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The Finesse Insulin Delivery System is indicated for the subcutaneous, bolus delivery of physician prescribed insulins, in adult persons requiring such medications for the management of diabetes mellitus.

The Finesse Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.

The Finesse Insulin Delivery System (IDS) is comprised of a sterile. nonpyrogenic, single-use, external, disposable, ambulatory, liquid medication, bolus dosing device (IDD); a single use, non-pyrogenic, sterile. syringe and needle (Fill Syringe); a reusable Inserter; and a Dose Count Card. The device is intended for subcutaneous delivery of clinicianprescribed medications, and is adhered to the skin for up to 72 hours with a biocompatible adhesive.

The Insulin Delivery Device (IDD) is a manual, user filled, positive displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissues. The syringe and needle are for patient filling of the IDD with liquid medication prior to deployment on the body, and have a maximum capacity of 2ml. The Dose Count Card is utilized by the patient during the dosing session and provides for a written record of date, time and amount of Insulin delivery.

The Finesse IDS materials are biocompatible plastics, elastomers, and stainless steel.

The provided text is a 510(k) summary for the Finesse Personal Insulin Delivery Patch. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not include a table of acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets specific acceptance criteria in the way typically found for AI/ML devices.

Instead, this submission primarily focuses on establishing "substantial equivalence" to previously cleared devices (K093065 and K100947) based on technological characteristics and intended use. The performance data mentioned are non-clinical and primarily relate to device reliability, usability, and biocompatibility, rather than clinical efficacy metrics or comparisons with human experts.

Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them (especially in the context of AI/ML performance) cannot be extracted from this document.

Here's what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The submission 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 and clinical evaluation testing."
The device relies on demonstrating "substantial equivalence" in its intended use, performance, safety, and effectiveness to its predicate devices.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated for any performance claims in the context of a "test set" for an algorithm. The document mentions "human factors and clinical evaluation studies" but does not give sample sizes.
• Data Provenance: Not specified.

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

Not applicable. This device is a manual insulin delivery system, not an AI/ML diagnostic tool that requires expert-established ground truth for its performance evaluation in the way a diagnostic algorithm would.

4. Adjudication method for the test set

Not applicable.

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 not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This is a hardware device for drug delivery, not an algorithm. Its performance is inherent to its mechanical function.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" would be the engineering specifications, biocompatibility standards, and functional requirements for a mechanical insulin delivery system. For example:

• Compatibility and stability studies for insulin: Demonstrating chemical, physical, and microbiological stability within the device.
• Design verification studies: Demonstrating wear and mechanical reliability.
• Human factors and clinical evaluation studies: Demonstrating device performance and usability. (Details on how "performance and usability" were measured or what their "ground truth" criteria were are not provided).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of what is present:

• Non-Clinical Performance Data (Section 10):

  • "Compatibility and stability studies have been completed that demonstrate the chemical, physical, microbiological stability and biocompatibility of insulin in the Finesse Insulin Delivery device for the period of time specified in the labeling."
  • "Design verification studies have been completed that demonstrate the wear and mechanical reliability of the device for the intended period of time."
  • "Design verification studies have been completed that demonstrate the usability and reliability of the Inserter accessory."
  • "Human factors and clinical evaluation studies have been completed that demonstrate device performance and usability."

• Clinical Performance Data (Section 11):

  • "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 and clinical evaluation testing."

The basis of this 510(k) clearance is substantial equivalence to predicate devices K093065 and K100947, and the non-clinical studies confirm the device's functional integrity and safety. It explicitly states that clinical performance data was not required for this 510(k) submission, meaning the acceptance criteria were met through non-clinical testing and demonstration of equivalence.

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