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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.

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The Glooko device system for Glooko Application 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 Glooko Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their mobile devices running on Android Operating System.

The Glooko device system for Glooko 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 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 Android Operating System mobile 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 Android Application. The system does not provide treatment decisions and cannot be used as a substitute for professional healthcare advice.

The Glooko device system for Glooko Application consists of the following components:

1. The Glooko MeterSync Cable for Android
2. The Glooko Application

The provided document describes the Glooko Device System for Glooko Application, which is 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 predicate device (K130886). The primary difference is the operating system platform (Android vs. iOS) and the meters supported.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it states that "All test results fell within the pre-determined specification parameters." The studies focused on confirming that the device performs according to its stated intended use and specifications, particularly regarding data integrity, software features, and error handling.

• Software Design/features Verification: Passed, all test results within pre-determined specification parameters.
• Error Handling Testing: Passed, all test results within pre-determined specification parameters. |
  | Intended Use | - Device performs according to its stated intended use (aid in review, analysis, evaluation, and communication of blood glucose readings, support diabetes management program). |
  | Substantial Equivalence | - Demonstrated substantial equivalence to the predicate device (K130886) in intended use, function, and technology for downloading and analyzing blood glucose data. |

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

The document mentions "functional testing performed pursuant to Glooko's design verification protocol" and lists categories like "Data Integrity Verification, Software Design/features Verification, and error handling testing." However, it does not specify the sample size used for these test sets (e.g., number of data transfers, number of unique meter readings, etc.).

Data Provenance: The document does not explicitly state the country of origin of the data or whether the data used for testing was retrospective or prospective. Given the nature of a software application for managing blood glucose readings, the "data" would likely refer to simulated or actual blood glucose readings downloaded from various meters.

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

The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on internal verification protocols and specifications. For a data management system that transfers and displays blood glucose readings, ground truth would typically involve comparing the downloaded data against the original data stored in the blood glucose meters or a reference system. This verification is usually performed by engineers and quality assurance personnel, rather than medical experts, unless the displayed interpretation itself needed clinical validation.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set. The testing appears to be based on a pass/fail criteria against pre-determined specifications, implying direct verification rather than a consensus-based adjudication process.

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:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not relevant for this type of device. The Glooko Device System is a data management tool for blood glucose readings; it is not an AI-powered diagnostic or interpretive tool that assists human readers (e.g., radiologists interpreting images). Therefore, there is no "human reader" component to improve or an "AI assistance" to measure an effect size against.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The "standalone" performance in this context refers to the Glooko Application and MeterSync Cable's ability to accurately download, store, process (generate graphs, statistics), and display blood glucose data without human intervention beyond initiating the download and viewing the data. The documentation indicates that functional testing, including data integrity verification, software design/features verification, and error handling, was performed. This implies a standalone assessment of the software's functionality in accurately handling the data.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For a device like the Glooko Application, the "ground truth" for the test set would be the actual blood glucose readings stored on the compatible FDA-cleared blood glucose meters. The system's performance is validated by ensuring that the data downloaded, processed, and displayed by the Glooko Application precisely matches the data from the source meters. This is a direct comparison, not based on expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

The Glooko Device System is a deterministic software application for data management, not a machine learning or AI algorithm that requires a "training set." Therefore, there is no training set mentioned or implied in the document.

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

Since there is no training set for this device, a method for establishing its ground truth is not applicable.

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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:

1. The Glooko MeterSync Cable
2. The Glooko IR Adapter
3. 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.

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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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

Study Details:

1. 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.

2. 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."

3. 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.

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:

   • 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.

5. 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.

6. 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.

7. 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.

8. 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.

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