Search Results

The EZ Scan Plus Blood Glucose Test Strips are used with the EZ Scan Plus Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood drawn from the fingertip and the alternate sites: palm and forearm. The EZ Scan Plus Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Scan Plus Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control.

The EZ Scan Plus Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, are adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. EZ Scan Plus device provides a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes. The EZ Scan Plus Blood Glucose Test Strips are used with the EZ Scan Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood obtained from the fingertip and the alternate sites: palm and forearm. When the edge of the EZ Scan Plus Test Strip is touched to a drop of blood, the test strip draws the blood into the sample chamber and the glucose reading is displayed on the meter after 10 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The EZ Scan Plus Test Strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.

Here's a breakdown of the acceptance criteria and study information for the EZ Scan Plus Blood Glucose Monitoring System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a formal table or list like "Accuracy must be X% within Y mg/dL." Instead, it relies on demonstrating substantial equivalence to a predicate device and presenting the performance characteristics of the new device. The key performance characteristic mentioned for the device's accuracy demonstration is its similarity to the predicate and the clinical alternate site testing results.

Given the information, the acceptance criteria implicitly align with established performance for blood glucose monitoring systems, particularly showing comparable performance to the predicate and demonstrating clinical utility for alternate site testing.

Here's a table based on the provided information, interpreting the "acceptance criteria" through the lens of equivalence and reported performance:

2. Sample Sizes Used for the Test Set and Data Provenance

The summary states: "The results of clinical alternate site testing demonstrate that the results obtained from the alternate site sampling using EZ Scan Plus system, are similar to those obtained from finger stick whole blood with no effect on clinical action."

• Test Set Sample Size: Not explicitly stated. The document only mentions "clinical alternate site testing" was performed.
• Data Provenance: Not explicitly stated (e.g., country of origin). It can be inferred that the studies were conducted by Tyson Bioresearch, Inc., which is based in Taiwan (ROC). The summary doesn't specify if the data was retrospective or prospective, but clinical studies are generally 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 summary. For blood glucose monitoring systems, ground truth is typically established by laboratory-reference methods, not expert consensus in the same way it might be for image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable in the traditional sense for a blood glucose meter. The "ground truth" for a blood glucose reading is the result from a highly accurate laboratory instrument, not a human interpretation that requires 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

This is not applicable to this device. The EZ Scan Plus Blood Glucose Monitoring System is a standalone diagnostic device, not an AI-assisted interpretation tool for human readers. There are no human "readers" in the context of interpreting results from this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance described is standalone. This device measures glucose directly and provides a numerical output. Its performance characteristics (accuracy, precision, range) are inherent to the device and its algorithm, without human intervention in the result generation or interpretation process.

7. The Type of Ground Truth Used

The ground truth used for blood glucose monitoring systems is typically established by laboratory reference methods. The summary states: "The EZ Scan Plus Test Strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods." This strongly implies that lab-based glucose measurements were used as the gold standard for comparison during validation.

8. The Sample Size for the Training Set

The summary does not provide information on a specific "training set" sample size. For an electrochemical biosensor like this, the device's algorithm and calibration are typically developed and refined using a variety of blood samples with known glucose concentrations, but this process isn't usually described as a "training set" in the same way machine learning models are. The 510(k) focuses on the validation of the finalized product.

9. How the Ground Truth for the Training Set Was Established

As with point 8, the concept of a "training set" isn't explicitly detailed. However, any calibration or development work would rely on laboratory reference methods to establish accurate glucose concentrations for various samples used during the development phase.

Ask a specific question about this device