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The Prodigy Blood Glucose Test System is intended for use in the quantitative measurement of glucose in whole blood taken from the finger. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

The Prodigy Blood Glucose Test System is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. It is intended for use by people with diabetes mellitus at home (Over -the-Counter) as an aid in monitoring the effectiveness of diabetes control program. The Prodigy blood glucose test system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood. It is not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates.

The Prodigy meter is to be used with the Prodigy Blood Glucose Test Strip, and the Prodigy Glucose Control Solutions.

The Prodigy glucose test 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.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided text is a 510(k) summary for a medical device. This document primarily focuses on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already on the market. It often doesn't contain detailed, standalone clinical trial reports with full statistical breakdowns, specific acceptance criteria for performance metrics (like accuracy targets), or comprehensive study methodologies. As such, some of the requested information (especially quantitative acceptance criteria, exact sample sizes for training, and specific details about ground truth establishment for training data) is not explicitly stated in this type of document. I will extract what is available and clearly state what is not present.

Acceptance Criteria and Device Performance

The 510(k) summary primarily establishes substantial equivalence by demonstrating that the new device, the Prodigy Blood Glucose Test System, is similar to its predicate device (TaiDoc Technology Corporation, K042005) in terms of technology and performance. While specific numerical acceptance criteria (e.g., "95% of readings must be within ±X% of reference") are not explicitly listed in the provided text for device performance, the overall acceptance criterion for the submission is that the device is "as safe and effective as the predicate."

The text states: "The results of clinical and non-clinical testing indicate that the new device is as safe and effective as the predicate." This implies that the device met performance standards comparable to those accepted for the predicate.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: The exact sample size for the test set (clinical study group) is not explicitly stated in the provided document. The document mentions "clinical and non-clinical testing data," but does not give numerical figures for the number of patients or samples.
   • Data Provenance: The document does not specify the country of origin of the data. It mentions "Diagnostic Devices, Inc.,Inc. Address: 8935 NW 27th street, Miami, FL 33172. U.S.A.", which implies the company is based in the US, but this doesn't confirm the origin of the clinical data. The data is retrospective or prospective is not explicitly stated, though clinical studies for 510(k) are typically prospective.

2. 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 a blood glucose meter, the "ground truth" would typically come from a laboratory reference method (e.g., YSI analyzer), not expert human adjudication in the way it might for imaging.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This concept of "adjudication" is generally relevant for subjective assessments (like interpreting medical images). For a quantitative device like a blood glucose meter, the ground truth is established by a more accurate reference method, not by expert adjudication. Therefore, an adjudication method is not applicable and not mentioned.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is used for diagnostic imaging systems where human readers interpret cases, often with and without AI assistance, to measure the AI's impact on human performance. The Prodigy Blood Glucose Test System is a direct quantitative measurement device, not an image interpretation aid. Therefore, this question is not applicable to this device.

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

   • Yes, implicitly. A blood glucose meter inherently operates as a "standalone" algorithm/device in that it directly measures glucose and provides a numerical output without requiring human interpretation or decision-making in its core function. The "clinical and non-clinical testing data" mentioned refers to the performance of the device itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The document does not explicitly state the ground truth method. However, for blood glucose meters, the standard ground truth is typically a laboratory reference method (e.g., hexokinase method on a YSI analyzer or similar highly accurate laboratory instrument).

7. The sample size for the training set:

   • This information is not provided in the 510(k) summary. Given that this is a relatively older electrochemical biosensor, the concept of a "training set" for a machine learning algorithm in the modern sense (with large datasets) might not be directly applicable as it would be for AI/ML-driven devices. Device development often involves calibration data, but it's not usually referred to as a "training set" in this context or documented with specific sizes in 510(k) summaries.

8. How the ground truth for the training set was established:

   • As with the training set details, this is not explicitly provided and not typically detailed in 510(k) summaries for this type of device. If there was a "training" or calibration phase, the ground truth would likely have been established using a highly accurate laboratory reference method, similar to the test set.

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