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The Microvolume Luer Access Device is a valve intended for the aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Microvolume Luer Access Device may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec.

The Microvolume Luer Access Device (LAD) consists of a body, piston, spike/nut, and a male luer lock cover. The Microvolume LAD is a neutral displacement needleless connector intended to provide needle-free access to IV gravity sets, pump sets and extension sets for the administration of IV fluids and blood. The Microvolume LAD may be used with a power injector. The Microvolume LAD is individually packaged and supplied as a sterile, nonpyrogenic, single use disposable device.

The provided text describes a 510(k) premarket notification for a medical device (Microvolume Luer Access Device) and its comparison to a predicate device, focusing on demonstrating substantial equivalence. However, it does not contain information about the acceptance criteria and study proving device performance as requested in the prompt. The document states that the device was evaluated using "Functional performance bench testing" and "No clinical was performed" because the device does not require clinical studies to demonstrate substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample size (test or training set), data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established, as these aspects relate to clinical studies or a more detailed performance evaluation that is not present in this 510(k) summary.

The document lists several standards and tests performed, but these are part of the bench testing to show the device meets certain functional requirements and not specifically "acceptance criteria" against which a study directly proves performance in the context of clinical outcomes or diagnostic accuracy.

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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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To administer IV fluids/medication to a patient's vascular system.

The Victus I.V. Administration and Extension Sets are single use, sterile, non-pyrogenic devices used to administer filtered intravenous solutions and/or nutritional solution to a patient's vascular system via a catheter venous site under gravity-controlled flow. When used, the purpose of the filter is for filtering solution during intravascular administration. The device may include a needle-free valve injection site/connector which eliminates the use of needle to access the set during IV administration and aids in the prevention of needlestick injuries.

This document describes a 510(k) premarket notification for Victus Intravascular (I.V.) Administration Sets and Victus I.V. Extension Sets. The submission details changes and additions to the product line, including substituting a Flow Regulator for a Roller Clamp, replacing PVC tubing, substituting a Needle-Free connector, and adding a filter and check valve to some configurations. The document asserts that these changes do not affect the safety and effectiveness of the devices.

The information provided is primarily focused on the declaration of substantial equivalence to predicate devices and the scope of the device's intended use. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested. The only mention of testing is "The VICTUS IV Extension Set and IV Administration Set have undergone Mechanical testing to verify performance," without detailing the tests, criteria, or results.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted based on the provided text, with significant gaps for the unavailable information:

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

Unfortunately, the provided text does not contain a table of acceptance criteria or specific reported device performance metrics beyond the statement "The VICTUS IV Extension Set and IV Administration Set have undergone Mechanical testing to verify performance." No quantitative results or predefined thresholds are mentioned.

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 any mechanical testing or the data provenance.

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 present as this is a mechanical medical device, not an AI or diagnostic imaging device.

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

This information is not applicable and not present. No adjudication method is mentioned for any testing.

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 this is a mechanical medical device and not an AI-assisted diagnostic device.

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

This information is not applicable as this is a mechanical medical device and does not involve an algorithm.

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

For mechanical devices, "ground truth" typically refers to established engineering standards or regulatory requirements that the device must meet (e.g., flow rate, tensile strength, sterility). The document states that the devices underwent "Mechanical testing to verify performance" and that the "Technological characteristics of the Victus Sets are substantially equivalent to the referenced predicates." This implies that the performance was compared to established standards for similar predicate devices, though the specific 'ground truth' metrics are not detailed.

8. The sample size for the training set

This information is not applicable and not present as this is a mechanical medical device, not an AI or machine learning device.

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

This information is not applicable and not present as this is a mechanical medical device, not an AI or machine learning device.

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

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

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

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

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

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

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To administer IV fluids/medication to the patient's vascular system through a needle-free system that aids in the elimination of needle-stick injury.

The Victus I.V. Administration Sets are single use, sterile, non-pyrogenic devices used to administer I.V. fluids/medication to a patient's vascular system via gravity control.

The provided text describes a 510(k) premarket notification for the Victus IV Administration Sets. However, it does not contain the detailed acceptance criteria, study design, or performance data that you've requested regarding device performance. The document explicitly states:

"The Victus I.V. Administration Sets have undergone performance and safety testing to verify mechanical properties and biocompatibility using FDA recognised standards."

This indicates that testing was performed, but the results of that testing (i.e., acceptance criteria and reported performance) are not included in this document. Instead, this document is a summary for a 510(k) submission, confirming that the device is substantially equivalent to predicate devices. Substantial equivalence means it has the same intended use and similar technological characteristics, and any differences don't raise new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer the specific questions about "the study that proves the device meets the acceptance criteria" using the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical or performance study report.

Here's what I can extract based on the limited information:

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):

• Not provided. The document states "performance and safety testing" was done, but gives no details about the sample size, type of test set, or data provenance.

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):

• Not applicable/Not provided. This type of information is relevant for studies involving human interpretation (e.g., medical imaging AI). For an IV administration set, "ground truth" would typically be established through engineering specifications, material science testing, and biological assays, not expert consensus on interpretations. No details on specific experts or their qualifications are mentioned.

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

• Not applicable/Not provided. Adjudication methods are typically used when multiple human experts provide opinions that need to be reconciled, such as in clinical studies evaluating diagnostic accuracy. This is not mentioned or relevant for the type of device and testing described.

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 not an AI device. It is a traditional medical device (IV administration set).

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

• Not applicable. This is not an algorithm or AI device.

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

• Inferred: For this type of device, ground truth would be established by engineering specifications, material properties, biocompatibility standards, and functional performance benchmarks (e.g., flow rates, leak integrity, particulate matter, pyrogenicity). The document mentions "FDA recognised standards" were used, implying these types of criteria formed the "ground truth." Specific details are not provided.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI device that requires a training set.

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

• Not applicable. This is not an AI device.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to pre-existing devices, rather than a detailed scientific study report outlining specific performance criteria and test results. It confirms that "performance and safety testing" was conducted using "FDA recognized standards," but the specifics of those tests and their outcomes are not included in this document.

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