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Health2Sync Mobile Application is data management software that is intended for use in home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. The Health2Sync Smart Cable allows users to upload blood glucose data from compatible FDA cleared meters to the Health2Sync Mobile Application on their iPhone operating system platform.

Health2Sync Mobile Application is not intended to provide treatment decisions nor is it to be used as a substitute for professional healthcare advice.

The Health2Sync Mobile Application and Smart Cable (Mobile App and adapters) allows the transfer of blood glucose readings from the compatible glucose meter to smartphone via Smart Cable.

The App features enable the user to view and analyze blood glucose readings from different meal time periods, other features including lifestyle diary, interpretable graphs option, inviting and sharing data with partners, and emailing reports are available for viewing and analyzing blood glucose readings within the different time slots.

The system includes: 1) Health2Sync Mobile Application (through Apple store only), 2) Smart Cable, 3) Smart Cable 3.5mm connector (optional) and 4) Smart Cable and Application Quick Start Guide

Compatible Meters include: OMNIS Health Embrace BGMS Meter, (K113098) OMNIS Health Embrace EVO BGMS Meter (K090043), and Medline EvenCare G2 BGMS meter (K113208)

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Health2Sync Mobile Application and Smart Cable for Diabetes Management
Intended Use: Data management software for home and professional settings to aid people with diabetes and healthcare professionals in reviewing, analyzing, and evaluating glucose test results to support diabetes management. The Smart Cable allows uploading blood glucose data from compatible FDA-cleared meters to the Health2Sync Mobile Application on iPhone. It is not intended to provide treatment decisions or substitute professional healthcare advice.

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating functional equivalence and safety rather than specific numerical acceptance criteria for a diagnostic performance. Acceptance is generally implied by successfully passing various verification tests.

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

• Data Transmission Memory Rollover Synchronization Verification:

  • Test Set Sample Size: 2 meters per model (total 6 meters) with fully loaded data, and 15 meters across 3 models with partially loaded data.
  • Data Provenance: Not explicitly stated, but implied to be laboratory-generated or controlled data for testing purposes within the manufacturer's verification process. No mention of country of origin or retrospective/prospective human data.

• User Performance Evaluation:

  • Test Set Sample Size: 21 participants.
  • Data Provenance: Not explicitly stated, but implied to be a prospective user study conducted by the manufacturer for evaluation. No mention of country of origin.

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

This type of information is generally not applicable for this device. The device's primary function is data transfer and display, not a diagnostic interpretation that requires expert ground truth.

• For the Data Transmission testing, the "ground truth" is the data stored on the blood glucose meters themselves, and the accuracy is verified against this known data. No human experts are involved in establishing this ground truth.
• For the User Performance Evaluation, the "ground truth" is the successful completion of tasks as defined by the study protocol. No external experts are required to establish this.
• For EMC and Readability, the ground truth is established by standardized testing protocols and algorithms (e.g., Flesch-Kincaid Grade Level), not human experts.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests focus on functional verification, user task completion, and adherence to technical standards rather than subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document does not describe any study involving human readers or comparing AI-assisted performance against unaided human performance. The device is a data management tool, not an AI diagnostic aid in the traditional sense that would warrant an MRMC study.

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

Yes, the described verification tests for "Data Transmission Memory Rollover Synchronization" and "Electromagnetic Compatibility (EMC)" represent standalone performance evaluations of specific device components (Smart Cable, Mobile App's data handling). The "Readability Assessment" is also a standalone evaluation of the documentation.

The "User Performance Evaluation" implicitly involves a human-in-the-loop, but the overall assessment of the device's core data management functions (e.g., accurate data transfer) is conducted in a standalone manner against predefined criteria.

7. The Type of Ground Truth Used

• Data Transmission Memory Rollover Synchronization Verification: The ground truth was the known data stored on the compatible blood glucose meters. The transferred data was compared against this known source for accuracy.
• User Performance Evaluation: The ground truth was the successful completion of predefined user tasks according to the device's instructions for use.
• Electromagnetic Compatibility (EMC): The ground truth was established by international and national safety standards for electrical equipment.
• Readability Assessment: The ground truth was established by the Flesch-Kincaid Grade Level algorithm, a standardized metric for readability.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/machine learning model. The Health2Sync Mobile Application appears to be a data management software that processes and displays glucose readings rather than learning patterns from a training dataset. Therefore, this information is not applicable.

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

Since there is no mention of a training set or an AI/machine learning component that requires one, this information is not applicable.

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