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Clave Neutral-Displacement Connectors (MicroClave™/ NanoClave™/ Clave™Neutron) are intended for the aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. Clave Connectors may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec. Clave Connectors will prevent microbial ingress for seven (7) days.

Clave Neutral-Displacement Connectors are needlefree, bi-directional connectors that utilize a pre-slit septum which prevents microbial ingress when in the un-activated state and allows access to the fluid path when activated with an ISO 80369-7 compliant male luer. The septum offers neutral displacement of fluid during connection or disconnection of a male luer and self-seals upon disconnection to prevent fluid loss or air ingress. The Neutron incorporates additional technology that will prevent fluid displacement resulting from syringe plunger compression; patient vascular pressure changes, such as coughing or sneezing; and IV solution container run-dry. The Clave Family of Connectors do not require a cap but may be used with disinfecting caps containing 70% isopropyl alcohol.

The provided text is a 510(k) clearance letter and summary for the Clave™ Neutral-Displacement Needlefree Connectors. This document describes a medical device, not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML device performance (e.g., effect size of human readers with AI vs. without AI, ground truth for training set, number of experts for ground truth) are not applicable.

However, the document does describe the device's acceptance criteria and the studies performed to demonstrate equivalence and support new claims.

Here's the information extracted from the document:

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

The document primarily focuses on demonstrating substantial equivalence to a predicate device and supporting new claims through non-clinical performance data and a retrospective clinical study.

Acceptance Criteria and Device Performance (Based on "Summary of Non-Clinical Testing" and "Performance Data: Non-Clinical Testing Summary")

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

• Non-Clinical Testing: The document does not specify the exact sample sizes for each non-clinical test (e.g., ISO 8536-4, ANSI/AAMI CN27). It states that "The subject device has been evaluated for the prevention of microbial ingress for a worst-case simulated use protocol of seven (7) days" and mentions conformance to various standards, which implicitly include testing of multiple units.
• Clinical Testing (CMS study):
  • Sample Size: Not explicitly stated as a "sample size" in the context of device testing. This was a retrospective study that analyzed 2019 CMS data. The study "analyzed 2019 CMS data" to compare hospitals using Clave connectors to those not using them.
  • Data Provenance:
    • Country of Origin: United States (CMS data).
    • Retrospective or Prospective: Retrospective.
    • Specifics: "analyzed 2019 CMS data," "adjusting for Hospital characteristics," "acute-care Hospitals which utilized the Clave Family of Connectors... had a statistically significant lower relative risk... when compared to acute-care Hospitals that did not utilize Clave Connectors."

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

• Not Applicable. This information is for AI/ML devices. The 510(k) is for a physical medical device (needlefree connector). Ground truth for the clinical study (bloodstream infection rates) would have been established through hospital records and CMS reporting, not by human experts adjudicating images or cases for AI training/testing.

4. Adjudication method for the test set

• Not Applicable. This information is typically for AI/ML devices involving human reviewer consensus. The clinical study used pre-existing CMS data on bloodstream infections.

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 is not an AI/ML device. The clinical study was a comparison of hospital outcomes based on device usage, not human reader performance.

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

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used

• Non-Clinical Testing: Ground truth is established by the specifications and measurement techniques defined in the referenced industry standards (e.g., ISO, ANSI/AAMI, USP). Performance is measured against these established parameters.
• Clinical Testing: The ground truth for the clinical claim (bloodstream infection reduction) was based on outcomes data from official government reporting (CMS data) regarding bloodstream infection rates (CLABSI) and bloodstream infection-associated mortality in acute-care hospitals.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device. There is no "training set."

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

• Not Applicable. This is not an AI/ML device.

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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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Rio™ Drug Reconstitution Transfer Device is indicated for single-use reconstituting or mixing of liquid or lyophilized drug in a vial, and the aseptic transfer of the reconstituted drug into the multi-port LifeCare IV container system (IV bag) for patient infusion administration.

