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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 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 type 2 adult diabetes patients and their healthcare team. Insulia Diabetes Management Companion includes three components:

• I 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 diabetesrelated 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 not to be used in conjunction with a type of long-acting insulin analog different from insulin glargine (Lantus®) or insulin detemir (Levemir®).

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 basalplus 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 nonadult patients.

The provided text is a 510(k) summary for the "Insulia Diabetes Management Companion" device. It outlines the device's indications for use, comparison to predicate devices, and concludes with a statement of substantial equivalence. However, it does not contain specific details about acceptance criteria, reported device performance figures, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details about comparative effectiveness studies (MRMC) or standalone performance studies.

The document broadly states:

• "Comprehensive performance testing was conducted on the Insulia Diabetes Management Companion to support a determination of substantial equivalence."
• "The results of the performance testing, including the human factors study results and software verification and validation documented in accordance with FDA's Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005), were provided and demonstrate that the device meets the performance requirements for its intended use, and supports substantial equivalence."
• "performance testing has demonstrated that the Insulia Diabetes Management Companion performs as intended and is substantially equivalent to the predicate devices."

Based on the provided text, I cannot complete the requested table and details. The document explicitly states that the results of performance testing were provided to the FDA, but these results themselves are not included in the summary.

Therefore, I am unable to provide the requested information from the given input.

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