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510(k) Data Aggregation
(27 days)
GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
The Glooko device system for Glooko Logbook+ Application is a 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 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 Glooko Loabook+ Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
The Glooko device system for Glooko Logbook+ Application is used to aid individuals with diabetes in the download, review, analysis, evaluation, and communication of their blood glucose readings. The system allows users to download readings from compatible, FDA-cleared, commercial blood glucose meters to their iPhone Operating System (iOS) devices, and then share this information with healthcare professionals. It is intended for use both in home and professional settings to support an effective diabetes management program. The data may be displayed on supported devices to provide an online view of all collected data and notes from the Glooko Logbook+ Application. The system does not provide treatment decisions and cannot be used as a substitute for professional healthcare advice.
The Glooko device system for Logbook+ Application consists of the following components:
- The Glooko MeterSync Cable
- The Glooko IR Adapter
- The Glooko Logbook+ Application
The document describes the Glooko device system for Glooko Logbook+ Application, which is a data management software for individuals with diabetes to download, review, analyze, evaluate, and communicate their blood glucose readings. The submission is a Special 510(k) and demonstrates substantial equivalence to a previously cleared predicate device (K122142).
Here's an analysis of the provided text in relation to the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., accuracy percentages, error rates) alongside reported device performance for a clinical study. Instead, it relies on verification and validation testing to confirm performance according to specifications and intended use. The core acceptance criteria appear to be functional compliance with design specifications and equivalence to the predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device performs according to stated intended use and specifications (functional, software, and data integrity). | "All test results fell within the pre-determined specification parameters." The device underwent "Software Verification and Validation" including "Data Integrity Verification, Software Design/features Verification, and error handling testing." These studies "demonstrated that the Glooko Device System for Glooko Logbook+ Application performed according to the specifications and the intended use." |
| Substantial equivalence to the predicate device (K122142) in intended use and function. | "The Glooko Device System for Glooko Logbook+ Application is substantially equivalent to the predicate device with regards to its intended use and function." Both use the same technology to download data and analyze blood glucose meter data producing basic statistics and graphs. |
| Data security (for new features like transmitting data across multiple devices/web browsers). | "To ensure data security, a login credential feature was added. To protect sensitive health information from unauthorized access during transmission, all data on the Glooko network is protected using the Secure Sockets Layer (SSL) protocol. In addition, Glooko forces the https:// standard for all mobile and web communication features... All data in the Glooko system is encrypted end-to-end using 256-bit Advance Encryption Standard (AES) encryption for message data both in transmission and storage." |
| No new questions of safety and effectiveness are raised by new features (e.g., new view options, goal setting). | "These additional features did not raise any new questions about safety and effectiveness." (referring to multiple view options). "This feature (goal setting) neither affects the blood glucose data nor raises any new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a distinct "test set" sample size in terms of patient data or clinical cases. The testing described is primarily functional and software verification/validation.
- Sample Size: Not explicitly stated for patient data. The testing involved various compatible meters and iOS devices.
- Data Provenance: Not applicable in the context of clinical trial data. The device functions by downloading data from FDA-cleared blood glucose meters, which implies the data itself originates from those meters. The device itself is a data management system, not a diagnostic one generating its own primary data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The device is a data management system, and its correctness is assessed through software verification and validation against its own design specifications and the data downloaded from compatible blood glucose meters, rather than against an expert-established "ground truth" for clinical outcomes or diagnoses.
4. Adjudication Method for the Test Set
This information is not provided and is likely not relevant for this type of software verification and validation. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient data by multiple experts. The testing here focuses on technical functionality and data integrity.
5. 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
This information is not provided and is not applicable. The Glooko Device System, as described, is a data management and display tool, not an AI-assisted diagnostic or interpretation system that would involve human "readers" interpreting output. Its purpose is to present blood glucose data for review by individuals and healthcare professionals.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a "standalone" software system in the sense that its algorithms perform data download, storage, calculation of statistics, and graphing without human intervention in those specific computational steps. However, it is explicitly stated that the device "does not provide treatment decisions and cannot be used as a substitute for professional healthcare advice." Therefore, it's a standalone component of a larger diabetes management program where humans (patients and healthcare professionals) still make all interpretative and treatment decisions. The document refers to "Software Verification and Validation" which implies standalone algorithm testing.
7. The Type of Ground Truth Used
The "ground truth" for this device primarily relies on:
- Design Specifications: The software's output (e.g., downloaded glucose readings, calculated statistics, displayed graphs) is validated against its pre-determined design specifications.
- Data Integrity Verification: Ensuring that the data downloaded from compatible, FDA-cleared blood glucose meters is transferred, stored, and displayed accurately, meaning the "ground truth" for the data points themselves comes from the original blood glucose meters.
- Predicate Device Functionality: The performance of the new features and overall functionality is compared for substantial equivalence to the previously cleared predicate device.
It does not use expert consensus, pathology, or outcomes data as its primary ground truth, as it is not a diagnostic device.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This is a software verification and validation report for a data management system, not a machine learning model that typically requires a large training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set or machine learning model, the concept of establishing ground truth for a training set is not applicable to this submission as described.
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