The MiniMed 780G insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

The MiniMed 780G insulin pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

The MiniMed 780G insulin pump contains a bolus calculator that calculates an insulin dose based on user-entered data.

The MiniMed 780G insulin pump is indicated for use in individuals 7 years of age and older.

The MiniMed 780G insulin pump is intended for single patient use and requires a prescription.

The MiniMed 780G insulin pump is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC). The pump is intended to be used both alone and in conjunction with compatible, digitally connected medical devices for the purpose of drug delivery.

The MiniMed 780G insulin pump is an ambulatory, battery-operated, rate-programmable micro-infusion pump that contains pump software and houses electronics, a pumping mechanism, a user interface, and a medication reservoir within the same physical device. The pump also contains a bolus calculator that calculates an insulin dose based on user-entered data. It is comprised of several discrete external and internal components including a pump case made of a polycarbonate blend, an electronic printed circuit board assembly stacks and a drive motor system.

The MiniMed 780G insulin pump is an interoperable device that can communicate via a Bluetooth Low Energy (BLE) wireless electronic interface with digitally connected devices. The MiniMed 780G insulin pump is a host device for the iAGC and integrates iAGC algorithm into the pump firmware. The pump is then able to receive, execute, and confirm commands from an iAGC to adjust delivery of insulin. The pump receives sensor glucose (SG) data via BLE interface from a compatible iCGM or a compatible interoperable Medtronic CGM and transmits these CGM data to the embedded iAGCs.

The MiniMed 780G insulin pump can operate in one of two modes: Manual Mode or Auto Mode (also referred to as "SmartGuard Mode"). The pump provides the user with keypad pump controls, as well as a data screen for configuring therapy settings and viewing continuous real-time glucose values, glucose trends, alerts, alarms, and other information. The user interface and alerts provide the user with the ability to interact with the pump delivery system and digitally connected devices.

The provided text is a 510(k) clearance letter and summary for a medical device, specifically an insulin pump. It details the device's characteristics, intended use, comparison to predicate devices, and a summary of non-clinical performance data.

However, it does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/Machine Learning device for image analysis or diagnostics.

The request asks for details like:

• A table of acceptance criteria and reported device performance (which is present in a limited form for the pump's mechanical performance, but not for AI performance).
• Sample size for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC study details and effect size.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

These specific points are highly relevant to the validation of AI/ML-enabled medical devices, particularly those that interpret or analyze data (like images) to aid in diagnosis or treatment decisions. The MiniMed 780G insulin pump, while having advanced software and interoperability, is primarily an infusion pump with a bolus calculator, not an AI/ML diagnostic or image analysis tool. Its software functions relate to pump control, communication, and basic dose calculation, not complex pattern recognition or inference typically associated with AI in medical devices that would require the detailed validation described in the prompt.

Therefore, I cannot extract the requested information from the provided text because the text describes a different type of medical device and its associated validation. The validation methods mentioned (Delivery Volume Accuracy, Occlusion Detection, Drug Stability, Cybersecurity, Human Factors) are appropriate for an insulin pump but do not align with the AI/ML-specific validation criteria outlined in your prompt.

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The twiist 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 6 and above. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The twiist system 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 twiist system described herein contains a modification of the labeling of the previously cleared DEKA ACE Pump System (K233952) to add the ConvaTec contact™ detach 23" subcutaneous infusion set and the ConvaTec inset™ 23" and 32" subcutaneous infusions sets as compatible for use with the twiist system.

The twiist system 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 twiist system is intended for the management of diabetes mellitus in persons six years of age and greater.

The twiist 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. Sequel twiist App: An iOS mobile application that serves as the primary user interface for the system. The twiist app can be downloaded onto the user's personal iPhone.

The provided FDA Clearance Letter, specifically the 510(k) Summary, details the technical characteristics and testing for the "twiist system" and its substantial equivalence to the "DEKA ACE Pump System" (K233952).

