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The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.

The SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.

The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.

SIGMA Spectrum is a large volume pump within the SIGMA Spectrum infusion system used by clinicians at the patient bedside to control the delivery of medications from a bag. The pump moves fluid from the bag to the patient via specified administration sets using a peristaltic pumping action. The pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the pump and its associated drug library are configured.

The pump provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical pump used for the controlled administration of fluids including pharmaceutical drugs, blood, blood products, and mixtures of required patient therapy through administration sets at clinician's selectable rates and volumes.

The pump is intended for the controlled administration of fluids through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous, and epidural. The pump is intended to be used in conjunction with legally marketed and compatible administration sets, as indicated in the device labeling, and medications provided by the user. The subject device is suitable for patient care in hospitals and outpatient health care facilities.

The Master Drug Library (MDL) is a stand-alone (not embedded in the pump) software application installed on a hospital-provided computing platform and used to create a drug library file. MDL facilitates the generation, configuration, and management of a facility-specific drug library file for dedicated infusion pumps. The drug library file is intended to be distributed to all compatible infusion pumps in the hospital.

This submission includes software design and labeling changes to address the issues leading to recalls Z-0530-2022 and Z-2103-2023.

This FDA 510(k) clearance letter pertains to an infusion pump, not an AI/ML powered medical device. Therefore, many of the requested categories in your prompt (such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Type of ground truth," and "Training set sample size/ground truth establishment") are not applicable to this type of medical device submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison of technical characteristics and verification of performance against established requirements.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the overall device in a quantifiable manner that would typically be found in an AI/ML context (e.g., specific sensitivity, specificity, or AUC targets). Instead, it demonstrates compliance with a range of technical specifications, which inherently act as acceptance criteria for the design and performance. The "Reported Device Performance" is implied by the statement that "Non-clinical testing met all acceptance criteria."

Below is a table summarizing key technical characteristics that function as performance criteria for the infusion pump. Since the subject device is deemed "substantially equivalent" to the predicate, and no new performance claims are made that deviate from the predicate, their performance characteristics are identical as presented.

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

The document indicates that "Non-clinical testing has been executed against requirements for performance and safety." However, it does not specify the sample sizes for this testing.

The "data provenance" is implied to be from internal lab testing ("Non-clinical testing") conducted by Baxter Healthcare Corporation for verification of the device's functional and safety requirements. Details regarding country of origin or whether it's retrospective/prospective are not provided, but typically such testing for physical devices like infusion pumps would be prospective, controlled lab experiments.

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

This information is not applicable and therefore not provided in the document. For an infusion pump, "ground truth" is typically defined by physical and engineering measurements against established standards and specifications, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication is a concept typically relevant to human review of (often ambiguous) data in clinical studies or AI performance evaluations, which is not the primary mechanism for verifying an infusion pump's compliance with engineering specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This information is not applicable and therefore not provided. The device is an infusion pump, not an AI-assisted diagnostic or therapeutic device used by human readers for interpretation.

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

This information is not applicable and therefore not provided. While the infusion pump contains software (algorithms), the "standalone performance" concept as typically applied to AI refers to the algorithm's performance in interpreting data directly without human intervention. The pump's performance is intrinsically linked to its electromechanical components and its interaction with fluids, administration sets, and clinical settings.

7. The Type of Ground Truth Used

For this infusion pump, the "ground truth" is established through design specifications, engineering standards, and direct physical/electrical measurements. For example, flow rate accuracy is measured against known volumes over time, alarm thresholds are tested against specific pressure or bubble sizes, and battery life is measured under defined operating conditions. This is not "expert consensus," "pathology," or "outcomes data" in the AI/ML sense.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. Infusion pumps are not typically "trained" using data sets in the way AI/ML models are. Their functionality is programmed based on engineering principles and validated through testing.

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

This information is not applicable and therefore not provided for the reasons outlined in point 8. The "ground truth" for developing an infusion pump's functionality is its detailed engineering design and the physical laws and medical requirements it must adhere to.

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The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, and blood products. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.

The Spectrum IQ Infusion System with Dose IQ Safety Software is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.

The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to reduce operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies. This automation is intended to reduce pump programming errors.

The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used by trained healthcare professionals.

Spectrum IQ is a large volume pump within the Spectrum IQ infusion system used by clinicians at the patient bedside to control the delivery of medications from a bag. The pump moves fluid from the bag to the patient via specified administration sets using a peristaltic pumping action. The pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the pump and its associated drug library are configured.

The pump provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical pump used for the controlled administration of fluids including pharmaceutical drugs, blood and blood products through administration sets at clinician's selectable rates and volumes.

The pump is intended for the controlled administration of fluids through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous, and epidural. The pump is intended to be used in conjunction with legally marketed and compatible administration sets, as indicated in the device labeling, and medications provided by the user. The subject device is suitable for patient care in hospitals and outpatient health care facilities.

Dose IQ is a standalone software application installed on a hospital-provided computing platform and used to create a drug library file. Dose IQ facilitates the generation, configuration, and management of a facility-specific drug library file for dedicated infusion pumps. The drug library file includes customers' dosing limits and additional pump configuration settings. The drug library file is intended to be distributed to all compatible infusion pumps in the hospital.

