(28 days)
endo.digital Platform is intended for the management of diabetes by people with diabetes and their healthcare providers in order to report, upload, log, track, share, monitor and review their data using web and mobile applications. endo.digital Platform also enables communication between people with diabetes and their healthcare providers as well as among healthcare providers.
endo.digital Platform enables the healthcare provider to use endo.digital Algorithm for treatment recommendations as described below and prescribe endo.digital Bolus Calculator for patient use.
endo.digital 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)
endo.digital 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.
endo.digital 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. endo.digital Algorithm does not replace clinical judgement.
endo.digital 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.
endo.digital Platform is a software device that is designed to be a diabetes management platform. It includes endo.digital 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). endo.digital 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). endo.digital Algorithm gathers and analyzes information inputted through the Diabetes Management Systems (DMS), which collect biological input information from various diabetes devices and data sources including the DreaMed Diary App. Diabetes device information required and used by endo.digital 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 endo.digital 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 (which can include Fixed Meal and Meal Estimation plans) or insulin to carbohydrate ratio and correction factor (insulin sensitivity) for bolus injections. endo.digital 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 endo.digital Bolus Calculator which is integrated in the DreaMed Diary App to aid in calculating their bolus injections.
The provided text details the 510(k) premarket notification for the "endo.digital Platform." While it discusses the device's intended use, description, and substantial equivalence to a predicate device, it does not contain specific information about the acceptance criteria or the study that proves the device meets those criteria. The document states that "software performance data demonstrates that endo.digital Platform is as safe and effective as the predicate device" and that "Design validation testing results confirmed that endo.digital Platform performs according to the stated intended use. Software evaluation consisted of functional testing performed pursuant to DreaMed's software test plan. All test results fell within the pre-determined specification parameters and acceptance criteria." However, it does not provide the acceptance criteria themselves, nor the details of the studies conducted to meet them.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample size used for the test set and the data provenance: This information is not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned. The device is a "decision-support software intended for assisting healthcare professionals," implying a human-in-the-loop, but no MRMC study details are shared.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not specified.
- The type of ground truth used: Not specified.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
The document focuses on the regulatory submission, equivalence to a predicate device ("Advisor Pro Platform, K210561"), and the general statement that "software performance data demonstrates that endo.digital Platform is as safe and effective as the predicate device." It also mentions "functional testing performed pursuant to DreaMed's software test plan" and that "All test results fell within the pre-determined specification parameters and acceptance criteria," but it does not disclose the specifics of these tests or criteria.
To obtain the requested information, one would typically need to review the full 510(k) submission, which often includes detailed validation reports, clinical studies, and software verification and validation documentation. These are usually not fully disclosed in the public 510(k) summary letter.
§ 862.1358 Insulin therapy adjustment device.
(a)
Identification. An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations;
(ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated;
(iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations;
(iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification;
(v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures;
(vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and
(vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level.
(2) The device must not be intended for use in implementing automated insulin dosing.
(3) Your 21 CFR 809.10(b) labeling must include:
(i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device;
(ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations;
(iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and
(iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).