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The DEKA ACE Pump System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, ages six and above. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, and confirm commands from these devices. The pump is intended for single patient, home use and requires a prescription.

The bolus calculator is indicated for use for aiding the user in determining the bolus insulin dosage for management of diabetes mellitus based on consumed carbohydrates, operator entered blood glucose, insulin sensitivity, insulin to carbohydrate ratio, target glucose values, and current insulin on board.

The DEKA ACE Pump System described herein contains a modification of the labeling of the previously cleared DEKA ACE Pump System (K233952) to add Novolog U-100 (insulin aspart) as a compatible insulin. The device is a wearable alternate controller enabled (ACE) insulin infusion pump intended to subcutaneously deliver insulin. at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices to receive, confirm, and execute commands. The pump is intended for single patient, ambulatory use and requires a prescription. The DEKA ACE Pump System is intended for the management of diabetes mellitus in persons six years of age and greater.

The pump was previously cleared and is indicated for use with Humalog U-100 insulin. This Special 510(k) utilizes the same methodology and acceptance criteria used to obtain the clearance and indication for Humalog U-100 to add the indication for Novolog U-100.

The DEKA ACE Pump System, consistent with the predicate K233952, consists of the following durable and disposable components:

1. Pump: A durable pump that incorporates fluid delivery algorithms and interfaces to a cassette, external wireless user interface, and iCGM. The pump is powered by a rechargeable lithium ion battery.
2. Cassette: A single-use pumping cassette that combines microfluidic valves, a pump chamber, insulin reservoir, and Acoustic Volume Sensing (AVS) measurement chamber. The cassette interfaces to a pump and off-the-shelf infusion sets.
3. DEKA Loop App: An iOS mobile application that serves as the primary user interface for the system. The DEKA Loop app can be downloaded onto the user's personal iPhone.

Also consistent with the predicate, the DEKA ACE Pump system includes the following electronic interfaces:

• Dexcom G6 iCGM: The DEKA ACE Pump System is compatible with Dexcom G6 iCGMs. Communication between the Dexcom G6 and DEKA ACE Pump is unchanged from the predicate device. The BLE central role on the ACE Pump radio processor connects directly to the Dexcom iCGM transmitter using the sensor's medical slot. The ACE Pump communicates with the iCGM transmitter at a regular interval to provide iCGM sensor data to the iAGC.
• Halo Cloud: Halo Cloud is a digital platform that connects the DEKA ACE Pump System to a variety of cloud-related services. These services include:
• Patient onboarding and device pairing via secure key transfer
• Prescription setting downloads to the ACE Pump
• Event log uploads from the ACE pump to the cloud
• Remote (OTA) software updates

No changes to the hardware or software of the system from that of the predicate are necessary to add the Novolog U-100 compatibility claim.

The provided text describes a 510(k) submission for the DEKA ACE Pump System, specifically seeking to add Novolog U-100 (insulin aspart) as a compatible insulin. The core of this submission is to demonstrate substantial equivalence to a previously cleared version of the same pump (K233952), which was cleared for use with Humalog U-100 insulin.

Based on the provided text, the device in question is an insulin pump, not an AI/Software as a Medical Device (SaMD) for image analysis or diagnosis. Therefore, many of the typical acceptance criteria and study aspects related to AI/SaMD (like MRMC studies, expert ground truth establishment for diagnostic images, sample sizes for training/test sets for AI models, etc.) are not applicable to this type of medical device submission.

The "acceptance criteria" in this context refer to the demonstration that the modified device (with Novolog U-100 compatibility) is substantially equivalent to the predicate device (with Humalog U-100 compatibility) in terms of safety and effectiveness, and that it meets all applicable Special Controls for Alternate Controller Enabled Infusion Pumps (21 CFR 880.5730, Product Code QFG).

Here's an attempt to answer the questions based on the provided document, highlighting what is and isn't applicable:

1. A table of acceptance criteria and the reported device performance

   The document doesn't present a table of quantitative acceptance criteria and reported numerical performance for a new study, but rather asserts that the same methodology and acceptance criteria used for Humalog U-100 were applied to Novolog U-100, implying the new performance matches the previously accepted thresholds. The comparison focuses on demonstrating equivalence across various characteristics.