This submission includes software design and labeling changes to address the issues leading to recalls Z-0529-2022 and Z-2104-2023.

The provided FDA 510(k) clearance letter for the Spectrum IQ Infusion System with Dose IQ Safety Software (K251636) does NOT describe a study involving an AI/Machine Learning algorithm for diagnostic or prognostic purposes, which would typically involve the criteria you've outlined.

Instead, this device is an infusion pump with safety software, intended to reduce operator interaction through guided programming to minimize "pump programming errors." The summary explicitly states: "This submission includes software design and labeling changes to address the issues leading to recalls Z-0529-2022 and Z-2104-2023." This suggests that the changes are primarily bug fixes, usability improvements, and potentially enhanced safety features rather than the introduction of a novel AI-driven diagnostic tool.

Therefore, many of the requested details about acceptance criteria and study design (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of device and submission. These criteria are typically relevant for AI/ML-enabled devices that perform interpretation of medical images, signals, or patient data for diagnostic or prognostic purposes where "ground truth" and human reader performance are central to validation.

The 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device (K230041) through a comparison of technological characteristics and non-clinical performance and safety testing.

Here's how to interpret the provided information in the context of your request:

Acceptance Criteria and Device Performance (Based on the provided document)

The document doesn't present specific quantitative acceptance criteria in a table format for a "study" as you might expect for an AI/ML diagnostic device. Instead, "acceptance criteria" for an infusion pump typically refer to meeting defined performance specifications (e.g., volumetric accuracy, alarm thresholds, power consumption, environmental limits) and safety standards (e.g., IEC 60601 series).

The document states that "Non-clinical testing met all acceptance criteria, demonstrating that the device is safe and effective for its intended use." However, it does not provide the specific quantitative criteria or the numerical reported device performance for each. It assumes these were adequately documented in the full submission to FDA.

The "performance" described relates to the functional aspects of the pump and software:

Regarding the other specific questions:

1. Sample sizes used for the test set and data provenance:
   This information is not provided in a way that aligns with AI/ML model validation. The "non-clinical testing" would refer to engineering tests (e.g., bench testing for flow accuracy, alarm functionality, battery life) rather than a dataset for an AI model. Therefore, specific "test set" sample sizes or data provenance (e.g., country, retrospective/prospective) are not detailed because it's not a data-driven AI/ML diagnostic product.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. This device does not use human experts to establish "ground truth" for a diagnostic "test set" in the way an AI/ML imaging device would. Ground truth for an infusion pump's performance is typically established by engineering measurement standards and physical verification methods, not expert consensus on medical data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable for this type of device.

4. 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 device is an infusion pump with safety software, not an AI-assisted diagnostic or interpretation tool that augments human readers. Its purpose is to "reduce operator interaction through guided programming... to reduce pump programming errors," which implies improved safety and efficiency, but not through a "reader" study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The "Dose IQ Safety Software" is part of the "Spectrum IQ Infusion System," which is a physical medical device (an infusion pump). It's inherently a human-in-the-loop device where clinicians interact with it for programming and administration. Its software functionality is integral to the pump's operation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Ground truth for an infusion pump's performance is based on engineering specifications, physical measurements (e.g., volume delivered over time, pressure readings, temperature, electrical parameters), and adherence to recognized industry standards (e.g., IEC 60601-1-8 for alarms). It's not based on expert consensus on clinical findings, pathology, or patient outcomes for diagnostic purposes.

7. The sample size for the training set:
   Not applicable. This is not an AI/ML device trained on a "dataset." The software is designed and validated against functional requirements and safety standards, not "trained" on a dataset in the machine learning sense. The "training set" for software development would typically be the iterative development and testing cycles against specifications.

8. How the ground truth for the training set was established:
   Not applicable, as there isn't a "training set" in the AI/ML context. Ground truth in this engineering context is established by design specifications derived from medical necessity, regulatory requirements, and established physical principles.

In conclusion, the provided FDA clearance letter details the regulatory approval of an infusion pump. While it includes "Dose IQ Safety Software," this software is focused on guided programming and error reduction (likely via a drug library and limits), not on AI/ML-driven diagnostics where the detailed validation criteria you've asked for would apply. The "study" referenced is non-clinical testing against performance and safety requirements, not a clinical trial or AI model validation study.

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The Iradimed Corporation's MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system when placed as close as clinically possible to the MR system, without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line.

The pump and infusion sets are designed to deliver saline and IV medication. The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in primary, loading, bolus, or KVO delivery mode.

The dedicated Iradimed 1056, 1058, and 1059 Infusion Sets for the MRidium 3870 MRI Infusion Pump are intended for single patient use up to 6 hours.

The device is intended for Adult and Pediatric patients, including Neonates. Careful clinical considerations involving drug and dosing should always be applied especially with regard to neonatal subpopulations (i.e., low and extremely low birth weight).

This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.

The MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion Pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system allowing placement as close as physically possible to the MRI scanner without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line. The magnetic content of the Pump is such that there is no hazard of magnetic attraction, up to 3T (30,000 gauss).

The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (non-magnetic) motor. The integral infusion set mounting channel is horizontally oriented in the front of the pump with position detection sensors and graphical user feedback to aid the user in the correct infusion set loading process. The main assembly of the pump unit contains the controls, display, power supply, battery, and processor/memory functions suitable to meet all system requirements.

