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SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older. SmartAdjust™ technology is intended for single patient use and requires a prescription.

SmartAdjust™ technology is a software-only device that enables automated insulin delivery by taking in glucose inputs from a connected iCGM and calculating insulin micro-bolus outputs for delivery by a connected ACE Pump.

SmartAdjust™ technology is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 ACE Pump and the SmartBolus Calculator regulated devices. The Omnipod 5 ACE Pump and the SmartBolus Calculator are functionally independent from SmartAdjust™ technology. SmartAdjust™ technology is intended to be digitally connected to a third party iCGM, the Omnipod 5 ACE Pump, and the SmartBolus Calculator.

The SmartAdjust™ technology software is installed on both the Omnipod 5 Pod and Omnipod 5 Controller (which contains the Omnipod 5 App), the 2 physical components that make up the Omnipod 5 System.

The Omnipod 5 System is a hybrid closed loop system and therefore can operate in either open loop (Manual Mode; SmartAdjust™ technology disabled) or closed loop (Automated Mode; SmartAdjust™ technology enabled). When Automated Mode is turned on, the SmartAdjust™ algorithm (installed on the Pod) controls insulin delivery based on recent CGM values.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

This document describes the 510(k) premarket notification for the SmartAdjust™ Technology, which is an interoperable automated glycemic controller. The submission aims to expand the indications for use to include individuals with Type 2 Diabetes Mellitus aged 18 years and older, in addition to the existing indication for Type 1 Diabetes Mellitus.

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

The provided text doesn't explicitly list a table of "acceptance criteria" with numerical targets in a typical performance study format. However, it does report on a primary safety endpoint from a clinical study which effectively serves as a key performance metric for the expanded indication.

Here's a table based on the information provided, focusing on the clinical study's primary safety endpoint:

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SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older. SmartAdjust™ technology is intended for single patient use and requires a prescription.

SmartAdjust™ technology is a software-only device that enables automated insulin delivery by taking in glucose inputs from a connected iCGM and calculating insulin micro-bolus outputs for delivery by a connected ACE Pump.

SmartAdjust™ technology is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 ACE Pump and the SmartBolus Calculator regulated devices. The Omnipod 5 ACE Pump and the SmartBolus Calculator functions are functionally independent from SmartAdjust™ technology. SmartAdjust™ technology is intended to be digitally connected to a third party iCGM, the Omnipod 5 ACE Pump, and the SmartBolus Calculator.

The SmartAdjust™ technology software is installed on both the OP5 Pod and OP5 Controller (which contains the OP5 App), the 2 physical components that make up the Omnipod 5 System.

The Omnipod 5 System is a hybrid closed loop system and therefore can operate in either open loop (Manual Mode; SmartAdjust™ technology disabled) or closed loop (Automated Mode; SmartAdjust™ technology enabled). When Automated Mode is turned on, the SmartAdjust™ alqorithm (installed on the Pod) controls insulin delivery based on recent CGM values.

This document is an FDA 510(k) clearance letter and summary for the Insulet SmartAdjust™ technology. It states that the device is substantially equivalent to a previously cleared predicate device (K220394), with the only change being an update to the specifications for glucose sensor performance for compatible integrated continuous glucose monitors (iCGMs). This means the core algorithm and its performance were already established with the original clearance.

Therefore, the document does not contain the detailed study information typically found in a new device submission or a clinical trial report that directly proves the device meets specific acceptance criteria in a new clinical study. Instead, it relies on the substantial equivalence argument, implying that the previous studies for the predicate device, or studies demonstrating the updated iCGM performance, are sufficient.

Based on the provided text, here's what can be extracted and what cannot:

Information Available:

• Device Name: SmartAdjust™ technology
• Predicate Device: SmartAdjust™ technology (K220394)
• Change: Updated iCGM Performance Specifications per 21 CFR 862.1356(1)(iv).
• Conclusion: The subject device is substantially equivalent to its predicate. The differences do not raise new questions of safety and effectiveness.

Information NOT Available (because this is a substantial equivalence submission for a minor update, not a new clinical trial submission document):

• A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics or acceptance criteria for a new study, as it's an update to an already cleared device. The performance requirements were presumably met by the predicate device and the updated iCGM.
• Sample sizes used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
• Adjudication method: Not applicable/provided for this type of submission.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable/provided.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is an algorithm/software, but the clinical performance data related to its efficacy (how well it manages glucose) would typically be from human-with-device studies from the original predicate submission. No new standalone study details are here.
• The type of ground truth used: Not specified, but for a glycemic controller, this would typically involve actual blood glucose measurements.
• The sample size for the training set: Not provided.
• How the ground truth for the training set was established: Not provided.

