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The twiist system is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, ages 6 and above. The 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 twiist system is intended for single patient, home use and requires a prescription.

The bolus calculator is indicated for use for aiding the user in determining the bolus insulin dosage for management of diabetes mellitus based on consumed carbohydrates, operator entered blood glucose, insulin sensitivity, insulin to carbohydrate ratio, target glucose values, and current insulin on board.

The twiist system described herein contains a modification of the labeling of the previously cleared DEKA ACE Pump System (K233952) to add the ConvaTec contact™ detach 23" subcutaneous infusion set and the ConvaTec inset™ 23" and 32" subcutaneous infusions sets as compatible for use with the twiist system.

The twiist system is a wearable alternate controller enabled (ACE) insulin infusion pump intended to subcutaneously deliver insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices to receive, confirm, and execute commands. The pump is intended for single patient, ambulatory use and requires a prescription. The twiist system is intended for the management of diabetes mellitus in persons six years of age and greater.

The twiist system, consistent with the predicate K233952, consists of the following durable and disposable components:

1. Pump: A durable pump that incorporates fluid delivery algorithms and interfaces to a cassette, external wireless user interface, and iCGM. The pump is powered by a rechargeable lithium ion battery.
2. Cassette: A single-use pumping cassette that combines microfluidic valves, a pump chamber, insulin reservoir, and Acoustic Volume Sensing (AVS) measurement chamber. The cassette interfaces to a pump and off-the-shelf infusion sets.
3. Sequel twiist App: An iOS mobile application that serves as the primary user interface for the system. The twiist app can be downloaded onto the user's personal iPhone.

The provided FDA Clearance Letter, specifically the 510(k) Summary, details the technical characteristics and testing for the "twiist system" and its substantial equivalence to the "DEKA ACE Pump System" (K233952).

This submission (K250930) is a Special 510(k), meaning it focuses on a modification rather than a completely new device. The primary modification here is the addition of compatibility with new infusion sets (ConvaTec contact™ detach 23" and ConvaTec inset™ 23" and 32") to an already cleared device. This type of submission relies heavily on demonstrating that the performance with the new components is equivalent to the established performance of the predicate device under the original clearance.

Therefore, the study described here is primarily focused on bench testing to demonstrate compatibility and similar performance with the new infusion sets, using established methodologies and acceptance criteria from the previous clearance (K233952).

Here's the breakdown of the acceptance criteria and the study as described in the provided document:

Acceptance Criteria and Device Performance for the twiist system (K250930)

This 510(k) submission for the twiist system (K250930) is a Special 510(k), specifically addressing the addition of new compatible infusion sets. As such, the acceptance criteria and reported performance for key functional aspects of the pump itself (e.g., basal and bolus accuracy, occlusion detection) are identical to those established and validated for the predicate device, DEKA ACE Pump System (K233952). The study conducted for K250930 primarily focused on demonstrating that these established performance characteristics are maintained when using the newly added infusion sets.

1. Table of Acceptance Criteria and Reported Device Performance

Since the core pump performance characteristics are "Unchanged from K233952" and "Same" as the predicate device, the acceptance criteria and reported performance values listed in the "Technological Characteristic Comparison" table reflect the established performance of the twiist system (and its predicate) for various parameters. The specific study for K250930 demonstrated that the device continues to meet these previously set criteria with the new infusion sets.

The supporting language states: "Performance testing with the added ConvaTec infusion sets demonstrates that subject device performance is equivalent to the predicate device. The methods and acceptance criteria used in this testing are well established in the previous clearance (K233952)."

Study Details for K250930

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

The document states: "Bench performance testing was conducted to qualify the additional infusion sets for use with the subject device, and to establish substantial equivalence to the predicate device in terms of safety and effectiveness."

• Test Set Sample Size: The exact sample size (number of devices, number of tests run per device/infusion set combination) for the bench testing is not specified in this 510(k) summary. However, it's implied that sufficient testing was performed to "demonstrate" performance equivalence.
• Data Provenance: The data is from bench testing, which typically occurs in a controlled laboratory environment. The country of origin of the data is not explicitly stated, but given DEKA Research & Development Corp. is based in Manchester, New Hampshire, USA, it's highly probable the testing was conducted in the USA. The data is prospective in the sense that it was generated specifically for this 510(k) submission to qualify the new infusion sets.

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

This question is not applicable to this type of device and study. The ground truth for infusion pumps involves precise physical measurements of fluid delivery, rather than subjective expert interpretations (like in radiology). The "ground truth" for the test set is established by calibrated laboratory equipment and measurement techniques compliant with relevant standards (e.g., ISO 13485:2016).

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where subjective human interpretation (e.g., image reading) requires consensus building. For bench testing of an infusion pump, the measurements are objective.

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 question is not applicable. MRMC studies are specific to diagnostic devices (often AI-powered) that assist human interpretation of medical images or data. The twiist system is an insulin infusion pump, a therapeutic device, not a diagnostic one.

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

Yes, in a sense. The "pump" itself (the microprocessor-controlled mechanism with AVS feedback) delivers insulin "standalone" based on its algorithms. The bench testing performed to verify its accuracy and safety with the new infusion sets is a form of standalone performance evaluation in a controlled environment, demonstrating the device's inherent functional capabilities without human intervention during the actual delivery process.

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

The ground truth used for this device's performance testing (and for the predicate) is objective physical measurement based on highly accurate and calibrated laboratory equipment designed for fluid delivery assessment. This would involve measuring the actual volume of insulin delivered, flow rates, pressure changes, and time to alarm, compared to the programmed parameters.

8. The sample size for the training set

This question is not applicable. Infusion pumps like the twiist system are engineered medical devices that operate based on deterministic algorithms and physical principles, not machine learning or AI models that require "training sets" in the typical sense.

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

This question is not applicable for the same reason as #8. The device's "behavior" is designed and verified rather than "learned" from a training set.

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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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