A remote display (3875) is also available as an option for independent viewing and control from the adjacent MRI Control Room area (Zone III).

The Dose Rate Calculator feature allows the user to set up a patient's infusion rate based upon user selected parameters, including volume to be infused, dose, concentration, weight, and/or time. The Dose Rate Calculator feature also provides a Drug Library, allowing the user to program a patient's infusion protocol from selected parameters, including volume to be infused, dose, concentration, weight and/or time with soft and hard limits for each drug. These Drug Library inputs can only be created or modified by the Iradimed in-house clinical team based on input and validation from the healthcare facility. Once programmed, the library is digitally signed requiring proper verification by a software 'key' within the 3870 MR IV pump upon loading. Loading of the drug library requires access to the Password protected Service Menu.

The Dose Error Reduction System (DERS) feature allows user-facilities to provide input to custom names, and doses, with hard and soft limits for use in the Drug Library. The Drug Library supports care area specific infusion protocols for primary, bolus, loading dose, and KVO delivery modes, retrievable by drug/protocol name. The library, as prescribed by the healthcare facility, is programmed with nominal starting values for: Dose, Concentration, and Time. Also, hard limits (maximum and minimum allowable) and soft limits (high and low limits that require a user confirmation to exceed) for Dose, Concentration, Time and Patient Weight can be programmed.

The provided FDA 510(k) clearance letter for the MRidium 3870 MRI Infusion Pump System focuses on demonstrating substantial equivalence to a predicate device (MRidium 3860+ MRI Infusion Pump/Monitoring System) through non-clinical performance testing. It does not describe a study involving human readers or the establishment of ground truth by expert consensus, as might be typical for AI/ML-driven medical device submissions.

Therefore, I will extract information related to the device's functional performance, which serves as its "acceptance criteria," and the "study" (non-clinical testing) that proves it meets these criteria. Many of the requested points (e.g., number of experts, adjudication methods, MRMC studies, sample sizes for training sets) are not applicable to this type of device and submission.

Here's the breakdown based on the provided document:

Acceptance Criteria and Study Proving Device Performance for MRidium 3870 MRI Infusion Pump System

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance specifications and indicates that the device meets them, primarily by demonstrating substantial equivalence to the predicate and through various verification tests. The "acceptance criteria" are implied by the specifications themselves, and the "reported device performance" is that it complies with these specifications and has been tested to perform as intended.

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

• Sample Size for Test Set: The document indicates that non-clinical bench testing was performed. Specific numerical sample sizes (e.g., how many pumps were tested, how many infusion sets) are not explicitly stated in the provided text. The testing categories include:

  • Verification Testing of Product Requirements (e.g., flow rate accuracy, essential performance, reliability, air-in-line, occlusion, alarms, software V&V, cybersecurity, battery, EMC/EMI, environmental, shock/vibration, electrical safety, mechanical, biocompatibility, ingress protection, wireless co-existence, standards testing).
  • Human Factors Validation Testing.
  • MRI Environment Conditions of Use Testing (magnetic displacement, spurious emissions, essential performance during MRI scans including flow accuracy, alarms, unintended bolus, wireless communication).

• Data Provenance: The data is from non-clinical bench testing performed by Iradimed Corporation (the manufacturer) as part of their 510(k) submission. No information about country of origin of "data" in the sense of patient data is relevant here, as it's not a clinical study on patients. It is implicitly prospective testing, designed to demonstrate compliance for the submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable. The device is an infusion pump, and its performance is evaluated against engineering and safety standards, not against human expert interpretations of medical images or patient outcomes. The "ground truth" for this device's performance verification comes from established engineering principles, metrology, and consensus standards (e.g., AAMI TIR101 for flow accuracy, IEC 60601 series for safety).

4. Adjudication Method for the Test Set

This section is not applicable. As the testing is non-clinical and pertains to physical and electrical performance, there is no need for expert adjudication in the traditional sense of clinical or image-based studies. Performance is measured against predefined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This section is not applicable. MRMC studies are typically performed for AI/ML-driven diagnostic devices where human readers provide interpretations (e.g., radiologists reading medical images) and their performance with and without AI assistance is compared. This device is an infusion pump, not a diagnostic AI tool.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

This is largely applicable to the extent that the device's functional performance (e.g., flow rate, alarm detection, battery life) is evaluated independently of human interaction for its core functions in a controlled bench setting. The "Summary of Performance Testing (Non-Clinical)" details various tests (e.g., flow rate accuracy, essential performance, reliability, air-in-line, occlusion performance, alarms, cybersecurity) that represent the device's standalone operation.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Engineering specifications and design requirements: The device is designed to meet specific measurable performance parameters (e.g., flow rate accuracy, pressure detection thresholds).
• Consensus standards: Performance is verified against recognized industry standards (e.g., AAMI TIR101 for flow accuracy, IEC 60601 series for safety and alarms).
• Bench testing measurements: Physical measurements using calibrated equipment are the "ground truth" to confirm the device's output against its specifications.

8. The Sample Size for the Training Set

This section is not applicable. This is a hardware medical device (an infusion pump) and not an AI/ML device that undergoes "training" on a "training set" of data. Its "training" is in its design, engineering, and manufacturing processes, culminating in verification and validation testing.

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

This section is not applicable for the same reason as point 8.