This submission (K250930) is a Special 510(k), meaning it focuses on a modification rather than a completely new device. The primary modification here is the addition of compatibility with new infusion sets (ConvaTec contact™ detach 23" and ConvaTec inset™ 23" and 32") to an already cleared device. This type of submission relies heavily on demonstrating that the performance with the new components is equivalent to the established performance of the predicate device under the original clearance.

Therefore, the study described here is primarily focused on bench testing to demonstrate compatibility and similar performance with the new infusion sets, using established methodologies and acceptance criteria from the previous clearance (K233952).

Here's the breakdown of the acceptance criteria and the study as described in the provided document:

Acceptance Criteria and Device Performance for the twiist system (K250930)

This 510(k) submission for the twiist system (K250930) is a Special 510(k), specifically addressing the addition of new compatible infusion sets. As such, the acceptance criteria and reported performance for key functional aspects of the pump itself (e.g., basal and bolus accuracy, occlusion detection) are identical to those established and validated for the predicate device, DEKA ACE Pump System (K233952). The study conducted for K250930 primarily focused on demonstrating that these established performance characteristics are maintained when using the newly added infusion sets.

1. Table of Acceptance Criteria and Reported Device Performance

Since the core pump performance characteristics are "Unchanged from K233952" and "Same" as the predicate device, the acceptance criteria and reported performance values listed in the "Technological Characteristic Comparison" table reflect the established performance of the twiist system (and its predicate) for various parameters. The specific study for K250930 demonstrated that the device continues to meet these previously set criteria with the new infusion sets.

The supporting language states: "Performance testing with the added ConvaTec infusion sets demonstrates that subject device performance is equivalent to the predicate device. The methods and acceptance criteria used in this testing are well established in the previous clearance (K233952)."

Study Details for K250930

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

The document states: "Bench performance testing was conducted to qualify the additional infusion sets for use with the subject device, and to establish substantial equivalence to the predicate device in terms of safety and effectiveness."

• Test Set Sample Size: The exact sample size (number of devices, number of tests run per device/infusion set combination) for the bench testing is not specified in this 510(k) summary. However, it's implied that sufficient testing was performed to "demonstrate" performance equivalence.
• Data Provenance: The data is from bench testing, which typically occurs in a controlled laboratory environment. The country of origin of the data is not explicitly stated, but given DEKA Research & Development Corp. is based in Manchester, New Hampshire, USA, it's highly probable the testing was conducted in the USA. The data is prospective in the sense that it was generated specifically for this 510(k) submission to qualify the new infusion sets.

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

This question is not applicable to this type of device and study. The ground truth for infusion pumps involves precise physical measurements of fluid delivery, rather than subjective expert interpretations (like in radiology). The "ground truth" for the test set is established by calibrated laboratory equipment and measurement techniques compliant with relevant standards (e.g., ISO 13485:2016).

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where subjective human interpretation (e.g., image reading) requires consensus building. For bench testing of an infusion pump, the measurements are objective.

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 question is not applicable. MRMC studies are specific to diagnostic devices (often AI-powered) that assist human interpretation of medical images or data. The twiist system is an insulin infusion pump, a therapeutic device, not a diagnostic one.

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

Yes, in a sense. The "pump" itself (the microprocessor-controlled mechanism with AVS feedback) delivers insulin "standalone" based on its algorithms. The bench testing performed to verify its accuracy and safety with the new infusion sets is a form of standalone performance evaluation in a controlled environment, demonstrating the device's inherent functional capabilities without human intervention during the actual delivery process.

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

The ground truth used for this device's performance testing (and for the predicate) is objective physical measurement based on highly accurate and calibrated laboratory equipment designed for fluid delivery assessment. This would involve measuring the actual volume of insulin delivered, flow rates, pressure changes, and time to alarm, compared to the programmed parameters.

8. The sample size for the training set

This question is not applicable. Infusion pumps like the twiist system are engineered medical devices that operate based on deterministic algorithms and physical principles, not machine learning or AI models that require "training sets" in the typical sense.

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

This question is not applicable for the same reason as #8. The device's "behavior" is designed and verified rather than "learned" from a training set.

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The embecta Insulin Delivery System with interoperable technology (the Patch) is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and older. The Patch is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute and confirm commands from these devices. The patch is intended for single patient, home use and requires a prescription.

