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

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

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

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

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

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

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

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

Conclusion based on the provided document:

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

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

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The 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 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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Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.

The Hospira Extension Sets are intended for use as gravity sets. Hospira Extension sets are comprised of various components including the following: male luer adapter with cap, tubing, female luer adapter, flow control device, in-line adapter, injection site assembly, and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Extension sets are intended for the delivery of fluids from a container to a patient's vascular system. The sets are disposable devices for single patient use.

The provided text describes a 510(k) premarket notification for Hospira Extension Sets, which are intravascular administration sets. The document focuses on demonstrating substantial equivalence to predicate devices, primarily due to changes in tubing material and a needleless valve component.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international standards for medical devices, specifically those relating to biocompatibility and mechanical/functional performance of IV administration sets. The reported device performance indicates that the new Hospira Extension Sets meet these standards.

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

The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., number of devices tested for liquid leakage, number of samples for cytotoxicity). It broadly states that "new data has been generated" and "all testing is acceptable."

The data provenance is not specified in terms of country of origin. The studies are non-clinical (laboratory testing) rather than studies on human subjects, so the retrospective or prospective nature isn't directly applicable in the same way it would be for clinical trials. The focus is on demonstrating compliance with recognized international standards for device performance and safety.

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

This information is not applicable and not provided in the document. The "ground truth" for non-clinical performance and biocompatibility testing is established by the specified standards (ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4), rather than expert consensus on interpretive data. The tests themselves are objective measurements against defined parameters.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective assessment (e.g., image interpretation by multiple readers). For objective bench testing against defined standards, the outcome is determined by whether the device's performance falls within the specified acceptance limits for each test.

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 done. This type of study is not relevant for the evaluation of an invasive medical device like an extension set, which does not involve human interpretation of diagnostic data or AI assistance in a clinical workflow.

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

No standalone algorithm performance study was done. This device is not an AI/ML-based diagnostic or therapeutic algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the device's performance is defined by adherence to objective, quantitative and qualitative criteria set forth in recognized international standards (ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4, ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11737-1). For example, for "liquid leakage," the ground truth is whether the device leaks or not under specified test conditions, as defined by the ISO standard. For "cytotoxicity," it's whether the materials cause a cytotoxic reaction above a defined threshold.

8. The Sample Size for the Training Set

This information is not applicable. The development of this medical device (Hospira Extension Sets) does not involve a "training set" in the context of machine learning or AI. The design and validation are based on engineering principles, materials science, and compliance with established performance standards.

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

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

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The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

The ChemoLock is a needlefree, single-use, Closed System Drug Transfer Device (CSTD). The ChemoLock has a mechanical means to prevent the transfer of environmental contaminants into the system, and the escape of drug or vapor concentrations outside the system. The system includes closed vial and bag access devices, a closed syringe adapter and closed patient administration sets. All components of the system include passive self-sealing mechanisms which cannot be deactivated and remain protective through disposal.

The provided document describes the ChemoLock Closed System Drug Transfer Device (K131549). Here's an analysis of its acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with numerical targets. Instead, it describes functional performance goals. Based on the "Intended Use" and "Non Clinical Performance Data Summary" sections, here's a representation of the acceptance criteria and the device's reported performance:

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

• Sample Size for Test Set: The document mentions "three separate trials" for the chemical egress testing. However, it does not specify the sample size (e.g., number of devices, number of repetitions) used within each trial or for the microbial ingress testing.
• Data Provenance: The document does not specify the country of origin of the data. It is a 510(k) submission to the US FDA, so the testing would likely have been conducted by or for ICU Medical, Inc., based in Salt Lake City, UT, USA. The studies are non-clinical performance data, implying they are laboratory or bench tests rather than studies involving human subjects (prospective or retrospective clinical studies).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the studies described are non-clinical (laboratory/bench testing) and do not involve human diagnostic interpretation or ground truth established by medical experts in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are non-clinical (laboratory/bench testing) and do not involve human interpretation or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The ChemoLock is a Closed System Drug Transfer Device, a physical medical device for drug preparation and administration, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The ChemoLock is a physical medical device, not an algorithm or software-only device. The described performance studies are for the physical device itself.

