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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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Vial access devices with SmartSite™ are standalone, single-vial use, disposable devices which provide access to a medication vial without the use of a needle during medication preparation. BD standalone vial access devices are not intended to be used on a patient.

Vial access devices with SmartSite™ are standalone, single-vial use, disposable devices which permit access to a medication vial without the use of a needle during medication preparation. Vial access devices with needle-free connectors are available in two configurations: 13 mm or 20 mm.

The provided text describes a 510(k) premarket notification for a medical device, the "BD SmartSite™ 13mm Vial Access Device" and "BD SmartSite™ 20mm Vial Access Device." This document focuses on demonstrating substantial equivalence to a predicate device rather than outright performance against specific acceptance criteria for a novel device or AI algorithm.

Therefore, the typical structure for acceptance criteria and human-in-the-loop studies for AI algorithms is not applicable to this document. This submission details the safety and performance testing to show that a new version of a device (subject device) is comparable to an already cleared device (predicate device).

Here's an analysis of the provided information, framed within the context of demonstrating substantial equivalence, and noting where the requested AI-specific information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of a specific table for acceptance criteria vs. device performance for a novel AI device, this document lists various bench and non-clinical tests performed according to recognized consensus standards. The "acceptance criteria" here implicitly refer to meeting the specifications of these standards to demonstrate safe and effective performance, thus supporting substantial equivalence.

The document states: "All test results met their acceptance criteria and support that the BD SmartSite™ Vial Access Device is substantially equivalent to the predicate SmartSite Access Pin."

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

The document does not specify exact sample sizes for each non-clinical test. It lists the standards followed (e.g., ISO, ASTM, USP), which inherently define the methodologies and often the sample sizes for such tests.

Data provenance isn't described in terms of "country of origin" or "retrospective/prospective" as typical for clinical data or AI training data. Instead, the tests were conducted according to recognized international standards and FDA guidance documents.

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

This information is not applicable as the device is not an AI algorithm requiring expert ground truth for image interpretation or similar tasks. The "ground truth" for these tests are the objective measurements against the specified performance parameters in the standards (e.g., proper fitting, no leaks, meeting particulate limits, etc.).

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. Testing involves objective measurements and adherence to specified standard protocols, not subjective expert adjudication.

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 is not applicable. The device is an intravenous administration set component, not an AI algorithm, and therefore no MRMC study or AI assistance evaluation was performed or required.

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

This is not applicable as the device is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical and bench testing presented in this submission is based on objective measurements defined by the referenced national and international consensus standards (e.g., ISO, ASTM, USP). Examples include:

• Measurement of luer taper conformance.
• Detection of leaks using specific pressure tests.
• Counting particulate matter within specified limits.
• Assessment of biological responses in accordance with biocompatibility standards (e.g., cytotoxicity, sensitization).
• Validation of sterilization efficacy.

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI algorithm that requires a training set.

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

This is not applicable for the same reasons as point 8.

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The BD Texium™ Needle-Free Syringe is a sterile, single-use closed system drug transfer device (CSTD) incorporating a bonded Texium™ Closed Male Luer and Syringe, intended for preparation and administration of hazardous and nonhazardous drugs when pared with the SmartSite™ Needle-free Connector (NFC). When paired with devices containing a SmartSite™ NFC the BD Texium™ Needle-Free Syringe mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ Needle-Free Syringe/ SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks, and spills. (e.g., airtight, leak-free and drip-free).

The BD Texium™ Needle-Free Syringe is a single use piston syringe that consists of a syringe (3mL, 5mL, 10mL, 20mL, 30mL, or 50mL) permanently bonded to a closed male luer device (BD Texium™ Closed Male Luer, K223076). The Texium" Syringe is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all phases of drug handling when the BD Texium™ Needle-Free Syringe is used in conjunction with the SmartSite™ Needle-Free Connector: the preparation of the drug, the administration of the drug to the patient, and waste handling. The BD Texium™ Needle-Free Syringe is a passive device – it requires no cap and automatically seals upon disconnection.

