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Plum 360™ Infusion System with Hospira MedNet™ is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

The Plum 360TM Infusion System withMedNet / Smart Card Plug 'n' Play Module remains a volumetric Infusion System intended for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Dedicated administration sets are used for delivery of infusion therapy to the patient. The device has a user interface consisting of LCD display, front panel alphanumeric keypads and keys, audible and visual indicators, audible indicator volume control, nurse call interface, network interface connectors, the drug library and software that provides pre-defined display screens for therapy programming. The continued use of the MedNet Software allows communication between the Infusion Pump, MedNet server and the facility's communication systems.

This appears to be an FDA 510(k) summary for an infusion pump, which is a medical device and not an AI/ML powered device. This document does not describe acceptance criteria or study results in the context of an AI/ML powered device. Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria, performance, ground truth, or study details from the provided text.

The document discusses:

• Device Name: Plum 360™ Infusion System with MedNet/ Smart Card Plug 'n' Play Module
• Regulation: 21 CFR 880.5725 (Infusion Pump)
• Key Changes: Introduction of a bolus feature, software updates (CPU and Communication Engine), and cybersecurity enhancements.
• Testing: Non-clinical testing, including compliance with IEC standards (60601-1, 60601-2-24, 60601-1-2, 60601-1-8), risk analysis, device safety assurance case, performance testing, human factors evaluations, and software verification and validation.
• Clinical Testing: Stated that clinical evaluation is not required for this submission to support substantial equivalence, though human factors studies were conducted.

The acceptance criteria mentioned are related to meeting these engineering and safety standards for an infusion pump, not an AI/ML system's performance on a dataset. Since the request is specifically for an AI/ML device, and this document pertains to a traditional medical device (an infusion pump), I cannot fulfill the request based on the provided text.

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

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

The Hospira Extension Sets and the Hospira Primary 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, , in-line adapter, injection site assembly, and Dial-A-Flo. Hospira Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with a spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, Dial-A-Flo assembly and tubing. Extension sets and Primary Sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.

The provided document (K161036) is a 510(k) summary for medical devices (Hospira Extension Set and Hospira Primary Set), which are intravenous administration sets. It describes the device, its intended use, and the technological characteristics compared to predicate devices. The primary change addressed in this submission is the replacement of the current Dial-A-Flo flow control device with a new one from a different manufacturer.

The document does not contain information about acceptance criteria or performance from a study in the context of an Artificial Intelligence/Machine Learning (AI/ML) device. The acceptance criteria and performance data presented here are for a traditional medical device (IV administration sets) undergoing a change in a component.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device meeting them as if it were an AI/ML device.

However, I can extract the acceptance criteria and reported device performance for the Hospira Extension Set and Hospira Primary Set as described in the document, which are related to non-clinical and performance testing of the physical medical device.

Acceptance Criteria and Reported Device Performance (as related to the physical medical device):

The acceptance criteria are generally implied by meeting applicable standards.

Information Not Applicable to this Document (as it's not an AI/ML device study):

• Sample sized used for the test set and the data provenance: Not applicable for this type of device submission. Performance testing is typically done on physical samples, and the number of samples is not detailed in this summary.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing is based on objective measurements against engineering specifications and standards.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For this device, ground truth is based on established ISO standards, engineering specifications, and validated test methods (e.g., flow rate measurement, leak detection, material compatibility assays).
• The sample size for the training set: Not applicable (no "training set" in the AI/ML sense).
• How the ground truth for the training set was established: Not applicable.

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Hospira Sapphire Sets are indicated for the delivery of fluids from a container to a patient's vascular system.

Hospira Sapphire Sets are intended for use with the Sapphire Infusion System. Hospira Sapphire sets are comprised of various components including the following: male luer adapter with cap, female luer with cap, piercing pin connector, sapphire cassette, tubing, flow control device, in-line adapter, injection site assembly, check valve, and burette chamber. Hospira Sapphire sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.

The document describes a 510(k) premarket notification for Hospira Sapphire Sets, an accessory for infusion pumps. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based only on the provided text. Many of the requested details about acceptance criteria and study specifics are not explicitly stated in this type of regulatory document, which focuses on demonstrating equivalence rather than a full clinical trial.