7. Type of Ground Truth Used

For the non-clinical performance studies:

• Microbial Ingress: The implicit ground truth would be the absence of bacterial growth after exposure to a bacterial challenge. This is determined by standard microbiological testing methods.
• Chemical/Vapor Egress: The implicit ground truth would be the absence of detectable chemical contamination (specifically cyclophosphamide) on surfaces. This is determined by analytical chemistry methods (e.g., chromatography, spectroscopy) that can detect the target chemical.

8. Sample Size for the Training Set

This information is not applicable. The ChemoLock is a physical medical device and does not involve AI or machine learning models that require a "training set." The testing described is performance verification for the physical product.

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

This information is not applicable for the same reason as above; there is no training set for a physical medical device like the ChemoLock.

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The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE®, Spikes, SPIROS™, GENIE™, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.

The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is a combination of ICU Medical's products and tested for compatibility with lipids and/or cytotoxic agents. The "System" part is where these devices are packaged individually or sold together as a custom set upon order of the physician for the purpose of enabling the user a safe and inexpensive alternative to other passively closed systems.

The provided text describes a 510(k) submission for the ChemoCLAVE® Cytotoxic Medication Preparation and Delivery System. However, it does not contain information about acceptance criteria, the specific studies performed to prove those criteria were met, sample sizes, expert involvement, or ground truth establishment in the way typically associated with AI/ML device performance studies.

This document is a regulatory submission for a combination of existing, cleared medical devices (hardware components) rather than for a new AI/ML-driven diagnostic or treatment device. Therefore, the questions related to AI/ML device performance metrics (such as sensitivity, specificity, MRMC studies, training set details, etc.) are not applicable to this submission.

The "Safety and Performance" section states: "ICU Medical conforms to international standards in the design, development, and manufacturing of all of their unique disposable medical devices. Additionally, ICU Medical's Sterility Assurance Level, (SAL) has an established and validated history of meeting a 10⁻⁶ level." This indicates adherence to manufacturing quality and sterilization standards, which are different from performance metrics for an AI algorithm.

The core of this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting novel performance study data for a new technology with specific acceptance criteria that would require a study design with sample sizes, expert ground truth, etc. It states, "The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent and are safe and effective for their intended use."

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria and study details for an AI/ML device using the provided text. The document does not contain that type of information.

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The WillCare GX-1020 external pump is indicated for intravenous and non-intravenous infusion of medicinal products at set and variable rates.

The WillCare GW-1020 is an electromechanical infusion pump designed for use with therapies requiring accurate delivery of small volumes of medication. The pump delivers fluid with a resolution of 0.002 milliliters and allows for continuous delivery, for intermittent delivery, or for a combination of both. Components of the pump that are essential for effective operation are listed in the operators manual (Components - Basic Kit), and must ONLY be supplied by ICU to ensure proper and safe operation.

The ICU WillCare Infusion Pump (GW-1020) is an electromechanical infusion pump designed for accurate delivery of small volumes of medication. It can deliver fluid continuously, intermittently, or both, with a resolution of 0.002 milliliters. The device is indicated for intravenous infusion of medicinal products at set and variable rates.

Here's an analysis of its acceptance criteria and the study proving compliance:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the WillCare GX-1020 are primarily established by demonstrating substantial equivalence to its predicate device, the MiniMed 404-SP Infusion pump, and conformity to safety standards. The document outlines a comparison of technical characteristics to the predicate device, which implies these are the de facto acceptance criteria for performance aspects.