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The BD Alaris Infusion System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. See Pediatric*, Neonate**, and Adult Patient Population Tables 2 and 3 for the module-specific variations. Administered fluids include pharmaceutical drugs, red blood cells, and other blood components (platelets and fresh frozen plasma) as required for patient therapy. The BD Alaris Infusion System with Guardrails Suite MX is an interoperable system capable of communicating and exchanging data with compatible information technology systems.

The BD Alaris Infusion System with Guardrails Suite MX includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, Patient-Controlled Analgesia (PCA) Module, and associated software applications. EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).

BD Alaris Pump Module and Syringe Module and the Alaris PCA Module are indicated for varying patient populations, routes of administration, and infusates.

The BD Alaris Infusion System with Guardrails Suite MX is a modular infusion and monitoring system designed to provide controlled delivery of drugs and fluids, and to provide monitoring of respiratory parameters. The BD Alaris Infusion System with Guardrails Suite MX has three (3) major components:

1. System Hardware: A core hardware unit with user interface (BD Alaris PC Unit or PCU) and attachable modules each with a distinct function.

   • BD Alaris Pump Module (LVP)
   • BD Alaris Syringe Module (SYR)
   • Alaris PCA Module (PCA)
   • BD Alaris EtCO2 Module (EtCO2)
   • Alaris Auto-ID Module (Auto-ID)

2. Guardrails Suite MX Software: Software applications for support and interaction with the system hardware

   • BD Guardrails Editor (GRE)
   • BD Alaris Systems Manager (SM)
   • BD Alaris Systems Maintenance (ASM)

3. Interoperability Software: Software applications for facilitating bi-directional communication between the PCU and attached LVP and SYR modules, and an electronic medical records (EMR) system via BD Alaris Infusion Systems Manager (SM) and Care Coordination Engine (CCE), a non-medical device Medical Device Data System (MDDS).

   • Calculation Services
   • Infusion Adapter (IA)

The PCU is the core of the BD Alaris Infusion System with Guardrails Suite MX and necessary for its operation. It provides a common user interface for programming, and powering and monitoring attached modules. Modules must be physically connected to the PCU to operate. The connection is made by direct attachment to a PCU or through attachment to a module that is attached to a PCU. The attachment is made using inter-unit interface (IUI) connectors built into both sides of the PCU and modules, which also serve to provide power to the modules and communication between the PCU and attached modules. The PCU is powered by AC power and has a rechargeable battery to allow for continued therapy during power interruptions.

The attachable modules are dedicated to controlled delivery of fluids, pharmaceutical drugs, parenteral nutrition, and blood and blood products into patients, patient-controlled administration of analgesics, monitoring of end-tidal carbon dioxide, and scanning identifications of patient, physician, and infusates into the system.

• The BD Alaris Pump Module (LVP) delivers fluids accurately over programmed times and can detect and notify the user of situations that could impact patient safety, such as improper set loading, occlusion, and air-in-line. It can deliver fluids continuously or intermittently from any compatible container using a dedicated BD Alaris infusion set. Flow rates range from 0.1 to 999 mL/h and bolus doses can be programmed at the start or during continuous infusion.

• BD Alaris Syringe Module (SYR) is designed for injecting fluids from compatible syringes and can detect and notify the user of situations that could impact patient safety, such as an improperly loaded syringe and occlusion. It can deliver continuous or intermittent volumes from 1 to 50 mL syringes at flow rates of 0.01 to 999 mL/hr.

• The Alaris PCA Module (PCA) is designed for patient-controlled analgesia. It shares core components and functionality with the BD Alaris Syringe Module but includes additional features such as: a dose request cord for self-administering pain medication, software with a dose lockout interval, and a locking syringe enclosure door with a key. When configured for use with the BD Alaris EtCO2 Module, it can also trigger a pause of the PCA infusion if the respiratory rate of a patient falls outside the limits.

• The BD Alaris EtCO2 Module (EtCO2) a capnograph used for continuous, non-invasive monitoring of end-tidal CO2, fractional inspired CO2, and respiratory rate. It can be used to monitor respiratory depression in patients when using the Alaris PCA Module.

• The Alaris Auto-ID Module (Auto-ID) features an internal barcode image scanner and an optional handheld scanner. Scanning a clinician ID unlocks the PCU panel in authorized user mode and links clinical event logs with the clinician. Scanning a patient ID band associates logs with the patient, while scanning IV fluid or medication barcodes selects the specific item from the drug library for infusion modules.

The PCU and attachable modules have multiple processors running embedded software. The embedded software provides various functions, such as: bootloader, user interface, networking, sensor monitoring, motor control, data processing, power control, keypad processing, and communication.

The PCU with its attached modules is designed to be configured to communicate and interact with the Guardrails Suite MX software applications including software for interoperability with Electronic Medical Record (EMR) systems. Communication between the PCU and the software applications is accomplished through either a direct serial connection or through a wireless connection utilize the respective Guardrails Suite MX Software applications.

• The BD Guardrails Editor (GRE) allows for the creation of drug and fluid libraries and guidelines, called 'profiles,' for specific patient populations. GRE also provides a transfer tool to transfer a profile to PCU via serial cable.