The embecta Insulin Delivery System is a prescription home use device intended to support insulin therapy for diabetes mellitus (DM) management. The embecta Insulin Delivery System is a disposable insulin delivery device (referred to as a Patch) that is operated by a Controller which consists of Controller software application provided on a locked down smartphone with Bluetooth Low Energy (BLE) and Wi-Fi capabilities. The embecta Insulin Delivery System performs the following functions: 1) Deliver user-set daily basal insulin 2) Deliver user-set or user-entered mealtime (prandial) or correction insulin doses 3) Generate system status and notifications. The Patch is a single use disposable patch pump device intended to be worn by the patient for a Patch Life period of up to 72 hours (3 Days). The Patch is adhered to the patient using a medical grade adhesive patch. The Patch features a syringe pump design that operates dose increment mechanism which controls the dose size. It stores and administers 300 U of user-filled U-100 insulin with variable basal and bolus dosage settings that are agreed upon between the user and their healthcare practitioner or provider. It is indicated for U-100 NovoLog® (insulin aspart) and U-100 Humaloq® (insulin lispro). The Controller App is a smartphone app running on a locked-down Android smartphone that is rechargeable with the provided charger. The Controller App will control the Patch. The embecta-provided smartphone will be non-sterile and is locked to run only the embecta Controller App to program the Patch discreetly. The Controller App will enable the user to pair, prime, and program basal and bolus dose via wireless transmission to the Patch as well as provide users with system alerts, including status information, and notifications. This includes, but is not limited to, controller battery life, total insulin delivered, calculation of a low insulin reservoir volume, occlusion, and other possible device faults. The Controller App is designed to program and display the patient's basal insulin delivery rate, delivered bolus doses, and insulin usage data on a color display touch screen.

The provided text is a 510(k) Summary for the embecta Insulin Delivery System. It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical performance data. There is no mention of a study involving AI/ML components or human reader performance. Therefore, I cannot provide information regarding:

• Number of experts used to establish ground truth
• Adjudication method
• Multi Reader Multi Case (MRMC) comparative effectiveness study
• Effect size of human readers improving with AI assistance
• Standalone (algorithm only) performance
• Sample size for the training set
• How the ground truth for the training set was established

However, based on the non-clinical performance data provided, I can construct a table of acceptance criteria (implicit from the reported performance) and the reported device performance for dose delivery accuracy and occlusion detection.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are inferred from the reported performance data, which demonstrates the device's capability within specific tolerances.

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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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The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of 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, 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 pump is indicated for use in individuals 2 years of age and greater.

The Subject Device, Tandem Mobi insulin pump with interoperable technology ("Mobi pump", "the pump"), is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. The Tandem Mobi insulin pump with interoperable technology ("pump") is screenless and includes visual LED, sound, and vibratory indicators to alert the user of the pump status. The Tandem Mobi insulin pump with interoperable technology system also includes: the Tandem Mobi Mobile Application and a 2mL (200 insulin unit) Tandem Mobi cartridge and a compatible FDA cleared infusion set. The Tandem Mobi Mobile Application ("Mobile app") displays all information from, and is the primary controller of, the pump. Through the Mobile app, users will program all aspects of basal and bolus insulin delivery therapy including managing personal profiles, viewing pump and CGM data, and actively acknowledging all pump and mobile app alerts, alarms, reminders, notifications, and messages. The Tandem Mobi Mobile Application will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The Tandem Mobi Mobile Application will be made available via the Apple® App Store for iOS compatible smartphones based on completed device verification and validation. The Tandem Mobi cartridge is a disposable insulin cartridge compatible only with the Tandem Mobi pump.

The Tandem Mobi ACE pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.

The pump may be used in combination with a compatible continuous glucose monitor (CGM) system. Use of CGM is optional.

This document is a 510(k) summary for the Tandem Mobi insulin pump with interoperable technology, submitted to the FDA. It primarily focuses on demonstrating substantial equivalence to a predicate device (K233044).

