(155 days)
The Glooko device system for the Glooko Logbook Application and Glooko Logbook Charts is data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for the Glooko Logbook Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their iPhone operating system platform.
The Glooko device system for the Glooko Logbook Application and Glooko Logbook Charts are not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
The Glooko device system for the Glooko Logbook Application includes the following:
- . Glooko MeterSync Cable
- . Glooko IR Adapter
- . Glooko Logbook Application
The Glooko™ Logbook Charts is a data management software tool designed to assist people with diabetes who self-manage their Blood Glucose (BG) readings. The Logbook Charts software is used in conjunction with the Glooko MeterSync Cable and the Glooko Logbook Application. The MeterSync Cable and the Glooko Logbook Application allow users to download BG readings from commercially available blood glucose meters to an iOS (iPhone Operating System) device. The Glooko Logbook Charts software tool enables the Glooko Logbook Application users to chart and graph their BG values from the Glooko Logbook Application. Glooko Logbook Charts is a spreadsheet program developed in Microsoft Excel and helps with quantitatively evaluating the BG data downloaded into the Glooko Logbook Application. Users can download the Glooko Logbook Charts sheet template from the Glooko website to generate and display reports on average BG values and BG trends. Several statistical parameters are calculated and the data is plotted as scattergrams relating blood glucose by time of day and by date. Glooko Logbook Charts specifically offers the following charts and table for view:
- a. BG readings By Time of Day: provides an overview of glucose readings during the day.
- BG readings By Dote: provides an overview of glucose readings over a specified date b. range.
- ﻥ BG readings Analysis By Time Of Day: provides an overview of analyzed glucose readings during the day with high and low values, percentiles, mean and medians. BG readings Summary Statistics: provides an overview of the analyzed glucose readings in table format.
The provided text describes the Glooko device system, focusing on its data management capabilities for blood glucose readings. The studies conducted are primarily for software verification and validation and usability, rather than a comparative effectiveness study of the device's diagnostic performance against a ground truth.
Here's an analysis of the acceptance criteria and study information provided:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly from Testing Goals) | Reported Device Performance |
|---|---|---|
| Software Verification & Validation | Device performs according to stated intended use and specifications. | All test results fell within pre-determined specification parameters. |
| Data Integrity Verification | Accurate transfer and processing of blood glucose data. | Confirmed (for both Glooko Device system and Logbook Charts). |
| Software Design/Features Verification | All software functions (syncing, annotating, viewing, sharing) work as designed. | Confirmed (for both Glooko Device system and Logbook Charts). |
| Error Handling Testing | Software correctly handles errors. | Confirmed for Glooko Device system. |
| Characterization of Spreadsheet | Glooko Logbook Charts spreadsheet functions as expected. | Confirmed. |
| Microsoft Excel Version Testing | Compatibility with various Excel versions. | Confirmed. |
| Glooko Logbook Version Testing | Compatibility and functionality across different Glooko Logbook versions. | Confirmed. |
| Usability - Accuracy of Data Download | Blood glucose data downloads accurately into the Glooko device System. | Validated in usability studies. |
| Usability - Data Sharing & Annotation | Users can share (transmit, download, save, email) and annotate data. | Validated in usability studies. |
| Usability - Effectiveness of User Manual | User manual is clear and helpful. | Validated in usability studies. |
| Usability - Ease of Use (Cables & App) | Glooko MeterSync Cable and Logbook Application are easy to use. | Validated in usability studies. |
| Usability - Ability to Transmit, Download, Save, Email CSV | Users can transmit, download, save, and email CSV files from Logbook Charts. | Validated in usability studies. |
| Usability - Ability to View and Print Charts | Users can view and print Logbook Chart graphs. | Validated in usability studies. |
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Glooko Device System (Logbook Application & MeterSync Cable) Usability Study (v1.0.0): 20 patients with Type 1 or Type 2 diabetes.
- Glooko Logbook Charts Usability Study: 20 patients with Type 1 or Type 2 diabetes and 15 healthcare professionals.
- Data Provenance: Not explicitly stated, but the studies were conducted under an IRB approved protocol, implying prospective collection within a controlled study environment. The country of origin is not specified.
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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):
- The studies described are primarily for usability and software verification, not a diagnostic accuracy study requiring expert-established ground truth for performance metrics like sensitivity or specificity.
- For the usability studies, healthcare professionals participated, but their role was as users/evaluators of the system's usability and functionality, not as experts establishing a diagnostic ground truth against a clinical condition. Their qualifications are not specified beyond "healthcare professionals."
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this was not a diagnostic study requiring adjudication for ground truth establishment. The studies focused on functional and usability testing.
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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:
- No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed. The studies focused on the performance and usability of the device system itself, not on how it enhances human reader performance in a diagnostic context. This device is a data management tool, not an AI-powered diagnostic aid for clinicians' interpretation of medical images or complex data.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the "Software Verification and Validation" sections for both the Glooko Device system and the Glooko Logbook Charts describe testing designed to confirm the software's functionality and data integrity according to specifications. This represents a form of standalone performance evaluation of the algorithms and software logic, ensuring they operate correctly independent of user interaction, before user-facing usability was tested.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the software verification and validation, the "ground truth" was the predefined design specifications and functional requirements of the software and device system.
- For the usability studies, the "ground truth" was the intended user experience and functional goals (e.g., successful data download, ability to share, ease of use), assessed via user feedback and observation of task completion. It was not a clinical "ground truth" for diagnostic accuracy.
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The sample size for the training set:
- This information is not provided. The document describes verification and validation studies (testing phase) but does not detail any machine learning model training. Given the device's function as a data management system rather than a predictive AI model, it's unlikely a "training set" in the machine learning sense was extensively used or relevant to this 510(k) summary, beyond standard software development and testing cycles.
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How the ground truth for the training set was established:
- As no information on a "training set" (in the machine learning context) is provided, the method for establishing its ground truth is also not mentioned.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.