The BD Texium™ Needle-Free Syringe has a unique closed male luer connector that is intended to be used with the currently marketed BD SmartSite™ Needle-Free Connector. As with the predicate device, the male luer design of the BD Texium™ Needle-Free Syringe includes an internal mechanism that causes the luer to seal when disconnected from a female luer. In doing so, it prevents the dripping or accidental spillage of fluids that otherwise occur when using a standard, unsealed male luer. When used with the BD SmartSite" Needle-Free Connector, the BD Texium™ Needle-Free Syringe is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy drugs. Furthermore, the BD Texium™ Needle-Free Syringe mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside of BD Texium™ Needle-Free Syringe/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks, and spills (e.g., airtight, leak-free and drip-free).

The provided text describes the BD Texium™ Needle-Free Syringe and its substantial equivalence to predicate devices, but it does not include specific acceptance criteria or reported device performance in a format that allows for a direct table comparison for all requested metrics.

However, based on the Discussion of Non-Clinical Tests and Performance Testing sections, I can infer some of the tests performed and their general outcomes. The document states "All test results met their acceptance criteria," but does not explicitly list those criteria numerically. No training set information is provided as this is a non-AI/ML device.

Here's an attempt to answer your questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific numerical acceptance criteria and reported performance for all aspects. Instead, it indicates that all tests met their acceptance criteria. Here's a summary of the mentioned performance testing, acknowledging the lack of specific numerical criteria in the provided text:

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The BD Alaris 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 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 System is an interoperable of communicating and exchanging data with compatible information technology systems.

The BD Alaris System 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. The EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).

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

The BD Alaris System with Guardrails Suite MX v12 is a modular infusion and monitoring system designed to provide accurate, automated infusion of a broad range of drugs and fluids, and to provide monitoring of respiratory parameters. The BD Alaris System with Guardrails Suite MX v12 has three major components:

• System Hardware: a core hardware unit with user interface (BD Alaris PC Unit or PCU) and attachable modules each with . a distinct function.
• . Guardrails Suite MX Software: software applications for support and interaction with the system hardware (BD Alaris System Manager, BD Alaris Guardrails Editor, and BD Alaris System Maintenance).
• Interoperability Software: applications for bi-directional communication between the PCU/attached modules and an . electronic medical records (EMR) system. (Care Coordination Engine, Infusion Adapter, and Calculation Services).

The PCU is the core of the BD Alaris System with Guardrails Suite MX v12 and powers, programs, and monitors the attached 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 inter-unit interface connectors built into both sides of the PCU and modules.

The attachable modules are dedicated to infusion of fluids/medication, patient-controlled administration of analgesics, monitoring of end-tidal carbon dioxide, and scanning identifications of patient, physician, and infusates into the system.

Each system must include a PCU. The rules for attachment of the modules are as follows:

• · The PCU is designed to operate a maximum of four infusion or monitoring modules. Modules added in excess of four are not recognized, with the exception of the Auto-ID Module that can be included as a fifth module.
• · Up to four Pump or Syringe Modules may be attached to a PCU at one time
• Only one PCA and one EtCO2 module can be included within the four attached influsion or monitoring modules, since each BD Alaris System v12 is dedicated to a single patient.
• In order to keep the PCU with attached modules well balanced when attached to a pole, it is important to distribute the . modules as evenly as possible on both sides of the PCU unit.

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

Communication occurs within the PCU or modules, and between the PCU and attached modules. Communication between the units is by direct electrical connection through the mechanical supports on each side of the PCU and modules.

The PCU with its attached modules is designed to communicate and interact with the BD Alaris System with Guardrails Suite MX v12 software applications including software for interoperability with electronic medical records (EMR) systems. Communication between the PCU and the software application is accomplished through either a direct serial connection with the PCU or through a wireless connection with the PCU. If communication is interrupted, the PCU and modules will continue to function as programmed, but clinicians will need to make changes or inputs manually.

