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The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.

The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

Not Found

1. Acceptance Criteria and Reported Device Performance:

This document is a 510(k) clearance letter for an "I.V. Administration Set." It is a regulatory document stating that the FDA has reviewed the manufacturer's premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

Crucially, this type of document is a clearance, not a study report. It does not contain acceptance criteria (e.g., specific performance metrics like sensitivity, specificity, or precision) or reported device performance data in the way one would see for a novel AI/ML device or a device requiring specific clinical efficacy or safety studies for its primary function.

For a traditional medical device like an I.V. Administration Set, "acceptance criteria" are implicitly met through the demonstration of substantial equivalence to a predicate device. This typically involves:

• Design and Material Specifications: The new device must meet comparable specifications to the predicate in terms of materials, dimensions, and construction.
• Performance Benchmarking: The new device must perform comparably to the predicate for its intended function (e.g., flow rate, pressure resistance, sterility, biocompatibility). These are usually physical and chemical tests rather than clinical performance studies with human subjects that yield metrics like sensitivity.
• Safety Standards: The device must comply with relevant safety standards (e.g., ISO standards for blood compatibility, sterility, and biocompatibility).

The document does not provide a table of acceptance criteria or reported device performance in the format requested because this information is part of the underlying 510(k) submission, not the public-facing clearance letter. The clearance letter only states that the FDA found the device "substantially equivalent" based on the submitted data.

If this were an AI/ML device submission, a table like the one requested would be a key component of the FDA's summary of the submission. Since it's a conventional I.V. administration set, the clearance is based on established equivalence.

Therefore, for questions 2-9, the answer directly from the provided text is that the information is not present, as this is a regulatory clearance letter, not a clinical study report.

Here's how to interpret the lack of information for a device like an I.V. Administration Set in the context of the questions:

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

• Not Applicable (N/A) / Not provided in this document. For an I.V. Administration Set, "test sets" would refer to engineering and biocompatibility tests rather than clinical imaging data sets. The document is a regulatory decision, not a study report.

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

• N/A / Not provided in this document. "Ground truth" in this context would likely refer to the established performance characteristics and safety profiles of predicate devices and the new device's ability to meet those. This would involve engineering experts, material scientists, and quality control professionals, not typically "radiologists" as the example suggests.

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

• N/A / Not provided in this document. Clinical adjudication methods are not typically part of the regulatory review for a simple administration set.

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 study is relevant for AI-powered diagnostic devices where human interpretation is involved. This device is an I.V. administration set, which is a physical fluid delivery device, not a diagnostic or AI-assisted interpretation tool.

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

• N/A. This question pertains to AI algorithms. The device is a traditional medical device.

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

• N/A / Not provided in this document explicitly. For this device, ground truth would be established through:
  • Engineering specifications and test standards: Meeting validated physical and chemical properties (e.g., flow rate, pressure, material integrity).
  • Biocompatibility testing: Compliance with ISO 10993 series standards.
  • Sterility testing: Compliance with relevant sterility assurance levels.

8. The sample size for the training set:

• N/A. This question refers to training data for AI/ML models. This is not an AI/ML device.

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

• N/A. This question refers to AI/ML models. This is not an AI/ML device.

In summary: The provided document is a 510(k) clearance letter for a conventional medical device (I.V. Administration Set). It confirms regulatory approval based on "substantial equivalence" to existing devices, but it does not contain the detailed study data or performance metrics that would be found in a clinical study report, especially for an AI-powered device. The questions posed are highly relevant to AI/ML medical devices but are mostly not applicable to the information contained within this specific regulatory letter for a traditional device.

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I.V. Administration Set for the infusion of parenteral fluids and medications from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.

The Volumat Polyethylene I.V. Administration Sets (PE Sets) are available for dedicated use with the Agilia Infusion Pump and the Agilia VP MC Pump, or they can administer parenteral fluids and medications by gravity flow. Both the Agilia Infusion Pump and the Volumat I.V. Administration Sets were cleared under K121613. The Agilia VP MC Pump was cleared under K210073. The PE Sets include a spike, drip chamber, roller clamp, upstream/downstream clamp, backcheck valve, pump segment, needle-free port, rotating male luer lock, and tubing.

The provided text describes the regulatory clearance of a medical device, the "Volumat Polyethylene I.V. Administration Set," by the FDA. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Baxter Administration Set K203609) rather than establishing novel performance metrics or conducting a clinical study with acceptance criteria.

Therefore, the specific information requested cannot be fully extracted from the provided text. However, I can provide the available information relevant to performance and testing:

Response based on available information:

The document outlines performance testing conducted to support the substantial equivalence determination by showing the device performs as intended and that differences from the predicate device do not raise new questions of safety or effectiveness. It does not explicitly state "acceptance criteria" in a quantitative table with "reported device performance" against those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with corresponding reported device performance values. Instead, it lists various standards and tests that were applied, and it states that these tests "demonstrate equivalence" or confirmed that differences "do not impact safety or effectiveness."