1. Table of acceptance criteria and the reported device performance:

The document outlines a series of tests performed to establish substantial equivalence, primarily focusing on materials, design, and performance characteristics compared to the predicate device. Specific numerical acceptance criteria are generally not provided in this summary. Instead, it states that "All testing is acceptable."

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

• Sample Size: The document does not specify the sample sizes used for any of the tests (biocompatibility, particulate contamination, leakage, tensile strength, or flow rate accuracy).
• Data Provenance: The tests were conducted to demonstrate substantial equivalence of the "Hospira Sapphire Sets," which are described as a "combination of Hospira IV set components with the Sapphire Cassette." The testing was performed for the new device as part of the 510(k) submission. It relates to the safety and performance of the device itself and its interaction with the Sapphire Infusion System. This would be considered prospective testing conducted by the manufacturer for regulatory submission. Country of origin of the data is not specified, but the applicant is Hospira, Inc. in Lake Forest, Illinois, USA.

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

This is not applicable to this type of device submission. The "ground truth" for infusion pump accessories, in this context, is established through adherence to recognized international standards (e.g., ISO) and engineering performance specifications. There is no concept of expert "ground truth" establishment in the way it might apply to diagnostic AI or imaging devices.

4. Adjudication method for the test set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where subjective interpretation (e.g., by radiologists) needs independent review to establish a consensus ground truth. For an infusion set, performance is measured against objective physical and chemical standards.

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

This is not applicable. MRMC studies are relevant for diagnostic devices, especially those incorporating AI, where human "readers" (e.g., clinicians interpreting images) are part of the diagnostic process and their performance might be augmented by AI. The Hospira Sapphire Sets are infusion pump accessories, not diagnostic imaging devices or AI-powered tools for interpretation.

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

This is not applicable. The device is an infusion set, not an algorithm or an AI-powered system. The tests described are for the physical and functional performance of the medical device itself.

7. The type of ground truth used:

The "ground truth" for the performance claims of the Hospira Sapphire Sets is based on adherence to recognized international standards (e.g., ISO 10993, ISO 8536-4, ISO 1135-4) and the engineering specifications and performance characteristics demonstrated to be "acceptable" through the conducted tests. It's essentially "compliance with established safety and performance benchmarks."

8. The sample size for the training set:

This is not applicable. The device is a physical medical device (infusion set), not a machine learning model that requires a training set.

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

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

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Hospira Administration Sets are intended for the delivery of fluids from a container to a patient's vascular system. Hospira Administration sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use. Hospira Administration sets are intended for the delivery of fluids, including blood and blood products where indicated, from a container to a patient's vascular system.

The subject of this Special 510(k): Device Modification is the addition of an alternate luer activated needleless valve to existing Hospira Administration sets cleared under the identified predicate 510(k)s. Hospira Administration Sets are comprised of components in various combinations of the following: male luer adapter with cap, female luer with cap, piercing pin connector, tubing, flow control device, filter, in-line adapter, injection site assembly, luer activated needleless valve Nuitiv™ Connector, check valve, burette chamber, and blood chamber.

This document describes the 510(k) premarket notification for Hospira Administration Sets, specifically addressing the addition of an alternate luer-activated needleless valve, the Nuitiv™ Connector, to existing administration sets. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from recognized international standards for medical devices, particularly those for intravascular administration sets and luer connectors. The reported performance demonstrates compliance with these standards.