Based on the provided text, the acceptance criteria and study proving the device meets them pertain to a diabetes management system (insulin pump), not an AI/ML-driven diagnostic or image-analysis device. Therefore, many of the requested points regarding AI/ML study design (e.g., ground truth establishment for a test set, expert consensus, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.

The document discusses "Clinical Testing" but states that the same testing provided in a previous 510(k) (K232380) was used. This implies that the current submission (K240309) is not presenting a new, dedicated clinical study for its substantial equivalence claim, but rather leveraging prior clinical data from a related submission.

However, I can extract the relevant information from the provided text based on the nature of this device type and the 510(k) submission process.

Here's an analysis based on the document:

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

The document doesn't present a table of specific acceptance criteria in the traditional sense of numerical thresholds for algorithm performance (like sensitivity/specificity for AI). Instead, it relies on demonstrating substantial equivalence to a predicate device (K233044). The "performance" is implicitly deemed acceptable if it performs the same function and does not raise new questions of safety or effectiveness compared to the predicate.

The key changes and comparisons are:

The overall "performance" is that the Subject Device "serves the same function as the Predicate Device" and "performs insulin therapy functions that are the same as that of the Predicate Device." The key performance difference identified is the expanded age indication from 6 years of age and greater to 2 years of age and greater.

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

• Sample Size: Not specified in terms of a "test set" for performance evaluation of an algorithm. The filing mentions "Clinical Testing was provided to support this 510(k) Notification. The clinical testing provided was the same testing provided in 510(k) K232380." The details of sample size for that K232380 study are not in this document.
• Data Provenance: Not specified in this document (e.g., country of origin, retrospective/prospective). This information would be found in the K232380 submission.

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

Not applicable to this type of device and submission. Ground truth for an insulin pump's functionality is typically established through engineering bench testing, simulated use, and clinical trials (for safety and efficacy in delivering insulin and managing blood glucose), rather than expert radiological review.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 is not an AI-assisted diagnostic imaging device.

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

Not applicable. This is not an AI algorithm. The device is an insulin pump that works with compatible interoperable technology, including automated insulin dosing software, but details on the performance validation of that software's algorithm are outside the scope of this specific 510(k) summary for the pump itself.

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

For an insulin pump, "ground truth" would relate to its ability to accurately and safely deliver insulin, receive and execute commands, and remain connected. This would be established through:

• Engineering specifications and bench testing (e.g., infusion accuracy, flow rates, alarm functionality).
• Software verification and validation (for reliable communication and command execution).
• Clinical data (likely outcomes data relating to glycemic control, safety, and adverse events if a study was performed in support of K232380).
• Usability/Human Factors testing (ensuring safe and effective interaction for the user).

The document states: "Appropriate testing was performed to confirm the Subject Device met specified requirements and performed as intended." This testing included:

• Usability/Human Factors (comparative Use Related Risk Analysis only, no new testing)
• Software Verification and Validation (no new testing)
• Electrical Safety/EMC (no new testing)
• Insulin Compatibility and Biocompatibility (no new testing)
• Sterilization and Shipping (no new testing)
• Special Controls (adherence confirmed)
• Clinical Testing (same as K232380)

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that uses training sets in this context.

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

Not applicable.

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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, execute, 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 bolus insulin dosage for management of diabetes mellitus based on consumed carbohydrates, operator entered blood glucose, insulin to carbohydrate ratio, target glucose values, and current insulin on board.

The DEKA ACE Pump system is a modification of the previously cleared DEKA ACE Pump System (K213536). The modified device is a wearable alternate controller enabled (ACE) insulin infusion pump (DEKA ACE Pump System) with the addition of an embedded iAGC (DEKA Loop). The user interface is an iOS app that can be downloaded to a user's iPhone.

The updated system is still 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 Pump is indicated for use with Humalog U-100 insulin.

The DEKA ACE Pump System is indicated for the management of mellitus in persons six years of age and greater.

The system as described in this submission is able to be integrated with an integrated Continuous Glucose Monitor (iCGM). This submission also details the integration process that was used to incorporate the DEKA Loop iAGC Algorithm onto the DEKA ACE Pump.

