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The CeQur Simplicity™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.

The CeQur Simplicity™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyrogenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 4 days (96 hours) using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The CeQur Simplicity™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.

The provided text is a 510(k) summary for the CeQur Simplicity™ On-Demand Insulin Delivery System. It describes the device, its intended use, and states that performance data demonstrates its safety and effectiveness. However, the document does not contain specific acceptance criteria, reported device performance metrics in tabular form, details of a study with sample sizes, expert qualifications, or adjudication methods.

The 510(k) summary states generalized information such as "The performance data reported in this 510(k) demonstrate that the proposed device modifications do not raise different questions of safety and effectiveness than those for the predicate device is as safe and effective as the predicate device." but lacks the detailed information requested in the prompt.

Therefore, I cannot provide the requested information from the given text. The text does not detail:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The CeQur Simplicity™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.

The CeQur Simplicity™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyroqenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 4 days (96 hours) using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Insed to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The Cequr Simplicity™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.

The provided document does not contain specific acceptance criteria or details of a study proving the device meets said criteria.

Instead, it describes the CeQur Simplicity™ On-Demand Insulin Delivery System and its substantial equivalence determination by the FDA based on modifications to labeling allowing for extended wear time (up to 4 days/96 hours, compared to 3 days/72 hours for the predicate device).

Here's a breakdown of the information that is and is not present, with regards to your request:

1. A table of acceptance criteria and the reported device performance:
* Not provided. The document states that "Verfication and validation data reported in this 510(k), including those assessing biocompatibility, and human factors, demonstrate that the proposed change in labeling does not raise different questions of safety and effectiveness than those for the predicate device, and that the subject device is as safe and effective as the predicate device." However, it does not specify what those acceptance criteria were or what performance metrics were achieved.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not provided. The document mentions "Verfication and validation data" but does not detail the sample sizes, data provenance, or whether the studies were retrospective or prospective.

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/Not provided. This device is an insulin delivery system, not an AI or diagnostic imaging device that typically requires expert-established ground truth for a test set in the way you describe. The "ground truth" for its performance would likely relate to objective measurements of insulin delivery accuracy, biocompatibility, and user-factor performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not provided. As with point 3, adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective expert review (e.g., radiology image interpretation) to establish a consensus ground truth. This is not directly relevant to the testing of an insulin delivery device's technical specifications or user experience.

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. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic systems where human readers interpret cases. This device is an insulin delivery system, not an AI diagnostic tool, so such a study would not be performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is a manual, user-filled, positive volume displacement bolus dosing pump, not an algorithm. Therefore, "standalone" algorithm performance testing is not relevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* Not explicitly stated in detail. For a medical device like this, the "ground truth" for performance would generally involve:
* Objective measurements: E.g., insulin delivery accuracy (volume delivered vs. intended), flow rates, mechanical integrity, battery life (if applicable).
* Biocompatibility testing: In vitro and in vivo tests to ensure the materials are safe for contact with the body.
* Human factors validation: User studies to ensure safe and effective operation by typical users.
* The document generally refers to "biocompatibility, and human factors" data.

8. The sample size for the training set:
* Not applicable/Not provided. This device is an electro-mechanical system, not an AI/machine learning model that undergoes "training."

9. How the ground truth for the training set was established:
* Not applicable. As above, there is no "training set" for this type of device.

In summary: The provided FDA 510(k) clearance letter and summary are focused on establishing substantial equivalence to existing predicate devices for an insulin delivery system, primarily based on a labeling change (extended wear time). It asserts that "Verfication and validation data" were submitted for biocompatibility and human factors, demonstrating that the change does not raise new safety or effectiveness concerns, but it does not provide the specific details of these studies, including acceptance criteria, sample sizes, or performance metrics.

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The One Touch Via™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.

The OneTouch Via™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyrogenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch," "the Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 72 hours using a biocompatible adhesive.

The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the patient during the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The OneTouch Via™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.

The provided text describes a 510(k) summary for the One Touch Via™ On-Demand Insulin Delivery System (K163357). This document focuses on demonstrating substantial equivalence to a predicate device (FINESSE™ Personal Insulin Delivery System, K111924) rather than presenting a study to prove acceptance criteria for a novel device's performance characteristics.

Therefore, the information requested can only be partially addressed based on the provided text. The document states that the new device has "minor modifications in component design for improved manufacturability associated with the relocation and increased automation of the manufacturing" and "minor changes to labeling content and format". It explicitly states that "The System technological characteristics, performance characteristics, and the user interface remain unchanged" and "No clinical performance data is required to validate the intended uses and user needs of the system."