• ISO 10993-4 Hemocompatibility
• ISO 10993-5 Cytotoxicity
• ISO 10993-10 Sensitization
• ISO 10993-11 Intracutaneous Irritation
• Systemic Toxicity
• Subacute Toxicity
• Subchronic Toxicity
• Pyrogenicity |
  | Luer Connector Performance | Complies with ISO 594-1 and ISO 594-2 for conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment. | Complies with ISO 594-1 and ISO 594-2, specifically:
• Section 4.1.1 Gauging (luer dimensions)
• Section 4.2.1 Liquid Leakage
• Section 4.2.2 Air Leakage
• Section 4.3 Separation Force
• Section 4.4 Unscrewing Torque
• Section 4.5 Ease of Assembly
• Section 4.6 Resistance to Overriding
• Section 4.7 Stress Cracking |
  | Administration Set Performance (general) | Complies with ISO 8536-4 and ISO 1135-4 for infusion equipment. | Complies with ISO 8536-4 and ISO 1135-4, specifically:
• Section 6.1 Particulate Matter
• Section 6.2 Air Leakage (for ISO 8536-4)
• Section 6.3 Tensile Strength (for ISO 8536-4)
• Section 5.1 Particulate Matter (for ISO 1135-4)
• Section 5.2 Air Leakage (for ISO 1135-4)
• Section 5.3 Tensile Strength (for ISO 1135-4) |
  | Administration Set Performance (with pressure infusion equipment) | Complies with ISO 8536-8 for infusion equipment for use with pressure infusion equipment. | Complies with ISO 8536-8, specifically:
• Section A.3.2 Air Leakage
• Section A.3.3 Air Leakage
• Section A.3.4 Liquid Leakage |
  | Sterility Assurance Level (SAL) | 10^-6 | 10^-6 |
  | Functional Claims & Intended Use | Meets functional claims and intended use as described in product labeling. | Meets functional claims and intended use as described in the product labeling. |

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

The document does not explicitly state specific sample sizes (number of units tested) for each individual non-clinical performance bench test. It uses the phrase "All testing is acceptable," implying that sufficient units were tested to demonstrate compliance with the specified standards.

The data provenance is from non-clinical bench testing conducted to evaluate the performance and material characteristics of the Nuitiv™ Connector and the administration sets incorporating it. This is prospective testing specifically performed for this 510(k) submission. The country of origin of the data is not explicitly stated, but it is implied to be internal testing by Hospira, Inc., a U.S.-based company.

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

This type of submission (device modification for administration sets) does not involve expert-established ground truth in the way a diagnostic AI product would. The "ground truth" for these tests are the established international standards (ISO standards) themselves and the objective, measurable criteria they define. No human experts are used to establish "ground truth" for these mechanical and material tests; the tests evaluate direct physical properties and biological responses against predefined limits.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method like 2+1 or 3+1. The tests yield objective, quantitative results (e.g., force measurements, leak rates, chemical analyses) that are compared against predefined pass/fail criteria from the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is typically relevant for medical imaging AI devices where human readers interpret medical images with and without AI assistance. This submission is for a physical medical device (administration sets) and a component change, not an AI or diagnostic imaging device.

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

Yes, in a sense, the "standalone" performance was evaluated. The performance bench tests described for the Nuitiv™ Connector are a standalone assessment of its properties and function without human interaction beyond its intended use. However, this is not an "algorithm-only" standalone performance as typically discussed in AI/software medical device contexts. It is a standalone evaluation of the physical device component.

7. The Type of Ground Truth Used

The ground truth used for this study is based on:

• Established International Standards: Specifically, various ISO standards for medical devices, infusion equipment, and luer connectors (e.g., ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4, ISO 8536-8, ISO 1135-4).
• Objective Engineering and Material Science Principles: The tests evaluate measurable physical properties and material characteristics against predefined limits identified in these standards.

It is not based on expert consensus, pathology, or outcomes data, as these are typically relevant for diagnostic or therapeutic efficacy studies.

8. The Sample Size for the Training Set

Not applicable. This is a submission for a physical medical device. There is no concept of a "training set" or "machine learning model" involved. The testing focuses on the performance of the manufactured device.

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

Not applicable, as there is no training set for a physical medical device submission of this type.

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The LifeCare PCA™ infusion system is intended for intravenous or epidural administration of analgesic medications that are delivered by a continuous rate of infusion and/or with patient-controlled demand doses.

