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The CURLIN® 8000 ambulatory infusion pump system is indicated for use in home care and clinical settings for the controlled administration of prescribed medical fluids through clinically accepted routes of administration: intravenous, intra-arterial, subcutaneous, epidural, and perineural, to adult and pediatric patients. The pump is intended to deliver a variety of therapies (drugs and fluids) which have been approved for these routes of administration. Examples of the therapies, which may be delivered using the CURLIN® 8000 pump, include hydration, parenteral nutrition, anti-infectives, pain management, inotropes, chemotherapy, immune globulin, and biologics. The CURLIN 8000 is not indicated for the delivery of cellular blood products.

RxManager Enterprise Solution Software allows the user to create and manage pump configurations and therapy-based protocols to be used with the CURLIN 8000 Ambulatory Infusion Pump.

CURLIN Administration Sets are intended to be used with CURLIN infusion pumps to deliver medication from a container to a patient.

The Curlin 8000 Ambulatory Infusion Pump is a small, compact and light weight infusion delivery device that utilizes a curvilinear peristaltic pumping mechanism to allow the pump to be more compact. The user activates the Curlin 8000 pump via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory.

The Curlin 8000 pump consists of components such as the user interface, sensors, communication ports, power ports, structural (housing) components, electronics, pumping mechanism, watchdog timer, pump battery and circuitry, real time clock, on-board memory, and pump log. Exterior surface components include the pump housing, platen (door assembly), LCD lens, keypad, and labels. Materials used for the construction of these components are widely used within the medical industry.

The Curlin 8000 pump is designed to deliver measured drug therapy to patients in homecare, infusion suites, oncology and other alternate site locations as appropriate. The pump also has applicability in the acute care market specifically in small hospitals (300 beds or less), Labor and Delivery Units, and other areas of the hospital where pain management is required.

The Curlin 8000 pump is designed to be used with Curlin 380-series administration sets, which provide a sterile pathway for the delivery of the infusate fluid from the infusion container (e.g., IV reservoir bag) to the distal connection, which connects to the patient's catheter / delivery site.

The Rx Manager Enterprise Solution (ES) pharmacy application, which consists of the Rx Manager, Admin Manager and Service Manager, incorporates a Dose Error Reduction System (DERS) software and intuitive workflows to support error prevention. The ES software subsystems are used by Pharmacy Staff, Biomed Staff, IT Staff and Moog Field Service Staff to achieve their specific needs. ES is architected to be scalable, i.e. it can be installed on one to many desktops in a campus-based server network. The applications utilize a common database manager software library along with secure connectivity to the database.

The provided text describes a 510(k) submission for the Curlin 8000 Ambulatory Infusion System, specifically focusing on the addition of a pediatric population to its intended use. The core of the study revolves around evaluating the levels of Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals after sterilization, to ensure they are safe for pediatric patients.

1. Table of Acceptance Criteria and Reported Device Performance:

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The CURLIN® 8000 ambulatory infusion pump system is indicated for use in home care and clinical settings for the controlled administration of prescribed medical fluids through clinically accepted routes of administration: intravenous, intra-arterial, subcutaneous, epidural, and perineural, to adult patients. The CURLIN® 8000 is not intended for use on pediatric patients. The pump is intended to deliver a variety of therapies (drugs and fluids) which have been approved for these routes of administration. Examples of the therapies, which may be delivered using the CURLIN® 8000 pump, include hydration, parenteral nutrition, anti-infectives, pain management, inotropes, chemotherapy, immune globulin, and biologics. The CURLIN 8000 is not indicated for the delivery of cellular blood products.

RxManager Enterprise Solution Software allows the user to create and manage pump configurations and therapy-based protocols to be used with the Curlin 8000 Ambulatory Infusion Pump.

Curlin Administration Sets are intended to be used with Curlin infusion pumps to deliver medication from a container to a patient.

The CURLIN® 8000 Ambulatory Infusion Pump is a small, compact and light weight infusion delivery device that utilizes a curvilinear peristaltic pumping mechanism similar is design to the CADD®-Solis VIP Model 2120 but curvilinear to allow the pump to be more compact. The user activates the CURLIN® 8000 pump via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory.