The Rio™ Drug Reconstitution Transfer Device (Rio) is a single use, sterile, two-way, drug transfer device that is designed to connect an ICU Medical LifeCare IV container system (IV bag)(up to 500 mL) via the drug additive port, to a drug vial having either a 13mm or 20mm stopper closure for reconstituting or mixing and aseptic transfer of the drug from the vial into the solution of the IV bag. Once connected, Rio is not separated from the IV bag or vial and should be disposed of with the IV bag when administration is complete. Rio is intended to be used in a pharmacy setting or patient care area, by trained clinicians.
The Rio design consists of a needle-free port spike that connects to the compatible IV bag on one end, and a vial spike on the other end to connect a standard liquid or lyophilized/powdered drug vial. The bag spike and vial spike contain protective caps that maintain the sterility of the device until the caps are removed prior to use. Rio also includes a flow director (rotating handle) that will isolate the fluid between the vial and bag until manipulated by the pharmacist or clinician to allow two-way fluid transfer between the vial and bag.

The provided text is a 510(k) summary for the Rio™ Drug Reconstitution Transfer Device. This document focuses on demonstrating substantial equivalence to a predicate device (K192154), rather than providing detailed acceptance criteria and study results for de novo device performance validation.

Therefore, the document does not contain the specific information required to answer most of your questions about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• MRMC or standalone comparative effectiveness studies.
• Types of ground truth used.
• Sample size or methods for establishing ground truth for training sets.

The document indicates that clinical data was not needed to support the substantial equivalence determination, which means there are no clinical studies of the type you're asking about (e.g., MRMC studies).

However, I can extract the information that is present regarding non-clinical testing and how it supports the device's conformance:

Summary of Non-Clinical Testing and Conformance:

The manufacturer states that "Non-clinical verification has been conducted to evaluate the safety, performance and functionality. The results of these test have demonstrated the overall safety of the subject device and ultimately supports a substantial equivalence device."

The document generally states that "Test results from the performance testing conducted demonstrate the subject device met all acceptance criteria requirements." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical results obtained for each test.

Here's what can be gleaned about the non-clinical testing performed:

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

• Acceptance Criteria: While specific numerical criteria are not provided, the testing aimed to meet various ISO and USP standards. For example, for particulates, the device had to "meet USP <788> requirements." For sterility, it had to meet a "SAL 1x 10-6."
• Reported Device Performance: The summary states that the device "met all acceptance criteria requirements" for the listed tests. No specific numerical performance values are given.

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

• Not specified in the provided text.

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

• Not applicable/Not specified. This is not a study involving expert readers or ground truth establishment in the context of diagnostic AI.

4. Adjudication method for the test set:

• Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. The document explicitly states: "Clinical data was not needed to support a substantial equivalence determination." This is not an AI device or a diagnostic device.

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

• No. This is a physical, mechanical device, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" is established by adherence to recognized standards (ISO, USP) and engineering specifications for mechanical and material performance. For example, for particulate testing, the USP <788> limits define the "ground truth" for acceptable particulate levels. For sterility, the SAL 1x10^-6 is the "ground truth" for validated sterility.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable.

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The Plum Duo Infusion System is intended for parenteral fluids and medications through clinically acceptable routes (limited to intravenous, intra-arterial, and subcutaneous therapies).

The Plum Duo Infusion System is intended for use in clinical environments in the hospital environment and other outpatient healthcare facilities by licensed healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use.

The Plum Duo Infusion System is intended for adult, pediatric (including infants and children), and neonatal patient populations.

The Plum Duo™ Infusion System is the next generation of the Plum™ family of devices that is based on the fundamental technology of the Plum 360™ Infusion System cleared under K161469. The pump design incorporates state-of-the-art features such as dual channel functionality, touch screen display, and lithium iron phosphate battery technology. The pump uses the same volumetric piston type technology with a plunger stepper motor to deliver fluids to a patient as the predicate Plum 360™ Infusion System.
Plum Duo™ Infusion System is a large volume pump (LVP) with two independent pump channels that can deliver fluid to a patient on up to 4 lines and is designed so that it is possible to use one channel only. In addition, although the channels can operate independently, patient parameters can be shared across the channels to aid in the speed of programming. Each channel accepts a cassette that is part of a PlumSet™ administration set and can connect to a primary and/or secondary container.