The Hospira LifeCare PCA™ Infusion System is a microprocessor controlled, pole mounted, electromechanical infusion pump that allows a patient to self-administer analgesic using an attached patient pendant, within physician prescribed, programmed parameters. The Hospira LifeCare PCA™ Infusion System also includes a sterile empty vial that can be pharmacy-filled with appropriate medications, and dedicated administration sets to administer the medication.
The infuser is powered from an AC power source and has an internal battery to maintain operation for short periods when an AC power source is not available. A stepper motor exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient.
The infuser will accept either a pre-filled drug vial manufactured by Hospira or a sterile empty vial that can be filled by a hospital's pharmacy. Administration Sets compatible for use in the LifeCare PCA™ Infuser are provided sterile (fluid path) and intended for single-use application.
The infuser is equipped with wireless (802.11 a/b/g) and wired interfaces to Hospira MedNet™ Software. Drug Libraries and Auto-Programs are transferred using these interfaces. The subject device bi-directionally communicates to the hospital information system through the Hospira MedNet™ Server, which is optional software, and the device can also be programmed and used without the Hospira MedNet™ software.

The provided document is a 510(k) summary for the Hospira LifeCare PCA™ Infusion System. It describes the device, its intended use, and a summary of performance data. However, it does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance against those criteria. Instead, it states that system verification and validation activities were conducted and that all testing met the acceptance criteria.

Here's an analysis based on the information provided:

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

The document does not provide a table with specific acceptance criteria and detailed reported device performance for each criterion. It broadly states: "System verification and validation activities for LifeCare PCA™ Infusion System confirmed that the system meets user needs and design inputs. All the testing met the acceptance criteria."

It lists several standards to which the device complies, implying that meeting the requirements of these standards constitutes the acceptance criteria. These standards include:

• Basic Safety and Essential Performance: ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
• Electromagnetic Compatibility: IEC Standard 60601-1-2:2007 3rd Ed.
• Alarm Systems: IEC 60601-1-8, Edition 2.1 2012-11
• Infusion Pump Basic Safety and Essential Performance: IEC 60601-2-24 Medical Electrical Equipment – Part- Edition 2.0 2012-10
• Biocompatibility: ISO 10993-1:2009 (Corrigendum 2010) and FDA Draft Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" issued April 2013

Without specific performance values against each standard's criteria, a table cannot be fully constructed from this document. The document only confirms that the device met these criteria.

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

The document does not specify sample sizes for any test sets used in performance testing. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. The reported data relates to non-clinical performance and human factors evaluations.

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

This information is not applicable and not provided. The testing described is for an infusion pump, focusing on engineering performance, safety standards, and human factors, rather than a diagnostic device requiring expert interpretation for ground truth. "Human factors evaluations" were conducted, but details on the number or qualifications of participants/experts for establishing a "ground truth" are not mentioned.

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

This information is not applicable and not provided. The described testing refers to compliance with engineering and safety standards and human factors evaluations, not diagnostic image interpretation where adjudication methods like 2+1 or 3+1 would be used.

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

This information is not applicable and not provided. The device is an infusion pump, not an AI-powered diagnostic tool used by "human readers" to interpret cases.

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

The device is an infusion pump with software, not a standalone algorithm in the context of AI performance. The document describes "System verification and validation activities" which imply testing of the integrated device. It also notes "Human factors evaluations," which specifically involve human-in-the-loop performance to validate the effectiveness of use error related mitigations. Therefore, testing was conducted on the complete system with human interaction being a component of the evaluation (for human factors).

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

For the non-clinical testing of the infusion pump, the "ground truth" is established by the requirements and specifications of the referenced international and national standards (e.g., IEC 60601 series, ISO 10993-1) and the device's own design inputs and user needs. The testing verifies if the device performs according to these engineering and safety specifications. For biocompatibility, the ground truth would be based on the biological evaluation criteria defined in ISO 10993. For human factors, the ground truth relates to the effectiveness of use-error mitigations and whether users can safely and effectively operate the device according to its design.

8. The sample size for the training set:

The concept of a "training set" is not applicable as this is a traditional medical device (infusion pump) and not an AI/machine learning model that undergoes training on data.

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

As the concept of a "training set" is not applicable, this question is not relevant to the provided document.

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Hospira Blood sets are indicated for the delivery of fluids including but not limited to blood products from a container to a patient's vascular system.

