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

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

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

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

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

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

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

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

Overview of Device and Study Focus

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

1. Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

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

7. The Type of Ground Truth Used

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

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

8. The Sample Size for the Training Set

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The submission explicitly states:

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

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

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

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

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

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

1. Table of Acceptance Criteria and the Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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

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

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

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

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

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

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

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

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

Conclusion based on the provided document:

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

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

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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 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 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 Diana ChemoLock Transfer Set is a sterile, single-use closed system transfer device used for drug preparation to transfer drug from a drug vial to an IV bag for intravenous drug administration. It prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.

Diana ChemoLock Transfer Set is intended for use with the Diana Compounding System. It is a disposable, single use ancillary device for Pharmacy Compounding Devices (PCD).

The transfer set is comprised of multiple components bonded together to form a single device. These components include the following: stopcock, tubing, ChemoLock, syringe, and cassette handle. When placed in the Diana Compounding System, the Diana ChemoLock Transfer Set allows the transfer of fluids from one container to the other container for reconstitution of lyophilized drug or transfer of stock drug solution to prepare medications.

The purpose of this submission is to release a new closed system transfer device (CSTD) drug transfer set to be used with Diana Pharmacy Compounding System

The provided text describes a 510(k) premarket notification for the Diana ChemoLock Transfer Set, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria and performance data for a standalone AI/algorithm device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text. The document details various functional and safety tests performed on the device to ensure its performance and safety, but these are not presented as "acceptance criteria" in the context of an AI/algorithmic performance study.

Here's what can be extracted, framed as general performance data rather than specific acceptance criteria for an AI/algorithm:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list acceptance criteria in a tabular format with corresponding reported performance for AI/algorithmic measures. Instead, it lists various performance tests conducted.

2. Sample size used for the test set and the data provenance: Not applicable. The document describes physical and chemical testing, not a test set for an AI/algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to AI/algorithm validation, not to the functional testing of a transfer set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This pertains to AI/algorithm validation.

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 a drug transfer set, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The testing described relies on established engineering and medical device standards (e.g., ASTM, ISO, USP, FDA guidance), rather than ground truth in the context of an AI model.

8. The sample size for the training set: Not applicable. This device does not involve a training set for an AI/algorithm.

9. How the ground truth for the training set was established: Not applicable. This device does not involve a training set for an AI/algorithm.

In summary, the provided document is a 510(k) submission for a physical medical device, not for an AI/algorithmic device. Therefore, the questions related to AI/algorithm performance and validation are not addressed within this text. The "performance data" section outlines various physical, chemical, and biological tests conducted to demonstrate the device's safety and functionality in accordance with relevant standards.

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The Cogent™ Hemodynamic Monitoring System (HMS) is intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. Suitability for use on a patient is up to the physician's judgment and the diameter to be used. The target population includes patients for whom hemodynamic monitoring will improve clinical care. The target populations are identical to those for the predicate devices and include: Critical Care Patients, Trauma Patients, Cardiac Surgery Patients. The Cogent™ HMS is intended for use with ICU Medical pulmonary artery catheters and central venous oximetry catheters, and with ICU Medical Cogent™ sensors. The Cogent™ HMS is intended to measure and calculate venous oxygen saturation in patients. PulseCO functionality is limited to adult patients. The intended environment for use is the hospital including Critical Care Units (such as Medical, Surgical, and Coronary), Trauma and Accident Emergency Units, Post Anesthesia Care Units, Operating Rooms, and Cardiac Catheterization labs. The Cogent™ HMS is intended to be used by trained and qualified individuals in medical and surgical intensive care units, operating rooms, trauma and accident emergency units, coronary and intensive care units and cardiac catheterization laboratories. The CogentTM HMS is restricted to one patient at a time.