The provided document is a 510(k) Summary for the Plum Duo™ Infusion System, which is an infusion pump. It demonstrates substantial equivalence to a predicate device. This type of regulatory submission focuses on engineering and performance validation rather than clinical studies involving patient data or human interpretation of medical images.

Therefore, the document does not contain the information requested regarding acceptance criteria and study details for an AI/ML-enabled medical device that typically involves:

• A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, AUC, etc., which are common for diagnostic or AI algorithms).
• Sample size for a test set based on patient data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication methods for test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance.
• Type of ground truth (pathology, outcomes data, expert consensus).
• Sample size for the training set and how its ground truth was established.

This document describes a more traditional medical device submission, focusing on the mechanical, electrical, and software safety and performance of an infusion pump. The "Summary of Non-Clinical Testing" section lists various engineering tests (e.g., flow rate accuracy, air in line performance, alarm testing, electrical safety, reliability testing, human factors validation), which are typical for infusion pumps to ensure their safe and effective operation, but these do not align with the criteria for evaluating an AI/ML model for diagnostic or predictive purposes.

The statement "Clinical evaluation is not required for this submission to support substantial equivalence" further confirms that the type of studies and data provenance you are asking about (which often involve clinical data and human interpretation) were not part of this specific submission.

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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 collected from compatible infusion pumps. Healthcare professionals may choose to use the collected 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™ 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™ 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 product is used by pharmacists to create approved drug libraries that can be downloaded by the infusion pumps. Drug libraries contain information on medications along with rulesets and associated clinical care areas (CCA) defined by pharmacists in accordance to their facility's best practices. Certain infusion pump parameters are also defined in the drug library. The LifeShield™ Device Manager (DM) and LifeShield™ Data Flow Management (DFM) are used to make the drug libraries available for the infusion pump to download and install. Download and installation of a drug library to the infusion pump establishes alert parameters for a medication that is being programmed for infusion. Additionally, the infusion pump applies the userdefined drug library settings for the configurable features of the pump.

The LifeShield™ Clinical Dashboards & Reports (CDR) software is used by clinical administrators to view infusion or device-related information received from the Plum Duo™ infusion pump via the LifeShield™ DFM. It provides a near real-time view of ongoing infusions and their status; a view of all infusion pumps with their asset information and operational status; dashboards that provides easy navigation of key infusion or asset metrics; and an analytics viewer that users can use to view historical infusion and/or asset information. 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. The information presented by the software does not create decisions or treatment pathways for patients. LifeShield™ CDR is able to display infusion and infusion pump information from a single or multiple facilities within the customer account.

LifeShield™ Infusion Safety Software Suite can be configured to interface with a facility's Hospital Information System (HIS) / EHR system to support auto-programming and infusion documentation. When the autoprogramming feature license is enabled, the LifeShield™ Infusion Safety Software Suite can receive a pharmacy-validated order (also referred as auto-program order) from the HIS/EHR and route it to the infusion pump where the therapy program is pre-populated with physician-prescribed medication and infusion parameters, helping to reduce manual entry by the clinician when programming the pump. LifeShield™ Infusion Safety Software Suite does not modify the contents of the auto-program order received from the HIS/EHR.

When the infusion documentation feature license is enabled, the LifeShield™ Infusion Safety Software Suite forwards the infusion data it receives from the infusion pump to the HIS/EHR system to support the facility's documentation of infusion information and HIS/EHR dashboards. Infusion data includes infusion status (e.g. volume change) and events (e.g. infusion start, stop, complete). LifeShield™ Infusion Safety Software Suite does not modify the contents of the infusion data sent to the HIS/EHR.

Here's an analysis of the acceptance criteria and study information for the LifeShield™ Infusion Safety Software Suite based on the provided document:

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

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria and device performance metrics in a direct table format. However, it implicitly states that the device met acceptance criteria through various tests.