The Hospira Blood Sets with Secure Lock are intended for use as gravity sets. Hospira Blood sets are comprised of various components including the following: male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette assembly / blood pump assembly / or blood cylinder assembly, and injection site assembly. Blood sets are configured to ensure the intended use of the device is met. Hospira Blood 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 Hospira Blood Sets are being compared to a predicate device, the Hospira Infusion Blood Sets (K101677), due to a modification to the Secure Lock Male Luer and a change in the male luer adapter material. The study aims to demonstrate substantial equivalence to the predicate device.

The document provides information on non-clinical and performance testing to ensure the modified device meets the required standards.

1. Table of Acceptance Criteria and 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)

The document does not specify the exact sample sizes for each test in the non-clinical and performance evaluations. It states that "New data has been generated" for these tests. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.

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

This is a medical device for fluid delivery, not an AI or imaging device that requires expert interpretation for ground truth. Therefore, this information is not applicable and not provided in the document. The "ground truth" for this device is based on objective measurements and adherence to international standards.

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

This is not applicable to the type of device and testing described. Adjudication methods are typically used in studies involving subjective interpretation (e.g., by experts in medical imaging). The tests mentioned here are objective chemical, physical, and functional performance tests.

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, an MRMC comparative effectiveness study was not done. This is a traditional medical device (blood sets) and not an AI-powered diagnostic or assistive technology.

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

No, this is not an algorithm or AI device. The performance is of the physical device itself.

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

The 'ground truth' for the Hospira Blood Sets is defined by the objective pass/fail criteria established by recognized international standards (ISO 10993 for biocompatibility and ISO 1135-4, ISO 594-1, ISO 594-2 for performance). The results of these tests, demonstrating compliance with these standards, constitute the "ground truth" for the device's acceptable performance.

8. The sample size for the training set

This is not an AI or machine learning device, so there is no concept of a "training set" for an algorithm.

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

Not applicable, as it is not an AI/ML device.

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

The Hospira Primary Sets with Secure Lock are intended for use as gravity sets. Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, dial-a-flo assembly and tubing. In addition to these components, a set may contain one or more of the following components: flow control device, drip chamber assembly and air inlet. Hospira Primary sets are intended for the delivery of fluids from a container to a patient's vascular system. Hospira infusion sets are disposable devices for single patient use.

The provided text describes a 510(k) premarket notification for a medical device, specifically Hospira Primary Sets. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Hospira Primary Sets - K142367).

Based on the information provided, it's clear this document is for a physical medical device (intravascular administration sets) and not an AI/ML-driven diagnostic or image analysis software. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

The "acceptance criteria" for a physical device like this typically revolve around compliance with relevant engineering standards, material biocompatibility, and functional performance tests rather than diagnostic accuracy metrics.

Here's a breakdown of the applicable information:

Acceptance Criteria and Device Performance for Hospira Primary Sets (K143015)

The device in question, Hospira Primary Sets, is an intravascular administration set. The criteria for its acceptance are based on its functional performance, material safety, and compliance with established international standards for such medical devices, demonstrating substantial equivalence to a previously cleared predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not explicitly detailed in the provided document. For physical device performance testing, sample sizes are typically determined by statistical methods to achieve a certain confidence level for the specific tests performed (e.g., tensile strength, leak tests). The data provenance is generally from internal lab testing by the manufacturer.

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

This is not applicable as the device is a physical product, not an AI/ML diagnostic. Ground truth for its performance is established through engineering and laboratory testing against defined standards.

4. Adjudication Method for the Test Set

This is not applicable for a physical device. Performance is objectively measured against engineering specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

This is not applicable. MRMC studies are relevant for diagnostic devices involving human interpretation, especially with AI assistance. This device is an intravenous fluid delivery set.

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

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

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is defined by:

• Compliance with international standards such as ISO 10993 (biocompatibility), ISO 594-1 (luer fittings), ISO 594-2 (luer fittings), and ISO 8536-4 (infusion sets).
• Demonstrated functional performance through engineering tests that confirm safe and effective fluid delivery.
• Material properties meeting specified requirements.
• Achieving a sterility assurance level of 10-6.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical product and does not involve AI/ML training.