It is important to note that interoperability of the BD Alaris System v12 does not include remote control of the BD Alaris System v12 components. 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 before they are activated.

The provided FDA 510(k) summary for the BD Alaris System with Guardrails Suite MX v12 explicitly states a "Summary of Non-Clinical Testing" and "No animal data was generated", and "No clinical data was generated". Therefore, the device performance is reported from non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

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The BD Alaris™ Pump Epidural Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through the epidural route for adults, pediatrics and neonates.

The BD Alaris™ Pump Epidural Infusion Set is an administration set consisting primarily of bag spike, vent cap, drip chamber, tubing (including pump segment), safety clamp, roller clamp, male NRFit™ connector, and male NRFit™ cap. The drip chamber cap located at the proximal end of the administration set, and the male NRFit™ cap, located at the distal end of the administration set, maintain sterility of the fluid path prior to usage. The spike located on the proximal end of the drip chamber is inserted into a prepared fluid container. The male NRFit™ connector enables connection of the administration set to a compatible female NRFit™ connector on the patient's epidural catheter. The BD Alaris™ Pump Epidural Infusion Set is intended to interface with the BD Alaris™ Pump Module. The device is supplied fluid-path sterile using gamma irradiation, in a perforated pouch, is non-pyrogenic, and is for single-use only. The device tubing is color-coded with a yellow stripe to signify administration of medication intended for an epidural route of administration. The BD Alaris™ Pump Epidural Infusion Set is not intended for gravity administration. The device is intended for prescription use only. DEHP or natural rubber latex are not part of the material formulation.

The BD Alaris™ Pump Epidural Infusion Set is designed to deliver medications intended for the epidural route of administration. The NRFit™ connector conforms to ISO 80369-6, Small-bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The NRFit™ connector is not compatible with the standard luer connector commonly used for intravenous infusion. The addition of the NRFit™ connector eliminates the risk of misconnection that may result in infusion of medications not intended for an epidural route of administration.

The provided document is a 510(k) summary for the BD Alaris™ Pump Epidural Infusion Set. It describes non-clinical safety and performance testing to demonstrate substantial equivalence to a predicate device, rather than a study proving that an AI device meets acceptance criteria. Therefore, most of the requested information regarding AI device evaluation is not applicable or available in this document.

However, I can extract information related to the general acceptance criteria and studies performed for this medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All testing met pre-established acceptance criteria and successfully demonstrated that the device... is safe for its intended use and performs as intended." However, it does not provide a specific table with detailed numerical acceptance criteria for each test and the corresponding device performance results. The testing was conducted according to various FDA recognized and internal consensus standards, implying that the acceptance criteria are inherent within these standards.

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

The document does not specify the sample sizes used for the various non-clinical safety and performance tests. It also does not mention data provenance in terms of country of origin or whether the tests were retrospective or prospective since these are non-clinical bench and lab tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable. This is a submission for a mechanical medical device (infusion set), not an AI device that requires expert-established ground truth for performance evaluation such as image interpretation.

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

This information is not applicable. Adjudication methods are typically relevant for clinical studies involving human interpretation or decision-making, which is not the case for this non-clinical submission.

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:

This information is not applicable. An MRMC study is relevant for AI devices assisting human readers/interpreters, which is not what the BD Alaris™ Pump Epidural Infusion Set is.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

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

For this device, "ground truth" would correspond to the established physical and chemical properties, functionality, and safety requirements defined by international standards (e.g., ISO, AAMI, ASTM) and FDA guidance documents. The device's performance was measured against these predefined specifications. For example, for biocompatibility, the ground truth is defined by the passing criteria of ISO 10993 tests.

8. The sample size for the training set:

This information is not applicable. This is not an AI device that requires a training set.

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

This information is not applicable. This is not an AI device that requires a training set or its associated ground truth establishment.