For example, regarding the listed technological characteristic differences:

• Operating Mechanism (presence of pumping cassette): "Difference has been verified through performance testing including flow rate accuracy under various environmental conditions (temperature, pressure, humidity) which demonstrate equivalence." (No specific flow rate accuracy acceptance criteria or results are given).
• Length: "Difference tested according to ISO 8536-4 and flow rate accuracy to demonstrate the subject device performance." (No specific length or flow rate acceptance criteria or results are given).
• Priming Volume: "Bench testing confirmed that the differences in priming volume do not impact safety or effectiveness." (No specific priming volume acceptance criteria or results are given).
• Internal/External Tube Diameter: "Difference tested to ISO 8536-8 has demonstrated equivalence." (No specific diameter acceptance criteria or results are given).
• Components (e.g., pump segment): "The differences have been verified in various aspects to demonstrate the subject device's safety and performance including: Biocompatibility testing according to ISO 10993 collateral standards, Microbial Ingress Testing, and Particulate Testing; Performance Testing according to ISO 8536-4, ISO 80369-20, ISO 8536-8 and ISO 8436-14." (No specific acceptance criteria or results for these tests are provided).

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

The document does not detail the sample sizes used for the "performance bench testing" or the specific data provenance (e.g., country of origin, retrospective/prospective). It only lists the types of tests conducted.

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

Not applicable. This information is typically relevant for studies involving human interpretation or subjective assessments, such as imaging AI algorithms. The described testing is primarily bench testing of a hardware device.

4. Adjudication Method for the Test Set

Not applicable for the type of bench testing described.

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

No MRMC study was done, as this is a physical medical device (I.V. administration set) and not an interpretive diagnostic tool or AI algorithm requiring human reader comparison. The document explicitly states: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device."

6. Standalone Performance Study (Algorithm Only)

Not applicable, as this is a physical medical device, not an algorithm. The testing described is for the physical device's performance.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" would be the specifications and requirements defined by the referenced ISO standards (e.g., ISO 8536-4, ISO 80369-20, ISO 8536-8, ISO 8436-14, ISO 11607-1 & 2, USP). The device's performance was compared against the pass/fail criteria within these standards to "demonstrate equivalence" and that it "performs as intended."

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms.

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

Not applicable, as this is a physical medical device.

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The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.

The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

The subject device is a single use device. It has ten models and their features are listed in Table 1. The ten models have differences in configurations. The differences are provided in Table 2.

The I.V. Administration Set is used to deliver sterile, infusion fluid from a container to the patient with or without flow control features. The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

There are ten different models, each configuration containing various components which may include: Spike Protector, Vented Air Cap, Air Filter, Spike, Drip Chamber, 10 Drops, Tubing, Back Check Valve, Needle Free TYPE Y, Clamp, Roller, Precision Filter, Robert Clamp, Male Luer Slip, Luer Lock Ring, Protective Cap, 15um Filter, Flow Regulator, Female Luer Connector. The devices are provided sterile and single use.

This document generally describes the submission of an I.V. Administration Set and I.V. Extension Set for FDA 510(k) clearance, asserting substantial equivalence to a predicate device. However, it does NOT contain the type of acceptance criteria and performance study data typically found for AI/ML-based medical devices.

The acceptance criteria and performance data provided in this document are based on bench testing and adherence to established medical device standards for physical and mechanical properties, not on the performance of a software algorithm or AI model in a clinical diagnostic setting.

Therefore, the following information, which is relevant to AI/ML device performance, is NOT available in the provided text:

• A table of acceptance criteria and the reported device performance (for AI/ML): The tables provided compare technological characteristics (e.g., product code, regulation, indications, configuration, materials, physical specifications) and note adherence to standards (e.g., ISO 8536-4 for infusion set performance). There's no AI/ML specific performance metrics like sensitivity, specificity, AUC, etc.
• Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML study. The "test sets" mentioned refer to physical samples of the IV sets for bench testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these devices is established by physical measurements and compliance with engineering standards.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML context. Ground truth for this type of device involves measurements and physical properties.
• The sample size for the training set: Not applicable as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

Based on the provided text, here is the information that is available regarding the device's acceptance criteria and the study proving it meets them:

The document describes the requirements for a traditional medical device (I.V. Administration Set, I.V. Extension Set) based on substantial equivalence to a predicate device, rather than an AI/ML-driven device.

1. Table of Acceptance Criteria and Reported Device Performance (as pertains to this type of device)

The acceptance criteria here are based on meeting design specifications and complying with recognized national and international standards. The "reported device performance" is the demonstration of compliance through non-clinical testing.

