(83 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 a drug delivery device filler. The device is adhered to the skin 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 does not contain information about acceptance criteria or specific studies that prove the device meets these criteria in the typical format of a clinical or performance study. Instead, it describes general design verification and user studies without specific metrics or methodologies.
Here's a breakdown of the available information based on your requested points:
1. A table of acceptance criteria and the reported device performance
The document mentions "Design verification studies have been completed that demonstrate the wear and mechanical reliability of the device for the period of time specified in the device labeling" and "User studies have completed that demonstrate the readability and user comprehension of the labeling."
However, specific acceptance criteria (e.g., "device must deliver X +/- Y% of intended insulin dose") and quantitative performance results are NOT provided in this 510(k) summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is NOT provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is NOT provided in the document. The studies mentioned are general "design verification" and "user studies," which typically don't involve expert establishment of ground truth in the same way a diagnostic device might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is NOT provided in the document.
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 information is NOT applicable as the device is an insulin delivery system, not an AI-powered diagnostic device that involves human "readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is NOT applicable as the device is an insulin delivery system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is NOT provided in the document. The general nature of the studies ("compatibility and stability," "wear and mechanical reliability," "user comprehension") suggests that ground truth would be established through direct measurements, chemical analysis, mechanical testing, and user feedback, rather than expert consensus on diagnostic interpretations.
8. The sample size for the training set
This information is NOT provided in the document. The device is a mechanical/electronic system, not a machine learning algorithm that typically requires a "training set."
9. How the ground truth for the training set was established
This information is NOT applicable as the device is a medical device, not a machine learning algorithm.
Summary of what is available:
The 510(k) Summary for the Finesse Personal Insulin Delivery Patch (K100947) states that:
- Compatibility and stability studies were performed to demonstrate chemical, physical, microbiological stability, and biocompatibility of insulin in the device for the specified period.
- Design verification studies were completed to demonstrate the wear and mechanical reliability of the device for the specified period.
- User studies were completed to demonstrate the readability and user comprehension of the labeling.
The document indicates that these studies (without providing details like sample sizes, specific metrics, or methodologies) were sufficient for FDA to determine substantial equivalence based on the modified labeling for extended usage duration. The primary change from the predicate device (K093065) was this extended usage period (from an unspecified duration to 48-72 hours, consistent with insulin manufacturer labeling).
§ 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).