The DEKA ACE Pump System consists of the following durable and disposable components:

• 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.
• 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.
• DEKA Loop App: An iOS mobile application that serves as the primary user face for the system. The DEKA Loop app can be downloaded onto the user's personal iPhone.

The provided text is a 510(k) summary for the DEKA ACE Pump System, focusing on demonstrating substantial equivalence to a previously cleared predicate device. It addresses modifications, primarily the addition of an embedded iAGC (DEKA Loop) and a change in the user interface to an iOS app, as well as a broadened age indication (from 13+ to 6+).

However, the document does not contain the specific information required to answer your request about acceptance criteria and study proving the device meets those criteria for aspects like deep learning model performance (e.g., accuracy, sensitivity, specificity, or AUC). The request is structured as if the document describes an AI/ML-based diagnostic device where performance metrics against a ground truth dataset would be evaluated.

Instead, this document describes a medical device (insulin pump) where the "performance testing" refers to engineering and quality assurance testing against technical standards and safety requirements (e.g., electrical safety, electromagnetic compatibility, biocompatibility, delivery accuracy of insulin). The "Acceptance Criteria" implicitly refer to meeting these established engineering and regulatory standards rather than statistical performance metrics of a diagnostic algorithm against a labeled test set.

Specifically:

• There is no mention of a deep learning model's performance metrics (accuracy, sensitivity, specificity, AUC) or related test set details (sample size, data provenance, ground truth establishment, expert adjudication, MRMC studies).
• The "DEKA Loop iAGC Algorithm" is mentioned as being integrated, but there are no details on how its performance was evaluated, other than "Human Factors testing demonstrates equivalent safety and effectiveness for the indicated population" (page 7). This suggests focus on usability and safety in human interaction, not algorithmic diagnostic performance.
• The document explicitly states "No clinical data was obtained in support of this premarket submission" (page 13), reinforcing that the evaluation was primarily non-clinical and focused on substantial equivalence based on existing data and engineering tests.

Given the content of the provided document, I cannot fulfill your request for the specific details outlined for an AI/ML-based diagnostic device. The available information relates to the regulatory submission for an insulin pump, which is evaluated against different types of performance criteria.

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The Inessa System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Inessa System 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 Inessa System is intended for single patient, home use and requires a prescription. The Inessa System is indicated for use in individuals 6 years of age and greater.

The Inessa System ("System") is intended for subcutaneous delivery of insulin at set and variable rates, bolus or basal. The Inessa System includes a skin-adhered Patch Pump that is programmed and controlled wirelessly by a handheld Controller. The System main components include: Patch Pump: a skin adhered, syringe pump type, designed for insulin delivery at set and variable basal and/or bolus doses. The Patch Pump includes two parts: Pump: a reusable part that includes motor, electronics, drive mechanism, and o rechargeable battery. Two Pumps are provided, one is charged (P2) while the other is in use (P1). Cartridge: a sterile disposable part that includes insulin Reservoir. o Controller: The System user interface is a handheld, Alternate Controller Enabled (ACE), providing instructions to the Pump and receiving information from the Pump using wireless Bluetooth Low Energy (BLE) communication. The System includes the following accessories: Inserter: disposable, for insertion of Soft Cannula and retraction of Insertion needle. Filling kit: disposable, for filling of the Cartridge. It includes Filling needle, Filling syringe and Vial adaptor . Charger: reusable, for charging the Pump and the Controller. Docker: reusable, docking station for pumps for charging and protecting the Pump when not in use. The System also includes a Bolus Calculator, accessible through the System Controller. Based on user inputs of blood glucose (current and targeted), carbohydrate intake (meals), patient's insulin characteristics (i.e., Insulin Duration of Action, Insulin Correction Factor, Insulin-to-Carbs Ratio), this feature calculates suggested and estimated values for: Correction Bolus (amount of insulin needed to correct elevated blood glucose (BG) ● level): . Meal Bolus (amount of insulin needed to cover carbohydrates in an upcoming meal); and "Insulin on Board" or "Bolus on Board" (estimation of how much Active Insulin (Al) . remains in the body from previous boluses).

