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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 diabetesrelated 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 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 only indicated for use with insulin detemir (Levemir® U-100) once or twice daily, insulin degludec (Tresiba® U-100) once daily, and insulin glargine (Basaglar® U-100, Lantus® U-100, Semglee® U-100, Toujeo® U-300) once daily.

Insulia should not be used for:

• basal dose recommendations for intermediate-acting insulin (NPH - Neutral Protamine Hagedorn);
• premixed insulin

Insulia should not be used in the following populations:

• pregnant women;
• non-adult patients;
• patients that are treated with a basal-plus or a basal-bolus regimen (i.e multiple mealtime insulin injections per day or insulin pump therapy)

The provided text is a 510(k) summary for the Insulia Diabetes Management Companion, specifically addressing a modification to the device (K202596), which is the addition of compatibility with Semglee® (Glargine U-100) insulin. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K172177).

Crucially, the provided text does not contain detailed information about specific acceptance criteria or the study that proves the device meets those criteria in the typical sense of a performance study with quantitative results (e.g., sensitivity, specificity, accuracy). Instead, it references general design control processes, risk management, and verification/validation testing without providing the numerical results or the specific methodology of such tests.

The information primarily describes the device, its intended use, and argues for its substantial equivalence to a predicate device based on similar intended use and technological characteristics, with the minor modification (Semglee compatibility) not raising new safety or effectiveness concerns.

Therefore, many of the requested points in your prompt cannot be directly answered from the provided text. However, I will extract and infer what information is available:

Device: Insulia Diabetes Management Companion (K202596)

Purpose of the study (as described here): To demonstrate substantial equivalence of the modified device (adding Semglee® compatibility) to the predicate device (K172177). The document implies that the "performance data" refers to verification and validation testing to ensure the modification does not negatively impact the device's functionality.

1. Table of acceptance criteria and the reported device performance:

The document does not provide a quantitative table of acceptance criteria (e.g., target accuracy, sensitivity, specificity for the basal calculator/insulin dose recommendations) or corresponding reported performance metrics. It generally 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" and "the data demonstrate that the new device is substantially equivalent to the predicate device."

Without specific numerical criteria or results, a table as requested cannot be constructed from this document. The "performance requirements" are not explicitly defined in terms of metrics.

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not explicitly stated. The document refers to "Design verification and validation testing" but does not give details on cohort size, number of cases, or data points used in these tests.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It refers to "risk assessment," "risk analysis," and "Failure Mode Effect and Analysis" (FMEA) as part of design control, but these are processes, not data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of experts: Not specified.
• Qualifications of experts: Not specified. The document mentions "a multidisciplinary team" conducting the risk assessment, which implies experts, but their number and specific qualifications (e.g., cardiologists, neurologists, imaging specialists, years of experience) are not detailed.

4. Adjudication method for the test set:

• Adjudication method: Not specified. Given the lack of detail on the test set itself, no adjudication method (e.g., 2+1, 3+1) is mentioned.

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:

• MRMC study: Not mentioned or implied. The device is a "basal calculator intended to provide direction to the patient" and a "diabetes management system." It's not an imaging AI device that assists human readers in diagnosis. Therefore, an MRMC study is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• The document implies that the "basal calculator" algorithm itself was subject to "verification and validation testing." It states that "The basal insulin calculator is unchanged as compared to the predicate device, i.e. the calculation rules are the same." The modification was only about compatibility with a new insulin type (Semglee®). Therefore, the calculation logic itself would have been tested previously for the predicate device, and the current submission likely focused on verifying its continued correct operation with the new compatible insulin type and ensuring the system as a whole functions as intended. However, specific details of such standalone testing (metrics, results) are not provided in this summary.

7. The type of ground truth used:

• For a basal insulin calculator, ground truth would typically refer to physiologically correct insulin dose recommendations or patient outcomes based on those recommendations. The document states the device provides "directions...similar to the directions provided to patients as a part of routine clinical practice" based on a "pre-planned treatment program from a healthcare professional." This suggests the ground truth for evaluating the calculator's outputs would be adherence to established medical guidelines or physician-prescribed treatment plans, potentially validated by clinical experts or simulation models. However, the specific method for establishing this "ground truth" for testing is not detailed.

8. The sample size for the training set:

• Given that the device uses a "basal calculator" with "calculation rules," it's more likely based on deterministic algorithms derived from medical guidelines and pharmacokinetics rather than a machine learning model that requires a training set in the typical sense. The document does not mention any "training set." If any part of the device involved machine learning (unlikely for a basal calculator of this description), no information on a training set size is provided.

9. How the ground truth for the training set was established:

• As no training set is mentioned (see point 8), this question is not applicable based on the provided text. The "ground truth" for the basal calculator's logic would be established by clinical consensus, medical literature, and expert input that defined the "pre-planned treatment program" and "calculation rules."

Ask a specific question about this device

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 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 only indicated for use with insulin detemir (Levemir® U-100) once or twice daily, insulin degludec (Tresiba® U-100) once daily, and insulin glargine (Basaglar® U-100. Lantus® U-100. and Toujeo® U-300) once daily.

Insulia Diabetes Management Companion should not be used for:

• basal dose recommendations for intermediate-acting insulin (NPH Neutral Protamine Hagedorn);
• " premixed insulin.

Insulia Diabetes Management Companion should not be used in the following populations:

• = pregnant women;
• non-adult patients:
• patients that are treated with a basal-plus or a basal-bolus regimen (i.e multiple mealtime insulin injections per day or insulin pump therapy).

I cannot provide a table of acceptance criteria and reported device performance or information about sample size, expert ground truth, adjudication methods, MRMC studies, standalone studies, or how ground truth was established for this device.

The provided document is an FDA 510(k) clearance letter and associated 510(k) summary for the "Insulia Diabetes Management Companion." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific performance metrics against acceptance criteria.

Here's why I can't fulfill your request based solely on the provided text:

• No detailed performance data: The document states, "Design verification and validation testing, clinical evidence, and updated Human Factors evaluation on the modification of Insulia Diabetes Management Companion demonstrated that the device meets the performance requirements for its intended use." However, it does not present any specific performance metrics, acceptance criteria, or study results (e.g., accuracy, sensitivity, specificity, or effect size) in numerical form.*
• Focus on Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This often involves demonstrating that technological characteristics are similar and that any differences do not raise new questions of safety or effectiveness. It doesn't typically require a full-scale clinical trial proving net positive clinical benefit from scratch.
• Limited "Clinical Evidence" Description: The document mentions "Clinical evidence provided supported that the addition Tresiba U-100 and Basaglar to the list of insulin analogs compatible with Insulia conforms to the general principles and rules identified in the previous analysis of the standard of care performed for the cleared device." This suggests a review of existing clinical knowledge and principles rather than a new comparative effectiveness study on the device's performance itself against a defined outcome.

Based on the provided text, the device was cleared because it was determined to be substantially equivalent to a previously cleared device (K170669), and the modifications (adding compatibility for two new insulin analogs) were assessed through design verification, validation, and risk management activities, without raising new issues of safety or effectiveness.

To get the information you asked for (acceptance criteria, specific performance metrics, sample sizes, expert details, etc.), you would typically need to refer to more detailed clinical study reports, scientific publications, or internal validation documentation for the device, which are not included in this FDA 510(k) summary.

Ask a specific question about this device

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.

Ask a specific question about this device

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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