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

This is not applicable for the same reason mentioned above.

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Plum 360™ Infusion System with Hospira Mednet™ and Plum A+™ (360 Enabled™) Infusion System are indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood products.

The Plum 360TM Infusion System with Hospira MedNet™ remains a volumentric Infusion System intended for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Dedicated administration sets are used for delivery of infusion therapy to the patient.

The device has a user interface consisting of LCD display, front panel numeric keypads and keys, audible and visual indicators, audible indicator volume control, nurse call interface, network interface connectors, the drug library, and software that provides pre-defined display screens for therapy programming.

The continued use of the Hospira MedNet™ Software allows communication between the Infusion Pump, Hospira MedNet™ server and the facility's communication systems.

The provided text is a 510(k) Summary for the Plum 360™ Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and technical characteristics, rather than a clinical study measuring diagnostic accuracy or human reader performance with AI. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth in the context of device performance metrics (like sensitivity, specificity, accuracy) is not directly available or applicable from this document.

However, I can extract the information that is present:

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

The document does not provide specific quantitative acceptance criteria or reported numerical device performance beyond stating "PASS" for various tests. The acceptance criteria for each test were meeting the requirements of the specified standard/guidance.

The document also states: "System verification and validation activities for subject devices confirmed that the system meets and design inputs. All the testing met the acceptance criteria."

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

This information is not provided in the document. The tests performed are engineering and analytical tests (e.g., electrical, mechanical, EMC, biocompatibility) rather than tests on a "test set" of patient data as might be relevant for AI/diagnostic devices.

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

This information is not applicable and not provided. The ground truth for these types of tests would be established by validated test equipment and established scientific principles, not expert human interpretation.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving human interpretation of data.

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 conducted or reported. This document pertains to a medical device's safety and effectiveness (infusion system) through performance testing, not a diagnostic AI system requiring reader studies. The document notes "Human Factors studies have been conducted to validate the effectiveness of use related error mitigations" but does not provide details on their design or results beyond "demonstrating passing results."

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

This information is not applicable in the context of an infusion system's performance testing described here. The "algorithm" here refers to the software controlling the infusion pump, and its performance is evaluated as part of the overall system.

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

The "ground truth" for the tests described consists of established engineering standards, regulatory requirements, and validated test methods (e.g., for electrical safety, EMC, alarm systems, pump performance, biocompatibility). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable and not provided. The device is not an AI/ML model that is "trained" on a dataset in the typical sense.

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

This information is not applicable and not provided, as there is no "training set" in the context of this device's submission.

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Hospira Burette sets are indicated for the delivery of fluids including but not limited to blood products from a container to a patient's vascular system.

The Hospira Burette Sets with Secure Lock are intended for use as gravity sets. Hospira Burette sets are comprised of various components including the following: male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette assembly and injection site assembly. Burette sets are configured to ensure the intended use of the device is met. Hospira Burette 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 document is a 510(k) summary for the Hospira Burette Sets, which is a medical device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study of AI performance.

Therefore, many of the requested elements for describing the acceptance criteria and study proving device meets those criteria, particularly those related to AI effectiveness, human readers, sample sizes for training sets, and expert adjudication, are not applicable to this document. This document describes a medical device, Burette Sets, not an AI or imaging diagnostic device.

However, I can extract and infer some information based on the document's content regarding the device's performance and the testing conducted.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific numerical targets and corresponding reported device performance values in the way you might expect for an AI diagnostic study. Instead, it refers to compliance with international standards and internal testing.

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

• Sample Size: The document does not specify the exact sample size used for performance or material testing. It states that "new performance data has been generated" and "all testing is acceptable."
• Data Provenance: Not explicitly stated, but assumed to be from internal lab testing conducted by Hospira, Incorporated as part of their 510(k) submission. This would be prospective testing for regulatory submission.

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

• Not Applicable. This is a physical medical device (intravascular administration set), not a diagnostic device requiring expert interpretation or ground truth establishment in the context of medical imaging or AI. Testing would involve engineering and laboratory personnel following established protocols and standards.

