(261 days)
The Glooko Mobile Insulin Dosing System (MIDS) is indicated for the management of type 2 diabetes by calculating appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a physician or healthcare provider knowledgeable in the care and management of diabetes. The physician or healthcare provider must activate the MIDS dose calculator and configure the patient-specific parameters. The system is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
The Glooko MIDS system will be an optional new module to support the titration of long acting basal insulin doses. Health care providers (HCPs) will be able to opt-in to this new MIDS module and use it with a subset of their patients. Although the Glooko App may interact with Blood Glucose (BG) meters, insulin pumps and Continuous Glucose Meters (CGM), the MIDS interface will get data ONLY from the BG meters.
Glooko MIDS consists of the following two interfaces:
- MIDS Provider Interface on the Glooko Web Application for use by HCP's to prescribe long acting insulin doses for their patients
- MIDS Patient interface on the Glooko mobile application for use by patients on compatible iOS and Android phones
Glooko MIDS provides directions to the patient based on a pre-planned treatment program as suggested by their HCP for titrating long acting insulin doses. Glooko MIDS is for titrating long acting insulin doses only.
The provided document is a 510(k) Summary for the Glooko Mobile Insulin Dosing System (MIDS). It describes the device, its indications for use, comparison to predicate and reference devices, and performance data to demonstrate substantial equivalence.
However, the document does not contain specific details about acceptance criteria or a clinical study proving the device meets those criteria in the format requested (e.g., a table of performance metrics, sample sizes, expert qualifications, etc.).
Instead, it states that:
- "The Glooko MIDS software was validated pursuant to the Major Level of Concern requirements."
- "Design validation testing and human factors study results confirmed that the Glooko MIDS software performs according to the stated intended use."
- "Software evaluation consisted of functional testing performed pursuant to Glooko's design verification protocol. All of the software tests were documented according to FDA's guidance document - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). All test results fell within the pre-determined specification parameters and acceptance criteria."
This indicates that internal functional and design validation testing, along with human factors validation, was performed, and acceptance criteria were met. However, the specific acceptance criteria, detailed performance metrics, sample sizes for these tests, information about ground truth establishment, or expert involvement are not explicitly provided in the public 510(k) summary.
Therefore, I cannot populate the requested table and details because the information is not present in the provided text. The document refers to "pre-determined specification parameters and acceptance criteria" but does not detail what those are, nor does it provide the results of any specific study (like an MRMC study or standalone performance study measuring clinical accuracy vs. human performance) that would typically prove such criteria were met.
Based on the provided text, I can state the following limitations in responding to your request:
- No explicit table of acceptance criteria and reported device performance is available. The document only states that "All test results fell within the pre-determined specification parameters and acceptance criteria," without listing them.
- Sample sizes for the test set are not specified.
- Data provenance (country of origin, retrospective/prospective) is not specified for any performance testing.
- Number and qualifications of experts for ground truth establishment are not specified.
- Adjudication method for the test set is not specified.
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is described with effect sizes.
- No standalone (algorithm-only) performance metrics are detailed beyond stating functional tests were performed.
- The type of ground truth used is not specified. (It's a software for calculating insulin doses based on physician configuration, implying correctness would be against a predefined algorithm or manual calculation, not necessarily pathological or outcomes data in a clinical sense for this type of device).
- Sample size for the training set is not applicable/specified as this is not an AI/ML device that requires a training set in the typical sense. It states "Software evaluation consisted of functional testing," implying rule-based or logic-based software rather than a learned model.
- How ground truth for the training set was established is not applicable/specified.
The submission focuses on demonstrating substantial equivalence to a predicate device (Insulia Diabetes Management Companion) through similar indications for use, technological characteristics, and "functional testing." It is not a submission for a novel AI/ML device requiring extensive clinical validation against human performance or a complex ground truth.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).