The provided text is a 510(k) summary for the Inessa System, an insulin pump. It details the device's classification, intended use, technological characteristics, and safety and performance data. However, it does not include information about a study that assesses the device's performance against specific acceptance criteria in the context of AI (Artificial Intelligence) or Diagnostic Accuracy.

The document focuses on demonstrating substantial equivalence to a predicate device (Omnipod DASH™ Insulin Management System) for regulatory clearance, primarily through engineering and safety testing (e.g., sterilization, biocompatibility, electrical safety, delivered volume accuracy, occlusion testing, human factors, and usability).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment related to AI or diagnostic accuracy, because this information is not present in the provided text.

The text does mention "automated insulin dosing software" as something the Inessa System can communicate with, but it does not describe any specific studies or acceptance criteria related to the performance of such AI/software in a diagnostic or prescriptive context. The "software verification and validation" mentioned refers to the general software within the device, not necessarily an AI component with specific diagnostic performance metrics.

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The t:slim X2 Insulin Pump with Interoperable Technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes melliting insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is intended for single patient, home use and requires a prescription. The Pump is indicated for use in individuals 2 years of age and greater.

The t:slim X2 Insulin Pump with Interoperable Technology is an ambulatory, battery operated, rate-programmable infusion pump designed for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

The t:slim X2 insulin pump includes a disposable cartridge with a 300 unit reservoir which is filled with insulin by the user with the use of the syringe and needle. The cartridge needs to be changed every 48-72 hours depending on the type of insulin used.

The pump is motor driven to deliver patient programmed basal rates and boluses through an infusion set into subcutaneous tissue. The desired timing and quantity of insulin delivery (bolus or basal) is programmed by the patient based on their healthcare provider's recommendations.

The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, execute, and confirm commands from these devices.

The t:connect mobile app enables a user to connect a smartphone to the pump using Bluetooth® wireless technology to display pump information and perform some pump functions on the smartphone as well as display pump notifications. The t:connect mobile app can transmit pump and therapy data from the pump to the cloud as long as the user's smartphone is connected to the internet.

The pump is designed to be able to receive and display alerts and alarms to users based on information received from other interoperable devices.

The pump is compatible with Interoperable Automated Glycemic Controllers, such as Basal-IQ Technology (K193483) and Control IQ Technology (K200467) to aid in diabetes management. The latter is being submitted concurrently.

In addition, the Subject Device is compatible with iCGM systems cleared under K223931 21 CFR 862.1355.

The provided text describes the 510(k) summary for the Tandem Diabetes Care t:slim X2 Insulin Pump with Interoperable Technology (K232380). This submission focuses on a change to the age indication for the device, lowering it to individuals 2 years of age and greater.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific quantitative acceptance criteria (e.g., minimum accuracy percentages, specific error rates) for the device's performance in relation to the expanded age indication. Instead, it makes a general statement about safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "clinical testing was performed to support the expanded age indication" and "the clinical testing provided in this 510(k) demonstrate that the t:slim X2 Insulin Pump with Interoperable Technology is the same as the predicate device in safety and effectiveness."

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. However, the nature of "clinical testing" for an expanded age indication typically implies a prospective clinical study involving the new patient population.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The text does not describe a process of expert review or establishing ground truth in the context of the clinical testing.

4. Adjudication Method 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

This information is not provided in the document. The study described is a clinical evaluation of the device itself rather than a comparison of human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is an insulin pump, which is a physical medical device that delivers insulin. While it has interoperable technology and can communicate with automated insulin dosing software, the "performance data" mentioned pertains to the overall device in a clinical setting with human interaction (patient programming, healthcare provider recommendations). Therefore, a "standalone algorithm only" performance study as typically understood for AI/CAD devices is not directly applicable or explicitly described in this context. The focus is on the device's safety and effectiveness for insulin delivery in the expanded age group.

