides a direct quantitative measurement, an MRMC study is generally not applicable or mentioned. The provided text does not indicate that such a study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a "Blood Glucose Monitoring System" which includes a meter and test strips. Its performance is inherently standalone in the sense that it provides a direct measurement without human interpretation of its output. The summary does describe "Performance Testing" to required standards, which implicitly refers to the standalone performance of the system.
7. The Type of Ground Truth Used
For a blood glucose monitoring system, the ground truth is typically established by laboratory reference methods for glucose measurement, which are considered highly accurate and precise. While not explicitly stated in the summary, this is the standard practice for validating such devices. The summary implicitly refers to this by mentioning compliance with standards like ISO 15197 and NCCLS EP9-A, which define acceptable accuracy against reference methods.
8. The Sample Size for the Training Set
For a blood glucose meter, there isn't typically a "training set" in the sense of a machine learning algorithm being trained on a dataset. The device uses an "electrochemical method-based meter and dry reagent biosensor" which operates on established chemical principles, not machine learning. Therefore, a training set is not applicable or mentioned.
9. How the Ground Truth for the Training Set Was Established
As explained above, a "training set" is not applicable for this type of device.
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(460 days)
The Prodigy Preferred 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 Preferred Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Prodigy Preferred 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 Preferred 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).
The Prodigy No Coding Test Strips are for use with the Prodigy Preferred Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh.
The Prodigy Preferred Blood Glucose Monitoring System consists of a meter and Prodigy No Coding Test Strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The Prodigy Preferred Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The Prodigy Preferred Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution. The Prodigy No Coding Test Strips utilizes the active enzyme is Glucose Oxidase, derived from Aspergillus niger.
Here's a summary of the acceptance criteria and study information for the Prodigy® Preferred Blood Glucose Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For many of the tests, the acceptance criterion specifically states "met the acceptance criteria" or "less than X" while also reporting the actual performance as "less than X" or "within acceptance criteria," implying that the stated performance is the acceptance criterion itself, or that the performance achieved the desired threshold.
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision Test | < 5.0 mg/dL for glucose < 75 mg/dL (pooled and maximum SD); < 5.0% for glucose ≥ 75 mg/dL (pooled and maximum CV); Maximum individual bias < 10% compared with YSI2300. | Pooled and maximum SD were < 5.0 mg/dL at glucose < 75 mg/dL; Pooled and maximum CV were < 5.0% at glucose ≥ 75 mg/dL; Maximum individual bias was < 10% compared with YSI2300. |
| Linearity | Correlation coefficient > 0.95; 100% of individual bias within ±10% between 20-600 mg/dL. | Correlation coefficient > 0.95; 100% of the bias of individual glucose results fell within ±10%. Linearity acceptable between 20-600 mg/dL. |
| System Accuracy | For blood glucose level < 75 mg/dL, 95% of results within ±15 mg/dL or 95% of results within ±20% for blood glucose level ≥ 75 mg/dL (ISO 15197 requirement). | >95% of all alternative site tested results fell within the acceptance criteria (15mg/dL for blood glucose <75 mg/dL and 20% for blood glucose ≥75mg/dL). Met ISO 15197 requirements. |
| Interference | No obvious interference (implied: bias compared to control pool within ~10%); No significant effect from specified normal/therapeutic concentrations of listed substances. | All bias of test results were ~ 10% compared with the measurements of the controlled pool. No obvious interference observed at therapeutic or physiological levels at three blood glucose levels. Specified substances (uric acid, ascorbic acid, acetaminophen, etc.) at normal/therapeutic concentrations did not significantly affect results. |
| Hematocrit | All individual difference < ±10% compared with individual YSI mean, for HCT 20-60%; All SD < 5mg/dL and all CV < 5%. | When HCT between 20% to 60%, all individual difference compared with individual YSI mean were < ±10%. All individual bias compared with YSI mean in HCT 40% was < ±10%. All SD were < 5mg/dL and all CV were < 5%. Accepted HCT range 20% to 60%. |
| Volume Verification | Sample volumes between 0.7 to 1.5uL fall within acceptable criteria. (Implied: accurate results) | Sample volumes between 0.7 to 1.5uL fell within acceptable criteria. (Required at least 0.7uL for accurate results). |
| Measurement Internal Determination Test (High Temp Exposure) | Glucose measurements with check strip before and after high temperature exposure < 2.0 mg/dL difference; Mean difference of before and after control solution measurements (Level N and H) < 5.0 mg/dL. | Glucose measurements with check strip before and after high temperature exposure < 0.2 mg/dL difference. Mean difference of before and after control solution measurements (Level N and H) < 3.6 mg/dL. (Performance exceeded acceptance criteria). The meters passed. |
| Altitude Study | Individual results fall within ± 10% from 91 to 3,402 meters altitude. | Individual results fell within ± 10% at altitude from 91 to 3,402 meters. No significant effects from 298 feet to 11,161 feet (91 to 3,402 meters). |
| Storage Condition (Test Strips) | All individual bias < ± 10%. (Implied: stability for 24 months unused, 90 days opened). | All individual bias < ± 10%. Unused test strips stable for 24 months and 90 days in used vials even after transportation. |
