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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.

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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:

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The BD Intelliport™ System is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients.

The BD Intelliport™ System allows the clinician to record anesthesia-related medication administration events during pre-procedure, intra-procedure and recovery phase. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.

The BD Intelliport™ System is intended for patients with body weights >20 kg.

Do not use the BD Intelliport™ System with blood, blood products, biologics, or chemotherapeutics.

BD Intelliport™ System integrates into an intravenous line and automatically captures information about the anesthesia medications administered to the patient. It wirelessly transmits anesthesia medication administration information to the patient's Electronic Medical Record (EMR) via hospital server applications (Gateway software). The BD Intelliport™ System provides core technologies that enable key functions of the system:
• Medication Identification: Informs clinician of medication and concentration along with any informational notifications such as patient allergy and expired medication reminders. This occurs when syringes with the correct type of RFID encoded label are attached.
• Dose Measurement: Measures volume of drug administered to the patient through the system, then calculates dose weight.
• Automatic Charting: Wirelessly transmits measured doses to the EMR.

The following are the main system components:
• BD Intelliport™ Injection Site which is comprised of the following two components:

• BD Intelliport™ Sensor
• BD Intelliport™ Reader
  • BD Intelliport™ Mount (optional accessory)
  • BD Intelliport™ 2-Bay Charger (accessory)
  • BD Intelliport™ Gateway

The provided FDA 510(k) clearance letter and summary for the BD Intelliport™ System (K243062) describes the performance testing conducted to demonstrate substantial equivalence to its predicate device (K182092). However, it does not provide specific acceptance criteria or reported device performance values in a quantifiable table format, nor does it detail a standalone study with quantitative results, or a multi-reader multi-case (MRMC) comparative effectiveness study.

The document primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics and a list of performance tests completed.

Here's an attempt to structure the answer based on the available information, with caveats where data is missing:

Acceptance Criteria and Device Performance

The 510(k) summary states that "The subject device, the BD Intelliport™ System, has met all predetermined acceptance criteria for the non-clinical and human factors testing conducted in accordance with relevant FDA guidance, recognized consensus standards, and internal requirements." However, the specific numerical acceptance criteria and the quantitative reported device performance values for most tests are not explicitly stated in the provided document.

The only quantitative performance criteria and reported values mentioned are for "Volume measurement accuracy" and "Volume Measurement Resolution."

Note: The document states these are "Identical" to the predicate device, implying the reported performance matches the specified criteria.

Study Information

Due to the nature of a 510(k) summary, detailed study reports with specific quantitative results (beyond volume measurement accuracy) are not included. The document generally refers to "performance testing" and "human factors evaluation."

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

   • Test Set Sample Size: Not explicitly stated for each test. For "Volume Measurement Performance Window," the volume range tested was 0.5ml to 30ml, and average push speed 10ml/min to 400 ml/min. This implies tests were conducted across this range, but the number of injections or trials is not provided.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be non-clinical (laboratory-based) and human factors studies. The human factors testing likely involved simulated clinical environments.

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

   • Not applicable/Not provided within the scope of this 510(k) summary. These types of details are usually found in full study reports, not the summary itself, especially for a device that primarily automates record-keeping and measurement, rather than making diagnostic assessments that require expert ground truth. The human factors testing involved "intended device users," but their specific qualifications or roles in establishing "ground truth" (in a diagnostic sense) are not outlined.

3. Adjudication method for the test set:

   • Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where there is disagreement in expert interpretation of diagnostic data. This device automates measurements and record-keeping, so such a method is not relevant.

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, an MRMC comparative effectiveness study was not explicitly reported or appears not to have been the primary method for demonstrating substantial equivalence. The device's primary function is "automated record keeping" and facilitating "documentation of the medications." It improves efficiency and accuracy of recording medication administration, rather than assisting human readers in interpreting medical images or data. The human factors evaluation assessed "critical tasks completed by intended device users," implying usability and user performance with the system, not a comparison of expert diagnostic accuracy with and without AI.

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

   • The document implies that standalone (algorithm-only) performance testing was conducted for various technical attributes. For example, "Bolus volume measurement accuracy," "Sensor flow rate," "Decoding response time," "Wifi functionality," and "Dose transmission time" are intrinsic functions of the system and its algorithms, which would have been tested independently of a human operator to verify their technical specifications. The "Flow Algorithm" itself was updated and "qualified through verification testing." However, explicit, detailed results from a standalone study with acceptance criteria are not presented in a formal table like format for all algorithm-driven functions.

