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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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