Given these statements, the "acceptance criteria" discussed are primarily related to ensuring the modified device performs comparably to the predicate device and meets established safety and performance standards for infusion pumps.

Here's a breakdown of the available information based on your request:

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

The document does not provide a specific table of acceptance criteria with numerical targets and corresponding performance results for the device itself in a typical "device meets acceptance criteria" format. Instead, it states that "Design verification studies per test methods and acceptance criteria previously established for the predicate device were conducted on finished devices which were representative of commercial device have demonstrated the function, wear and mechanical reliability of the device for the intended period of time."

It also states: "Performance bench testing demonstrated that the subject device met all the existing device specifications, thereby demonstrating that the device is as safe, as effective, and performs as well as the predicate device (K111924)."

This implies that the acceptance criteria are the "existing device specifications" (presumably inherited from the predicate device) and the "test methods" used to verify them. However, these specific criteria and the detailed performance against them are not provided in this summary.

The document lists categories of testing performed:

• Insulin compatibility and stability studies
• Biocompatibility testing (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Subacute/Subchronic Toxicity, Genotoxicity, Implantation, Material Mediated Pyrogen, Hemolysis)
• Design verification studies for function, wear, and mechanical reliability (including dimensional inspection, IDD performance testing at nominal and extreme environmental conditions, alarm function, leak testing, cannula function, needle function, chemical compatibility, packaging testing, fluid ingress, and adhesive performance)
• Design verification studies for Inserter and Fill Syringe accessories (including chemical exposure, cleanability, and functional testing)
• Human factors studies (labeling comprehension and usability)

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

The document does not specify sample sizes for the "test set" (i.e., the samples used for the non-clinical performance data). It only mentions that "finished devices which were representative of commercial device" were used.

The data provenance (country of origin, retrospective/prospective) is not mentioned.

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)

This is not applicable as the study described is non-clinical performance testing (bench testing, biocompatibility, human factors) and does not involve "ground truth" derived from expert review in the context of clinical observations or diagnostics. Human factors studies are mentioned, which would involve users, but details on "experts" for ground truth are not provided.

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

This is not applicable as the study described is non-clinical performance testing.

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 is not applicable. The device is an insulin delivery system, not an AI-assisted diagnostic or imaging device. The document explicitly states: "No clinical performance data is required to validate the intended uses and user needs of the system."

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

This is not applicable. The device is a mechanical insulin delivery system, not an algorithm. It is a "manual, user filled, positive volume displacement, bolus dosing pump" and "insulin delivery requires competent human interaction to actuate the buttons to deliver insulin."

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

This is not applicable for this type of non-clinical device testing. The "ground truth" for non-clinical performance testing would be established engineering specifications, physical/chemical standards, and recognized biological response criteria (e.g., for biocompatibility).

8. The sample size for the training set

This is not applicable. There is no mention of a "training set" for an algorithm, as the device is a mechanical insulin delivery system.

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

This is not applicable as there is no "training set."

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence of a modified medical device (an insulin delivery system) to an existing predicate device. It relies heavily on non-clinical performance data (bench testing, biocompatibility, human factors) to show that the modifications do not negatively impact safety or effectiveness. The specific numerical acceptance criteria and detailed performance results are not included, nor are clinical trial details or AI-related study design elements.

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The Finesse Insulin Delivery System is indicated for the subcutaneous, bolus delivery of physician prescribed insulins, in adult persons requiring such medications for the management of diabetes mellitus.

The Finesse Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.

The Finesse Insulin Delivery System (IDS) is comprised of a sterile. nonpyrogenic, single-use, external, disposable, ambulatory, liquid medication, bolus dosing device (IDD); a single use, non-pyrogenic, sterile. syringe and needle (Fill Syringe); a reusable Inserter; and a Dose Count Card. The device is intended for subcutaneous delivery of clinicianprescribed medications, and is adhered to the skin for up to 72 hours with a biocompatible adhesive.

The Insulin Delivery Device (IDD) is a manual, user filled, positive displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissues. The syringe and needle are for patient filling of the IDD with liquid medication prior to deployment on the body, and have a maximum capacity of 2ml. The Dose Count Card is utilized by the patient during the dosing session and provides for a written record of date, time and amount of Insulin delivery.

The Finesse IDS materials are biocompatible plastics, elastomers, and stainless steel.