• The BD Alaris Systems Manager (SM) manages connectivity and includes a web application, communications server, and database software for managing data, creating reports, connecting with a healthcare facility's network, and storing system configuration, user permissions, and historical data. Use of SM also supports transferring wireless software updates to the PCU during system servicing.

• BD Alaris Systems Maintenance (ASM) is used for standard maintenance tasks, including module calibration and network configurations

• The BD Alaris Interoperable software includes the Infusion Adapter (IA) and Calculation Services to support bi-directional communication between the BD Alaris Infusion System with Guardrails Suite MX and the healthcare facility's EMR. The Infusion Adapter facilitates data exchange ensuring correct message formats and content. Calculation Services performs pre-defined rule-based calculations to obtain infusion duration, body surface area (BSA), and weight-based dose.

It is important to note that interoperability does not include remote control of the BD Alaris Infusion System with Guardrails Suite MX. The PCU and attached modules cannot be programmed remotely. Only infusion parameters can be prepopulated on the pump using interoperability and these parameters must be manually confirmed by the clinician at the bedside before they are activated.

The provided FDA 510(k) clearance letter and summary for the BD Alaris Infusion System with Guardrails Suite MX (K243855) do not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm performance evaluation. Instead, the document focuses on the substantial equivalence of an infusion pump system to a predicate device, with an emphasis on its hardware, software (including safety management and interoperability features), and general electrical and functional safety.

The text does not describe an AI/algorithm in the sense of a diagnostic or assistive AI that requires expert-driven ground truth, MRMC studies, or standalone performance metrics typically associated with AI/ML-based medical devices. The "Guardrails Suite MX" and "Calculation Services" mentioned are primarily about drug library management, dose error reduction, and rule-based calculations, which are more akin to conventional software functionalities rather than adaptive AI algorithms that learn from data.

Therefore, many of the requested categories for describing an AI/algorithm acceptance study are not applicable to the information provided in this document. Given the nature of the device (an infusion pump system), the "acceptance criteria" discussed are related to its functional performance, safety, and compliance with regulations and standards.

However, I can extract the relevant "acceptance criteria" and "performance" data that are presented in the document, framed within the context of a traditional medical device's non-clinical testing.

Reported Device Performance and "Acceptance Criteria" (based on functional and safety requirements):

The document describes non-clinical testing to verify essential performance requirements. These requirements serve as the de facto "acceptance criteria" for the device's main functions.

Since the provided document is a 510(k) clearance letter for an infusion pump system, not an AI/ML-based diagnostic or assistive device, the following points are largely not applicable or not explicitly detailed in the text. I will state if the information is unavailable or implies "None" for the context of this specific device's clearance.

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for all performance tests. The document refers to "testing" and "statistical methods in sample size determination and data analysis" but does not provide specific numbers for each test (e.g., how many pumps were tested for flow rate accuracy). This is common for 510(k) summaries where detailed test reports are typically referenced but not fully included.
   • Data Provenance: Not specified regarding country of origin. The testing would generally be conducted by the manufacturer (BD/CareFusion) or their approved test labs. It describes "non-clinical testing" and "simulated clinical conditions," which indicates a prospective validation within a controlled environment.

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

   • Not Applicable in the AI/ML sense. Ground truth for an infusion pump's performance (e.g., flow rate accuracy, alarm function) is established through engineering measurements and adherence to international standards (like AAMI TIR 101, ISO 80601-2-55). It doesn't involve expert consensus on medical images or clinical outcomes in the way an AI diagnostic would. The "Human Factors evaluation" mentions "clinical assessment" and "biomedical engineering use," implying input from relevant experts, but not for "ground truth" labeling of data.

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

   • Not Applicable. This is a method for resolving discrepancies in expert labeling of data, which is not relevant for the type of objective functional performance testing described for an infusion pump.

4. 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 device is an infusion pump system, not an AI for human reader assistance in diagnostic tasks.

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

   • Partially Applicable / Different Context. The document details extensive "essential performance" testing of the device (hardware and embedded software) in a standalone capacity, demonstrating its accuracy, safety mechanisms, and compliance with standards. This constitutes "algorithm only" performance in the sense of the pump's control algorithms (e.g., for flow rate, pressure detection). However, it's not an "AI algorithm" in the typical understanding of machine learning where a "human-in-the-loop" interaction for clinical decision-making is assessed.

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

   • Engineering Measurements and Compliance with Standards. The "ground truth" for this device's performance is derived from precise engineering measurements, calibration standards, and adherence to established medical device performance standards (e.g., AAMI TIR 101 for flow rate accuracy requires specific test methods and reference measurements). For the EtCO2 module, it's based on accuracy against known gas concentrations.

7. The sample size for the training set:

   • Not Applicable (in the AI/ML sense). This device is not described as utilizing machine learning that requires a "training set" of data for algorithm development. Its software functionalities (e.g., Guardrails Suite MX) are rule-based systems or deterministic algorithms, developed through traditional software engineering and verification processes.

8. How the ground truth for the training set was established:

   • Not Applicable. As no AI/ML training set is indicated, this question is not relevant.

In summary, the provided document meticulously outlines the non-clinical validation of an infusion pump system, demonstrating its safety and effectiveness through adherence to performance specifications and regulatory standards. It does not, however, pertain to the clearance of an AI/ML diagnostic or assistive algorithm, which would involve the specific types of studies and ground truth methodologies requested in the prompt.

