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The EasyGluco® Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by patients with diabetes. The EasyGluco® Plus Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared with any other person.

EasyGluco® Plus System is for self testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The EasyGluco® Plus Blood Glucose Monitoring System should not be used for the diagnosis 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 EasyGluco® Plus Blood Glucose Test Strips are for use with the EasyGluco® Plus Blood Glucose Monitor for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh.

The EasyGluco® Plus Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the EasyGluco® Plus Test Strips.

The test principle is:
This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

The provided document does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria in a format allowing for direct extraction into the requested table and parameters.

The document is a 510(k) premarket notification summary for the EasyGluco® Plus Blood Glucose Monitoring System, which focuses on establishing substantial equivalence to a predicate device (G5 Infinity Blood Glucose Monitoring System, K082201). While it describes the device, its intended use, and claims substantial equivalence, it does not explicitly detail the performance acceptance criteria or the specifics of a study designed to demonstrate those criteria were met, such as accuracy metrics, sample sizes for testing sets, ground truth establishment, or expert involvement.

Therefore, it's not possible to populate the requested table and answer the specific questions based solely on the provided text. The document is primarily a regulatory submission for equivalence, not a detailed study report.

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The GS Infinity TM Meter device is used along with the G5 Infinity TM Test Strips for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes manage:nent in the home by patients with diabetes and in clinical settings by healthcare professionals. G5 Infinity TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the dorsal palm, ventral palm, forearm, upper arm, calf and thigh. The G5 Infinity™ Blood Glucose Monitoring System is not intended for screening or diagnosis of diabetes and also not for use with neonates.

The Infinity ™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the Infinity ™ Test Strips.
The test principle is:
This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

The provided text describes the U.S. Diagnostics, Inc. G5 Infinity™ Blood Glucose Monitoring System, including its intended use and comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document is a 510(k) summary and clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results that would include acceptance criteria and specific data about how those criteria were met.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the given document:

• 1. A table of acceptance criteria and the reported device performance: This information is not available in the provided text. The document refers to "substantial equivalence" to predicate devices without listing specific performance metrics or their acceptance criteria.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not available in the provided text.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not available in the provided text.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not available in the provided text.
• 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 information is not available in the provided text. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not available in the provided text. The device is a "Blood Glucose Test System" for quantitative measurement of glucose, implying a direct output rather than an "algorithm only" performance in the context of interpretation by human readers.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not available in the provided text. For a blood glucose monitor, the "ground truth" would typically refer to a reference laboratory method for glucose measurement, but this is not mentioned.
• 8. The sample size for the training set: This information is not available in the provided text.
• 9. How the ground truth for the training set was established: This information is not available in the provided text.

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The EASYGLUCO™ Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. EASYGLUCO™ System is for testing outside the body (in vitro diagnostic use only). The EASYGLUCO Diabetes Monitoring System is not for use with neonatal blood specimens. Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, palm, calf and thigh.

The EASYGLUCO™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the EASYGLUCO™ Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

This 510(k) submission (K061431) for the EASYGLUCO™ G2 Blood Glucose Monitoring System provides a summary of the device and its intended use, but it does not contain the detailed study information or acceptance criteria you've requested.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It explicitly states in the "510(k) Summary" section: "According to the requirements of 21 CFR.807.92, the following information provides sufficient data to understand the basis for a determination of substantial equivalence." This means it's designed to show that the new device is as safe and effective as a legally marketed predicate device, not necessarily to present a full clinical study report with detailed performance metrics and acceptance criteria.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: This level of detail is typically found in the full submission, not the summary.
• Sample size used for the test set and the data provenance: Not mentioned in the summary.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size: Not applicable for a blood glucose monitor, and not mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device, and not mentioned.
• The type of ground truth used: Not explicitly stated for performance evaluation, though for a blood glucose monitor, ground truth would typically be a laboratory reference method.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

What the document does provide:

• Device Name: EASYGLUCO™ G2 Blood Glucose Monitoring System
• Predicate Device: LifeScan, Inc., OneTouch® Ultra® (K024194), LifeScan, Inc. SURESTEP® (K984261), Roche Diagnostics Corp. Accu-Chek Advantage (K021513)
• Device Description: An in vitro diagnostic device for measuring glucose in whole blood using a test strip with an electrochemical signal.
• Intended Use: Quantitative measurement of glucose in whole blood to monitor diabetes management in home and clinical settings, for in vitro diagnostic use only, not for neonatal blood specimens. Testing sites include fingertip and alternate sites (forearm, palm, calf, thigh).

To obtain the detailed study information, acceptance criteria, and performance data, one would typically need to review the full 510(k) submission, which is much more extensive than the summary document provided here.

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