| Temperature for Equipment | Maximum individual bias < 10% compared with YSI 2300. | Maximum individual bias of meters treated to extreme temperature measurements < 10% by using venous whole blood. |
| Humidity Test for Equipment | Maximum individual bias < 10% compared with YSI 2300. | Maximum individual bias of meters treated to extreme humidity measurements < 10% by using venous whole blood. |
| Operating Condition (Test Strips) | Performance of individual bias < ± 10%. | Performance of individual bias of test strips evaluated in extreme environments < ± 10%. |
| Low Temperature Test | Glucose measurements with check strip before and after low temperature exposure < 2.0 mg/dL difference; Mean difference of before and after control solution measurements (Level N and H) < 5.0 mg/dL. | Glucose measurements with check strip before and after low temperature exposure < 0.2 mg/dL difference. Mean difference of before and after control solution measurements (Level N and H) < 3.9 mg/dL. (Performance exceeded acceptance criteria). The meters passed. |
| Humidity Detection Limit | All CV of test results < 4% for different humidity levels; Total CV of average values < 4% for "Normal" and "High" control solution (RH 10 ~ 85%). | All CV of test results < 4%. Total CV of average values < 4% for "Normal" and "High" control solution for RH 10 ~ 85%. |
| High Temperature Test | Glucose measurements with check strip before and after high temperature exposure < 2.0 mg/dL difference; Mean difference of before and after control solution measurements (Level N and H) < 5.0 mg/dL. | Glucose measurements with check strip before and after high temperature exposure < 0.2 mg/dL difference. Mean difference of before and after control solution measurements (Level N and H) < 3.6 mg/dL. (Performance exceeded acceptance criteria). The meters passed. |
| Temperature Test | All precisions of test results < 4%; Total CV of average values < 4% for "Normal" and "High" control solution (10 to 40°C). | All precisions of test results < 4%. Total CV of average values < 4% for "Normal" and "High" Prodigy control solution for 10 to 40°C. Passed operating (10 |
| Robustness Test | Appearance, structure, and function of meters regular after cleaning/disinfection (5,000 times for single-patient use, 156 times for lancing devices); All individual bias < 10 mg/dL (< 75 mg/dL glucose) and < ± 10% (≥ 75 mg/dL glucose) compared with YSI mean. | Appearance, structure, and function of meters regular after cleaning/disinfection (5,000 times for single-patient use, lancing devices 156 times). All individual bias compared with YSI mean < 10 mg/dL at glucose < 75 mg/dL and < ± 10% at glucose ≥ 75 mg/dL. |
| Disinfection Efficacy Validation | HBV of clinical sera could be efficaciously removed from the Blood Glucose Meter after completing the designed disinfection procedure. (Implied: robust disinfection method to protect users). | HBV of clinical sera could be efficaciously removed from the Blood Glucose Meter provided by OKBiotech CO., Ltd after completing the designed disinfection procedure. Demonstrates robust method to protect users from HBV infection. |
| Software Validation | Meets the requirements of FDA's guidance document "Guidance for the Content of Pre-market Submission for Software Contained in Medical Devices". | Met the requirements of FDA's guidance document. |
| Human Factor Study | Ease of Use = high percentage, Label Comprehension = high percentage. (Specific threshold not provided, but implicitly met by reported percentages) | Ease of Use = 98.5%; Label Comprehension = 99.5%. |
| Electrical Testing | Pass EN 61236-1 EMC Test; Pass EN 60601-1-2 EMC Test; Pass FCC CFR 47 18 Subpart C. | Passed all listed electrical tests (EN 61236-1 EMC, EN 60601-1-2 EMC, FCC CFR 47 18 Subpart C). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the test set for each specific study. It frequently refers to "test results," "data," or "blood samples" without providing the precise number of participants or measurements.
- Provenance: Not explicitly stated, but the studies involve "fresh capillary whole blood samples" and "venous whole blood" in a medical device context, suggesting a clinical or laboratory setting. The approval is from the US FDA, implying testing relevant to US regulatory standards. It does not state whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- The document mentions "glucose analyzer YSI2300" as the reference method for ground truth in several performance tests (Precision, Linearity, System Accuracy, Hematocrit, Temperature for Equipment, Humidity for Equipment, Robustness).
- The YSI 2300 STAT Plus Glucose & Lactate Analyzer is a laboratory-grade reference instrument. Thus, the ground truth is established by a highly accurate and precise analytical instrument, not by human experts. The qualifications of the operators of this instrument are not detailed, but it's implied that they are qualified laboratory personnel.
4. Adjudication Method for the Test Set
- No adjudication method by human experts is mentioned for the test set. The direct comparison is against a reference instrument (YSI2300).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device is a blood glucose meter, which provides a direct numerical reading, not an interpretation like an imaging device that would typically involve human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, the performance tests described (Precision, Linearity, System Accuracy, Interference, etc.) represent standalone performance of the device (meter + test strip system). The device provides a direct quantitative measurement, and these studies evaluate its accuracy and performance independently of human interpretation, although human users operate the device and apply the blood sample. The "Human Factor Study" addresses ease of use and label comprehension for the human operator, but the core performance metrics are device-centric.
