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510(k) Data Aggregation
(171 days)
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
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate Devices) | Reported Device Performance |
|---|---|
| Intended Use: Continuous delivery of insulin, at set and variable rates, for management of diabetes mellitus. | "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." |
| Technological Characteristics: External, portable insulin infusion pump; remote-controlled; RF communication; worn on user's skin; modular design (disconnection/reconnection); sterilization method and use lifetime of sterile parts. | "The Solo™ Insulin Patch Pump's technological characteristics are the same as those of its predicate devices." |
| "Solo™ communication is by means of radio frequency." | |
| "Same as OmniPod, the Solo™ insulin dispensing patch is worn on the user's skin." | |
| "Same as Minimed's Paradigm, the Solo™ has a modular design which enables disconnection and reconnection of the insulin dispensing unit from the cannula at the user's discretion." | |
| "Sterilization method and use lifetime of the sterile parts is identical to the predicate devices." | |
| Safety and Performance Features: Includes functions, mechanical and software safety features, alarms and alerts comparable to predicate devices. | "Solo™ includes the same functions, mechanical and software safety features, and alarms and alerts as the predicate devices." |
| "Solo™ accuracy and In-house functional performance testing of Solo™ was conducted... based on risk analysis, literature search and requirements of applicable standards." | |
| Biological Safety: Biocompatibility, microbial ingress, insulin compatibility. | "The following studies were conducted in certified contract laboratories: Biocompatibility, Insulin Compatibility, microbial ingress..." |
| Environmental & Electrical Safety: Electrical Safety, Environmental, EMC and RF Compatibility. | "...cleaning and disinfection verification, Shelf life, Electrical Safety, Environmental, EMC and RF Compatibility." |
| Software Validation: Software functions correctly and safely. | "Software validation was performed in Medingo by an external software QA contractor." |
| Overall Equivalence: No new safety or effectiveness issues. | "Medingo believes that... the Solo™ Insulin Patch Pump is substantially equivalent to its predicate devices without raising any new safety or effectiveness issues." |
| "Solo™ and its components successfully passed all performance evaluations according to its performance criteria." |
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.
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