The CURLIN® 8000 pump consists of components such as the user interface, sensors, communication ports, power ports, structural (housing) components, electronics, pumping mechanism, watchdog timer, pump battery and circuitry, real time clock, on-board memory, and pump log. Exterior surface components include the pump housing, platen (door assembly), LCD lens, keypad, and labels. Materials used for the construction of these components are widely used within the medical industry.

The CURLIN® 8000 pump is designed to deliver measured drug therapy to patients in homecare, infusion suites, oncology and other alternate site locations as appropriate. The pump also has applicability in the acute care market specifically in small hospitals (300 beds or less), Labor and Delivery Units, and other areas of the hospital where pain management is required.

The CURLIN® 8000 pump is designed to be used with CURLIN® 380-series administration sets, which provide a sterile pathway for the delivery of the infusate fluid from the infusion container (e.g., IV reservoir bag) to the distal connection, which connects to the patient's catheter / delivery site.

The Rx Manager Enterprise Solution (ES) pharmacy application, which consists of the Rx Manager, Admin Manager and Service Manager, incorporates a Dose Error Reduction System (DERS) software and intuitive workflows to support error prevention. The ES software subsystems are used by Pharmacy Staff, Biomed Staff, IT Staff and Moog Field Service Staff to achieve their specific needs. ES is architected to be scalable, i.e. it can run on a single desktop, many desktops in a campus-based server network, and can be advanced to multiple server-based topology. The applications utilize a common database manager software library along with secure connectivity to the database.

The associated accessories include:

• Lockbox capable of mounting to a bar and accepting 500 mL bags and sets
• Pole clamp that is tilt adjustable and is capable of mounting both horizontally and vertically to a bar and still allows the pump to be viewed in a vertical orientation
• PCA Bolus Cable with 2-meter cable with Micro-B USB Plug
• USB Data Cable with 2-meter cable with Micro-B USB Plug at one end and USB Type A pluq at the other end
• Power AC Adapter cord with input voltage of 100 Vac to 240 Vac and Input line frequency range of 50 Hz to 60 Hz. Rated output voltage of 5.00 Vdc and rated output current of at least 3.0 A
• Rechargeable Battery with 2 Lithium-Ion cells in a 1s2p configuration (2 cells in parallel) and rated for at least 23.4 Watt-Hours (3.6 Volts at 6.5 Amp-Hours)
• Battery Charger that charges up to 4 battery packs simultaneously

The provided document is a 510(k) Premarket Notification from the FDA for the Curlin 8000 Ambulatory Infusion System, RxManager Enterprise Solution Software, and Curlin 380-series Administration Sets. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in a quantitative sense with reported performance metrics.

The document describes various performance tests and evaluations conducted, but it doesn't provide a table of acceptance criteria with corresponding reported device performance metrics in the format typically used for studies demonstrating diagnostic or predictive accuracy (e.g., sensitivity, specificity, AUC). Instead, the performance data section generally states that the device was verified and validated through testing and compliance with various standards.

However, I can extract information related to the performance studies and what was evaluated.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly provide a table of quantitative acceptance criteria alongside precise numerical reported device performance in the context of diagnostic accuracy, sensitivity, or specificity commonly found in AI/CADe study reports. Instead, it lists the types of performance testing and compliance with standards.

For example, under "Device Performance", it states:

• "Performance testing of essential performance attributes to duration of therapy: Head height, Viscosity, Back-pressure"
• "Reliability testing"
• "Flow rate accuracy testing across all operating conditions"
• "Alarm detection: Battery, Air in Line, Up and Down Stream Occlusion, Hardware and Software failures, Pump Unattended, Infusion Complete Alarms comply with IEC 60601-1-8"
• "Ambulatory, Transportation, Environmental Conditions: Operating Temperature, Operating Altitude"

And in the "Substantial Equivalence Discussion Summary", there's a comparison table that includes some numerical specifications for the subject device and the predicate. While these are specifications, they implicitly act as "acceptance criteria" for the device's technical characteristics, and the "Comparison" column indicates whether these criteria were met (similar, same, or tighter specification).