The provided text is a 510(k) summary for the Finesse Personal Insulin Delivery Patch. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not include a table of acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets specific acceptance criteria in the way typically found for AI/ML devices.

Instead, this submission primarily focuses on establishing "substantial equivalence" to previously cleared devices (K093065 and K100947) based on technological characteristics and intended use. The performance data mentioned are non-clinical and primarily relate to device reliability, usability, and biocompatibility, rather than clinical efficacy metrics or comparisons with human experts.

Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them (especially in the context of AI/ML performance) cannot be extracted from this document.

Here's what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The submission states, "No clinical performance data is required to validate the intended uses and user needs of the system. Design validation is completed by human factors simulated use and clinical evaluation testing."
The device relies on demonstrating "substantial equivalence" in its intended use, performance, safety, and effectiveness to its predicate devices.

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

• Test Set Sample Size: Not explicitly stated for any performance claims in the context of a "test set" for an algorithm. The document mentions "human factors and clinical evaluation studies" but does not give sample sizes.
• Data Provenance: Not specified.

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

Not applicable. This device is a manual insulin delivery system, not an AI/ML diagnostic tool that requires expert-established ground truth for its performance evaluation in the way a diagnostic algorithm would.

4. Adjudication method 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 device is not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This is a hardware device for drug delivery, not an algorithm. Its performance is inherent to its mechanical function.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" would be the engineering specifications, biocompatibility standards, and functional requirements for a mechanical insulin delivery system. For example:

• Compatibility and stability studies for insulin: Demonstrating chemical, physical, and microbiological stability within the device.
• Design verification studies: Demonstrating wear and mechanical reliability.
• Human factors and clinical evaluation studies: Demonstrating device performance and usability. (Details on how "performance and usability" were measured or what their "ground truth" criteria were are not provided).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of what is present:

• Non-Clinical Performance Data (Section 10):

  • "Compatibility and stability studies have been completed that demonstrate the chemical, physical, microbiological stability and biocompatibility of insulin in the Finesse Insulin Delivery device for the period of time specified in the labeling."
  • "Design verification studies have been completed that demonstrate the wear and mechanical reliability of the device for the intended period of time."
  • "Design verification studies have been completed that demonstrate the usability and reliability of the Inserter accessory."
  • "Human factors and clinical evaluation studies have been completed that demonstrate device performance and usability."

• Clinical Performance Data (Section 11):

  • "No clinical performance data is required to validate the intended uses and user needs of the system. Design validation is completed by human factors simulated use and clinical evaluation testing."

The basis of this 510(k) clearance is substantial equivalence to predicate devices K093065 and K100947, and the non-clinical studies confirm the device's functional integrity and safety. It explicitly states that clinical performance data was not required for this 510(k) submission, meaning the acceptance criteria were met through non-clinical testing and demonstration of equivalence.

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The Finesse Insulin Delivery System is intended for the subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin.

The Finesse Insulin Delivery System is a sterile, nonpyrogenic, single-use, external, disposable, ambulatory, insulin, bolus dosing system through which clinician-prescribed medications are delivered subcutaneously. The Finesse Insulin Delivery System is composed of a positive volume displacement drug delivery device with infusion cannula and integrated Inserter, and a drug delivery device filler. The device is adhered to the skin with a biocompatible adhesive.

The Finesse Insulin Delivery System has an integrated cannula and Inserter. The infusion cannula Inserter is used to place the cannula in the subcutaneous tissues. It contains an insertion needle located in the lumen of the infusion catheter cannula. A safety mechanism prevents premature actuation of the insertion needle mechanism to prevent injuries. Following cannula placement, the needle is retracted within the body of the Inserter to prevent sharps exposure. Once the needle is retracted, the Inserter automatically releases the Inserter from the drug delivery component.

The Finesse Insulin Delivery System materials are biocompatible plastics, elastomers, and stainless steel.

The provided text does not contain information about acceptance criteria or specific studies that prove the device meets these criteria in the typical format of a clinical or performance study. Instead, it describes general design verification and user studies without specific metrics or methodologies.

Here's a breakdown of the available information based on your requested points:

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

The document mentions "Design verification studies have been completed that demonstrate the wear and mechanical reliability of the device for the period of time specified in the device labeling" and "User studies have completed that demonstrate the readability and user comprehension of the labeling."

However, specific acceptance criteria (e.g., "device must deliver X +/- Y% of intended insulin dose") and quantitative performance results are NOT provided in this 510(k) summary.

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

This information is NOT provided in the document.

