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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:

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

The document does not explicitly state a sample size in terms of a specific number of individual devices tested. Instead, it refers to a "Full EO sterilization Cycle with extended aeration time" being "conducted for Validation of EO/ECH residuals under simulated use extraction method." This suggests a test was performed on one or more representative samples of the administration sets to measure the residuals.

• Sample Size: Not explicitly stated as a number of distinct units. The testing involved a "Full EO sterilization Cycle" on the administration sets.
• Data Provenance: The study is a prospective test conducted specifically to evaluate the device changes for the 510(k) submission. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying adherence to international and U.S. standards.

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

This type of study does not involve human experts establishing ground truth in the traditional sense. The "ground truth" here is based on established international standards (ANSI/AAMI/ISO 10993-7) for acceptable levels of sterilization residuals in medical devices, particularly for vulnerable populations like neonates. These standards are developed by multidisciplinary expert panels in the fields of biocompatibility and toxicology, but no specific number or qualification of experts establishing the ground truth for this particular test is mentioned because it refers back to the existing standard.

4. Adjudication Method for the Test Set:

Not applicable. This is a laboratory-based chemical analysis comparing measured values against predefined acceptable limits from an international standard, not a subjective assessment requiring adjudication.

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 study is not an MRMC comparative effectiveness study, nor does it involve AI. It is a biological evaluation of material safety.

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

Not applicable. This study does not involve an algorithm.

7. The Type of Ground Truth Used:

The ground truth used is based on established international biological evaluation standards (ANSI/AAMI/ISO 10993-7) which define the maximum tolerable exposure limits for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals, especially for sensitive populations like neonates.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not a machine learning or AI study.

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

Not applicable, as there is no training set.

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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:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify a distinct "test set" sample size or data provenance in the context of an AI/CADe study for diagnostic performance. The studies mentioned are primarily engineering-focused verification and validation tests and human factors studies (e.g., electrical safety, EMC, device performance, biocompatibility). These types of tests do not typically involve patient "test sets" or data provenance in the same way as AI model validation would.

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)

This information is not applicable and is not provided in the document. The studies performed are not clinical or diagnostic accuracy studies that involve expert-established ground truth on medical images or patient data.

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

This information is not applicable and is not provided. The document describes compliance with engineering standards and performance testing for a medical device (infusion pump and its software), not a diagnostic algorithm requiring adjudication of ground truth.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CADe devices that assist human readers in interpreting medical data, which is not the function of this infusion pump or its software. The software's function is for creating and managing pump configurations and therapy-based protocols (Dose Error Reduction System).

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

Yes, for the non-clinical performance of the device, the document implies standalone testing was performed to verify the device's adherence to engineering standards and specified performance metrics. This is not a standalone "algorithm only" in the sense of a diagnostic AI, but rather the pump's mechanical and software functions operating independently as designed.

For instance, the "Software verification and validation per FDA guidance" and "Device Performance" sections describe testing the pump's functions (e.g., flow rate accuracy, alarm detection, software integrity) without human intervention in the real-time execution of the primary functions once programmed. The software itself, as a Dose Error Reduction System, operates "standalone" in its ability to check dosing limits.

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

The concept of "ground truth" as typically defined in diagnostic AI studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. For the engineering and performance tests, the "ground truth" would be the expected or specified performance according to design requirements, recognized industry standards (e.g., IEC standards), and FDA guidance documents. Compliance with these established criteria serves as the "ground truth" for verification and validation.

For example:

• Electrical Safety: Ground truth is compliance with IEC60601-1.
• EMC: Ground truth is compliance with IEC 60601-1-2 Ed 4.1.
• Device Performance (Flow Rate Accuracy, Alarms): Ground truth is compliance with specified accuracy ranges and alarm trigger conditions as defined by design and relevant guidance (e.g., FDA Guidance "Infusion Pumps Total Product Life Cycle").
• Biocompatibility: Ground truth is compliance with ISO10993 series of standards.

8. The sample size for the training set

This information is not applicable and is not provided. The device (infusion pump and its software) does not use machine learning in a way that requires a "training set" of data for diagnostic or predictive model development. The software is a rule-based system for managing pump configurations and protocols.

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

This information is not applicable, as there is no "training set" for this type of device.

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