Summary of relevant information from the document (focused on device evaluation):

• Acceptance Criteria: Implicitly defined by the numerous FDA recognized and internal consensus standards followed, including:
  • Human Factors: ANSI/AAMI HE75: 2009 (R2013), IEC 62366-1: Edition 1.0 2015.
  • Functional/Bench/System Testing: ISO 8536-4: 2010/Amd1: 2013(E), ISO 8536-8: 2015, ISO 80369-1: 2018, ISO 80369-6: 2016, ISO 80369-20: 2015. Specific tests listed: Flow Rate Accuracy, Bolus Accuracy, Air-in-Line, Upstream Occlusion Time-to-Alarm, Post Occlusion Bolus & Downstream Occlusion Time to Alarm.
  • Biocompatibility: ISO 10993-1, ISO 10994-5, ISO 10993-10, ISO 10993-23, ISO 10993-11, ASTM F756-2017, ISO 10993-4, USP 41 General Chapter , ISO 10993-3, ISO 10993-12, ISO 10993-17, ISO 10993-18.
  • Sterilization and Shelf Life/Packaging: ISO 11137-1, ISO 11137-2, ISO 11737-1, ANSI/AAMI ST72, ASTM D4728-17, ASTM D4169-16, ASTM D5276-19, ASTM F1980-16, USP 41 General Chapter , USP 41 General Chapter .
• Studies Performed: Non-clinical safety and performance testing were conducted to demonstrate substantial equivalence to the predicate device. These included:
  • Human factors testing.
  • Functional, bench, and system testing (e.g., flow rate accuracy, air-in-line, occlusion time-to-alarm).
  • Biocompatibility testing.
  • Sterilization and shelf life/packaging testing.
• Device Performance: All testing met pre-established acceptance criteria, demonstrating that the device is safe for its intended use and performs as intended. Specific quantitative results are not provided in this summary.
• Ground Truth: For non-clinical tests, the "ground truth" is defined by the pass/fail criteria and specifications outlined in the referenced national and international standards.
• Clinical Data: No clinical data were included in the submission.

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The BD Alaris™ Pump Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through intravenous, intra-arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults.

The BD Alaris™ Pump Infusion Set is designed to interface with the BD Alaris™ Pump Module or to be used for gravity infusion. The BD Alaris™ Pump Infusion Set is a single-use infusion set that is available in various configurations of the following components: fluid container spike, vent cap, drip chamber, pump segment assembly, roller clamp and/or pinch clamp, SmartSite™ Y-sites, check valve and male luer lock connector. The drip chamber cap located at the proximal end of the infusion set and the male luer lock cap located at the distal end of the infusion set maintain sterility of the fluid path prior to use. The spike located on the proximal end of the drip chamber is inserted into a fluid container. The infusion set is supplied fluid-path sterile using gamma irradiation and is non-pyrogenic.

The BD Alaris™ Pump Infusion Sets are infusion sets used by healthcare professionals for administering fluids and medications. The device's performance was evaluated through non-clinical design verification testing, including functional, bench, system, and biocompatibility tests. No clinical data was included in the submission.

Here is a summary of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each non-clinical test performed. It generally refers to "Design verification testing" and "Performance testing completed on the subject device." The testing would have been conducted internally by CareFusion/BD.

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

Not applicable, as this was a non-clinical premarket notification (510(k)) for a medical device (infusion set), not an AI/software device requiring expert interpretation of results for ground truth establishment. The "ground truth" here is defined by engineering standards, physical measurements, and biological compatibility test results.

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

Not applicable, as this was not a study involving human reader interpretation or clinical 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. No MRMC study was conducted as this device is an infusion set, not an AI or imaging device requiring human-in-the-loop performance evaluation.

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

Not applicable. This is a medical device, not a software algorithm. The "standalone performance" would be the device functioning according to its specifications, which was evaluated through the functional and performance tests.

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

The "ground truth" for the non-clinical testing was based on:

• Established engineering and performance standards: e.g., ISO 8536-4 for gravity flow rate, AAMI TIR101:2021 for flow rate and bolus accuracy.
• Biocompatibility standards: e.g., ISO 10993 series and USP .
• Sterilization and shelf-life standards: e.g., ISO 11137 series and ASTM standards.
• FDA guidance documents: for various aspects like microbial ingress and general infusion pump lifecycle.
• Internal protocols: where specific external standards might not cover all aspects.