7. The Type of Ground Truth Used

The "ground truth" for the clinical testing would be the actual physiological responses and outcomes of the pediatric patients using the insulin pump, as assessed by healthcare professionals. This would include parameters like blood glucose levels, incidence of hypoglycemia/hyperglycemia, and adverse events. The document refers to "safety and effectiveness," which points to clinical outcomes.

8. The Sample Size for the Training Set

The document describes a clinical study to support an expanded age indication for an existing device. This implies that the device's core algorithm and functionality were developed and "trained" (in a non-AI sense, meaning designed and validated) prior to this specific submission. The text does not provide information regarding a training set for an AI/algorithm, as this submission is not about the initial development or a new AI component. If the "interoperable technology" involves AI, the training data for that specific AI component is not detailed here.

9. How the Ground Truth for the Training Set Was Established

Given that this submission is for an expanded age indication of an existing device, and not a new AI model, the concept of a "training set" and its ground truth establishment, as typically understood for AI/ML, is not applicable or described in this document. The device's fundamental insulin delivery mechanism and safety profile would have been established through prior design, testing, and regulatory submissions. The current clinical testing validates the device's safety and effectiveness for a younger population.

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The Omnipod 5 ACE Pump (Pod) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Omnipod 5 ACE Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Omnipod 5 ACE Pump is intended for single patient, home use and requires a prescription.

The Omnipod 5 ACE Pump is intended to deliver insulin via a tubeless insulin pump (the Pod) that wirelessly connects to and receives insulin delivery commands from the Omnipod 5 App, which is installed on a locked-down Android controller device or a user's personal smartphone device. The predicate device allowed the user to download the Omnipod 5 App to an Android compatible phone. This submission includes an iOS compatible Omnipod 5 App to allow users to download it to a compatible iPhone.

The Omnipod 5 ACE Pump is part of the Omnipod 5 Automated Insulin Delivery System, which also includes SmartAdjust Technology (iAGC), and the SmartBolus Calculator. SmartAdjust Technology and the SmartBolus Calculator functionally independent from the Omnipod 5 ACE Pump. The Omnipod 5 ACE Pump is intended to be digitally connected to a third party iCGM, SmartAdjust Technology, and the SmartBolus Calculator.

The Omnipod 5 ACE Pump can operate in Manual Mode, delivering insulin based on userprogrammed basal rates, or in Automated Mode, where insulin is automatically delivered based on the calculations and command of a compatible iAGC. Currently, the Omnipod 5 ACE Pump is compatible with SmartAdjust Technology, the software which is pre-installed on the Pod and the App. Future alternate controllers may be established for use with the Pod, in which case the software modules of the SmartAdjust Technology would be disabled. The Pod is a bodywearable insulin pump that affixes to the user on the back of the arm, the lower back, the abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The Omnipod 5 App is a software application installed on a handheld touchscreen device (Android and iOS) that connects to the Pod via Bluetooth Low Energy (BLE) and serves as the user interface of the system. In addition to programmed basal delivery and automated insulin delivery, the Omnipod 5 ACE Pump allows users to deliver bolus doses at values that are either inputted manually or calculated by the SmartBolus Calculator based on the user's settings and user-entered parameters. The Pod has the ability to connect to a compatible iCGM through BLE and receive data for use with SmartAdiust Technology and the SmartBolus Calculator.

The Omnipod 5 App has the ability to wirelessly connect to the Insulet Cloud which it utilizes for registering new devices, authenticating users, ensuring hardware devices and host operating systems are compatible, and completing over the air software (OTA) and firmware (FOTA) updates.

The provided text is a 510(k) summary for the Omnipod 5 ACE Pump, which describes the addition of an iOS compatible mobile application. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K203768).

Based on the provided text, the acceptance criteria and study details are primarily related to software verification and validation, interoperability, cybersecurity, electrical safety and EMC, and human factors validation for the new iOS application, rather than clinical performance of the insulin delivery itself (as the Pod itself was not modified).