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The Plum Solo™ Precision IV Pump is intended for administration of parenteral fluids, medications, and whole blood and blood products through the following routes of administration: intravenous, intra-arterial, and subcutaneous.

The Plum Solo™ Precision IV Pump is intended for use in clinical environments in the hospital and other outpatient healthcare facilities by licensed healthcare professionals. These healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use.

The Plum Solo™ Precision IV Pump is intended for adults, pediatric (including infants and children), and neonatal patient populations.

The Plum Solo™ Precision IV Pump is a large volume pump (LVP) with one pump channel that can deliver fluid to a patient from 1 to 2 lines independently. The Plum Solo™ Precision IV Pump can only be used with dedicated PlumSet™ administration sets (not subject of this filing). The pump channel accepts a cassette that is part of a PlumSet™ administration set and can connect to a primary and/or secondary container. The fluid is delivered from the upstream lines either serially (piggyback) or concurrently through the cassette to the downstream line. The flow rate accuracy precision has been improved (lower allowed variance) by implementing the new motor mechanism, as well as increased precision for programming concentration, flow rate and VTBI entries. The overall delivery accuracy of the system has improved to +/- 3% per TIR 101 standard condition testing and +/-5% for non-standard conditions.

The provided FDA 510(k) clearance letter pertains to the Plum Solo™ Precision IV Pump, which is a large volume infusion pump. The document focuses on demonstrating substantial equivalence to a predicate device, the Plum Duo™ Infusion System (K223607).

It's important to note that the detailed information typically associated with acceptance criteria and study results for AI/ML-enabled medical devices (like the number of experts, adjudication methods, MRMC studies, or specific ground truth methodologies for training data) is not present in this clearance letter. This is because an IV pump, while an advanced medical device, is not an AI/ML diagnostic or prognostic system that relies on interpreting complex data like medical images, waveforms, or patient parameters to derive a diagnosis or predict an outcome.

Instead, the acceptance criteria and study results described for the Plum Solo™ Precision IV Pump focus on engineering performance specifications, reliability, and human factors validation, which are standard for such devices.

Therefore, the following information is extracted and presented based on the provided text, and where information is not available (as it is not typically part of the clearance for this class/type of device), it will be explicitly stated.

Overview of Device and Study Focus

The Plum Solo™ Precision IV Pump is a large volume pump (LVP) designed for administering parenteral fluids, medications, and blood products. The primary goal of the 510(k) submission was to demonstrate substantial equivalence to its predecessor, the Plum Duo™ Infusion System. The key improvements highlighted are enhanced flow rate accuracy and increased precision for programming.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the performance targets for flow rate accuracy and bolus delivery accuracy, compared to the predicate device.

Note on Acceptance Criteria: For a device like an infusion pump, "acceptance criteria" are implicitly met when the device demonstrates performance that is either equivalent to or improved upon a legally marketed predicate, in addition to meeting relevant safety standards (e.g., IEC standards, risk management requirements, human factors). In this case, the improved flow rate accuracy (from +/-5% to +/-3%) is a key performance metric that exceeds the predicate, serving as a strong point of "acceptance" in terms of performance.

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

The document does not specify a sample size for the test set in terms of "patient data" as this is not an AI/ML diagnostic device analyzing patient-derived data. Instead, testing involves engineering verification and validation runs on the physical device and its software. The provenance of such data would be controlled laboratory settings.

• Sample Size: Not applicable in the context of "patient data" or "images." Testing involved verification and validation of product requirements, reliability goals, and human factors. The exact number of test units or test repetitions for each performance metric (e.g., flow rate accuracy tests per AAMI TIR101) is not specified in the summary but would be detailed in internal test reports.
• Data Provenance: Not applicable in the sense of country of origin for "data" like patient scans. This is laboratory-generated performance data from device testing. The testing was conducted as part of the device's design verification and validation processes. It is implicitly retrospective in the sense that the testing was performed before the 510(k) submission.

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

This concept is not applicable to the type of device discussed. Ground truth for an infusion pump's performance (e.g., flow rate, bolus accuracy) is established through precise physical measurements using calibrated equipment and reference standards (e.g., gravimetric methods for flow rate), not through expert interpretation of medical data.

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

This concept is not applicable to the type of device discussed. Adjudication (e.g., 2+1, 3+1 for imaging consensus) is used for subjective evaluations where multiple human readers assess data. Performance metrics for an infusion pump are objective and measured.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for assessing the impact of AI on human reader performance, typically in diagnostic imaging or similar fields. An infusion pump's primary function is fluid delivery, not diagnostic interpretation.

6. If a Standalone (Algorithm-Only Without Human-in-the-Loop) Performance Study was done

The term "standalone performance" in the context of an infusion pump refers to its ability to accurately deliver fluids based on its internal mechanics and software programming, independent of immediate human intervention during the delivery phase. The document details that:

• Flow rate and bolus accuracy testing were conducted by following AAMI TIR101. This is a standard for evaluating the performance of infusion pumps without a human directly influencing each delivery cycle. This essentially serves as the "standalone" performance assessment for this device.
• The reported performance of +/- 3% for flow rate accuracy directly reflects this standalone capability.

7. The Type of Ground Truth Used

The ground truth for an infusion pump's performance is established through physical measurements against established standards, not through expert consensus, pathology, or outcomes data in the medical sense.

