(269 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 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."
§ 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).