Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device