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The Advisor Pro Platform is intended for the management of diabetes by people with diabetes and their health care providers in order to report, log, track, share, monitor and review their data using the dedicated computer or mobile software. Advisor Pro Platform also enables communication between people with diabetes and their health care providers as well as among health care providers.

The Advisor Pro Platform enables the healthcare provider to use the Advisor Pro Algorithms for treatment recommendations as described below and prescribe the Advisor Pro Bolus Calculator for patient use.

Advisor Pro Algorithm is a decision-support software intended for assisting healthcare professionals in the management of their patients with diabetes who monitor their glucose levels using continuous glucose monitor (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter; and use any of the following insulin types as their therapy to manage glucose levels via subcutaneous injections or continuous sub-cutaneous insulin infusion (CSII; insulin pump) reported either manually or automatically:

• Long Acting insulins (for injections only)
• Short acting insulins:
  • Rapid acting analogs (for injections and insulin pump according to manufacturer indications for use)
  • Regular human insulin (for injections only)

The Advisor Pro algorithm is intended to be used for patients with:

• Type 1 diabetes over the age of 6 using an insulin pump or subcutaneous insulin injections.
• Type 2 diabetes over the age of 10 who use subcutaneous insulin injections.

Advisor Pro Algorithm is indicated for use by healthcare professionals when analyzing CGM, SMBG and/or insulin delivery data to generate recommendations for optimizing a patient's insulin treatment plan for basal therapy and/or bolus therapy and/or glucose targets; without considering the full clinical status of a particular patient. Advisor Pro Algorithm does not replace clinical judgment.

The Advisor Pro Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information.

The initial setup of the user's treatment plans, and bolus calculator settings must be performed by a healthcare provider.

The Advisor Pro Platform is a software device that is designed to be a diabetes management platform. It includes the Advisor Pro Algorithm that provides insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump or multiple daily injections, a continuous glucose monitoring (CGM) system and/or self-management blood glucose meter (SMBG). The Advisor Pro Algorithm also provides insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 2 diabetes on basal-bolus therapy via multiple daily injections (MDI), a continuous glucose monitoring (CGM) system and/or self-management blood glucose meter (SMBG).

The Advisor Pro Algorithm gathers and analyzes information inputted through the Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices and data sources including the DreaMed Diary App. Diabetes device information required and used by Advisor Pro Algorithm includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care.

Following data collection and analysis, the Advisor Pro Algorithm generates results containing summary data and recommendations for adjustments to the patient's insulin therapy parameters, including basal insulin delivery rate(s), insulin to carbohydrate ratio and correction factor (insulin sensitivity) for pump patients and for MDI patients a daily injection plan including a basal plan and either a sliding scale or insulin to carbohydrate ratio and correction factor (insulin sensitivity) for bolus injections. Advisor Pro Algorithm may also advise on personalized diabetes management tips. Results are sent to the Diabetes Management System, which displays results to physicians and a report provided by the algorithm. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient.

For MDI patients using rapid acting analogs for insulin bolus dose, the healthcare provider may prescribe the Advisor Pro Bolus Calculator which is integrated in the DreaMed Diary App to aid in calculating their bolus injections.

The provided text describes the DreaMed Advisor Pro Platform, a software device intended for diabetes management. It includes two main components: the Advisor Pro Algorithm (a decision-support tool for healthcare professionals) and the Advisor Pro Bolus Calculator (for patient use).

Here's an analysis of the acceptance criteria and the study proving device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or specific thresholds for agreement. Instead, it focuses on demonstrating that the device's recommendations are "as good as" or "similar to" those of experts.

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

• Test Set Sample Size: The clinical study involved a data set of 17 Type 1 patients and 15 Type 2 patients.
• Data Provenance: The document does not specify the country of origin for the data. It indicates the study was "retrospective clinical study."

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

• Number of Experts: A total of 36 experts were involved.
• Qualifications of Experts: The text states these were "healthcare professional who work at leading centers with a wealth of experience in the field of diabetes and who are especially familiar with diabetes technology devices." Specific professional titles (e.g., endocrinologist, specialized diabetes nurse), years of experience, or board certifications are not provided.

4. Adjudication Method for the Test Set

The document states, "Recommendations were compared to examine the level of agreement between one expert to his colleague versus the level of agreement between Advisor Pro Algorithm recommendations and experts." This implies some form of comparison or consensus evaluation, but a specific adjudication method (e.g., 2+1, 3+1) is not explicitly detailed. It seems to be a comparison of agreement levels rather than a formal adjudication process to establish a single ground truth from multiple expert reads for each case.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

While the study involved multiple experts evaluating cases and comparing their recommendations to the algorithm and to each other, the description doesn't explicitly label it as a formal MRMC comparative effectiveness study in the sense of directly measuring human reader improvement with AI assistance vs. without.

The study aimed to show that the AI's recommendations were "as good as" expert recommendations. It compared "the level of agreement between one expert to his colleague versus the level of agreement between Advisor Pro Algorithm recommendations and experts."

Therefore, it was not a direct MRMC study to quantify how much human readers improve with AI assistance. It was designed to show the equivalence/similarity of the algorithm's recommendations to those of experts. No effect size for human reader improvement with AI assistance is reported because that was not the stated purpose of this particular comparison.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the study described is a standalone performance evaluation of the Advisor Pro Algorithm's recommendations compared to expert recommendations. The algorithm generated recommendations independently, which were then compared to expert decisions.

7. The Type of Ground Truth Used

The ground truth for the clinical study appears to be expert consensus or expert recommendations for insulin therapy adjustments. The algorithm's recommendations were compared against the recommendations of these experts to establish "level of agreement."

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set for the Advisor Pro Algorithm. The clinical study described involved a test set.

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

The document does not provide information on how the ground truth for the training set was established. The clinical study described focuses on the evaluation of the algorithm's performance on a test set, not on its training data.

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