The Cogent™ HMS system is designed to compute and display cardiac and oximetry parameters relevant to patient care in the hospital acute care areas including Intensive Care Units and the Operating Room. Parameters include cardiac output and blood oxygen saturation levels, as well as other derived hemodynamic parameters. Measurements are obtained through ICU Medical pulmonary artery and central venous oximetry catheters, and ICU Medical CardioFloTM sensors. Input data for derived parameters may be keyed in by a clinician or may be obtained from a bedside monitor. The Cogent™ HMS provides the following functions: monitors patient cardiac output continuously, using continuous thermodilution, and intermittently, using bolus thermodilution; monitors cardiac output continuously using Pulse Power analysis on an arterial pressure waveform; monitors venous oxygen saturation by measuring the reflectance spectrum of the blood; and provides a general-purpose interface to the analog input/output channels of other monitoring devices. The Cogent" HMS consists of a base unit (patient interface module, PIM), a dedicated touch-screen display unit (user interface module, UIM) which allows for patient monitoring remotely (up to 50 feet), and the associated cables. The modules communicate with each other in docked, tethered (wired) or wireless mode. A physically separate optical module (OpMod) connects with an oximetry catheter. The Cogent™ HMS is designed for compatibility with PA catheters via connection to existing patient cables, i.e. unchanged cables as supplied with the primary predicate Q2 Plus. For the purpose of PulseCO™ data acquisition, the Cogent™ HMS is designed for compatibility with the CardioFloTM sensor and the new CardioFloTM reusable cable. In order to calculate blood oxygen saturation, the Cogent™ HMS is designed for compatibility with the existing optical module, its existing integrated cable and its associated compatible PA and oximetry catheters.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining specific acceptance criteria for a novel device performance. However, based on the content, we can infer some "acceptance criteria" through the comparison to predicate devices.

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

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

• Bench Tests (CCO, TdCO, SO2 algorithms): The sample size or specific dataset characteristics for the simulated physiological data are not explicitly provided. It simply states "bench simulation."
• Bench Test (PulseCO algorithm): The sample size or specific dataset characteristics are not explicitly provided. It states "the same simulated physiological data set as was used for the secondary predicate device."
• Animal Study: The sample size was 5 pigs. The provenance is not specified (e.g., country of origin, prospective/retrospective), but it describes an intervention-based study, suggesting it was prospective in design within the animal model.

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)

• For the bench tests, the ground truth was established by the simulated physiological data set. There is no mention of human experts establishing ground truth for these tests.
• For the animal study, the ground truth was established by "accepted reference devices." The number, qualifications, or adjudication method of human experts in establishing this "ground truth" or comparing to reference devices is not specified.

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

• None explicitly mentioned. The ground truth for bench tests was simulated data, and for the animal study, it was "accepted reference devices." There's no indication of human expert 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

• No MRMC study was done. The device (Cogent™ Hemodynamic Monitoring System) is a diagnostic computer for physiological parameters, not an imaging AI device where human readers interact directly with AI output. The document explicitly states: "No clinical performance testing was required to demonstrate device safety and effectiveness."

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

• Yes, standalone performance was assessed. The bench studies and the animal study evaluated the algorithms and hardware of the Cogent™ HMS independently against simulated data or accepted reference devices. The system is designed to compute and display parameters, not to provide an initial AI interpretation for a human to then review or modify.

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

• Bench Studies: Simulated physiological data.
• Animal Study: Measurements from "accepted reference devices" following pharmacological and ventilator interventions.

8. The sample size for the training set

• Since this is a 510(k) submission for a device primarily relying on established algorithms (continuous thermodilution, bolus thermodilution, oximetry, and PulseCO, which is also from a predicate), and not explicitly an AI/machine learning model that undergoes a distinct "training" phase with a large dataset, the concept of a "training set sample size" as typically understood for deep learning is not applicable or mentioned. The algorithms are described as being "measurement algorithms" or "analysis" algorithms, implying deterministic or well-defined computational processes rather than adaptive learning from a large training dataset.

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

• As noted above, a distinct "training set" with ground truth in the context of machine learning is not applicable to the description of this device. The algorithms are based on established physiological measurement principles. For the PulseCO algorithm, it is stated to be "the PulseCO algorithm which is used in the secondary predicate device," suggesting its design and validation are tied to previous work on that predicate, not a new training process described here.

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