8. The sample size for the training set:

Not applicable. This is a medical device, not an AI/machine learning model that requires a training set.

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

Not applicable, as there was no training set.

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The BD Secondary Set is indicated for continuous or intermittent delivery of IV fluids, medications, including lipids, through intravascular routes of administration. The BD Secondary Set may be used with any patient with consideration given to the procedure being performed and fluids being infused.

The BD Secondary Infusion Set is an administration set consisting primarily of a bag spike, drip chamber, tubing, roller clamp, micro luer lock connector, and a hanger. The drip chamber cap is located at the proximal end of the administration set, and the micro luer lock cap is located at the distal end of the administration set. The bag spike, located on the proximal end of the drip chamber is inserted into a prepared fluid container. The BD Secondary Infusion Set is supplied as fluid-path sterile using gamma irradiation in a perforated pouch, is non-pyrogenic, and is for single-use only. The BD Secondary Infusion Set is for gravity administration. The device is intended for prescription use (RX) only. DEHP or natural rubber latex are not part of the material formulation. The set can be used for up to 7 days (168 hours) provided the set is continuously attached to the primary administration set.

This request is about a medical device, not an AI/ML powered device. The document describes a 510(k) premarket notification for a medical device called the "BD Secondary Infusion Set." It does not involve any AI or machine learning components. Therefore, the questions related to acceptance criteria and studies for AI/ML performance (such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical safety and performance testing, and biocompatibility testing. It explicitly states: "Not Applicable. There are no clinical data included in this submission."

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several FDA-recognized consensus standards that the device met. It states: "The subject device met the applicable test specifications and acceptance criteria as described in the submission." However, it does not provide a table with specific numerical acceptance criteria and reported performance values. It only lists the standards themselves:

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

• Sample size: Not specified. The document states "bench and nonclinical testing" was conducted according to various standards, but does not detail the sample sizes for these tests.
• Data provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by CareFusion/BD, as is typical for non-clinical device testing for 510(k) submissions. There is no mention of country of origin of data in a research context. It's retrospective in the sense that the testing was completed before the submission.

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

This is not applicable. For non-AI/ML medical device testing like this, "ground truth" is typically established by physical measurements, chemical analysis, and adherence to established engineering and biological standards, rather than expert consensus on data interpretation.

4. Adjudication method for the test set:

This is not applicable. Device performance is assessed against predefined specifications and standard test methods (e.g., fluid flow rates, material compatibility, sterility checks), not through human adjudication of interpretations.

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:

This is not applicable. This device is not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. This device does not have an algorithm.

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

For the non-clinical and biocompatibility testing, the "ground truth" is based on:

• Adherence to recognized consensus standards (e.g., ISO, USP, ASTM).
• Physical and chemical measurements meeting predefined engineering specifications (e.g., priming volume, drip rate accuracy, material properties).
• Biological responses in controlled laboratory tests (e.g., cytotoxicity, sensitization, hemocompatibility).

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable. There is no "training set" as this is not an AI/ML device.

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The BD SmartSite™ Needle-Free Connector (NFC) is a sterile, single patient use connector for needle free access to the IV line and/or IV catheter during IV therapy. The BD SmartSite™ NFC can be used for direction, intermittent infusion and/or the continuous infusion of fluids, drugs, IV nutrition, lipids, and/or blood/blood products or the aspiration of blood. The BD SmartSite™ NFC may be used with power injector procedures to a maximum pressure of 325 psi up to a flow rate of 10 mL per second.

The BD SmartSite™ NFC allows the user to add medication into the primary line without the use of a needle. It consists of a female luer on one side and a male luer connection on the other side. Both connections have locking threads. The connector has a silicone valve inside which is in an expanded position in the free state. When the male luer end of a compatible vascular access device is attached securely to the female luer of the SmartSite connector, the valve/piston is compressed which opens the fluid pathway. This open pathway allows administration of fluids as well as aspiration through the connector without the use of a needle.

