(105 days)
Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog.
Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetes related healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, and evaluation of patient data in order to support effective diabetes management.
Insulia Diabetes Management Companion includes a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments, similar to the directions provided to patients as a part of routine clinical practice.
Insulia Diabetes Management Companion intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols.
Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Insulia Diabetes Management Companion is a mobile and web based diabetes management system for adult type 2 diabetes patients and their healthcare team. Insulia Diabetes Management Companion includes three components:
- A mobile medical application for use by patients on commercially available smartphones (iPhones and Android phones) and tablets.
- A web-based application for use by patients in their home on their personal computer and on their mobile device, or by HCPs in professional healthcare settings through a compatible web browser on a personal computer.
- A secure database hosted in a private cloud environment and used to securely store patient data.
Insulia Diabetes Management Companion provides secure capture, storage and transmission of blood glucose data and other diabetes-related healthcare information to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management.
Insulia Diabetes Management Companion includes a Basal Calculator intended to provide directions to the patient in response to blood glucose measurements and other diabetes related events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments. The guidance is similar to the directions provided to patients as a part of routine clinical practice.
Insulia Diabetes Management Companion provides educational coaching messages based on blood glucose values.
Insulia Diabetes Management Companion is only indicated for use with insulin detemir (Levemir® U-100) once or twice daily, and insulin glargine (Lantus® U-100, and Toujeo® U-300) once daily.
Insulia Diabetes Management Companion is not to be used by patients using NPH (Neutral Protamine Hagedorn) insulin and premixed insulin.
Insulia Diabetes Management Companion is not to be used by patients treated with a basal plus or a basal-bolus regimen (i.e. including multiple mealtime regular or rapid-acting insulin injections per day or insulin pump therapy).
Insulia Diabetes Management Companion is not to be used during pregnancy nor by non-adult patients.
The provided document is a 510(k) summary for the Insulia Diabetes Management Companion. It describes a modification to the previously cleared device, primarily the addition of compatibility with Toujeo® (insulin glargine U-300).
However, the document does not contain a detailed study report with specific acceptance criteria and comprehensive study results in the format requested. Instead, it states that "Design verification and validation testing on the modification of Insulia Diabetes Management Companion demonstrated that the device meets the performance requirements for its intended use."
It also mentions that a risk assessment was conducted and addressed through performance testing.
Therefore, I cannot extract the detailed information for the table and points 2-9 from the provided text. The document refers generally to "performance requirements" and "performance testing" but does not explicitly list the acceptance criteria or the specific results.
Here's a summary of what can be inferred from the document regarding the acceptance criteria and study, limited by the information available:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. The document generally states that "Design verification and validation testing... demonstrated that the device meets the performance requirements for its intended use" and "the data demonstrate that the new device is substantially equivalent to the predicate device." Specific metrics, thresholds, and reported performance values are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. 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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 MRMC study is not mentioned in the document. The device is a "Diabetes Management Software" with a "basal calculator" and is not an imaging device that would typically involve human readers for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions that the basal calculator is intended to "provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments." This implies a human-in-the-loop (HCP input for the treatment program and patient interaction). However, the specific details of a standalone performance evaluation of the algorithm without human interaction are not explicitly detailed. The document focuses on demonstrating that the new modification (compatibility with Toujeo®) does not raise new issues of safety or effectiveness and that the basal calculator rules are unchanged.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided. Given the nature of the device (insulin adjustment recommendations), "ground truth" would likely relate to the accuracy and safety of the recommendations compared to established medical guidelines or expert clinical judgment, but this is not detailed.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
§ 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).