Here's an interpreted table based on the non-clinical testing summary:

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

The document does not specify the sample size used for any of the test sets (design verification, design validation, cybersecurity, human factors). It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

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

The document does not provide information on the number of experts used or their specific qualifications for establishing ground truth for any of the tests. It refers to "trained healthcare professionals" for the intended use and "pharmacists" for drug library creation but does not detail their involvement in formal ground truth establishment for testing.

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

The document does not describe any adjudication method used for establishing ground truth or evaluating test results.

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:

The document states, "A Clinical Study is not required for this submission to support substantial equivalence." Therefore, no MRMC comparative effectiveness study was done, and there is no information on human reader improvement with or without AI assistance. This device is a software suite for managing infusion pump data, not an AI-powered diagnostic or assistive tool for human interpretation.

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

The device is described as a "software-as-a-service (SaaS)" that facilitates data management and communication for infusion pumps. It explicitly states that "All data entry and validation of infusion parameters on compatible infusion pumps is performed by a trained healthcare professional." While portions of the software may operate automatically (e.g., routing data), the core functionality involves human interaction and oversight. Therefore, a purely standalone algorithm-only performance study as typically understood for AI algorithms would not be applicable or detailed here. The "non-clinical testing" and "design verification" cover its functional performance.

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

The document does not explicitly state the type of "ground truth" used for its internal verification and validation studies. Given the nature of the device (infusion safety software), the "ground truth" would likely involve:

• Design requirements and specifications: For design verification, the software's output and functionality are compared against its documented requirements.
• User needs: For design validation, the software's ability to meet the needs of trained healthcare professionals (pharmacists, clinical administrators) for tasks like drug library management, data viewing, and auto-programming would be assessed.
• Industry standards: Adherence to standards like IEC 62304 for software and ISO 14971 for risk management implies these standards served as a form of "ground truth" for compliance.

8. The sample size for the training set:

As this is not an AI/ML device that requires a training set in the conventional sense, the document does not mention a training set or its sample size. The software development process aligns with IEC 62304, focusing on verification and validation of designed functionality.

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

Not applicable, as there is no mention of a training set.

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The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.

The ChemoCLAVE® Cytotoxic Medication Preparation and Delivery System devices are sterile, single use CSTDs, which prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. The Spiros and ChemoClave components comprise the primary components of the ChemoClave CSTD System, which connect to form a closed fluid path for transfer of hazardous medications. The devices which include the ChemoClave component are vial access devices, bag access devices, adapters, and administration sets. The devices which include the mating Spiros component are syringes, adapters, and administration sets. The Spiros and the ChemoClave will each independently self-seal when they are disconnected from one another.

The provided text describes the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System and its substantial equivalence to a predicate device. However, the document does not contain information about the acceptance criteria for an AI/ML powered device, nor does it detail a study that proves a device meets such criteria.

The context of the document is a 510(k) premarket notification for a medical device (ChemoCLAVE Cytotoxic Medication Preparation and Delivery System) that is not an AI/ML powered device. The "acceptance criteria" discussed in the document refer to the performance of this physical medical device in functional and performance tests like microbial ingress testing, emission testing, hazardous drug exposure testing, and sterility validation, to demonstrate substantial equivalence to an existing predicate device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML powered device meets those criteria based on the given text. The provided text is about a traditional medical device, not an AI/ML system.

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The Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter (PICCOx), is indicated for access to the central venous system for continuous in vivo measurement of the oxyhemoglobin saturation of blood (ScvO2), intravenous therapy, blood sampling, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the PICCOx may not exceed 300 psi.