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

   • For the technical performance tests (e.g., volume measurement), the "ground truth" would have been established using calibrated instruments and reference standards (e.g., known volumes, known flow rates) in a laboratory setting.
   • For the human factors evaluation, the "ground truth" would be defined optimal task performance and safety outcomes as determined by medical device standards and clinical best practices.

7. The sample size for the training set:

   • The document does not provide information on a training set size. The BD Intelliport System involves embedded software and algorithms (e.g., flow algorithm, RFID reading, EMR communication). While such systems often involve development and testing cycles, the summary does not detail a specific "training set" like one would find for a machine learning or AI algorithm that learns from data in a traditional sense. The "Flow Algorithm" was updated and "qualified through verification testing," which implies validation against known physical models or experimental data, rather than a statistical "training set" in the context of deep learning.

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

   • As no "training set" is explicitly mentioned for a machine learning model, this question is not applicable in the context of the provided information. The "ground truth" for verifying the updated flow algorithm would have been established through physical experiments and engineering measurements with known parameters (e.g., precise drug volumes, flow rates) to ensure the algorithm accurately processes the sensor data.

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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.

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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 LifeShield™ Infusion Safety Software Suite is a collection of software products that facilitates networked communication between compatible systems. The Infusion Safety Software Suite provides trained healthcare professionals the ability to manage data for compatible infusion pumps. All data entry and validation of infusion parameters on compatible infusion pumps is performed by a trained healthcare professional. LifeShield™ Infusion Safety Software Suite is indicated for use in patients including adult, pediatric and neonate undergoing infusion therapy with connected compatible infusion pumps (as per the indications for use specified for the compatible infusion pump).

The LifeShield™ Drug Library Management (DLM) software product is intended to be used by pharmacists to create, configure, edit, and manage drug library data, including infusion pump settings, for use with compatible infusion pumps. Drug library contents are constructed based on the healthcare provider's defined best practices.

The LifeShield™ Clinical Dashboards & Reports (CDR) software product provides trained healthcare professionals with the capability to view and manage infusion information collected from compatible infusion pumps. Healthcare professionals may choose to use the collected infusion information to support continuous quality improvement programs, or to analyze and trend various aspects of the infusion pumps and therapies used. It is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.

The LifeShield™ Data Flow Management (DFM) software product is intended to facilitate bi-directional communication with compatible infusion pumps, information technology systems, and other LifeShield™ Infusion Safety Software Suite products. LifeShield™ DFM provides a way to automate the programming of infusion parameters, thereby decreasing the number of manual steps necessary to enter infusion data. LifeShield™ DFM forwards infusion-related information received from the infusion pump to compatible information technology systems.

The LifeShield™ Infusion Safety Software Suite is a cloud-based platform provided as a software-as-a-service (SaaS) designed to be compatible with the Plum Duo™ Precision IV infusion pump and Plum Solo™ Precision IV infusion pump. The LifeShield Infusion Safety Software Suite is hosted by Amazon Web Services (AWS) as its cloud provider.

LifeShield™ Infusion Safety Software Suite consists of a collection of software services which, when used together, provide a comprehensive set of data management capabilities for trained healthcare professionals when working with infusion pumps. LifeShield™ Infusion Safety Software Suite does not remotely control or program the infusion pump or provide the ability to remotely manage pump alarms such as real-time monitoring, clearing and silencing alarms.

The LifeShield™ Drug Library Management (DLM) software is used by pharmacists to create approved drug libraries that can be downloaded by the infusion pumps. The latest software version introduces enhancements to its user interface and additional drug library settings for support of Plum Duo™ and Plum Solo™ pumps.

The LifeShield™ Clinical Dashboards & Reports (CDR) software is used by clinical administrators to view infusion or device-related information received from the infusion pumps via the LifeShield™ DFM. The information presented by the software does not create decisions or treatment pathways for patients. The latest version of the software improves the data presented for ongoing infusions and dashboards.

