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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 (CGM) and an interoperable automated glycemic controller (iAGC), in people 6 years of age or older with diabetes mellitus. The iLet ACE Pump is intended for single-person use; it is not to be shared.

The iLet ACE Pump described herein includes changes to the graphic user interface (GUI) and alarms to improve the safety of the device. Instructions were added to the User Guide and Quick Reference Guide to advise users regarding CGM sensor calibration.

No significant changes have been made to the technological characteristics of the device.

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 (CGM) 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, CGM 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 System consists of the iLet ACE Pump (K231485) with iLet Dosing Decision Software (K232224) and disposable consumables.

The iLet System is only for use with a compatible CGM and U-100 rapid acting insulin.

The CGM communicates with the iLet via Bluetooth. The iLet ACE Pump gets glucose readings from the CGM every 5 minutes and the iAGC uses that information as one of the inputs to calculate the person's insulin needs.
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 infusion set must be placed at least 3 inches away from the CGM sensor.

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. The iLet is charged on a wireless charging pad which comes with the device. The Luer connector and drug cartridge need to be changed every 3 days. The insulin infusion set and CGM sensor need to be changed as indicated in the manufacturers' labeling.

The provided FDA 510(k) Clearance Letter for the iLet ACE Pump (K252770) describes a device modification to an already cleared predicate device (iLet ACE Pump, K231485). As such, the information regarding acceptance criteria and the study that proves the device meets the acceptance criteria is focused on verifying that the changes did not introduce new safety or effectiveness concerns and that the device remains substantially equivalent to its predicate.

Based on the provided document, the focus of the clearance is on non-clinical testing related to software and labeling changes, rather than a new clinical performance study establishing general efficacy and safety from scratch.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a device modification, the "acceptance criteria" are predominantly related to the successful verification of the specific changes made and continuous compliance with existing standards. The "reported device performance" refers to the outcome of these verification activities.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for software verification testing (e.g., number of test cases, number of alarm scenarios). It broadly states "Software design verification testing was performed."
• Data Provenance: The data is generated from non-clinical software verification testing performed internally by Beta Bionics, Inc. The document does not specify country of origin for this testing but implies it aligns with internal design controls and regulatory requirements. It is a "prospective" evaluation of the modified software.

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

Not applicable in this context. For software verification testing of GUI and alarms, the "ground truth" is defined by the device's functional specifications and regulatory requirements. The testing is performed against these engineering and regulatory specifications, not against expert clinical consensus or pathology findings.

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

Not applicable. Software verification testing involves comparing observed software behavior against predefined requirements and expected outcomes, not an adjudication process by 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

Not applicable. This device is an Alternate Controller Enabled (ACE) infusion pump, which delivers insulin based on CGM input and an automated glycemic controller (iAGC). It is not an AI-assisted diagnostic imaging device that involves human readers interpreting results. Therefore, an MRMC study with human readers is not relevant to this specific clearance.

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

Yes, in a sense. The "Software Design Verification Testing" implies a standalone evaluation of the modified GUI and alarms. This testing would assess the functionality of these software components in a controlled environment, confirming they operate according to specifications without direct real-time human intervention in the loop of the test itself (though a human designed and executed the tests). The iAGC (automated glycemic controller) within the pump itself operates autonomously based on CGM input, representing an "algorithm only" component that was part of the original device's clearance. This specific 510(k) did not require new clinical performance testing for the iAGC algorithm.

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

For the software modifications addressed in this 510(k), the "ground truth" is primarily based on:

• Functional Specifications: The intended design and behavior of the GUI and alarms as defined by Beta Bionics.
• Regulatory Requirements: Compliance with relevant FDA regulations for medical device software and labeling.

8. The sample size for the training set

Not applicable. This 510(k) is for a device modification involving GUI and alarm changes. The underlying iAGC algorithm (which would have had a "training set" in its development phase) was previously cleared (K231485 & K232224). No new training or re-training of the core control algorithm was indicated by these specific modifications.

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

Not applicable to this specific 510(k). For the original iAGC algorithm, the "ground truth" for its training (if an AI/ML approach was used) would have been established through extensive physiological modeling, clinical trial data, and expert endocrinologist input regarding optimal glycemic control targets and safety parameters. However, this information is not part of the provided document for this modification submission.

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