This FDA 510(k) summary describes the BD SmartSite™ Needle-Free Connector (NFC) and its equivalence to a predicate device. The information provided is for a medical device (intravascular administration set) and does not involve AI or algorithms, human readers, or image analysis. Therefore, many of the requested categories in your prompt are not applicable to this document.

However, I can extract and present the relevant information that is available:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly list "acceptance criteria" alongside "reported device performance" in a direct table format for each performance claim. Instead, it describes "equivalence discussion" which implies the subject device met the criteria established by the predicate device or a new test. The performance attributes and the testing conducted to support them are discussed.

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

The document is a 510(k) summary for a medical device. It does not provide specific sample sizes for test sets (e.g., number of devices tested for each performance criterion) or data provenance details like country of origin or retrospective/prospective nature. This level of detail is typically found in the full submission, not the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes a physical medical device, not an AI/algorithm-based diagnostic tool requiring expert ground truth establishment for a test set.

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

This is not applicable for the same reasons as point 3.

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

This is not applicable as the document describes a physical medical device and does not involve AI or human readers.

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

This is not applicable as the document describes a physical medical device and does not involve an algorithm.

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

Given this is a physical medical device, "ground truth" as typically defined for AI/diagnostic studies is not directly applicable. The "truth" for device performance is established through adherence to recognized standards (e.g., ISO, USP, ASTM) and successful completion of specific verification and validation tests as outlined. For instance:

• Biocompatibility: Demonstrated by passing tests defined in ISO 10993 series.
• Sterilization: Demonstrated by meeting requirements of ISO 11137 series and USP chapters.
• Performance: Demonstrated by compliance with ISO 8536-4, ISO 594-1, ISO 594-2, and internal test protocols for specific claims (e.g., Harsh Infusates, Microbial Ingress, Valve Activations).
• Particulate Matter: Demonstrated by meeting USP .
• Package Integrity/Shelf Life: Demonstrated by passing tests defined in ISO 11607 series and ASTM standards.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device and does not involve a "training set" in the context of machine learning.

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

This is not applicable.

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The BD Texium™ Closed Male Luer (CML) is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer and administration of hazardous drugs when paired with the SmartSite™ NFC.

The BD Texium™ Closed Male Luer (CML) is indicated for use by trained healthcare professionals within healthcare facilities who prepare and/or administer non-hazardous drugs for adults, pediatrics and neonates.

The BD Texium™ CML is an airtight, leak-free and drip-free closed system drug transfer device (CSTD). When paired with devices containing a SmartSite™ NFC, the BD Texium™ CML mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ CML/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks and spills. The BD Texium™ CML is a sterile single-use CSTD intended for the reconstitution, transfer and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ NFC.

This document describes the premarket notification (510(k)) for the BD Texium™ Closed Male Luer (CML). It is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer, and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ Needle-Free Connector (NFC).

Here's an analysis of the acceptance criteria and study data:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a dedicated section. However, the "Technological Characteristics and Substantial Equivalence" table outlines differences and similarities between the subject device (BD Texium™ CML) and the predicate device (Alaris® Safety Male Luer, K053049) and indicates where testing was conducted to verify new claims or differences. The "Substantial Equivalence Discussion" and "Discussion of Non-Clinical Tests" sections detail the types of tests performed and state that "All test results met their acceptance criteria".

Below is a reconstructed table based on the provided text, indicating acceptance criteria implicitly by reference to the predicate or standards, and the reported performance as meeting those criteria.

Study Details

The document describes non-clinical testing to demonstrate substantial equivalence to a predicate device.

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

   • The document does not specify the exact sample sizes for each non-clinical test (e.g., number of devices tested for leakage, biocompatibility, flow rate).
   • The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given it's a premarket submission for a new device design and material changes, the testing is prospective and conducted by the manufacturer, CareFusion/BD.