LifeShield™ Data Flow Management (DFM) software facilitates bidirectional communications between the infusion pump and hospital information systems (HIS); it routes pharmacy-validated orders to the connected pumps and infusion-related information to the HIS. The latest software version adds the ability to forward alarms to the HIS.

The provided FDA 510(k) clearance letter for the LifeShield™ Infusion Safety Software Suite (K242117) does not contain the specific details required to construct a table of acceptance criteria with reported device performance, nor does it detail a study that proves the device meets specific performance criteria in terms of accuracy or clinical outcomes.

This document primarily focuses on demonstrating substantial equivalence to a predicate device (K223606) based on non-clinical testing (design verification, design validation, cybersecurity, risk management, and human factors) and software modifications, rather than performance metrics related to clinical accuracy or diagnostic capabilities (which would be more common for AI/ML devices in image analysis, for example).

The submission explicitly states:

• "Summary of Clinical Testing: Not applicable. A clinical study is not required for this submission to support substantial equivalence."

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. The device is a software suite for managing infusion pump data, not an AI/ML diagnostic or predictive tool that would have performance metrics like sensitivity, specificity, or AUC against a ground truth of disease.

However, I can extract information related to the types of testing performed and what they aimed to prove, which indirectly serve as acceptance criteria for this type of software device.

Analysis of Acceptance Criteria and Study Details based on the Provided Document

Given the nature of the device (infusion safety software suite) and the information provided in the 510(k) summary, the "acceptance criteria" here are aligned with software quality, safety, and functionality, rather than clinical performance metrics typically associated with AI/ML diagnostic tools.

The study proving the device meets acceptance criteria is a comprehensive set of non-clinical tests described below, rather than a single clinical trial.

1. Table of Acceptance Criteria and the Reported Device Performance

Since this is not an AI/ML diagnostic device with performance metrics like accuracy, sensitivity, or specificity against disease presence, the "acceptance criteria" relate to software design, functionality, safety, and usability. The document reports that all these tests "pass established acceptance criteria."

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

• Test Set Sample Size: The document does not specify a "sample size" in terms of patient data or clinical cases. For software verification and validation, the "test set" would consist of numerous test cases, simulated use scenarios, and functional tests. These numbers are not detailed in the summary.
• Data Provenance: Not applicable in the traditional sense of patient data. The testing is focused on software functionality, safety, and usability. There is no mention of retrospective or prospective data collection from patients or clinical settings for performance evaluation.

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

• Ground Truth Establishment: For this type of software, "ground truth" isn't established by clinical experts in the same way it would be for a diagnostic image. Instead, it's defined by design specifications, regulatory requirements, industry standards (e.g., IEC 62304, ISO 14971, IEC 62366-1), and best practices in software engineering and cybersecurity.
• Experts: The development team, regulatory affairs, quality assurance, and potentially third-party cybersecurity and human factors experts would define and verify these "ground truths" (i.e., whether the software behaves as intended and safely). The specific number or qualifications of these internal or external experts is not detailed in the provided K summary. The human factors study implies the use of representative users (trained healthcare professionals), but not necessarily "experts" defining a ground truth about a medical condition.

4. Adjudication Method for the Test Set

• Not applicable in the context of clinical expert adjudication of medical cases. Adjudication in software testing would involve bug reporting, resolution, and re-testing processes managed by the development and QA teams, not described here.

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

• No, an MRMC study was not done. The document explicitly states: "Summary of Clinical Testing: Not applicable. A clinical study is not required for this submission to support substantial equivalence." An MRMC study is a type of clinical study often done for diagnostic AI to compare human performance with and without AI assistance. This device is not a diagnostic AI.

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

• This concept is not directly applicable. The "LifeShield™ Infusion Safety Software Suite" is inherently a human-in-the-loop system designed to assist trained healthcare professionals. It manages data, facilitates communication, and supports drug library management but does not "decide" or "treat" on its own. Its "standalone" performance would pertain to its functional correctness in processing data and facilitating communication, which is covered by the general "design verification" and "performance" testing.

7. The Type of Ground Truth Used

• The "ground truth" for this software pertains to its functional correctness, adherence to specifications, safety requirements, cybersecurity posture, and usability standards. It is not based on clinical "outcomes data" or "pathology" in the medical sense, but rather on:
  • Design Specifications: Whether the software performs its programmed functions as intended.
  • Regulatory Standards: Compliance with relevant medical device software (IEC 62304), risk management (ISO 14971), and human factors (IEC 62366-1) standards.
  • User Needs/Requirements: Whether the software meets the needs of its intended users in its intended environment.