The Peripherally Inserted, Pressure Injectable Central Venous Oximetry Catheter (PICCOx) is a single or multi-lumen catheter capable of intravenous infusion including pressure infusion up to 300psig, central venous pressure monitoring, venous blood sampling, and allows for continuous measurement of central venous oxygen saturation (ScvO2) in the superior vena cava. The device includes fiber optics in a dedicated lumen for light transmission and single or multiple fluid lumens. Constructed of barium sulfate filled polyurethane, these catheters are radiopaque enabling the use of fluoroscopy or X-ray, to guide insertion and verify position. The maximum recommended infusion rate for the pressure injectable lumen is 5 mL/sec. Distance markings on the catheters provide a visual indication of insertion depth. Every 5cm the insertion depth is printed with an actual number and in between the numbers are black dots which are printed every 1cm. The catheter is non-trimmable, and offered in usable lengths of 40cm, 45cm, 50cm, and 55cm. Individual lumen hubs are ISO standard female luers which are adaptable to NeedleFree Connectors, syringes or IV tubing compliant with the ISO standard. The fiber optic lumen which is terminated in a housing, can be plugged into a compatible Optical Module. PICCOx is intended to be used with a user defined convenience kit. These "kits" are cleared under 510(k) K052865. All kits are terminally sterilized. The contents of the kit are sterile, medical devices intended for single patient use only with fluid path and invasive surfaces non-pyrogenic (or as indicated on the labeling of internal component packaging.)

This is a medical device 510(k) premarket notification summary for the PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter. The submission aims to demonstrate substantial equivalence to predicate devices, and the provided text focuses on the device's technical characteristics and non-clinical performance data. There is no information in the provided text that describes a study comparing the device's performance against acceptance criteria using patient data or expert assessments. The information primarily covers device description, intended use, and a comparison of features with predicate devices.

Therefore, the following information is not available in the provided text:

• Acceptance criteria table and reported device performance based on a study of that nature.
• Sample size used for the test set and data provenance specific to such a study.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone (algorithm only) performance study.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data) for a performance study.
• Sample size for the training set.
• How ground truth for the training set was established.

The provided text focuses on non-clinical performance testing and biocompatibility, as stated:

"The successful results of the key tests involving dynamic response, fiber optics, flow rates, leakage, force at break, lead tubing, markings, priming volumes, radiopacity, needlefree connector compatibility, and catheter to introducer fitment demonstrate that the proposed PICCOx Peripherally Inserted Central Venous Oximetry Catheter has met the pre-determined acceptance criteria applicable to the safe use of the devices."

This indicates that internal performance specifications were met through non-clinical bench testing, but these acceptance criteria and results are not detailed in a way that allows for filling out the requested table. The summary confirms that "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices." Instead, the device "has been tested in accordance with its performance specification which accommodates known functional requirements."

Without further details on these specific "performance specifications" and their corresponding results, the requested table and other study-related information cannot be generated from the given text.

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The high pressure extension set is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. Fluids may include: Contrast media (at 10mL/second) or other medications, and blood or blood products as the physician may prescribe. The fluids are administered through a cannula or catheter placed in a vein or artery. The incorporation of ICU proprietary connectors such as the CLAVE; MicroCLAVE; Y-CLAVE; and CLC2000 with the extension sets, allows for needleless connectivity to other devices via universal luer connection. The maximum pressure is 400 psi and other ancillary devices must also be rated for pressure up to 400 psi.

The High Pressure Sets are a group of luer compatible connection devices that aid in the prevention of needlesticks and offer ease of use in the environment for the healthcare professional. The use of the CLAVE®; MicroCLAVE™; Y-CLAVE™; and CLC2000™ is a natural fit with the high pressure sets. Testing included with this submission, validates the 400 psi claim with these unique connectors. The functional technology of the high pressure set has not changed but is augmented by the addition of the ICU connectors. The devices are sterilized to ensure a 10⁻⁶ SAL and they have been tested under the ISO 10993-1:2003 ~ Biological evaluation of medical devices ~ Part 1: Evaluation and resting and the results from these tests were found to be acceptable and are enclosed in this submission.

The provided document describes the ICU Medical High Pressure Sets - 400 psi, which are luer compatible connection devices intended for use in cardiovascular procedures where contrast media is injected using control syringes or power injectors. The document focuses on demonstrating the substantial equivalence of this device to existing predicate devices.

Here's an analysis of the acceptance criteria and the study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance that are then directly compared to "reported device performance" in a typical table format. Instead, it relies on demonstrating that the device has undergone "non-clinical testing (simulated use) ... according to the product specification and that testing demonstrates that the device is safe and effective by meeting predefined criteria." The key performance claim is its ability to safely handle up to 400 psi.

