Search Results

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.

Study Details that Prove the Device Meets Acceptance Criteria

1. Sample Size Used for the Test Set and Data Provenance:

   • Basal Delivery Accuracy: 89 embecta patch pumps were tested. 44 of these were subjected to accelerated aging (simulated 6-month shelf life), and all 89 were pre-conditioned for simulated shipping and handling.
   • Bolus Delivery Accuracy: 30 patch pumps were tested for each bolus size (0.05 U, 6.00 U, 30.00 U). A total of 90 pumps (30 for each bolus size) were pre-conditioned for simulated shipping and handling, and 45 of these were treated by accelerated aging (simulated 6-month shelf life).
     • Min Bolus Delivery (0.05 U): 15,000 boluses measured.
     • Intermediate Bolus Delivery (6.00 U): 750 boluses measured.
     • Max Bolus Delivery (30.00 U): 300 boluses measured.
   • Occlusion Detection: 160 pumps were tested. All 160 were pre-conditioned for simulated shipping and handling, and 80 of these were treated by accelerated aging (simulated 6-month shelf life).
   • Data Provenance: The document does not specify the country of origin of the data. The studies described are non-clinical performance tests (bench testing), designed to verify the physical and functional aspects of the device in a controlled laboratory environment. They are not human subject studies (neither retrospective nor prospective in the typical clinical trial sense).

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable. The ground truth for this medical device (an insulin pump) is established through precise physical measurements of insulin delivery and occlusion detection in a lab setting, using calibrated equipment. This is a technical performance verification, not an AI/ML diagnostic or image interpretation task requiring human expert adjudication.

3. Adjudication Method for the Test Set:

   • Not applicable, as the performance is based on direct physical measurements against engineering specifications, not observational data requiring human adjudication.

4. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

   • No, a MRMC comparative effectiveness study was not done. The device is an insulin delivery system, not an AI/ML-driven diagnostic tool that assists human readers.

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

   • Yes, in a sense, the performance tests described are "standalone" in that they evaluate the device's mechanical and software performance directly (e.g., its ability to deliver insulin accurately and detect occlusions) without a human user actively influencing the measurement outcome, beyond initiating the tests. These are bench performance tests of the device itself.

6. The Type of Ground Truth Used:

   • The ground truth is established through physical measurement and engineering specifications. For example, the "target bolus" or "requested units" for insulin delivery is the ground truth against which the actual delivered amount is measured. Similarly, the presence of an occlusion is the ground truth for occlusion detection tests. This is a technical/physical ground truth, not expert consensus, pathology, or outcomes data in a diagnostic context.

7. The Sample Size for the Training Set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set of data in the common sense. It's an electromechanical device with embedded software. Its "performance" is verified through engineering tests against predefined specifications.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no mention of an AI/ML training set as part of this submission. The device's functionality is based on its physical design and embedded deterministic software, which is verified through testing, not trained on data.

Ask a specific question about this device