Reconstruction of "Acceptance Criteria" based on the document's type:

Since this is a 510(k) for an update, the "acceptance criteria" revolve around demonstrating that the change (updated iCGM specifications) does not negatively impact safety or effectiveness, and that the device still meets the requirements for its classification.

Table of "Acceptance Criteria" and "Reported Device Performance" as implied by a 510(k) for an update:

Study Information (based on the context of a 510(k) for an update):

• Sample size used for the test set and data provenance: No specific sample size for new clinical testing is mentioned. The approval hinges on the existing data for the predicate device and the updated iCGM meeting its own specifications. The data provenance for the original predicate would have included clinical trial data (likely prospective).
• Number of experts and qualifications, Adjudication method, MRMC study, Standalone performance: These details are not relevant to this specific 510(k) summary, as it's establishing equivalence based on a minor technical update, not presenting new clinical efficacy data for the core algorithm from scratch. Such studies would have been part of the original K220394 submission.
• Type of ground truth used: For the underlying technology (which is unchanged here), the ground truth for an automated glycemic controller would be actual blood glucose measurements, measured by a reference method (e.g., lab venous plasma glucose, or accurate point-of-care devices).
• Training Set Sample Size and Ground Truth Establishment: Not mentioned, as this is an established, already-trained algorithm.

In summary, this document is a regulatory approval for a minor update to an already-cleared medical device software, rather than a detailed report of a new clinical study. The "proof" lies in the argument of substantial equivalence to the predicate device, with the specific change (iCGM specifications) not introducing new safety or effectiveness concerns.

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The SmartBolus Calculator is software intended for the management of diabetes in persons aged 2 and older requiring rapid-acting U-100 insulin. The SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose value (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The SmartBolus Calculator is intended for single patient, home use and requires a prescription.

The SmartBolus Calculator is a software device that is a component of the Omnipod 5 Automated Insulin Delivery System. The SmartBolus Calculator exists on the Omnipod 5 App portion of the Omnipod 5 ACE Pump and relies on the user interface of the App.

The SmartBolus Calculator receives input parameters and settings from other components of the system and calculates a suggested bolus amount of insulin to correct an elevated glucose level (a correction bolus) and/or to cover carbohydrates from a meal (meal bolus). The SmartBolus Calculator allows users to have the option of populating the current estimated glucose value and trend, which is communicated by the connected iCGM. Users may also manually enter the estimated glucose value or a blood glucose (BG) reading from a blood glucose meter. In addition to glucose, the suggested bolus dose is calculated based on the following parameters: user-entered carbohydrates, rate of change of the sensors qlucose (if using a CGM), correction factor, insulin to carbohydrate ratio, target glucose value, and insulin on board (IOB). Once the calculation is complete, the user has the option of delivering the suggested dose of insulin, modifying the amount, or canceling.

The SmartBolus Calculator can be used in the Omnipod 5 Automated Insulin Delivery System with both Manual Mode and Automated Mode.

Here's a summary of the acceptance criteria and study information for the SmartBolus Calculator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific acceptance criteria in a quantitative manner for the SmartBolus Calculator's performance. Instead, it states that:

• "Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the device is safe for use."
• "Through performance testing, the Subject device has been shown to meet the Special Controls and determined to be substantially equivalent to its predicate."
• "There was no impact to clinical performance of the SmartBolus Calculator for the design change discussed in this submission."

This implies that the assessment for this 510(k) submission focused on demonstrating that the new iOS version of the SmartBolus Calculator (subject device) performs identically to the predicate Android version (K222239) and meets the same safety and effectiveness standards, rather than establishing new performance metrics.

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

The document does not specify a sample size for a test set in the context of clinical or performance data for the SmartBolus Calculator itself. The testing mentioned is primarily "software verification and validation testing" and "risk management" activities.

The data provenance is also not explicitly stated as retrospective or prospective clinical data. The testing described appears to be internal software development and validation, rather than a clinical trial.

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

This information is not provided in the document. The testing described is software-centric, and there's no mention of expert-established ground truth for a test set in a medical diagnostic sense.

4. Adjudication method for the test set

This information is not provided in the document, as it doesn't describe a clinical test set requiring adjudication.