Based on the information provided, we can infer the following:

Note: The document emphasizes substantial equivalence to predicate devices for characteristics like materials, functional use (high-pressure infusion), sterilization method (Gamma), and packaging (Peel pouch). While not explicit acceptance criteria, demonstrating equivalence implies meeting the safety and performance standards of these legally marketed devices.

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

The document does not specify the sample size used for the "non-clinical testing (simulated use)." It only states that "Test data is part of this submission as evidence."

The data provenance is retrospective as the testing was conducted on the device to demonstrate compliance with specifications for the purpose of the 510(k) submission. There is no mention of country of origin for the data, but it is implied to be from testing conducted by ICU Medical Inc., a US-based company.

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

This information is not provided in the document. The testing described is non-clinical, simulated use testing against product specifications. This typically does not involve human experts establishing "ground truth" in the way a clinical study might for diagnostic accuracy. The "ground truth" for the performance characteristics (e.g., pressure resistance, sterility) would be the physical measurements and results of the laboratory tests.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. As the testing is non-clinical, simulated use, and involves objective measurements (e.g., pressure, sterility), an adjudication method as typically defined for human-expert validation is not applicable or mentioned.

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 typically performed for diagnostic or prognostic devices that involve human interpretation of images or data. The ICU Medical High Pressure Sets are infusion sets, and their effectiveness is determined by their physical performance (e.g., pressure resistance, biocompatibility), not by human interpretation.

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

Yes, a standalone study (or rather, standalone testing in this context) was done. The "non-clinical testing (simulated use)" evaluates the device's inherent performance characteristics, such as its ability to withstand 400 psi pressure and its sterility, without human intervention or interaction as part of the performance evaluation. The device itself is evaluated in isolation against its predefined criteria.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective physical and chemical measurements and engineering standards. This includes:

• Pressure Resistance: Verification that the device can safely handle up to 400 psi.
• Sterility: Confirmation that the device meets a Sterility Assurance Level (SAL) of 10⁻⁶.
• Biocompatibility: Results from tests conducted according to ISO 10993-1:2003, ensuring materials are safe for biological contact.
• Luer Compatibility: Adherence to industry standards like ISO 594-1 and ISO 594-2 for luer connections.

8. The Sample Size for the Training Set

This question is not applicable as the ICU Medical High Pressure Sets are medical devices with mechanical and material properties, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

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

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CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. The device may also be used with power injector procedures up to 10mL per second of contrast media and a maximum pressure of 350psi. The device incorporates a technology that will prevent fluid displacement resulting from the following: Connection of a luer; syringe plunger compression; patient vascular pressure changes, such as coughing or sneezing; and IV solution container run-dry. The CLAVE Neutron incorporates a pre-slit septum that does not reguire the use of needles and will therefore passively aid in the reduction of needlestick injuries.

The CLAVE Neutron is a normally closed, bidirectional connector that incorporates a unique silicone valve within the fluid path. The unique valve prevents fluid displacement, both positive and negative at all times, including when the device is accessed.

Here's a breakdown of the acceptance criteria and study information for the CLAVE® Neutron™ device based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally demonstrated by the CLAVE Neutron's performance being "substantially equivalent" to predicate devices, or meeting specific physical and functional benchmarks. The table below integrates information from the "Technological Characteristics and Substantial Equivalence Table" and other sections of the summary.

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

The document mentions "a variety of functional tests including microbial ingress and performance criteria" and "simulated use environment testing" as part of the "CLAVE Neutron Design Verification Report." However, specific sample sizes for these tests (e.g., number of devices tested for each functional criterion) are not provided in this summary.

• Data Provenance: The document states that the CLAVE Neutron Design Verification Report is proprietary and included in the submission. The information provided about the CLAVE and its use in pediatric/immunocompromised patients comes from two published clinical studies:
  • Bouza (2003): Randomized clinical trial. Patient population: immunocompromised, intensive care patients. Location: Department of Cardiovascular Surgery, Hospital General University of Madrid, Madrid, Spain. Outcome: reduced catheter hub and tip bacterial colonization.
  • Maragakis (2006): Clinical study. Patient population: pediatric ICU and pediatric oncology service patients. Location: John's Hopkins Hospital in Baltimore, Maryland. Outcome: observed catheter-related bloodstream infection rates.