7. Type of Ground Truth Used
- The primary ground truth used for analytical performance studies is comparison to a laboratory reference instrument, specifically the YSI 2300 STAT Plus Glucose & Lactate Analyzer. This is a highly accurate and precise method for determining blood glucose levels. For the Disinfection Efficacy, the ground truth was the efficacious removal of HBV as per FDA guidance.
8. Sample Size for the Training Set
- The document does not provide information on a "training set" sample size. This type of medical device (blood glucose meter) is typically developed through analytical validation of its electrochemical principles and biochemical components, rather than through machine learning model training on large datasets in the way an AI-driven diagnostic would be. The "design verification and validation testing" refers to broader engineering and performance validation rather than machine learning training.
9. How Ground Truth for the Training Set Was Established
- As no "training set" for a machine learning model is mentioned or implied, the method for establishing its ground truth is not applicable. The device's "training" in a broad engineering sense would involve iterative design, prototyping, and testing against known glucose concentrations and reference methods to optimize its performance characteristics.
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(356 days)
The Prodigy® Diabetes Management Software is indicated for use as a data management tool for the acceptance, transfer, display, storage, processing (e.g., averaging). Reporting, and printing of patient blood glucose monitoring data.
The Prodigy® Diabetes Management Software is indicated for use with the Prodigy Blood Glucose Monitoring Systems only.
The Prodigy® Diabetes Management Software is a moderate level of concern software management system that allows the user an additional method of tracking their blood glucose level. The software allows for an accident member of their blood Glucose Monitor via a USB cable. The Prodigy® Diabetes Management Software is designed to operate on the patient's PC with Microsoft SQL Server 2005 or later operating system. Prodigy® Diabetes Care LLC website will provide a link to download the Microsoft SQL Server 2005 Server 2005.
Here's a breakdown of the acceptance criteria and study information for the Prodigy® Diabetes Management Software, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided document, primarily a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating quantitative or qualitative "acceptance criteria" and then directly reporting performance against them in the traditional sense of a clinical trial. Instead, the "acceptance criteria" are implied by the features and functionalities deemed necessary to be equivalent to the predicate device. The "reported device performance" is largely qualitative, indicating that these functionalities are present and work.
| Parameter (Implied Acceptance Criteria) | Prodigy Diabetes Management Software Performance (Reported as Present/Functional) |
|---|---|
| Download blood glucose meter readings via USB interface cable | Yes |
| Electronic Log Book | Yes |
| Create User Profile | Yes |
| Create reports | (Implied by existing report/trending functionality) |
| Create trending graphs | Yes |
| Option for printing reports | Yes |
| Set Target - target blood glucose range | Yes |
| Average reading for each meal over the past several | Yes |
| Patient can create personal and meter profiles | Yes (Stated in Substantial Equivalence summary) |
| Patient can import data from the Prodigy Blood Glucose Meter | Yes (Stated in Substantial Equivalence summary) |
| Patient can set blood glucose target ranges and personal schedule | Yes (Stated in Substantial Equivalence summary) |
| Patient has a Log book to view recorded data | Yes (Stated in Substantial Equivalence summary) |
| Patient can retrieve reports and trending graphs | Yes (Stated in Substantial Equivalence summary) |
| Patient can print Trend graphs and reports | Yes (Stated in Substantial Equivalence summary) |
| Ease of use | Verified (by clinical usability study) |
| Label comprehension | Verified (by clinical usability study) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "clinical usability study" or "Human Factor Study" but does not specify the sample size used for the test set.
The data provenance is not specified (e.g., country of origin). It can be inferred that the study was prospective, as it was conducted "to verify ease of use and label comprehension" for the device being submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications, nor does it explicitly mention "ground truth" in the context of expert review for the usability study. The usability study would typically involve end-users, not necessarily experts for ground truth establishment.
4. Adjudication Method for the Test Set
The document does not provide any information regarding an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The performance data section only mentions a "clinical usability study" or "Human Factor Study" to verify ease of use and label comprehension. This type of study is not an MRMC comparative effectiveness study, and there is no mention of comparing human readers with and without AI assistance, nor any effect size.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is described as "software management system" and "data management tool" for blood glucose monitoring data. Its primary function is displaying, storing, processing, reporting, and printing data from a blood glucose meter. It is not an AI algorithm performing diagnostic tasks in a standalone manner where performance metrics like sensitivity/specificity for a diagnosis would be relevant. The "performance data" refers to a usability study, not a standalone algorithmic performance test. Therefore, a standalone algorithmic performance study in the typical sense for an AI diagnostic device was not conducted or is not applicable to this type of device.
7. The Type of Ground Truth Used
For the "clinical usability study," the "ground truth" would implicitly be the successful and intuitive completion of tasks by the study participants and their feedback on ease of use and comprehension, as measured against predefined usability criteria. It's not a "ground truth" derived from expert consensus, pathology, or outcomes data, as those are typically associated with diagnostic or image analysis devices.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is because the device is a data management software, not a machine learning or AI model that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an AI/ML model, there is no information on how ground truth for a training set was established.
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