Search Results

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

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.

Ask a specific question about this device

The Solo™ Insulin Patch Pump 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™ Insulin Patch Pump (Solo™) is a miniature, portable programmable insulin pump, which adheres to the patient's skin. The patch 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 patch is controlled via a remote control unit.

The Solo™ Insulin Patch Pump 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Solo™ Insulin Patch Pump:

Based on the provided text, the device is an Insulin Infusion Pump, and the document is a 510(k) Summary. In the context of 510(k) submissions, the “acceptance criteria” are typically met by demonstrating “substantial equivalence” to legally marketed predicate devices, rather than through a strict set of predefined performance thresholds for a novel device. The “study” that proves the device meets these criteria is the comparison to predicate devices and a series of performance evaluations.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state sample sizes for specific performance tests (e.g., number of pumps tested for accuracy, number of components for biocompatibility). The testing was conducted in Medingo (Israel) for in-house functional performance and by "certified contract laboratories" for other tests. The provenance of this data is prospective, as it involves testing the Solo™ device specifically for this submission.

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

This information is not provided in the summary. For a 510(k) submission of this type (an insulin pump), the "ground truth" is typically defined by engineering specifications, recognized standards (e.g., for infusion pumps), and comparisons to the performance characteristics of predicate devices, rather than expert clinical judgment on a test set of data in the way one might see for an AI diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable and not mentioned. The document describes engineering and laboratory testing against specifications and standards, not a diagnostic interpretation scenario requiring adjudication by multiple experts.

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

This is not applicable and not mentioned. The Solo™ Insulin Patch Pump is a medical device for insulin delivery, not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

This is not applicable in the context of an insulin pump. The device is a physical system with embedded software, intended for use by a patient under a physician's prescription. Its performance is evaluated on its ability to deliver insulin according to programmed settings, not as a standalone diagnostic algorithm. The "functional performance testing" and "software validation" refer to the testing of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the Solo™ Insulin Patch Pump's performance is established by:

• Engineering Specifications and Design Requirements: The device must meet its own design requirements for accuracy, safety features, and functional operations.
• Applicable Standards: Compliance with recognized industry standards for insulin infusion pumps.
• Predicate Device Performance: Demonstrating that the Solo™ device performs similarly to or better than its predicate devices in relevant aspects (e.g., insulin delivery accuracy, safety mechanisms).
• Laboratory Test Results: Measurable outcomes from mechanical, electrical, biocompatibility, and software tests.

8. The sample size for the training set

This is not applicable. The Solo™ Insulin Patch Pump is a hardware-based medical device with fixed functions and embedded software, not a machine learning model that requires a "training set" of data in the typical sense. Software validation ensures the software functions as intended, but it's not a learning algorithm.

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

This is not applicable, as there is no "training set" for an insulin pump in the context of AI/machine learning. The "ground truth" for software validation would be the functional and performance specifications that the software is designed to meet.

Ask a specific question about this device