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

An MRMC comparative effectiveness study was not mentioned or described. The device is an "Insulin Therapy Adjustment Device," not a diagnostic imaging device where MRMC studies are typically conducted. The document focuses on demonstrating substantial equivalence of a new software implementation (iOS) to an existing one (Android).

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

The SmartBolus Calculator is described as an "Algorithmic software device." Its function is to "calculate a suggested bolus dose." However, it operates as a component of the Omnipod 5 App, and "Once the calculation is complete, the user has the option of delivering the suggested dose of insulin, modifying the amount, or canceling." This indicates it's a human-in-the-loop system, where the user has ultimate control and decision-making power over the suggested dose. Therefore, a purely standalone clinical performance evaluation without human decision-making is not explicitly implied or discussed in this context. The software's calculation itself is standalone, but its application involves a human.

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

The document does not specify a type of ground truth related to clinical outcomes or expert consensus for its performance evaluation for this particular submission. The "verification activities" and "software verification and validation testing" likely used predefined software requirements, simulated data, and mathematical correctness of calculations as their "ground truth" to ensure the algorithms produced the expected outputs given specific inputs according to the established insulin calculation formulas.

8. The sample size for the training set

The document does not describe a training set in the context of machine learning. The SmartBolus Calculator is an algorithm that computes a bolus dose based on programmable factors and user inputs, not a machine learning model that requires a training set.

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

As there's no mention of a machine learning model or a training set, this information is not applicable.

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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 Omnipod GO Insulin Delivery Device is intended for the subcutaneous infusion of insulin at a preset basal rate in one 24-hour time period for 3 days (72 hours) in adults with type 2 diabetes.

The Omnipod GO Pod helps manage diabetes by providing continuous subcutaneous insulin delivery. To facilitate insulin dose titration and provide appropriate options across a wide range of daily insulin needs, the Omnipod GO Device will come in seven different models: 10, 15, 20, 25, 30, 35, and 40 units per day, with each model delivering insulin at a fixed rate over the 72hour life of the device. There is no ability to deliver a bolus dose of insulin using the Omnipod GO device. Like the proposed predicate device (V-GO Insulin Delivery System, K103825), Omnipod GO will be entirely self-contained in an on-body device that is single-use, sterile, and disposable. It is small, lightweight, and designed to the body via an adhesive pad. The adhesive backing keeps the device securely in place for up to 3 days (72 hours).

The provided text describes the Omnipod GO Insulin Delivery Device, but it does not contain specific acceptance criteria or the study details to prove the device meets those criteria, especially in the format of a table with reported device performance.

Here's what can be extracted from the document regarding performance and evaluation, and where information is missing:

Missing Information:

• Specific Acceptance Criteria Table: The document doesn't provide a table explicitly listing acceptance criteria for performance metrics (e.g., specific accuracy ranges they aimed for). It mentions "predetermined acceptance criteria were met" but doesn't detail what they were.
• Reported Device Performance: While it states the device delivers insulin accurately and detects occlusions, specific numerical performance results (e.g., X% accuracy, occlusion detection time) are not provided in the summary.
• Test Set Sample Size: The document refers to "human factors validation" and "performance testing" but does not specify the sample size used for these tests.
• Data Provenance (Test Set): Not explicitly stated whether the test data was retrospective or prospective, or its country of origin.
• Number of Experts & Qualifications (for Ground Truth): Not mentioned for any ground truth establishment.
• Adjudication Method: Not mentioned.
• MRMC Comparative Effectiveness Study: Not mentioned as being performed.
• Effect Size of Human Readers Improvement with AI: Not applicable as no MRMC study with AI assistance is mentioned.
• Standalone (Algorithm Only) Performance: The device is an insulin delivery device, not an AI diagnostic/screening algorithm, so this concept (algorithm only performance) doesn't directly apply in the typical sense for medical imaging or similar devices. Its performance is inherent to its physical operation.
• Type of Ground Truth Used: For mechanical performance, "ground truth" would implicitly be highly accurate measurements against known standards. For human factors, it would be based on participant observations and feedback. However, it's not explicitly detailed.
• Training Set Sample Size: Not applicable/not mentioned, as there is no mention of a machine learning model being "trained" in the typical sense for this device.
• How Ground Truth for Training Set was Established: Not applicable/not mentioned.

What is provided in the document:

The document outlines a series of non-clinical performance data categories and general statements about compliance and effectiveness.