4. Adjudication method for the test set

• Not Applicable. As above, this type of testing for a physical device does not typically involve adjudication methods like those used for expert consensus in diagnostic studies. Compliance with standards (e.g., ISO) is the primary method of evaluation.

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 study is not an MRMC comparative effectiveness study, nor does it involve AI assistance for human readers. It's for a physical medical device.

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

• Not Applicable. This is not an AI algorithm. It's a medical device. Performance testing for the device would be analogous to "standalone" performance testing for a physical product, demonstrating it meets its specifications independently.

7. The type of ground truth used

The "ground truth" for this device is based on compliance with established international standards for medical devices (ISO 10993 for biocompatibility, ISO 594-1, ISO 594-2, ISO 8536-4 for various performance aspects of injection and infusion equipment) and achieving a specific sterility assurance level (10-6). The performance claims are also against the intended use of the device for fluid delivery.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not Applicable. As above, this is not an AI model.

In summary, the provided document is a regulatory submission for a physical medical device, not a study evaluating an AI diagnostic tool. Therefore, many of the questions related to AI performance, human readers, and ground truth establishment for AI models are not relevant to this context. The "study" proving the device meets the criteria refers to the non-clinical performance testing and material testing conducted to ensure compliance with relevant ISO standards and the stated Sterility Assurance Level.

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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 with Secure Lock 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, stopcock and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Externsion 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hospira Extension Sets, formatted to answer your specific questions.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a clinical effectiveness study of a new AI-powered medical device. Therefore, many of your questions regarding AI-specific studies, such as effect size of human readers with AI, training set details, and specific expert qualifications for ground truth in AI, are not applicable to this document. This device is a physical medical device (intravascular administration set), not an AI/software device.

Acceptance Criteria and Device Performance for Hospira Extension Sets

This document describes a 510(k) submission for Hospira Extension Sets, a physical medical device. The "acceptance criteria" here refer to performance standards and substantial equivalence claims, not diagnostic performance of an AI model.

The study presented focuses on demonstrating that the revised Hospira Extension Sets (with modifications to the Secure Lock Male Luer) perform comparably to previously cleared predicate devices and meet relevant performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

• ISO 594-1 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements)
• ISO 594-2 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings)
• ISO 8536-4 (Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed)
• ISO 8536-10 (Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment)
  "All testing is acceptable." |
  | Sterility Assurance Level (SAL) | SAL of 10⁻⁶ | Product Sterility Assurance Level is 10⁻⁶. |
  | Substantial Equivalence | Device is substantially equivalent to predicate devices. | The device is declared "substantially equivalent to the LifeShield Vision Infusion Sets cleared under K113683 and Hospira Infusion Blood Sets cleared under K101677." |

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

• Sample Size for Test Set: Not explicitly stated in this summary. The summary refers to "performance testing" and "new performance data" under various ISO standards, which would imply defined sample sizes for physical testing, but these specifics are not provided in the publicly available 510(k) summary.
• Data Provenance: Not explicitly stated. Given the nature of a 510(k) for a manufacturing change to an existing device, it's highly likely this "new performance data" would come from laboratory testing conducted by or for Hospira. There is no indication of retrospective or prospective clinical data in the traditional sense for this type of device.

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

• Not applicable. This device is a physical, non-diagnostic medical device. The "ground truth" here is adherence to engineering standards and functional performance, not human expert interpretation of medical images or data.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies (e.g., radiology reads). This document describes the testing of a physical medical device against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is not applicable to this physical medical device. This type of study is specifically designed for assessing the diagnostic performance of software or imaging systems, often with and without AI assistance to human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No. This question applies to AI algorithms. The Hospira Extension Set is a physical medical device with no AI component. The performance discussed is the standalone performance of the physical device according to engineering and functional standards.

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on adherence to international engineering standards (ISO 594-1, ISO 594-2, ISO 8536-4, ISO 8536-10) and the functional claims outlined in the product labeling. This is determined through physical and mechanical testing, not by expert consensus on clinical findings or pathological outcomes.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

• Not applicable. As there is no AI component, there is no training set or ground truth established for it.

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