Extracted from the "Substantial Equivalence Discussion Summary" comparison table:

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The devices in this product family are used to dispense liquid nutrients (feeding solution) at a preprogrammed pump or user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a prefilled container.

These enteral feeding sets are designed to be used with or without an enteral feeding pump, (pump is not in scope for this 510k) model specific. Refer to diagrams below for explanation of components. The enteral sets terminate in a bonded conical connector, the ENFit connector; that is designed to be incompatible with ISO 594-1/2 and other non-enteral feeding connections. The ENFit connector is a new connector and it is anticipated that not all patient feeding tubes will be compatible with it, so the administration sets include an adapter that connects to the ENFit connector on one end while providing the traditional "Christmas Tree" shaped transitional stepped connector on the other.

This document appears to be a 510(k) summary for an enteral feeding set, which is a medical device. Based on the provided text, the device is not an AI/ML device. Therefore, the specific criteria for AI/ML device studies (such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable or detailed in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions. This is achieved through non-clinical performance data.

Here's an analysis of the acceptance criteria and supporting study information, focusing on the available details from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests performed to support substantial equivalence. While specific quantitative acceptance criteria are not explicitly stated in a table format in the provided text, the performance is reported as "Passed" or "Acceptable" for each test.

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

Not applicable for an AI/ML device. For this physical medical device, specific sample sizes for tests like bond strength or leak testing are not provided in the summary. The provenance would be the manufacturing facility where the tests were performed.

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

Not applicable. This is a physical device, and its performance is evaluated against engineering specifications and industry standards, not through expert-labeled ground truth in the context of an AI/ML model.

4. Adjudication method for the test set

Not applicable. This is a physical device.

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

No. This is not an AI/ML device.

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

No. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device is defined by:

• Engineering specifications: The device's design inputs and required performance characteristics.
• Industry standards: Notably ISO 80369-3 for small-bore connectors.
• Predicate device performance: The new device is compared to a legally marketed predicate device (K012147) to demonstrate similar safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary for the provided document:

The document describes an enteral feeding set, which is a physical medical device, not an AI/ML device. Therefore, most of the requested information pertaining to AI/ML device studies (such as test/training set sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not relevant or available in this submission.

The device's conformity is established through non-clinical performance data, showing that it "Passed" or was "Acceptable" for a series of tests related to its physical integrity, biocompatibility, connection safety (especially ISO 80369-3 compliance), human factors, and risk management. The "ground truth" here refers to the device meeting its design specifications and applicable industry standards. The submission asserts substantial equivalence to a predicate device based on these non-clinical tests, without requiring clinical testing.

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The EnteraLite® Infinity® Enteral Feeding Pump is a rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.

The EnteraLite® Infinity® Enteral Feeding Pump as referred to as Infinity® with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bedridden or ambulatory patients. The device is also designed for use with pediatric patients.

The device is software controlled, variable flow rate, peristaltic pump. It operates up to 24 hours (at a nominal flow rate of 125 ml/hr) from internal rechargeable batteries. The batteries are recharged by a wall mounted charger that plugs into a standard 100 to 240 volt alternating current wall socket. The charger is available in various input voltage and plug configurations to accommodate international requirements. The charger converts line voltage to a safe low voltage of 5 volts DC that is supplied from the charger to the pump. A "fuel gauge" type indicator on the pump's LCD display continuously shows the state of battery charge.

The pump motor runs at a single speed and is turned on and off at programmed intervals to obtain the desired flow rate. The motor drive circuit is controlled by a microcontroller that allows the motor to pause longer at lower flow rates with correspondingly shorter pauses at higher flow rates. The software embodied within the microcontroller is validated and verified as part of the design process.

The pump includes several safety features. An air-in-line sensor rapidly detects whenever nutrient flow is interrupted and alerts the user with both a visual and audible alarm. Two pressure sensors detect occlusions both on the nutrient bag (distal) side and the patient (proximal) side of the pump. The user is alerted to proximal or distal occlusions by both visual and audible alarms.

