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The FastTake® Compact Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The FastTake® System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.

The FastTake® system includes four main components:

• · FastTake® Test Strips
• FastTake® Compact Blood Glucose Meter .
• · FastTake® Control Solution
• · Penlet II or Penlet Plus lancing device and FinePoint lancets.

Here's an analysis of the provided text regarding the FastTake® Compact Blood Glucose Monitoring System's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 19 diabetic patients.
• Data Provenance: The study was a "consumer-use study," implying real-world or simulated home use. The location/country of origin is not explicitly stated, but Selfcare, Inc. is located in Waltham, MA, USA, suggesting a US-based study. It was a prospective study as it evaluated users interactively with the device feature.

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 given text. The study focused on consumer perception and ability to detect correct filling, implying the "ground truth" for the confirmation window's effectiveness was based on the physical state of the strip (correctly filled vs. under-filled), which would likely be objectively observable or determined by the study administrators rather than expert consensus on a diagnosis.

4. Adjudication Method for the Test Set

This information is not provided in the given text. As the "ground truth" likely related to objective observation of the test strip filling, a formal adjudication method like 2+1 or 3+1 might not have been necessary for this specific performance metric.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The study was a consumer-use study to evaluate the usability and effectiveness of a visual confirmation window, not a comparison of human reader performance with and without AI assistance for diagnosis.

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

This device, a blood glucose monitoring system, is a diagnostic device that requires human interaction (applying blood to the strip). There is no mention of a standalone algorithm-only performance study independent of human use for the FastTake® Compact Blood Glucose Monitoring System as described. The "confirmation window" is a visual aid for the user, not an automated algorithm to interpret results.

7. The Type of Ground Truth Used

The ground truth for the consumer-use study regarding the confirmation window was based on the adequacy of sample filling (i.e., whether the strip was correctly filled or under-filled). This is an objective characteristic of the test strip's physical state rather than a medical diagnosis.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is not an AI/ML-based system requiring a training set in the typical sense. The "FastTake® strips with the new confirmation window feature" were evaluated, implying a design change rather than a learned model.

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

This information is not applicable as there is no training set for an AI/ML model for this device.

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