Summary of Non-Clinical Performance Data (What was done, but not detailed results or acceptance criteria):

• Risk Management: Completed in accordance with ISO14971:2019. "Verification activities... demonstrated that the predetermined acceptance criteria were met." (Details of criteria and results are missing).
• Safety Assurance: Device utilizes an insulin pump design marketed with other Omnipod devices. Risk mitigations from previous devices are similarly implemented to provide safety against overdose and underdose (occlusion detection, delivery accuracy).
• Human Factors Validation: Followed IEC 62366:2015-1, HE75:2009, and FDA guidance. "A robust validation evaluation was performed to demonstrate safe and effective use... Results... demonstrate that the Omnipod GO has been found to be safe and effective." (Specific data, sample size, or acceptance criteria are missing).
• Software Validation: Performed in accordance with IEC 62304:2015 and FDA guidance.
• Cybersecurity: Analysis performed following FDA guidance.
• Performance Testing: "Demonstrated that the device delivers insulin accurately at various flow rates and that it can effectively detect when an occlusion occurs and promptly notify the user." (Specific metrics, acceptance criteria, and results are missing).
• Biocompatibility: Evaluation performed per ISO 10993-1:2018 (patient-contacting materials are the same as currently marketed Omnipod Pod devices).
• Sterilization: Product adoption completed into the family of devices under sterilization validation.
• Electrical Safety and EMC Testing: Performed to verify compliance with IEC 60601-1:2005 and IEC 60601-1-2.

Key Performance Claim related to Predicate Device Comparison (Table 1.01):

This is the only specific quantitative performance metric with a value mentioned in the entire document. The document implies this "improved" accuracy value meets the new device's acceptance criterion for insulin delivery accuracy.

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The SmartBolus Calculator is software intended for the management of diabetes in persons aged 2 and older requiring rapid-acting U-100 insulin. The SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose value (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The SmartBolus Calculator is intended for single patient, home use and requires a prescription.

The SmartBolus Calculator is a software device that is a component of the Omnipod 5 Automated Insulin Delivery System. The SmartBolus Calculator exists on the Omnipod 5 App portion of the Omnipod 5 ACE Pump and relies on the user interface of the App. The SmartBolus Calculator receives input parameters and settings from the other components of the system and calculates a suggested bolus amount of insulin to correct an elevated glucose level (a correction bolus) and/or to cover carbohydrates from a meal (meal bolus). The SmartBolus Calculator allows users to have the option of populating the current estimated glucose value and trend, which is communicated by the connected iCGM. Users may also manually enter the estimated glucose value or a blood glucose (BG) reading from a blood glucose meter. In addition to glucose, the suggested bolus dose is calculated based on the following parameters: user-entered carbohydrates, rate of change of the sensor glucose (if using a CGM), correction factor, insulin to carbohydrate ratio, target qlucose value, and insulin on board (IOB). Once the calculation is complete, the user has the option of delivering the suggested dose of insulin, modifying the amount, or canceling. The SmartBolus Calculator can be used in the Omnipod 5 Automated Insulin Delivery System with both Manual Mode and Automated Mode.

The information provided focuses on the substantial equivalence of the SmartBolus Calculator to a predicate device, specifically regarding the expansion of its age range of intended users. The document details the clinical study performed to support this expanded indication, rather than a general acceptance criteria study for the device's core functionality.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a tabular format for the SmartBolus Calculator's overall performance. Instead, the "acceptance criteria" can be inferred from the clinical study's primary objective, which was to evaluate safety based on glucose metrics. The study aimed to show that the use of the SmartBolus Calculator in the expanded age group (2.0-5.9 years) did not significantly worsen these safety metrics compared to manual entry of blood glucose values.

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

• Sample Size: 5 subjects in the preschool cohort (aged 2.0-5.9 years).
• Data Provenance: The study was a "single-arm, multi-center, prospective clinical study" conducted across "2 US clinical sites." Therefore, the data is prospective and from the USA.

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

This document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. The clinical study collected glucose metrics directly from the subjects, which served as the primary data for evaluation.

4. Adjudication Method for the Test Set

The document does not mention an explicit adjudication method for the clinical study's data. Clinical study data, particularly objective metrics like blood glucose levels, typically do not require adjudication in the same way imaging or subjective diagnostic interpretations might. Safety events would be reviewed by the study investigators and reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This study was a clinical trial evaluating the safety and effectiveness of the device in a specific patient population, not a comparative study of human readers with and without AI assistance.