   Implicit Acceptance Criteria (based on equivalence to predicate and Special Controls):

   • Indications for Use: No change.
   • Prescription Use: Yes.
   • Intended Population: Persons with Diabetes Mellitus ages 6 and above.
   • Environment of Use: Professional healthcare facilities and home healthcare environments.
   • Patient Environment: On-body wearable ambulatory pump.
   • Delivery Method: Microprocessor controlled Micro-dosing pump mechanism supplemented with acoustic volume sensor (AVS) feedback for monitoring delivery accuracy.
   • Insulin Basal Rate Delivery Range: 0 units/hour - 30 units/hour.
   • Insulin Bolus Delivery Range: Programmable from 0.05 - 25.00 Units in 0.01 Unit increments.
   • Basal Accuracy: Unchanged from K213536 (predicate's reference).
   • Bolus Accuracy: Unchanged from K213536 (predicate's reference).
   • Bolus Volume after Occlusion Release: No more than 0.74 units.
   • Time to occlusion alarm: 10 min (Bolus); 3 hours (Basal, 1 U/h); 6 hours (Basal, 0.1 U/hr).
   • Material Biocompatibility: Compliant with ISO-10993.
   • Cartridge/Cassette Shelf Life: 1 year.
   • Ingress Protection: IP28.
   • Applicable Safety Standards: Compliance with listed IEC and ISO standards (e.g., IEC 60601-1, ISO 14971).
   • Power Source: Rechargeable Lithium Ion Battery.
   • Pump Storage Conditions: Temperatures of -25 °C to 70 °C, Non-condensing humidity 15% to 90%.
   • Operating Conditions: Temperatures of 5 °C to 40 °C, Non-condensing humidity of 15% to 90%.
   • System User Feedback: Visual, audible, and vibratory.
   • Battery Operating Time: 72 hours.
   • New "Acceptance": The addition of Novolog U-100 compatibility does not impact the safety and effectiveness, and testing with Novolog U-100 is equivalent to that performed with Humalog U-100.

   Reported Device Performance (based on assertion of equivalence):
   For all the criteria listed above, the "Subject Device" (DEKA ACE Pump with Novolog U-100 compatibility) is stated to have the exact same characteristics and performance as the "Predicate Device" (DEKA ACE Pump with Humalog U-100 compatibility), or that its performance is equivalent to the predicate's established performance for the relevant aspects (e.g., Novolog U-100 testing being equivalent to Humalog U-100 testing). The key is that "No new or modified risks" are introduced.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   The document states: "No clinical data was obtained in support of this premarket submission."
   It also states that "Performance testing was performed in order to establish substantial equivalence for the compatibility claim of Novolog U-100 in comparison to the previously cleared compatibility claim for Humalog U-100 in terms of both safety and effectiveness..."

   This heavily implies in vitro or bench testing rather than human subject testing. The "test set" in this context would likely refer to the number of tests/replicates performed with Novolog U-100 to demonstrate equivalent performance to Humalog U-100, not a dataset for an AI model. This information (specific sample sizes for bench testing, e.g., number of pump cycles, number of insulin lots tested) is not provided in this summary document. Data provenance for such non-clinical testing is typically internal lab data, not human patient data with country of origin.

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)

   Not applicable. This is not an AI/SaMD for diagnostic image analysis. Ground truth would be established through engineering specifications, validated test methods, and measurement standards for pump performance, not expert consensus on medical images.

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

   Not applicable. This is not an AI/SaMD for diagnostic image analysis.

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 is not an AI/SaMD for diagnostic image analysis. The device is an insulin pump.

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

   Not applicable. The device has algorithms (fluid delivery, bolus calculator) but it's a physical pump with user interaction, not a standalone diagnostic algorithm being evaluated. Its performance is inherent to the pump's mechanical and electronic design working with insulin.

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

   The ground truth for the performance of the insulin pump (e.g., basal/bolus accuracy, occlusion detection, battery life) would be established through engineering specifications, standardized test methods, and quantifiable measurements (e.g., precision volumetric measurements, pressure sensor readings, time-to-event logging). For this submission, the "ground truth" for Novolog U-100 compatibility is that its chemical and physical properties allow the pump to perform identically or equivalently to how it performs with Humalog U-100, which has already been established as safe and effective.

8. The sample size for the training set

   Not applicable. This device does not use machine learning that requires a "training set" in the conventional AI sense for diagnostic tasks. The "training" of the pump would be its design, development, and validation testing based on engineering principles and regulatory standards.

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

   Not applicable. As above, there isn't a "training set" in the AI sense. The "ground truth" for the pump's design and function comes from established medical device standards, diabetes management requirements, and rigorous engineering testing.

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