• Ground Truth: Utilized reference standards and precise measurement techniques (e.g., gravimetric measurement for flow rate) as per AAMI TIR101. The "truth" is the actual volume delivered compared to the commanded volume, measured by calibrated instruments.
• Human Factors Validation: While not "ground truth" per se, human factors evaluations were conducted to validate the effectiveness of safety-critical use-related features/functionality and use error-related mitigations, in accordance with FDA guidance and IEC 62366-1. This ensures the user interface and interactions are safe and effective.

8. The Sample Size for the Training Set

This concept is not applicable to the type of device discussed. Infusion pumps are not "trained" on large datasets in the way AI/ML algorithms are. Their operational parameters are set by design and engineering specifications. While the device contains software, it's not a machine learning model that learns from a "training set."

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

This concept is not applicable because there is no "training set" for an infusion pump in the AI/ML sense. The device's functionality is a result of engineering design, mathematical algorithms for pump control, and calibration, not machine learning from data.

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The Plum Duo™ Precision IV Pump is intended for administration of parenteral fluids, medications, and whole blood and blood products through the following routes of administration: intravenous, intra-arterial, and subcutaneous.

The Plum Duo™ Precision IV Pump is intended for use in clinical environments in the hospital and other outpatient healthcare facilities by licensed healthcare professionals. These healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use.

The Plum Duo™ Precision IV Pump is intended for adults, pediatric (including infants and children), and neonatal patient populations.

The Plum Duo™ Precision IV Pump is a large volume pump (LVP) with two independent pump channels that can deliver fluid to a patient from 1 to 4 lines independently. In addition, although the channels can operate independently, patient parameters can be shared across the channels to aid in ease of programming. The Plum Duo™ Precision IV Pump can only be used with dedicated PlumSet™ administration sets (not subject of this filing). Each pump channel accepts a cassette that is part of a PlumSet™ administration set and can connect to a primary and/or secondary container. The fluid is delivered from the upstream lines either serially (piggyback) or concurrently through the cassette to the downstream line. Each pump channel cassette has an independent downstream line (patient line), so the clinician can connect each downstream line to a single infusion site or two separate infusion sites. The flow rate accuracy precision has been improved (lower allowed variance) by implementing the new motor mechanism, as well as increased precision for programming concentration, flow rate and VTBI entries. The overall delivery accuracy of the system has improved to +/- 3% per TIR 101 standard condition testing and +/-5% for non-standard conditions.

The provided FDA 510(k) clearance letter and summary for the Plum Duo™ Precision IV Pump discuss the device's technical specifications and how it meets regulatory requirements for significant equivalence to a predicate device. However, this document does not describe the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven medical device, as implied by the user's detailed request.

The Plum Duo™ Precision IV Pump is an infusion pump, a hardware medical device with embedded software, not an AI/ML diagnostic or prognostic tool. Therefore, the requested information (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) does not apply to this specific device or the information provided in the 510(k) summary.

The 510(k) summary focuses on "Non-Clinical Testing" which includes:

• Verification testing of product requirements
• Human factors validation testing
• Reliability goals testing
• Safety assurance case following FDA Guidance for Infusion Pumps
• Flow rate and bolus accuracy testing per AAMI TIR101
• Software verification and validation per relevant FDA guidance documents (2005 and 2021 draft for software functions), which are focused on traditional software engineering principles, not AI/ML model performance.
• Human factors evaluations per FDA guidance and IEC 62366-1
• Electrical and Electromagnetic Compatibility testing per IEC 60601-1 and IEC 60601-1-2
• Cybersecurity testing per FDA guidance documents (2014 and 2016)
• Risk management activities per ISO 14971:2019 +A11 2021

Conclusion based on the provided document:

The provided document does not contain the information required to answer the specific questions about acceptance criteria and study proving an AI/ML device meets them. The device described, the Plum Duo™ Precision IV Pump, is an infusion pump, and its clearance relies on non-clinical performance and safety data relevant to its mechanical and software functions, not AI/ML-driven insights or diagnostics.

Therefore, I cannot populate the table or answer the specific questions regarding AI/ML study design and ground truth establishment for this device based on the given text. The text explicitly states: "Clinical evaluation is not required for this submission to support substantial equivalence." This further indicates that the type of studies and data provenance you are asking about (which are typical for AI/ML diagnostic devices) were not part of this 510(k) submission.

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

The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection 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 RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is prescription use only. The pump assembly is composed of a durable pump and a disposable, single-use cassette with a userfilled 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 subject device has updated branding and also modifies the predicate device to be used with an additional infusion set.

The provided text describes a 510(k) summary for the RemunityPRO™ Pump for Remodulin® (treprostinil) Injection. This is a submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to establish acceptance criteria for an entirely new device or an AI algorithm. Therefore, many of the requested categories related to medical AI studies (like expert involvement, MRMC studies, or training sets) are not applicable.

The core of this submission is to show that the minor changes to an existing device (the RemunityPRO™ Pump compared to the Remunity® 2.0 Pump) do not raise new questions of safety or effectiveness. The primary change highlighted is the addition of compatibility with an additional infusion set.