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)

This information is NOT provided in the document. The studies mentioned are general "design verification" and "user studies," which typically don't involve expert establishment of ground truth in the same way a diagnostic device might.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is NOT applicable as the device is an insulin delivery system, not an AI-powered diagnostic device that involves human "readers."

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

This information is NOT applicable as the device is an insulin delivery system, not an algorithm.

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

This information is NOT provided in the document. The general nature of the studies ("compatibility and stability," "wear and mechanical reliability," "user comprehension") suggests that ground truth would be established through direct measurements, chemical analysis, mechanical testing, and user feedback, rather than expert consensus on diagnostic interpretations.

8. The sample size for the training set

This information is NOT provided in the document. The device is a mechanical/electronic system, not a machine learning algorithm that typically requires a "training set."

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

This information is NOT applicable as the device is a medical device, not a machine learning algorithm.

Summary of what is available:

The 510(k) Summary for the Finesse Personal Insulin Delivery Patch (K100947) states that:

• Compatibility and stability studies were performed to demonstrate chemical, physical, microbiological stability, and biocompatibility of insulin in the device for the specified period.
• Design verification studies were completed to demonstrate the wear and mechanical reliability of the device for the specified period.
• User studies were completed to demonstrate the readability and user comprehension of the labeling.

The document indicates that these studies (without providing details like sample sizes, specific metrics, or methodologies) were sufficient for FDA to determine substantial equivalence based on the modified labeling for extended usage duration. The primary change from the predicate device (K093065) was this extended usage period (from an unspecified duration to 48-72 hours, consistent with insulin manufacturer labeling).

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The Finesse Insulin Delivery System is intended for the subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin.

The Finesse Insulin Delivery System is a sterile, nonpyrogenic, single-use, external, disposable, ambulatory, insulin, bolus dosing system through which clinician-prescribed medications are delivered subcutaneously. The Finesse Insulin Delivery System is composed of a positive volume displacement drug delivery device with infusion cannula and integrated Inserter, and drug delivery device filler. The device is adhered to the skin for up to 48 hours with a biocompatible adhesive. The Finesse Insulin Delivery System has an integrated cannula and Inserter. The infusion cannula Inserter is used to place the cannula in the subcutaneous tissues. It contains an insertion needle located in the lumen of the infusion catheter cannula. A safety mechanism prevents premature actuation of the insertion needle mechanism to prevent injuries. Following cannula placement, the needle is retracted within the body of the Inserter to prevent sharps exposure. Once the needle is retracted, the Inserter automatically releases the Inserter from the drug delivery component. The Finesse Insulin Delivery System materials are biocompatible plastics, elastomers, and stainless steel.

The provided text describes a 510(k) summary for the Finesse Personal Insulin Delivery Patch. It outlines the device description, intended use, technological characteristics, and non-clinical performance data. However, it explicitly states:

"No clinical performance data is required to validate the intended uses and user needs of the system. Design validation is completed by human factors simulated use testing."

This means that the document does not contain acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, accuracy, etc.) for the device itself or any study that proves the device meets such criteria through clinical trials. Instead, reliance is placed on conformance to consensus standards, FDA guidance, and human factors simulated use testing for design validation.

Therefore, many of the requested items in your prompt, particularly those related to clinical performance, a test set, ground truth, experts, and comparative effectiveness studies, cannot be extracted from this document.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the explicit statement that no clinical performance data is required and that design validation is completed by human factors simulated use testing, the acceptance criteria are primarily defined by adherence to a list of consensus standards and FDA guidance. The document does not provide specific quantitative performance metrics beyond this.

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

Not applicable, as no clinical performance test set data is presented. The design validation was conducted through "human factors simulated use testing," but details on sample size, data provenance, or specific test outcomes are not provided.

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

Not applicable, as no clinical performance test set data requiring expert ground truth is presented.

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

Not applicable, as no clinical performance test set data requiring adjudication is presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an insulin delivery system, not an AI-powered diagnostic or assistive tool, and the document explicitly states no clinical performance data was required, let alone an MRMC study with AI.

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

Not applicable. This device is not an algorithm, but a physical medical device requiring human interaction.

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

Not applicable for clinical performance data. The "ground truth" for the device's substantial equivalence and safety/effectiveness is based on its conformance to established consensus standards and FDA guidance, as well as the outcome of human factors simulated use testing.

8. The sample size for the training set

Not applicable, as this is a physical medical device and not an AI algorithm that undergoes training on a data set.

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

Not applicable, as this is a physical medical device and not an AI algorithm.

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