(112 days)
The Finesse Insulin Delivery System is intended for the subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin.
The Finesse Insulin Delivery System is a sterile, nonpyrogenic, single-use, external, disposable, ambulatory, insulin, bolus dosing system through which clinician-prescribed medications are delivered subcutaneously. The Finesse Insulin Delivery System is composed of a positive volume displacement drug delivery device with infusion cannula and integrated Inserter, and drug delivery device filler. The device is adhered to the skin for up to 48 hours with a biocompatible adhesive. The Finesse Insulin Delivery System has an integrated cannula and Inserter. The infusion cannula Inserter is used to place the cannula in the subcutaneous tissues. It contains an insertion needle located in the lumen of the infusion catheter cannula. A safety mechanism prevents premature actuation of the insertion needle mechanism to prevent injuries. Following cannula placement, the needle is retracted within the body of the Inserter to prevent sharps exposure. Once the needle is retracted, the Inserter automatically releases the Inserter from the drug delivery component. The Finesse Insulin Delivery System materials are biocompatible plastics, elastomers, and stainless steel.
The provided text describes a 510(k) summary for the Finesse Personal Insulin Delivery Patch. It outlines the device description, intended use, technological characteristics, and non-clinical performance data. However, it explicitly states:
"No clinical performance data is required to validate the intended uses and user needs of the system. Design validation is completed by human factors simulated use testing."
This means that the document does not contain acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, accuracy, etc.) for the device itself or any study that proves the device meets such criteria through clinical trials. Instead, reliance is placed on conformance to consensus standards, FDA guidance, and human factors simulated use testing for design validation.
Therefore, many of the requested items in your prompt, particularly those related to clinical performance, a test set, ground truth, experts, and comparative effectiveness studies, cannot be extracted from this document.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given the explicit statement that no clinical performance data is required and that design validation is completed by human factors simulated use testing, the acceptance criteria are primarily defined by adherence to a list of consensus standards and FDA guidance. The document does not provide specific quantitative performance metrics beyond this.
| Acceptance Criteria (Primary Source) | Reported Device Performance (Primary Source) |
|---|---|
| Conformance to various ANSI/AAMI/ISO, USP, IEC, and ASTM standards (e.g., ISO 10993-1 for biocompatibility, ASTM F 88-07a for seal strength, ISO 11608-1 for pen-injectors) | "Data establishing conformance to the following consensus standards and FDA guidance is maintained in the design history file and establishes the substantial equivalence with the predicate devices. The conclusions drawn from the data support the equivalence, safety, and effectiveness of the system." |
| Conformance to FDA Guidance documents (e.g., Guidance on the Content of Premarket Notification 510(k) Submissions for Piston Syringes) | "Data establishing conformance to the following consensus standards and FDA guidance is maintained in the design history file and establishes the substantial equivalence with the predicate devices. The conclusions drawn from the data support the equivalence, safety, and effectiveness of the system." |
| Design validation by human factors simulated use testing | "Design validation is completed by human factors simulated use testing." (No specific performance metrics from this testing are detailed in the provided text.) |
2. Sample size used for the test set and the data provenance
Not applicable, as no clinical performance test set data is presented. The design validation was conducted through "human factors simulated use testing," but details on sample size, data provenance, or specific test outcomes are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical performance test set data requiring expert ground truth is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance test set data requiring adjudication is presented.
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
Not applicable. This device is an insulin delivery system, not an AI-powered diagnostic or assistive tool, and the document explicitly states no clinical performance data was required, let alone an MRMC study with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, but a physical medical device requiring human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for clinical performance data. The "ground truth" for the device's substantial equivalence and safety/effectiveness is based on its conformance to established consensus standards and FDA guidance, as well as the outcome of human factors simulated use testing.
8. The sample size for the training set
Not applicable, as this is a physical medical device and not an AI algorithm that undergoes training on a data set.
9. How the ground truth for the training set was established
Not applicable, as this is a physical medical device and not an AI algorithm.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).