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

This study was a human-in-the-loop study. The SmartBolus Calculator is a software device that recommends a bolus dose, but the user "has the option of delivering the suggested dose of insulin, modifying the amount, or canceling." The clinical study evaluated the device's performance when used by patients/caregivers in Manual Mode.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on objective clinical outcomes data (glucose metrics and adverse events) directly measured from the study participants during the two phases of the study (Manual Mode with manual BG entry vs. Manual Mode with SmartBolus Calculator use).

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set used to develop the SmartBolus Calculator. The submission focuses on the clinical validation of the device's expanded indication, not its initial development.

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

The document does not provide information on how the ground truth for the training set was established.

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The Omnipod 5 SmartBolus Calculator is software intended for the management of diabetes in persons aged 6 and older requiring rapid-acting U-100 insulin. The Omnipod 5 SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose reading (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The Omnipod 5 SmartBolus Calculator is intended for single patient, home use and requires a prescription.

The Omnipod 5 SmartBolus Calculator is a software device that is a component of the Omnipod 5 Automated Insulin Delivery System. The SmartBolus Calculator exists on the Omnipod 5 App portion of the Omnipod 5 ACE Pump and relies on the user interface of the App.

The Omnipod 5 SmartBolus Calculator receives input parameters and settings from the other components of the system and calculates a suggested bolus amount of insulin to correct an elevated glucose level (a correction bolus) and/or to cover carbohydrates from a meal (meal bolus). The Omnipod 5 SmartBolus Calculator allows users to have the option of populating the current estimated glucose value and trend, which is communicated by the connected iCGM. Users may also manually enter the estimated glucose value or a blood glucose (BG) reading from a blood glucose meter. In addition to glucose, the suggested bolus dose is calculated based on the following parameters: user-entered carbohydrates, rate of change of the sensor glucose (if using a CGM), correction factor, insulin to carbohydrate ratio, target glucose value, and insulin on board (IOB). Once the calculation is complete, the user has the option of delivering the suggested dose of insulin, modifying the amount, or canceling.

The Omnipod 5 SmartBolus Calculator can be used in the Omnipod 5 Automated Insulin Delivery System with both Manual Mode and Automated Mode. When the Omnipod 5 SmartBolus Calculator is used with manually-entered BG readings, it suggests a bolus dose based on the same calculations as the currently cleared Omnipod DASH Insulin Management System (K180045, most recently cleared in K192659).

The document describes the Omnipod 5 SmartBolus Calculator, a software device for diabetes management. Here's a breakdown of the acceptance criteria and the study proving it meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied through the statement that the device meets "Insulin Therapy Adjustment Device special controls and to be safe and effective." The clinical study focused on glycemic control within 4 hours of bolusing. While explicit acceptance criteria for these percentages are not given as strict pass/fail thresholds, the performance observed is presented as evidence of safety and effectiveness, particularly regarding hypoglycemia.

*Note: The primary analysis focused on comparing the CGM-informed SmartBolus Calculator with the standard one, and a statistically significant difference was observed for time spent

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SmartAdjust technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust technology is intended for the management of type 1 diabetes mellitus in persons 6 years of age and older. SmartAdjust technology is intended for single patient use and requires a prescription.

The Omnipod 5 iAGC (SmartAdjust technology) is a software-only medical device intended for the management of type 1 diabetes mellitus. The Omnipod 5 iAGC uses data from a connected iCGM along with user-defined parameters to predict future glucose trends and automatically increase, decrease, or suspend the delivery of insulin via a compatible alternate controller enabled (ACE) pump.

The Omnipod 5 iAGC software is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 ACE Pump, Omnipod 5 Bolus Calculator, and an interoperable iCGM. The Omnipod 5 iAGC is intended to be digitally connected to an iCGM and an ACE Pump.

The Omnipod 5 iAGC software resides on the Omnipod 5 ACE Pump (the Omnipod 5 Pod and Omnipod 5 App). The iAGC software is responsible for controlling insulin delivery via compatible ACE Pump when the system is in Automated Mode. iCGM data is transmitted from the iCGM to the ACE Pump via Bluetooth Low Energy technology. The Omnipod 5 iAGC uses this transmitted iCGM data in its calculations. The Omnipod 5 iAGC can be turned off, and the Omnipod 5 ACE Pump will operate in Manual Mode, which delivers insulin based on HCP- or user-defined Basal Programs.