Here's an attempt to fill in the requested information based on the provided text, noting where information is not applicable to this type of regulatory submission:

Acceptance Criteria and Device Performance

The provided document details a comparison between the subject device (RemunityPRO™ Pump) and its predicate (Remunity® 2.0 Pump). The "acceptance criteria" can be inferred from the performance characteristics of the predicate device, which the subject device is shown to match or be equivalent to.

Study Details

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

   • The document states: "Bench performance testing was conducted in order to qualify the additional infusion set for use with the subject device, and to establish substantial equivalence to the predicate device in terms of safety and effectiveness."
   • Specific sample sizes for these bench tests are not provided in the summary.
   • Data provenance is not specified, but it would typically be internal laboratory testing by DEKA Research & Development Corp.

2. 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):

   • Not Applicable. This is a bench performance study for a physical medical device (infusion pump), not a study involving interpretation of medical data by experts to establish ground truth for an AI algorithm. The performance metrics are objective and measurable (e.g., flow rate accuracy, occlusion alarm time).

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

   • Not Applicable. As this is a bench performance study of a physical device, there is no "adjudication" in the sense of resolving discrepancies between human readers or AI outputs. The tests involve direct measurement against established physical standards.

4. 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-assisted diagnostic or interpretative device; it's an infusion pump. Therefore, an MRMC study is not relevant.

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

   • Not Applicable. While the pump contains a microprocessor and control algorithms, the "standalone" context typically refers to the performance of an AI algorithm in isolation for diagnostic tasks. This device is a complete system with mechanical, electronic, and software components, and its performance is evaluated as a whole in bench testing.

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

   • The "ground truth" for this type of device performance would be established physical and electrical measurement standards, regulatory standards (e.g., IEC 60601-2-24 for infusion pumps), and the known performance characteristics of the predicate device. These are objective engineering and regulatory requirements, not medical "ground truth" derived from patient data or expert consensus.

7. The sample size for the training set:

   • Not Applicable. This device, while containing software, is not an AI/ML-driven device that undergoes a "training" phase in the context of machine learning. Its operation is based on programmed control logic and physical components.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no AI/ML training set, this question is not relevant.

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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 Belmont Rapid Infuser RI-2 is designed to be used in general or alternative care environments to provide warmed blood and fluids to any patients ≥ 10 kg requiring warmed infusion from 2.5 mL/min to 1000 mL/min. - Infusion of crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery. - Infusion of warmed fluid to rewarm patients after surgery or for hypothermia. - Infusion of warmed fluid for irrigation in urology procedures. The 3.0L reservoir is an optional accessory for use in adults only.

The Belmont® Rapid Infuser, RI-2 combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluids. The Rapid Infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set rates from 10 to 1000 milliliters per minute (mL/min). Low infusion rates of 2.5 mL/min (150 mL/hr) and 5.0 mL/min (300 mL/hr) are also available to keep the venous line open. The system monitors temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid infused, temperature of the infusate, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation. A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation limited to 50mL/min and safety monitoring remain active.

The provided text describes the regulatory clearance for the "Belmont Rapid Infuser, RI-2" and its substantial equivalence to a predicate device. However, it does not contain a study that quantitatively proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy (like sensitivity, specificity, accuracy, etc., which are common for AI/ML medical devices). The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device, primarily through comparison of technical specifications and non-clinical performance testing.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for test and training sets) are not explicitly present in this regulatory submission.

The acceptance criteria mentioned are related to:

• Flow rate accuracy: ± 10% from 20 – 1000 mL/min, ± 25% for 2.5, 5.0, 10 mL/min.
• Steady state fluid output temperature: 37.5°C at high flow (60 mL/min and higher); 39°C at low flow (less than 60 mL/min).
• High temperature alarm condition: Output temperature >42°C for 20 mL of fluid pumped or fluid temperature >45°C for 0.25 seconds.
• Maximum speed for steady state 37°C: 1000 mL/min.
• Pressure limit: 300 mmHg standard (user adjustable).
• High pressure alarm: At 400 mmHg.
• Battery running time: 30 minutes @ 50 mL/min.
• Compliance with various international standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62304, ISO 10993-1.

Here's the information that can be extracted, along with explanations for unavailable data:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
Not applicable/Provided. The document describes "Non-clinical performance testing" and "Bench / Performance Testing" but does not specify sample sizes for these tests in terms of patient data or clinical cases. The tests are focused on device specifications and regulatory compliance rather than statistical performance on a clinical dataset. The nature of the device (infusion pump) typically relies on engineering and laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Provided. This type of information is typically relevant for AI/ML devices where human experts establish ground truth for diagnostic or prognostic tasks. For an infusion pump, "ground truth" is established by instrument calibration and physical measurement standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Provided. This is specific to human-read diagnostic tasks.

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 device is an infusion pump, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/relevant for this type of medical device functionality. The concept of "standalone performance" is typically applied to AI/ML algorithms performing diagnostic or analytical tasks. This device is a mechanical-electronic system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For performance parameters like flow rate, temperature, pressure, etc., the "ground truth" is established by precise physical measurements using calibrated equipment and reference standards in a laboratory setting. For safety and regulatory compliance (e.g., electrical safety, EMC, biocompatibility), the ground truth is adherence to the specified international standards.

8. The sample size for the training set:
Not applicable/Provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established:
Not applicable/Provided, as there is no training set for this type of device.

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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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