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The Evolution™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip, ventral palm, dosal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. Evolution™ Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady- state times when alucose is not changing rapidly.

The Evolution™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the Evolution™ Test strip. The principle of the test replies upon a specific type of glucose in blood sample, the oxidase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generation an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood qlucose result.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a dedicated table format. Instead, it relies on a qualitative assessment of "substantial equivalence" to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "clinical performance evaluation" but does not specify the sample size for the test set.

• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "clinical performance evaluation using the EVOLUTION™ Blood Glucose Monitoring System components were conducted for the purpose of validating the consumer use for the user and the professional accuracy." This phrasing generally implies a prospective study conducted for the purpose of the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. Blood glucose monitoring systems typically use a laboratory reference method as ground truth rather than expert consensus on individual readings.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set. Given the nature of blood glucose measurement, a process like 2+1 or 3+1 expert adjudication would not be applicable.

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. This type of study is more relevant for diagnostic imaging interpretation where human readers analyze independent cases. The study here focuses on the accuracy and performance of a blood glucose meter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the "Performance Data" section discusses "Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the EVOLUTION™ Blood Glucose Monitoring System with respect to the predicate device. Testing involved the verification of software requirement specifications, product requirement specifications and user interface requirement specifications from risk analysis." This describes standalone testing of the device itself (its software, product, and user interface) to ensure it meets specifications, which is essentially an algorithm-only performance assessment in the context of a medical device.

7. The Type of Ground Truth Used:

While not explicitly stated as "ground truth," for blood glucose monitoring systems, the implicit ground truth would be a laboratory reference method for glucose measurement. The clinical performance evaluation would compare the device's readings against these highly accurate laboratory results.

8. The Sample Size for the Training Set:

The document does not specify the sample size for any training set. For blood glucose meters, the "training" (calibration) is usually inherent to the manufacturing process and chemistry of the test strips and meter, not a separate data-driven machine learning training set in the typical sense.

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

As there is no explicit mention of a separate training set or machine learning model training, the document does not describe how ground truth for a training set was established.

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LifeScan OneTouch Ultra control solution is intended for use to verify the performance of LifeScan BGM systems using the OneTouch Ultra or OneTouch FastTake test strips at glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home. For In Vitro Diagnostic Use

LifeScan OneTouch Ultra control solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution. LifeScan OneTouch Ultra control solution provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip. LifeScan OneTouch Ultra control solution contains glucose representing typical, normal-range glucose values in blood to verify performance of LifeScan BGM systems using the OneTouch Ultra or OneTouch FastTake test strips. LifeScan OneTouch Ultra control solution is a non-hazardous aqueous solution containing no biological materials.

Here's a breakdown of the acceptance criteria and study information for the LifeScan OneTouch Ultra control solution, based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission is for an extension of an existing control solution, stating "There has been no change in formulation, labeling or intended use of the control solution since the original 510(k) submission, K000318." Therefore, the acceptance criteria are implicitly tied to the performance requirements of the control solution's ability to verify the various LifeScan BGM systems. The reported performance is that the control solution successfully addresses these requirements.

The control solution's intended use is "to monitor and evaluate the analytical performance of LifeScan BGM family systems using the OneTouch Ultra or OneTouch FastTake test strips." The device performance is deemed adequate because it provides a convenient method of performing periodic QC checks and contains glucose representing typical, normal-range glucose values in blood to verify performance.

1. Sample Sized Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly state the sample sizes (number of tests, number of control solution lots, etc.) used for the non-clinical tests (closed bottle stability, stability after opening, test precision and range). No detailed testing protocols or results are included in this summary.

The data provenance is not specified beyond "Tests were conducted to verify specific performance requirements." It does not mention the country of origin of the data or whether it was retrospective or prospective.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a control solution for glucose meters, not a diagnostic device requiring expert interpretation of results. The "ground truth" for a control solution would be its known glucose concentration, established through a traceable reference method, not through expert consensus on diagnostic images or pathology.

3. Adjudication Method for the Test Set

Not applicable. As this is not a diagnostic device involving subjective interpretation, there is no adjudication process for the test set.

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

Not applicable. This is a control solution for blood glucose meters, not an AI-powered diagnostic device or a system for human readers.

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

This question is not directly applicable in the context of a control solution. A control solution itself operates "standalone" in the sense that its chemical properties and stability are assessed intrinsically. It doesn't involve a separate algorithm for interpretation in the way an AI diagnostic tool would. Its performance is measured by how well it verifies the performance of the BGM system.

6. The Type of Ground Truth Used

The ground truth for a glucose control solution's performance stability, precision, and range would be:

• Reference Glucose Concentration: The known, accurately measured glucose concentration of the control solution itself, established through highly precise and traceable chemical analytical methods.
• Performance of Predicate Device/System: The expected and validated performance (accuracy, precision) of the OneTouch Ultra and OneTouch FastTake glucose meters when measuring known glucose concentrations. The goal of the control solution is to ensure these meters perform within their established specifications.

7. The Sample Size for the Training Set

Not applicable. This is a chemical control solution, not a machine learning or AI model that requires a training set.

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

Not applicable, as there is no training set for a chemical control solution.

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