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The Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Health Care System Software transfers data from the device's memory into a computer for enhanced data management.

The Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.

The Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) blood glucose meters, b) blood glucose plus blood pressure monitors, and c) blood pressure monitors. When use with one of these devices, Health Care System Software transfers data from the device's memory into a computer for enhanced data management.

Here's a breakdown of the acceptance criteria and study information for the Health Care System Software (K110948), based on the provided text:

Important Note: The provided 510(k) summary (K110948) focuses on demonstrating substantial equivalence rather than detailed performance studies with specific statistical metrics typical for AI-powered diagnostic devices. The device is a data management software, not a diagnostic AI. Therefore, many standard AI/ML acceptance criteria (e.g., sensitivity, specificity, AUROC) and the sophisticated study designs to prove them are not applicable or detailed in this document. The "performance studies" mentioned are primarily about software and hardware validation to ensure data transfer integrity and functionality.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. The document states "Testing of Health Care System Software included validation of hardware (data transfer through the cable) and software validation." No specific number of data points, transfers, or users are mentioned for the test set.
   • Data Provenance: Not specified. It's unclear if the testing involved real-world patient data or simulated data, where it originated (e.g., country), or if it was retrospective or prospective. Given the nature of a software accessory for data management, it likely involved simulated or controlled data transfer scenarios rather than clinical patient data analysis for diagnostic accuracy.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not applicable/Not specified. This device is a data management software accessory, not an AI diagnostic tool that requires expert-established ground truth for medical conditions. The "ground truth" here would relate to the correctness of data transfer and display, which is typically validated through engineering and software testing.
   • Qualifications of Experts: Not applicable/Not specified.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable/Not specified. As it's software validation for data management rather than diagnostic interpretation, multi-reader adjudication methods are not relevant.

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:

   • MRMC Study: No, an MRMC comparative effectiveness study was not done.
   • Effect Size: Not applicable. The device is a data management software, not an AI designed to assist human readers in making diagnostic decisions. Its purpose is to facilitate review and analysis of historical test results, not to interpret them or improve diagnostic accuracy directly.

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

   • Standalone Performance: Yes, in a sense, the "Performance Studies" section describes validation of the software and hardware working independently to transfer and manage data. The device's primary function is its standalone capability to capture and organize data from connected meters. It does not perform diagnostic tasks that would typically involve "human-in-the-loop" interaction in the context of AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Type of Ground Truth: For this type of device, the "ground truth" would be established by the expected behavior of the software and hardware according to its specifications. This means:
     • Correct Data Transfer: Verification that data points (e.g., blood glucose readings, blood pressure) are transferred accurately and completely from the meter to the computer.
     • Correct Data Display: Verification that the transferred data is displayed correctly (e.g., tabular format, graph format for temperature) as per the software design.
     • Data Integrity: Confirmation that transferred data remains unmodified.
     • This is typically validated through software testing and quality assurance protocols comparing actual output against expected output based on source data. It does not involve medical ground truths like pathology reports or expert consensus on a diagnosis.

7. The sample size for the training set:

   • Sample Size: Not applicable/Not specified. This device is a traditional software application for data management, not a machine learning or AI model that requires a "training set" in the conventional sense. The software is developed based on programming logic and specifications, not trained on data.

8. How the ground truth for the training set was established:

   • Ground Truth Establishment: Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for a training set.

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The Clever Chek Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.

The Clever Chek Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.

The Clever Chek Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a)Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.

Here's a breakdown of the acceptance criteria and study information for the Clever Chek Health Care System Software (K070941), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It vaguely refers to "Testing... included validation of hardware (data transfer through the cable) software and user evaluation."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. Given the nature of the device (data management software for blood glucose and blood pressure monitors), the "ground truth" would likely be the raw, accurate readings from the meters themselves, rather than interpretations by medical experts.

4. Adjudication Method

The document does not describe an adjudication method. This is likely because the "ground truth" for this type of device would be the direct data from the connected medical devices, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is software for data management, not an interpretive diagnostic tool that human readers would use to assess cases for improved effectiveness.

6. Standalone Performance Study

A standalone performance study was done. The "Performance Studies" section states, "Testing of Clever Chek Health Care System Software included validation of hardware (data transfer through the cable) software and user evaluation. It demonstrated that the system meets its intended use." This indicates the software was tested on its own to confirm its functionality and adherence to its intended purpose.

7. Type of Ground Truth Used

The type of ground truth used was the raw data generated by the associated medical devices (blood glucose meters and blood pressure monitors). The software's function is to transfer and display this data accurately, without modification.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. Given that this is a data management software, it's unlikely to rely on traditional machine learning models that require a separate training set. Its validation would focus on data transfer accuracy, software functionality, and user interface.

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

As there's no mention of a traditional "training set" in the context of machine learning, the document does not describe how ground truth for a training set was established. The "ground truth" pertinent to this device's function would be the accurate transmission and display of data from the aformentioned medical devices.

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