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

The provided document does not specify a numerical sample size for "test sets" in the conventional sense of clinical trials or algorithm validation (e.g., patient data). The testing described is "Safety compliance testing (SCR043S-004)," which typically involves a set of physical devices undergoing various performance and safety evaluations.

• Sample Size: Not explicitly stated as a number of devices or data points for a "test set." It refers to the physical device undergoing testing.
• Data Provenance: The testing was conducted by ICU Medical, the manufacturer, presumably in a controlled laboratory environment. The country of origin for the data is not specified, but the manufacturer is based in San Clemente, CA, USA. The testing is prospective in the sense of evaluating the newly manufactured device against established standards and the predicate device's performance.

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

Since the testing is primarily hardware performance and safety compliance against engineering specifications and a predicate device, the concept of "experts establishing ground truth for a test set" in the context of diagnostic algorithms or clinical outcomes does not apply directly.

The "ground truth" for this medical device's performance is derived from:

• Engineering specifications and design requirements.
• The performance characteristics of the predicate device (MiniMed 404-SP).
• International safety and performance standards (IEC 60601-2-24).

Therefore, there wouldn't be a panel of human "experts" like radiologists or pathologists to establish this type of ground truth. The "experts" involved would be the design engineers, quality assurance personnel, and regulatory affairs specialists who ensured the device met these technical benchmarks and standards. Their qualifications would be in engineering, medical device manufacturing, and regulatory compliance.

4. Adjudication Method for the Test Set

Again, given the nature of the device and testing (performance and safety compliance against specifications), a clinical adjudication method like "2+1" or "3+1" is not applicable.

The "adjudication" for this type of testing is typically:

• Comparison of measured device performance against pre-defined acceptance limits derived from specifications and predicate device data.
• Verification against the requirements of the referenced safety standards (IEC 60601-2-24).
• Review by regulatory bodies (FDA) to confirm substantial equivalence.

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 AI or diagnostic imaging devices to assess how human readers' performance (e.g., diagnostic accuracy) is impacted by AI assistance. The ICU WillCare Infusion Pump is a hardware device for drug delivery, not a diagnostic or AI-powered system that directly assists human interpretation.

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

N/A (Not Applicable). As established, this is a hardware infusion pump, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant. The device's performance is inherently its "standalone" performance.

7. The Type of Ground Truth Used

The ground truth used for evaluating the WillCare GX-1020 is primarily based on:

• Engineering Specifications: The design and performance parameters defined for the device itself.
• Predicate Device Performance: The established, legally marketed performance characteristics of the MiniMed 404-SP.
• International Safety and Performance Standards: Specifically, IEC 60601-2-24 for safety compliance.

The document directly states: "Safety compliance testing (SCR043S-004) has been conducted to demonstrate device reliability and conformance to IEC 60 601-2-24. The results are in conformity to the technical specifications and all referenced standards." This confirms that compliance with established technical specifications and standards forms the core of the ground truth.

8. The Sample Size for the Training Set

No "training set" is applicable or mentioned. This device is an electromechanical infusion pump, not a machine learning model that requires a training set. Its functionality is based on programmed logic and physical mechanics, not learned patterns from data.

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

Not Applicable. Since there is no training set, there is no ground truth established for a training set.

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The intended use of the device is to inject fluids into, or withdraw fluids from, parts of body below the surface of the skin.

The PUNTUR-GUARD protects the health care worker from accidental needlestick by providing a blunting that renders safe the needle once it has entered the patient's vein. The PUNCTUR-GUARD is intended to enhance current safety needle programs

The provided text is a 510(k) premarket notification approval letter for the PUNCTUR-GUARD® Winged Set for Blood Collection and Intravenous Infusion. This document does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information submitted in the 510(k) application, which typically includes device description, indications for use, comparison to predicates, and sometimes performance data if necessary to establish substantial equivalence. However, the details of any performance studies, acceptance criteria, or their results are not present within this specific document.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than a detailed technical report of device performance and testing.

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