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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 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.

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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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 infusion sets are disposable devices for single patient use.

The provided text is related to a 510(k) premarket notification for a medical device called "Hospira Extension Set." This is an IV administration set. The document confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the specific information requested in the prompt concerning acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a software algorithm or AI device.

The document discusses:

• Device Name: Hospira Extension Set
• Regulation Number: 21 CFR 880.5440
• Regulation Name: IV Administration Sets
• Regulatory Class: II
• Product Code: FPA
• Indications for Use: "Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system."
• Predicate Devices: LifeShield Vision Infusion Sets - K113683, Hospira Infusion Blood Sets - K101677, LifeShield Latex Free Microbore Set - K052722
• Reason for 510(k) submission: Modification to Secure Lock Male Luer
• Summary of non-clinical tests: Stated that "All materials of construction for Hospira Extension Sets meet the applicable material test requirements for ISO 10993."
• Summary of Performance Testing: "Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable. The product Sterility Assurance Level is $10^{-6}$."

The information requested in the prompt (acceptance criteria table, sample sizes for test/training, data provenance, number/qualifications of experts, adjudication method, MRMC study, standalone performance, type of ground truth, etc.) is typically associated with studies for AI/ML-enabled devices involving diagnostic or predictive tasks. The Hospira Extension Set is a physical medical device (IV administration set), and its 510(k) submission primarily relies on demonstrating substantial equivalence to predicates through material compatibility, physical performance testing, and sterility, rather than clinical studies with human readers or AI algorithms as described in your request.

Therefore, I cannot extract the requested information from the provided document as it is not relevant to this type of device and submission.

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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. Hospira infusion sets are disposable devices for single patient use.

This document is a 510(k) premarket notification for a medical device called "Hospira Primary Sets." It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices.

Based on the provided text, the device is an Intravascular Administration Set, which is a hardware device, not an AI/ML device.

Therefore, I cannot provide information regarding acceptance criteria and studies related to AI/ML device performance, as the requested information is not applicable to this submission. The document discusses performance testing in a general sense to ensure the device performs as intended in accordance with applicable standards, but does not provide specific acceptance criteria or study details that would be relevant to an AI/ML device.

Here's an analysis based on the document if we were to interpret it for a standard medical device, but with the caveat that it doesn't involve AI/ML:

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

The document broadly states: "Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable."

However, it does not provide a table of specific acceptance criteria (e.g., flow rate, burst pressure, leak rate maximums) or their corresponding reported device performance values. It only states that the product Sterility Assurance Level is 10-6, which is a performance characteristic, but not part of a comparative table.

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

The document does not specify the sample size used for performance testing, nor does it mention the data provenance (country of origin, retrospective/prospective). It only refers to "performance testing" generally.

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 as the device is a hardware product (intravascular administration set) and does not involve the interpretation of data by experts to establish ground truth in the way an AI/ML device would.

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

This information is not applicable for the same reason as point 3. It's a hardware device, not an AI/ML diagnostic tool.

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 as the device is a hardware product and does not involve human readers or AI assistance.

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

This information is not applicable as the device is a hardware product and does not have an algorithm.

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

For a hardware device like this, "ground truth" would typically refer to established engineering and material standards, or physical measurements that confirm the device meets its specifications (e.g., fluid flow rate, material strength, sterility). The document states: "All materials of construction for Hospira Primary Sets meet the applicable material test requirements for ISO 10993." and "Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards." This implies that industry standards and physical measurements are used as the "ground truth" for evaluating the device's performance.

8. The sample size for the training set:

This information is not applicable as the device is a hardware product and does not involve machine learning or training sets.

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

This information is not applicable as the device is a hardware product and does not involve machine learning or training sets.

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The Hospira MedNet™ Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira Infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters.

The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician's orders.

The Hospira MedNet™ Medication Management Suite (MMS) is an optional software product intended for use in healthcare facilities by trained healthcare professionals to facilitate networked communications (wired or wireless) between MMS compatible hospital information systems and compatible infusion pumps.
The MMS provides healthcare professionals with the capability to send, receive, and store information from infusion pumps. The bi-directional communication includes infusion parameters, pump default configurations, pump location, history, events, trending, alarms and status. The MMS cannot remotely start, modify, or terminate ongoing infusions.

