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The iLet ACE Pump is an alternate controller enabled (ACE) pump intended to deliver insulin under the skin based on input from an integrated continuous glucose monitor (iCGM) and an interoperable automated glycemic controller (iAGC) in people 6 years of age or older with diabetes mellitus. The iLet ACE Pump provides a graphical user interface and alerts to interact with the iLet delivery system and an iAGC. The iLet Bionic Pancreas System is a collection of wearable medical devices that work together to deliver insulin with minimal user oversight. The iLet System is made up of the iLet bionic pancreas (consisting of the iLet ACE Pump (with accessories) and iAGC which resides on the ACE pump hardware), ACE pump disposables and accessories, iCGM and infusion set. The insulin is filled for iLet use by a user, in a ready-to-fill cartridge (from an insulin vial supplied by a drug manufacturer) with the use of the syringe and needle. The iLet ACE Pump includes a motor-drivetrain pumping mechanism, which independently actuates the delivery of insulin from a cartridge that is separately loaded into the iLet. Insulin is injected under the skin via continuous infusion. The iLet ACE Pump has a wirelessly rechargeable battery and is designed to be used by a single person and have a useful life of at least 4 years.

AI/ML Overview

This document describes a Special 510(k) Notification for a device modification, specifically updating the User Guide and Quick Reference Guide to indicate that the iLet bionic pancreas can be used with U-100 Fiasp® PumpCart® (insulin aspart) in a pre-filled 1.6 mL cartridge. The core device (iLet® ACE Pump) itself has not undergone significant technological changes. Because this is a modification to an already cleared device (K223846) to support compatibility with a new insulin formulation, the information provided focuses heavily on non-clinical testing for this specific change and cross-references prior clinical data.

Based on the provided text, a full description of acceptance criteria and the study proving the device meets all acceptance criteria (including for its original clearance) cannot be fully extracted, especially regarding clinical studies for the core device's efficacy. The document explicitly states: "No new clinical testing was required for this Special 510(k) notification. Clinical data to support use of Fiasp® (insulin aspart) with the iLet Dosing Decision Software was reviewed under K220916."

However, I can provide information relevant to this specific modification and what the document implies about the original clearance and its support for a new insulin type.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (for this modification)

For this specific modification (Fiasp® compatibility), the criteria and performance are focused on non-clinical aspects related to the insulin itself, not the overall pump performance.

Acceptance Criteria Category (for Fiasp® compatibility)	Specific Criteria	Reported Device Performance/Conclusion
Non-Clinical Testing	In-Use Stability (with Fiasp®)	"The same test methods previously established in K223846 for In-Use Stability... were followed, with acceptance criteria specific to Fiasp." (Implies satisfactory performance based on these tests, otherwise, a Special 510(k) would not be granted).
	In-Use Compatibility (with Fiasp®)	"The same test methods previously established in K223846 for... In-Use Compatibility... were followed, with acceptance criteria specific to Fiasp." (Implies satisfactory performance).
	Preservative Efficacy (with Fiasp®)	"The same test methods previously established in K223846 for... Preservative Efficacy were followed, with acceptance criteria specific to Fiasp." (Implies satisfactory performance).
Clinical Testing	Clinical effectiveness and safety with Fiasp® (Algorithm)	"No new clinical testing was required for this Special 510(k) notification. Clinical data to support use of Fiasp® (insulin aspart) with the iLet Dosing Decision Software was reviewed under K220916." (This implies that efficacy/safety for the algorithm's interaction with Fiasp was previously established and met criteria in K220916).
Overall Conclusion	No New Questions of Safety or Effectiveness (Modification)	"Modifications to the device labeling do not raise any new or different questions of safety or effectiveness."

Note: The document does not provide the specific numerical data or thresholds for the acceptance criteria for In-Use Stability, Compatibility, or Preservative Efficacy, only that the same methods and Fiasp-specific criteria were met.

Regarding the other requested information, the document does not provide details for the iLet ACE Pump's initial clearance (K223846) or the clinical data for Fiasp (K220916). It only references their existence. Therefore, many of the subsequent points will indicate that the information is "Not provided in this document."

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

For this K231485 Special 510(k) (Fiasp® compatibility):
- Test set sample size: Not specified for the non-clinical tests (In-Use Stability, Compatibility, Preservative Efficacy). These would typically involve laboratory testing, not human subjects, so "sample size" refers to the number of test units.
- Data provenance: Not specified, but generally, such non-clinical testing is done in a lab environment.
- Retrospective/Prospective: Not applicable for non-clinical lab testing.
For K220916 (Clinical data for Fiasp® with the iLet Dosing Decision Software):
- Test set sample size: Not provided in this document.
- Data provenance: Not provided in this document.
- Retrospective/Prospective: Not provided in this document.

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

Not applicable to this Special 510(k) directly. This type of information is typically relevant for studies involving human interpretation or clinical endpoints. The current submission focuses on technical compatibility with a new insulin type.
For the referenced clinical study (K220916), this information is not provided in this document.

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

Not applicable to this Special 510(k) directly.
For the referenced clinical study (K220916), this information is not provided in this 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:

Not applicable. This device is an insulin pump with an automated glycemic controller, not an AI-assisted diagnostic imaging device that involves human "readers."

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

The iLet ACE Pump's automated glycemic controller (iAGC) is inherently designed for "algorithm-only" performance in terms of calculating insulin needs based on iCGM input. While human interaction is part of its use (e.g., loading insulin, changing cartridges, responding to alerts), the core insulin delivery decisions are automated.
The document implies that the iAGC's performance (including with Fiasp) has been evaluated, "Clinical data to support use of Fiasp® (insulin aspart) with the iLet Dosing Decision Software was reviewed under K220916." However, the specifics of that study (e.g., comparison to human-in-the-loop) are not provided in this document.

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

For the non-clinical Fiasp® compatibility: Ground truth would be based on laboratory measurements and standards for insulin stability, compatibility with materials, and preservative efficacy.
For the referenced clinical study (K220916) concerning the iLet Dosing Decision Software with Fiasp®: The ground truth would likely involve clinically measured glucose levels, HbA1c, and adverse event rates, and potentially comparison to a standard of care for diabetes management. This information is not provided in this document.

8. The sample size for the training set:

Not provided in this document. (Relevant for the iAGC algorithm development, but not the current K231485 submission).

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

Not provided in this document. (Relevant for the iAGC algorithm development, but not the current K231485 submission).

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