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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:

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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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.

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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.

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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