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The Remunity® 2.0 Pump for Remodulin® (treprostinil) Injection (the Remunity 2.0 System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in patients, ages 17 and older.

The Remunity 2.0 System is a wearable infusion pump designed to deliver Remodulin® (treprostinil) subcutaneously for the treatment of pulmonary arterial hypertension (PAH). Remodulin® was FDA-approved under NDA 021272. The system consists of several components: a wearable pump assembly, a remote interface, and accessories (e.g., rechargeable batteries, battery charger, charging cable, power adapter). A commercially available subcutaneous infusion set is connected to the pump assembly via a standard luer connector for the delivery of Remodulin® from the system to the patient. The Remunity 2.0 System is prescription use only.

The pump assembly is composed of a durable pump and a disposable, single-use cassette with a user-filled drug reservoir. The pump infuses Remodulin® subcutaneously into the patient based on an individualized programmed rate. Each disposable cassette may be used for up to 72 hours after attachment to the pump. The subject system utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.

The provided text describes the Remunity 2.0 Pump for Remodulin® (treprostinil) Injection, an infusion pump, and its substantial equivalence to a predicate device. However, it does not contain information about the acceptance criteria and study that proves a device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for an infusion pump, which is a hardware device for drug delivery. The "Performance Data" section lists various functional areas evaluated for device performance (e.g., delivery accuracy, occlusion performance, durability) but does not provide specific acceptance criteria values or detailed results for these evaluations. It also mentions software, cybersecurity, human factors, electrical safety, EMC, and alarms as evaluated areas, but again, without specific acceptance criteria or study outcomes.

Therefore, I cannot populate the requested table and answer questions 2 through 9 based on the provided text. The information requested (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set size and ground truth establishment) is typically associated with studies for AI/ML-driven diagnostic or prognostic devices, which is not the type of device described here.

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The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician.

The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products.

The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.

The subject device is a modified version of the predicate DEKA Infusion System. Updates have been made to the predicate device software to increase the maximum programmable flow rate (from 300 to 600 mL/h), update the labeling to reflect the increased maximum programmable flow rate and update the performance of tilt angle detection. The administration set is unchanged.

The DEKA Infusion System, comprised of the DEKA Infusion Controller and DEKA Administration Set, is a gravity-based infusion controller. The Infusion Controller uses a camera to view drop formation in an Administration Set Drip Chamber in order to measure flow rate. During an infusion, the Infusion Controller can adjust the Flow Control Valve (FCV) as necessary against the DEKA Administration Set to maintain the desired flow rate without user intervention.

The DEKA Administration Set is a single-use, non-DEHP intravascular administration set provided sterile. It is compatible with the DEKA Infusion Controller or can be used as a standalone administration set for performing manual gravity infusions.

The provided text is a 510(k) summary for the DEKA Infusion System and DEKA Administration Set. It primarily focuses on demonstrating substantial equivalence to a predicate device after a modification, specifically an increased maximum programmable flow rate and an update to tilt angle detection.

However, the document does not contain the detailed information required to answer your specific questions about acceptance criteria, the study proving the device meets the criteria, sample sizes, expert involvement, ground truth, or MRMC studies for an AI/ML-based device.

This document is for a mechanical/electrical infusion system that uses a camera for drop formation detection and flow rate measurement, not an AI/ML diagnostic or prognostic device that would involve a training set, test set, expert adjudication, or MRMC studies in the way your questions imply. The "Vision System Performance" mentioned is likely related to the camera's ability to accurately detect drops, not a complex AI model requiring extensive human-in-the-loop validation or ground truth established by multiple medical experts interpreting images.

Therefore, I cannot extract the requested information from this document. The questions you've asked are typical for the validation of Artificial Intelligence/Machine Learning (AI/ML) medical devices, particularly those involving image interpretation or complex diagnostic algorithms. This 510(k) summary does not describe such a device or its corresponding validation studies.

The closest aspects discussed are:

• Acceptance Criteria for Flow Rate Accuracy: Mentioned as "± 10% nominally" and "± 25% under environmental limits of normal use." The document states "All tests met acceptance criteria."
• Study Proving Device Meets Criteria: "Formal performance testing was conducted on all areas of the subject device that are impacted by its changes with respect to the predicate device."
• Performance Data: "Flow Rate Accuracy," "Vision System Performance," "Stopping Flow," and "Device Handling Alarms" were tested.

But none of these provide the level of detail (sample size, expert ground truth, adjudication, MRMC) specific to AI/ML device validation that your questions are designed to elicit.

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