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

• For the CLAVE Neutron's design verification tests: This information is not provided in the summary. These are laboratory-based functional and performance tests, not clinical studies requiring expert ground truth setting in the same way an imaging AI might.
• For the clinical studies referenced (Bouza 2003, Maragakis 2006): These studies evaluated clinical outcomes (bacterial colonization, bloodstream infection rates). The "ground truth" would be established by clinical diagnostic methods relevant to those outcomes, performed by healthcare professionals at the respective hospitals. The qualifications of these professionals are not explicitly detailed in this summary, beyond the fact they were conducted at medical institutions.

4. Adjudication Method for the Test Set

• For the CLAVE Neutron's design verification tests: Adjudication methods are not described in the summary. These are typically objective measurements against engineering specifications.
• For the clinical studies referenced: Standard clinical trial methodologies would have been used for data collection and outcome assessment in the Bouza (2003) and Maragakis (2006) studies. Specific adjudication methods for outcomes are not detailed in this summary.

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

• No MRMC comparative effectiveness study was mentioned or performed for the CLAVE Neutron. This device is a physical medical device (needleless connector), not an AI algorithm assisting human readers. The summary explicitly states: "There is no clinical data included in this submission." The referenced clinical studies (Bouza 2003, Maragakis 2006) are about the clinical performance of the predicate CLAVE connector, not about AI assistance.

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

• Not applicable. The CLAVE Neutron is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For the CLAVE Neutron's design verification tests: The "ground truth" is defined by the predetermined performance criteria and product specifications outlined in the submission (e.g., specific mL/minute flow rates, psig leak pressures, lbf-in component assembly strength).
• For the referenced predicate CLAVE clinical studies (Bouza 2003, Maragakis 2006):
  • Bouza (2003): Clinical outcomes data (catheter hub and tip bacterial colonization).
  • Maragakis (2006): Clinical outcomes data (catheter-related bloodstream infection rates).

8. The Sample Size for the Training Set

• Not applicable. The CLAVE Neutron is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. As the device is not an AI algorithm, there is no training set or corresponding ground truth establishment in that sense. The device's design and manufacturing rely on engineering principles, materials science, and functional testing to meet specified performance standards.

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The Antimicrobial CLAVE® Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to an intravascular administration set for the administration of fluids to a patient through a cannulae placed in the vein or artery.

The connector includes two antimicrobial agents. The first agent is compounded with liquid silicone rubber to provide a protective seal around the cannula. The second agent is compounded with the polycarbonate alloy and is intended to reduce microbial contamination in the device fluid path. The antimicrobial agents are not intended for treating existing patient infections.

The ICU Medical Ag CLA VE is created with two different and effective antimicrobial agents. The first antimicrobial agent, compounded with the liquid silicone rubber (LSR), then molded into the plug that seals around and protects the first line of defense. The second antimicrobial agent, compounded with the plastics used to mold the cannula protects the fluid path from bacteria growth. Both the plug material and the cannula material are identical to the traditional CLA VE Connector as described in K970855 before the antimicrobial agents are compounded with them. Both the submitted and predicate CLA VE device are made up of three components; an internal plastic cannula (spike) which incorporates the fluid path, a plastic housing which allows for standardized ISO 594-1/2 luer lock connections and a silicone septum (plug) which provides the sealing mechanism and swabbing surface.

The provided document is a 510(k) summary for a medical device called the "Antimicrobial CLAVE". It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance results in the format requested.

It states that "Efficacy and functional testing of the device are included in this submission" and "ICU Medical has also performed testing recommended by the draft guidance 'Premarket Notification [5]0(k)] Submissions for Medical Devices that Include Antimicrobial Agents' and has included that testing as part of this submission." However, these tests and their results are simply referenced as being included in the submission, not detailed within this particular 510(k) summary document itself.

Therefore, I cannot provide the requested information from the given text. The document acts as a summary of the intent to market and the basis for substantial equivalence, rather than a detailed report of the device's technical acceptance criteria and accompanying study results.

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