The disposable tubing set consists of a bag, or spike for nutrient bag, PVC connecting tubing, an integral cassette with a silicone pumping segment, and an enteral adapter. The set also contains a patented anti-free flow device within the cassette, which prevents free flow of fluids if the tubing set is inadvertently or purposely removed from the pump.

A backpack (convertible to a waistpack) is available for use under ambulatory conditions. The pump may be operated in any orientation.

The provided document describes a "Special 510(k): Device modification" for the EnteraLite® Infinity® Enteral Feeding Pump, focusing on a modification to the disposable tubing set's cassette. The study aimed to verify the contact of the door/top housing to the cassette after the addition of three bumps.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document refers to "testing including statistical and graphical analysis" for the two design verification reports (TR-49430 and TR-49071), but the number of units or tests performed is not provided.
• Data Provenance: Not explicitly stated. It's an internal verification study by ZEVEX, Inc. (now Moog Medical), so the data would be proprietary and likely generated within their testing facilities. The country of origin of the data is not mentioned, but the company is based in Salt Lake City, UT, USA. The study is prospective as it's a verification test for a design modification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This study is a non-clinical performance test validating a design modification, not a diagnostic or clinical study requiring expert ground truth for interpretation. The "ground truth" here is successful mechanical function and adherence to design specifications as determined by engineering verification.

4. Adjudication Method for the Test Set

Not applicable, as this is a non-clinical engineering verification study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a non-clinical engineering verification study to assess the impact of a physical design modification. It does not involve human readers or comparative effectiveness for diagnostic tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a mechanical pump with software control, but the study described is an engineering verification of a mechanical modification, not an algorithm's standalone performance in a diagnostic context.

7. The Type of Ground Truth Used

The ground truth used is the successful fulfillment of engineering design specifications and safety requirements for the modified cassette. This is based on internal verification tests and risk analysis (FMECA).

8. The Sample Size for the Training Set

Not applicable. This is a verification study for a physical modification, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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The devices in this product family are used to dispense liquid nutrients (feeding solution) at a user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include an interesting point on a spike to connect to a pre-filled container.

The devices in this product family are used to dispense liquid nutrients (feeding solution) at a controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a use gravity of an interesting point on a spike to connect to a pre-filled container.

The provided document is a 510(K) summary for ZEVEX, Inc.'s Enteral Feeding Sets for Gravity and Pump Use. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study showing device performance against specific acceptance criteria.

The document discusses various modifications to the enteral feeding sets, including a new "Slip Loc" enteral adapter design, a modified cap, an Anti Free Flow Fitting for pump models, and smaller surface area bags for some models. The "study" mentioned isn't a complex clinical trial but rather a series of engineering tests to confirm the modifications do not reduce safety or effectiveness.

Here's an analysis based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like a typical clinical study. However, it lists tests performed and a general conclusion.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The tests mentioned (volumetric accuracy, blow-by pressure, bond test, cytotoxicity) likely involved a representative number of samples of the modified components and complete sets, but the exact count is not provided.
• Data Provenance: Not specified, but given it's a 510(k) submission, the testing would have been conducted by the manufacturer (ZEVEX, Inc.) in a controlled environment. The data is prospective for the modified devices. There is no mention of country of origin for the data, but it can be assumed to be from the US, where ZEVEX is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable in the context of this device and testing. The "ground truth" for these engineering tests is established through objective measurement against engineering specifications and regulatory standards (e.g., USP Class VI, FDA food-grade approval).
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This type of testing does not involve expert adjudication in the way a clinical study with subjective assessments would. The results are based on objective measurements against predefined criteria or established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices where human interpretation is involved. The ZEVEX enteral feeding sets are medical devices concerned with physical performance and material safety, not diagnostic interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This document describes physical medical devices, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" for this submission are objective engineering specifications, material standards (e.g., USP Class VI), and regulatory requirements (e.g., FDA approval for food-grade colorants). For example, a material either is USP Class VI or it isn't.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. There is no "training set" in the context of physical device testing as described. Machine learning models use training sets, not directly manufactured products undergoing physical performance tests.

9. How the Ground Truth for the Training Set Was Established

• Establishment of Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.

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