Below is a summary of the acceptance criteria and study information for the Hospira MedNet™ Medication Management Suite:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on software changes to an existing device and primarily relies on non-clinical performance testing for validation. Therefore, the acceptance criteria are related to meeting design requirements and ensuring safety and effectiveness after software modifications.

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

The document does not explicitly state a "test set" in the context of clinical data for a machine learning model. Instead, the validation involved software verification and validation activities and Human Factors studies.

• Sample Size: Not applicable in the traditional sense of a clinical test set. The validation refers to software testing and human factors studies, but specific numbers of test cases or participants are not provided.
• Data Provenance: Not applicable for clinical data. The studies performed were non-clinical (software verification/validation) and human factors studies. The geographical origin of these studies is not specified, but they were conducted by Hospira, Inc.

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

This information is not provided. Given that the validation involves software testing and human factors studies for a medical device accessory software, "ground truth" would likely be established by internal engineering and human factors experts, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies for establishing ground truth from multiple expert interpretations, especially in image analysis. Since no clinical trials or image interpretation tasks were involved, no adjudication method is described or applicable.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical trials have been performed." The device is an infusion pump accessory software for medication management, not a diagnostic imaging device that typically requires MRMC studies.

6. Standalone Performance Study

No standalone performance study in the typical sense of algorithm-only performance without human interaction was conducted. The device is software designed to be used by trained healthcare professionals to facilitate communication and automate programming, meaning human-in-the-loop interaction is inherent to its intended use. The validation focused on the software meeting design requirements and human factors.

7. Type of Ground Truth Used

The "ground truth" for this device's validation was based on:

• Design Specifications and Requirements: The software's performance was evaluated against its pre-defined design inputs and user needs.
• Risk Analysis Outcomes: Demonstrating that identified risks were acceptably mitigated.
• User Performance in Human Factors Studies: Validating the effectiveness of use-related error mitigations during interaction with the software.

8. Sample Size for the Training Set

Not applicable. The document describes a software update to an existing medical device, not a machine learning or AI model that requires a "training set" in the traditional sense. The development likely involved standard software engineering practices and testing, rather than an AI training paradigm.

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

Not applicable. As no training set for a machine learning model was described, there is no information on how its "ground truth" would be established.

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The ADD-Vantage ADDaptor™20 mm binary connector is a double ended for use in a pharmacy setting or patient care area, by trained clinicians, to connect an ADD Vantage diluent solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.

ADD-Vantage ADDaptor™ vial adapter transfer device is a double ended vial transfer device which allows the use of a 20mm single dose standard drug vial, to be connected to an ADD-Vantage diluent container bag.

The information below is extracted from the provided text, primarily sections {2} and {3}. Please note that the document is a 510(k) submission for a medical device (vial adapter transfer device), which typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy trials. Therefore, much of the requested information, particularly around human reader studies or sophisticated ground truth establishment, is not present for this type of device.

1. Table of acceptance criteria and the reported device performance

The summary states: "The ADD-Vantage ADDaptor™ vial adapter transfer device has passed all specified test requirements. The validation and verification testing have confirmed these devices meet user needs and design inputs for a vial adapter. Testing also confirmed physical attributes and device performance meets requirements of the standards listed in the Performance Test Summary-New Devices table above. These standards address sterility, biocompatibility, and particulate."

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

The document does not specify the exact sample sizes for each test listed. The tests are non-clinical (bench testing for performance, biocompatibility, and sterilization) rather than clinical studies on humans. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective, as these are typically not applicable to laboratory-based non-clinical testing.

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 to the type of device and testing described. The "ground truth" for non-clinical performance and safety tests is typically established by fulfilling the requirements of the specified ISO or ANSI/AAMI standards, which are laboratory benchmarks and protocols, not expert consensus on medical cases.

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

Not applicable. This device underwent bench testing against established standards, not a diagnostic or interpretative study requiring 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. This is a non-AI medical device (a vial adapter transfer device). MRMC studies are not relevant or mentioned.

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

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

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

The "ground truth" for the tests performed is adherence to the specified international and national standards for device performance, biocompatibility, and sterility (e.g., ISO 10993 series and ANSI/AAMI/ISO 11137/11737 series). These standards define acceptable limits and methodologies, and passing these tests constitutes meeting the "ground truth" for the device's characteristics.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. There is no training set for this device.

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