Here's an attempt to structure the information based on your request, highlighting what is and isn't explicitly stated in the document:

Device: Omnipod 5 ACE Pump (with added iOS compatible Omnipod 5 App)
Purpose of Submission: To add a new mobile application compatible with iOS mobile devices. The Omnipod 5 App (iOS) is the new configuration being added to the previously cleared Omnipod 5 ACE Pump.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several types of performance testing and their adherence to standards and regulations. It doesn't present specific quantitative acceptance criteria or detailed performance metrics in a tabular format that is typically seen for accuracy, sensitivity, or specificity in AI/ML medical devices. Instead, it states that tests were performed and demonstrated that predetermined acceptance criteria were met and the device is safe and effective for use.

Note on Insulin Delivery Accuracy: The document states that the "Pod Delivery Accuracy (tested per IEC 60601-2-24)" for basal and bolus rates is a characteristic of the predicate device and is unchanged for the subject device. It is listed as:

• Basal: ± 5% at rates ≥ 0.05 U/hr
• Bolus: ± 5% for all set values ≥ 1.0 unit, ± 0.05 unit for set values

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The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of 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, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

The pump is intended for single patient, home use and requires a prescription.

The pump is indicated for use in individuals six years of age and greater.

The Subject Device, Tandem Mobi insulin pump with interoperable technology ("Mobi pump", "the pump"), is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. The Tandem Mobi insulin pump with interoperable technology ("pump") is screenless and includes visual LED, sound, and vibratory indicators to alert the user of the pump status. The Tandem Mobi insulin pump with interoperable technology system also includes: the t:connect mobile app and a 2mL (200 insulin unit) Tandem Mobi cartridge and a compatible FDA cleared infusion set. The t:connect mobile app ("Mobile app") displays all information from, and is the primary controller of, the pump. Through the Mobile app, users will program all aspects of basal and bolus insulin delivery therapy including managing personal profiles, viewing pump and CGM data, and actively acknowledging all pump and mobile app alerts, alarms, reminders, notifications and messages. The t:connect mobile app will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The t:connect mobile app will be made available via the Apple® App Store for iOS compatible smartphones based on completed device verification and validation. The Tandem Mobi cartridge is a disposable insulin cartridge compatible only with the Tandem Mobi pump.

The Tandem Mobi ACE pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.

The pump may be used in combination with a compatible continuous glucose monitor (CGM) system, such as the Dexcom G6 Continuous Glucose Monitoring System (DEN170088). Use of CGM is optional.

This document K233044 is a 510(k) premarket notification for the Tandem Mobi insulin pump with interoperable technology. It is a "Special 510(k)" submission, which means it relies on a previously cleared predicate device (K223213) to demonstrate substantial equivalence, rather than providing entirely new data.

Therefore, the document explicitly states that "No new clinical testing was performed to support this 510(k) Notification." This means that the information requested regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document, as the submission relies on the prior clearance of the predicate device.

Based on the provided text, I cannot provide the details you requested because the submission is a Special 510(k) and explicitly states that no new performance testing (including clinical, usability, software, electrical safety, or biocompatibility) was performed.

The relevant sections that confirm this are:

• "IV. Overview of Non-Clinical Performance Tests"
  • "Usability/Human Factors: No new Usability or Human Factors testing was performed to support this 510(k) Notification."
  • "Software Verification and Validation: No new Software testing was performed to support this 510(k) Notification."
  • "Electrical Safety/ EMC: No new Electrical and Electromagnetic Compatibility (EMC) was performed to support this 510(k) Notification."
  • "Insulin Compatibility and Biocompatibility: No new insulin compatibility testing was performed to support this 510(k) Notification."
  • "Clinical Testing: No new clinical testing was performed to support this 510(k) Notification."
• "Conclusion: The Subject Device serves the same function as the Predicate Device. Furthermore, the Subject Device performs insulin therapy functions that are the same as that of the Predicate Device. The required technical documentation provided in this Special 510(k) demonstrates the Subject Device is as safe and as effective as the Predicate Device. Therefore, the Subject Device has been evaluated to be substantially equivalent to the Predicate Device and does not raise new or different questions of safety or effectiveness."

To get the information you requested, one would need to review the original 510(k) submission for the predicate device (K223213), as that would presumably contain the "new" testing data that established its safety and effectiveness.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on this K233044 document.

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