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):

   • This is a non-clinical device test for physical and chemical properties, not a clinical study involving diagnosis or interpretation by human experts. Therefore, the concept of "experts establishing ground truth" as it applies to AI/clinical diagnostic studies is not relevant here. Ground truth is established by standardized test methods and measurement equipment.

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

   • Not applicable as this is not a study involving human interpretation or clinical adjudication. Test results are objective measurements against predefined criteria from 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 MRMC study was done. This is a non-clinical device submission, not an AI/software as a medical device (SaMD) product.

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

   • Not applicable. This is a physical medical device, not an algorithm or AI.

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

   • The "ground truth" for the non-clinical tests is established by recognized international and national standards (e.g., ISO, USP, ASTM, ANSI/AAMI) and the performance of a legally marketed predicate device. For example:
     • Biocompatibility: Conformance to ISO 10993 series of standards.
     • Sterilization: Conformance to ISO 11137 series and USP chapters.
     • Packaging: Conformance to ISO 11607 series and ASTM standards.
     • Performance (Leakage, Flow Rate, etc.): Conformance to ISO 80369 series and ISO 8536-4, as well as showing performance equivalent to or better than the predicate device.
     • Particulate: Conformance to USP .

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML model that requires a training set. The device design and materials are developed and then validated through testing.

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

   • Not applicable, as there is no training set for a physical device.

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The V. Mueller Cosgrove™ Flex Clamps are indicated to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.

Each V. Mueller Cosgrove™ Flex Clamp device consists of a ring handle, flexible shaft and jaw. The design of the flexible shaft allows the end user to bend the shaft following clamping of the blood vessel providing the user a clear field of visualization to the surgical site.

The proposed device and the predicate device have a similar design, the same materials and the same manufacturing and fabrication methods/processes. The main difference between the subject device and the predicate device is a change to the wire configuration of the cable. In addition, the cleaning and sterilization instructions in the instructions for use were updated in accordance with current guidance. These changes do not raise different questions of safety or effectiveness.

The provided text describes a 510(k) premarket notification for a medical device called "V. Mueller Cosgrove Flex Clamps." This device is a vascular clamp used to temporarily occlude blood vessels.

Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to an AI or algorithm-driven system. The document, K210324, is for a physical medical device (vascular clamps) and its substantial equivalence to previously marketed predicate devices. The "Performance Data" section explicitly states: "N/A - No clinical tests were conducted for this submission." and "The results of the non-clinical tests demonstrate the V. Mueller Cosgrove™ Flex Clamps meet all performance requirements and are substantially equivalent to the predicate devices."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/algorithm-driven device, as this document is not about such a device. The "acceptance criteria" and "performance data" discussed in the document relate to the physical properties, reusability, sterilization, and biocompatibility of the vascular clamp itself, as demonstrated by non-clinical tests.

If you intended to ask about a different document or a different type of device, please provide that information.

However, I can extract and present the existing acceptance criteria and performance data for the V. Mueller Cosgrove Flex Clamps as presented in the document, though it won't match the format for an AI/algorithm study:

Acceptance Criteria and Device Performance for V. Mueller Cosgrove Flex Clamps (K210324)

1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical)

Note: These criteria pertain to the physical characteristics and functionality of the vascular clamp, not to an AI or algorithm.

Regarding the other points you requested for an AI/algorithm study, they are not applicable to this document as it concerns a physical medical device:

2. Sample size used for the test set and the data provenance: Not applicable. The performed tests are non-clinical (e.g., strength tests, material biocompatibility tests), not involving data sets like those for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI validation (e.g., expert consensus on medical images) is not relevant here. Device testing would be performed by qualified engineers/technicians according to established protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is not an AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, "ground truth" would be the engineering specifications and performance standards (e.g., tensile strength, sterilization efficacy), which are determined by established scientific methods and industry standards. It's not a "truth" derived from human interpretation of data in the AI sense.
8. The sample size for the training set: Not applicable. This device is not an AI.
9. How the ground truth for the training set was established: Not applicable. This device is not an AI.

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