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510(k) Data Aggregation
(89 days)
The Solo™ MicroPump Insulin Delivery System is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The Solo™ Insulin Patch Pump is for prescription use only.
The Solo™ MicroPump Insulin Delivery System (Solo™) is a miniature, portable programmable insulin pump, which adheres to the patient's skin. The MicroPump is comprised of two connected parts: a disposable reservoir, in which the insulin is stored and a reusable pump, which includes the pumping mechanism and electronic components. The MicroPump is controlled via a remote control unit.
The Solo™ is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician, and includes the features available in the predicate devices.
The document provided is a 510(k) summary for the Solo™ MicroPump Insulin Delivery System. It describes the device, its intended use, and its substantial equivalence to predicate devices. It also mentions performance testing in the context of usability studies. However, the document does not contain detailed acceptance criteria, specific reported device performance metrics against those criteria, or the methodology of a study that directly proves the device meets such criteria in terms of clinical efficacy or diagnostic accuracy.
The provided text focuses on demonstrating substantial equivalence, primarily by addressing a change in the age contraindication.
Therefore, much of the requested information cannot be extracted from this specific document.
Here's a breakdown of what can be inferred or directly stated, and what is missing:
Acceptance Criteria and Reported Device Performance
This document does not define specific acceptance criteria (e.g., accuracy of insulin delivery, specific safety thresholds) nor does it present a table of reported device performance against such criteria. The "Performance Testing" section refers to usability studies rather than objective performance metrics.
Study Information
The document describes two simulated clinical use studies to support the 510(k) submission, specifically for non-adult users and sharps injury prevention features.
- Sample size used for the test set and the data provenance: Not specified in terms of numbers. The studies were "simulated clinical use studies" for "non-adults and their caregivers." The provenance is Medingo Ltd., Israel. These studies appear to be prospective usability studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were usability studies, not diagnostic accuracy studies using ground truth established by experts.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned.
- 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: Not applicable. This is not an AI/diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for insulin delivery.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for usability studies. The "ground truth" for usability would be successful completion of tasks and user feedback, not clinical outcomes or expert consensus on diagnosis.
- The sample size for the training set: Not applicable. This describes usability studies, not machine learning model training.
- How the ground truth for the training set was established: Not applicable.
Summary of Available Information
| Category | Information from Document |
|---|---|
| Acceptance Criteria & Reported Performance | Not provided. The document does not list specific technical or clinical acceptance criteria (e.g., insulin delivery accuracy, occlusion detection time) and corresponding device performance data. It briefly mentions that "Study results clearly demonstrated that Solo™ is safe for use by non-adults and their caregivers," addressing a usability and safety aspect related to the expanded indications. |
| Study Type & Purpose | Two simulated clinical use studies were conducted for usability: 1. Operation by Non-Adults (Summative Usability Study). 2. Simulated Clinical Use of the Sharps Injury Prevention Features. These were conducted to support the deletion of the age contraindication (under 18). |
| Sample Size (Test Set) | Not specified numerically. The studies involved "non-adult users" and "caregivers." |
| Data Provenance | Medingo Ltd., Yoqneam, Israel. The studies were described as "simulated clinical use studies" and appear to be prospective, focusing on usability and safety. |
| Number & Qualifications of Experts for Ground Truth | Not applicable. These were usability studies, not studies requiring expert-established ground truth for diagnostic accuracy. |
| Adjudication Method | Not applicable. Not mentioned for usability studies. |
| MRMC Comparative Effectiveness Study | Not applicable. This is an insulin pump, not an AI/diagnostic imaging device where human readers are involved in diagnosis. |
| Standalone Performance (Algorithm only) | Not applicable. This is a medical device; its performance is always in the context of its function (insulin delivery) and user interaction. |
| Type of Ground Truth Used | Not applicable. For usability studies, the "ground truth" would relate to successful task completion, user errors, and user satisfaction, not clinical outcomes or expert diagnoses. The studies aimed to demonstrate safety for use by non-adults and their caregivers. |
| Sample Size (Training Set) | Not applicable. The document describes usability studies, not the training of a machine learning model. |
| How Ground Truth for Training Set was Established | Not applicable. |
Conclusion based on the provided text: The document provides excellent detail regarding the regulatory submission (510(k)), device description, and predicate devices. However, it does not include the detailed performance study information with acceptance criteria that would typically be associated with clinical efficacy or technical performance specifications for the device's primary function (insulin delivery). The "performance testing" described is specifically related to usability and safety for an expanded user population (non-adults), rather than comprehensive performance metrics.
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