The Omnipod 5 iAGC has three states of operation: Automated Mode, Automated: Limited, and Activity. In Automated Mode, the system calculates insulin delivery every 5 minutes based on the user-customizable glucose target (110–150 mg/dL). Automated: Limited is enabled when the Omnipod 5 iAGC is not receiving data from a connected iCGM for 20 minutes or more and during sensor warm-up. While in Automated: Limited, the user will receive no more than preprogrammed basal insulin. When a valid glucose value is received from the iCGM, the Omnipod 5 iAGC will resume delivery of insulin in full Automated Mode. Activity is a user-selected temporary feature intended for use during periods when insulin sensitivity is expected to be higher, such as during exercise. With Activity, the algorithm reduces insulin delivery and sets a temporary glucose target of 150 mg/dL.

Acceptance Criteria and Device Performance for SmartAdjust Technology

The SmartAdjust technology, an interoperable Automated Glycemic Controller (iAGC) for type 1 diabetes management, was evaluated through a clinical study. The acceptance criteria and reported device performance are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list pre-defined quantitative acceptance criteria for all aspects. Instead, the study aims to demonstrate improvements in glycemic control and safety compared to standard therapy. The "Change" columns in the glycemic results tables effectively represent the performance metrics, and a "P 180mg/dL | Significant decrease | -15.1%* |
| Avg % ≥250mg/dL | Significant decrease | -9.4%* |
| Avg % ≥300mg/dL | Significant decrease | -5.1%* |
| Adolescents & Adults (14 to 70 years) | | |
| Avg A1C, % | Significant decrease | -0.38%* |
| Avg sensor glucose, mg/dL | Significant decrease | -8* |
| Avg % time 70-180mg/dL | Significant increase | 9.3%* |
| Median % 180mg/dL | Significant decrease | -7.7%* |
| Avg % ≥250mg/dL | Significant decrease | -4.3%* |
| Avg % ≥300mg/dL | Significant decrease | -2.0%* |

Safety Results (Incidence of Adverse Events)

**Change between standard therapy phase and Omnipod 5 System phase was significant (P 180 mg/dL, ≥250 mg/dL, ≥300 mg/dL).

• Safety: Measured by the incidence of severe hypoglycemia and diabetic ketoacidosis (DKA), as well as other adverse events reported during the clinical trial.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set. This is typical for device submissions where the algorithm's development (training) might involve proprietary data and methods not usually detailed in the 510(k) summary. The clinical study focuses on the validation and performance of the fully developed device.

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

The document does not specify how the ground truth for any potential training set was established. Given the nature of an automated glycemic controller, it's plausible that the training could involve:

• Simulated physiological models of diabetes.
• Retrospective data from patients with T1D (e.g., CGM data, insulin delivery logs, meal information).
• Rule-based logic derived from clinical guidelines and expert knowledge, rather than a "trained" machine learning model in the conventional sense.

Without further information in the submission, the exact method for establishing ground truth for training cannot be determined.

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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 alternate controller enabled (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 Application (App), which is installed on a locked-down controller device or a user's personal compatible smartphone device.

The Omnipod 5 ACE Pump is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 Interoperable Automated Glycemic Controller (iAGC), Omnipod 5 Bolus Calculator, and the third-party Dexcom G6 iCGM. Omnipod 5 iAGC and Bolus Calculator functions are functionally independent from the Omnipod 5 ACE Pump. The Omnipod 5 ACE Pump is intended to be digitally connected to the iCGM, the iAGC, and the Bolus 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 the Omnipod 5 iAGC, whose software is pre-installed on the Pod and the App. Future alternate controllers (iAGCs) may be established for use with the Pod, in which case the software modules of the Omnipod 5 iAGC would be disabled.

The Pod is a body-wearable 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 an Android software application installed on a handheld touchscreen device 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 Omnipod 5 Bolus Calculator based on the user's settings and userentered parameters. The Pod has the ability to connect to a compatible iCGM through BLE and receive data for use with the Omnipod 5 iAGC and Omnipod 5 Bolus 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. In addition, data from the App uploads regularly to the Insulet Cloud for data management purposes.

The Omnipod 5 ACE Pump is intended for the subcutaneous delivery of insulin and is stated to be substantially equivalent to the Omnipod DASH Insulin Management System with Interoperable Technology.

Acceptance Criteria and Reported Device Performance

The provided text primarily focuses on regulatory compliance and substantial equivalence to a predicate device rather than precise acceptance criteria and their corresponding empirical results in a clear tabular format. However, the document does mention performance aspects, particularly regarding Delivery Accuracy and Occlusion Detection.

Based on the available information, the following can be inferred:

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