8. The Sample Size for the Training Set

• Not applicable. This device is a software suite, not an AI/ML model that undergoes a "training phase" with a distinct "training set" of data to learn patterns. The software's capabilities are based on explicit programming and configuration, not machine learning from a dataset.

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

• Not applicable, as there is no "training set" for this type of software.

In summary, the FDA 510(k) clearance for the LifeShield™ Infusion Safety Software Suite is based on a demonstration of substantial equivalence to a predicate device through extensive non-clinical software verification and validation, risk management, cybersecurity testing, and human factors analysis. The "acceptance criteria" are related to software quality, safety, and functionality, rather than clinical performance metrics against a medical ground truth or AI model training 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.

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The VIA360™ Surgical System is indicated for delivery of controlled amounts of viscoelastic fluid during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.

The VIA360™ Surgical System is a manually operated surgical instrument used by ophthalmologists to deliver controlled amounts of ophthalmic viscoelastic fluid into the anterior segment of the eye. The VIA360™ Surgical System is comprised of a surgical-grade stainless steel cannula and a nylon microcatheter. The cannula is attached to a nose piece that can be rotated to a desired position for use in either eye. The microcatheter is advanced and retracted up to 40 mm per cycle by rotating the scroll wheel. The microcatheter has patterned markings every 10 mm to help measure the extended length. A controlled amount of viscoelastic fluid is dispensed through multiple outlets located on the microcatheter's distal tip by depressing the scroll wheel or the surrounding button. An external reservoir is included for the purpose of priming the device. The device is single-use only.

The provided text describes the 510(k) submission for the VIA360™ Surgical System. This device is a manually operated surgical instrument for ophthalmic procedures, specifically for delivering viscoelastic fluid and cutting trabecular meshwork tissue.

Based on the document, it's clear that this is not a submission for an AI/ML medical device. The device is a physical, manually operated surgical instrument. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, etc.) are not applicable to this submission.

The acceptance criteria and device performance evaluation detailed in the document are for a physical medical device, not a software or AI/ML product.

Here's a breakdown of the acceptance criteria and study information provided for the VIA360™ Surgical System, as it pertains to a physical device:

Acceptance Criteria and Reported Device Performance

Study Details (Non-AI/ML Device):

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

   • The document does not specify a numerical sample size for "test sets" in the context of typical AI/ML validation datasets. Instead, it refers to "samples" or "units" for each specific non-clinical test (e.g., "All samples met the acceptance criteria" for visual inspection). The number of samples for each test is not detailed.
   • Data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), as this is non-clinical performance and biocompatibility testing of a physical device.

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

   • Not applicable. This is a physical device; ground truth in the AI/ML sense (e.g., for image annotations) is not relevant. The "ground truth" here is compliance with engineering specifications, material properties, and biological safety standards.

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

   • Not applicable. This is not a human-in-the-loop diagnostic study requiring adjudication.

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 is a physical surgical device, not an AI-assisted diagnostic tool.

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

   • Not applicable. Again, this is not an algorithm. The "performance" is the physical function and safety of the device itself, evaluated through non-clinical bench testing.

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

   • For this physical medical device, the "ground truth" is defined by established engineering standards (ASTM, ISO), biocompatibility guidelines (ISO 10993 series), and the functional requirements of the device (e.g., accurate fluid dispense, sufficient joint strength). Compliance with these defined standards and specifications forms the basis of "truth."

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/ML model for this physical device. Device design and manufacturing processes are iterative but not "trained" in this manner.

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

   • Not applicable for the same reason as point 7.

Key takeaway from the document: The applicant demonstrates substantial equivalence for the VIA360™ Surgical System by comparing its design, materials, and non-clinical performance data to a legally marketed predicate device (OMNI Surgical System). The 510(k) summary explicitly states: "Clinical data is not included in this submission and is not required. Substantial equivalence is based on technological comparison." This further confirms that no AI/ML specific evaluations (which often require clinical data or extensive simulation/test data for model validation) were conducted or needed.

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