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The EasyMax V Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

The EasyMax V Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by heatthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

The EasyMax V Blood Glucose Test Strips is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

EasyMax V Glucose Control Solutions: For use with the EasyMax V meter and EasyMax V Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

The EasyMax V Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

The EasyMax V Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by heatthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

The EasyMax V Blood Glucose Test Strips is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.

EasyMax V Glucose Control Solutions: For use with the EasyMax V meter and EasyMax V Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Here's an analysis of the provided text to extract information about acceptance criteria and study details for the EasyMax V SMBG System:

The provided text is an FDA 510(k) clearance letter and its associated "Indications for Use" statement. It formally states that the device has been cleared for market based on substantial equivalence to a predicate device. However, this document does not contain a detailed study report or specific acceptance criteria and performance data for the EasyMax V SMBG System itself.

The FDA clearance letter signifies that the device has met regulatory requirements, which would inherently involve studies demonstrating performance. However, the details of those studies, including specific acceptance criteria, reported performance, sample sizes, ground truth establishment methods, and expert qualifications, are not present in this document. Such information is typically found in the full 510(k) submission, which is not provided here.

Therefore, I cannot directly populate the requested table and answer many of the questions based solely on the provided text. I can only infer general information about the device's intended use and regulatory status.

Inferences based on the provided text:

• Device Type: Self-Monitoring Blood Glucose (SMBG) System.
• Intended Use: Quantitative measurement of glucose in fresh capillary whole blood samples (fingertips or forearm). Aid to monitor the effectiveness of diabetes control.
• Users: Persons with diabetes (at home / OTC) or healthcare professionals (clinical settings).
• Exclusions: Not for diagnosis or screening of diabetes, not for visually impaired users or neonates.
• Regulatory Class: Class II.

Attempt to answer based on the lack of information in the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not specified in the provided document. For SMBG systems, regulatory bodies typically look for agreement with a lab reference method (e.g., ISO 15197 standards for accuracy, precision under various conditions).
   • Reported Device Performance: Not specified in the provided document. Performance metrics would typically include accuracy (e.g., % within ±15 mg/dL or ±15% of reference), precision (CV%), and various interference studies.

2. Sample size used for the test set and the data provenance: Not specified in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided document.

4. Adjudication method for the test set: Not specified in the provided document.

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: Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation tool that would involve "human readers" in that context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "Self Monitoring Blood Glucose Test System," implying direct measurement by the system without a complex "algorithm only" component separate from the integrated device function. However, the specific details of its standalone performance (e.g., how its readings compared to a gold standard) are not in this document.

7. The type of ground truth used: Not specified in the provided document. For blood glucose monitors, the ground truth is typically a laboratory reference method (e.g., YSI glucose analyzer).

8. The sample size for the training set: Not specified in the provided document.

9. How the ground truth for the training set was established: Not specified in the provided document. (If a "training set" in the machine learning sense was even used, which is unlikely for a device of this type).

Conclusion:

The provided FDA 510(k) clearance letter and Indications for Use document confirm the regulatory clearance of the EasyMax V SMBG System but do not contain the detailed study information, acceptance criteria, or performance data that would answer most of your questions. Such information resides in the full 510(k) submission document, which is not available in the given text.

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