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

The document describes non-clinical (bench) testing rather than clinical study data. Specific sample sizes for each test (e.g., how many devices were tested for seal strength or biocompatibility) are not detailed in this summary. The data provenance is implied to be from the manufacturer's internal testing (BQ PLUS Medical Co., Ltd, China), as is typical for 510(k) submissions based on non-clinical testing. This is retrospective data from device manufacturing and testing processes.

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

Not applicable in the context of an AI/ML device. For a traditional medical device like an IV administration set, the "ground truth" for performance is established by adherence to engineering standards, validated test methods, and quantitative measurements (e.g., flow rate, seal strength, material properties). This is typically performed by qualified engineers, technicians, and potentially third-party labs specializing in medical device testing, not "experts" in the sense of clinical reviewers for diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not applicable. This concept is relevant for establishing ground truth in clinical data (e.g., expert consensus on image reads), not for bench testing of physical properties.

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

No, an MRMC study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not relevant to an IV administration set.

6. If a Standalone Performance Study was done:

No, an AI "standalone" performance study was not done. The performance studies conducted were non-clinical bench tests (e.g., flow rate, material biocompatibility, sterility) to demonstrate that the device meets its design specifications and complies with relevant international standards.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on quantifiable physical and chemical properties measured against established international and national standards (e.g., ISO, ASTM, USP). It is verified through laboratory testing and engineering principles to ensure the device functions as intended, is safe for patient contact, and is sterile.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable.

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The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.

The I.V. Extension Set may act as an extension of other infusion tubing intravenous fluids from a container to patient.

The propose device, I.V. Administration Set, is a single used device. It has seven models. The models and their features are listed in Table 1. There are seven different models, each configuration comprise of various components which may include: IV Chamber, Tubing, Roller Clamp, Y Site, Needle Free Valve, Slide Clamp, Back Check Valve, Male Luer Lock, 3 Way Stop Cock, Female Luer Lock, Flow Regulator, Rotating Luer Lock, T-Connector, Luer Lock Cap, Hanger, Drop, Female Luer Connector and Cap. The devices are provided sterile and single use. The proposed devices are sterilized by EO to achieve a SAL 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

Here's a breakdown of the acceptance criteria and study information based on the provided document, restructured to address your specific points.

First, it's important to note that this document is a 510(k) Premarket Notification for an I.V. Administration Set. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving independent effectiveness from scratch. Therefore, the "acceptance criteria" and "study" described herein are primarily focused on showing that the new device performs as safely and effectively as a legally marketed predicate, meeting relevant industry standards. It's not a study proving the clinical effectiveness of the device itself (like an AI algorithm's diagnostic performance), but rather its engineering performance and biocompatibility to ensure equivalent safety and function compared to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

For an I.V. Administration Set, the acceptance criteria are generally defined by compliance with recognized international standards (ISO, ASTM, USP) and demonstrating equivalent performance to the predicate device across critical parameters. The "reported device performance" is essentially that the proposed device demonstrated compliance with these standards and equivalency through non-clinical testing.

Note on "Remark" column from original table: The document highlights differences between the proposed device and the predicate in configuration, flow rate, pore size, and patient-contact material. For each difference, the applicant provides a justification that it does not affect the safety and effectiveness based on specific testing or the range of the parameter. For example, for "Flow Rate" and "Pore Size," the proposed device's values are stated to be within the predicate's range or to meet declared requirements. For "Patient-contact Material" and "Biocompatibility," comprehensive testing showed no adverse effects despite material differences.

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

• Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of devices tested for leakage, tensile strength, or biocompatibility). It states "Non clinical tests were conducted to verify that the proposed device met all design specifications." For in-vitro tests and bench testing for device performance, samples are tested to statistical validity for the specific test method outlined in the standards (e.g., ISO, ASTM).
• Data Provenance: The testing was "non-clinical," meaning it was bench testing and in-vitro laboratory testing of the physical device components and assembled products. The manufacturer is BQ PLUS Medical Co., Ltd in Songjiang, Shanghai, China. The testing was presumably conducted by or on behalf of the manufacturer, likely in China. The data is prospective, generated specifically for this 510(k) submission.

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

This type of information is not applicable to this 510(k) submission. This is not a study involving human interpretation of medical images or data requiring expert consensus or ground truth establishment in a clinical sense. The "ground truth" for the performance criteria is defined by the technical specifications of the standards (e.g., a specific tensile strength value, a defined flow rate, a negative cytotoxicity result). These are objective measurements from laboratory and bench tests, not subjective interpretations by medical experts.

4. Adjudication Method for the Test Set

This is not applicable. Since the testing is objective and based on validated laboratory and bench test methods from international standards, there is no need for an adjudication method as would be required for subjective clinical assessments or image interpretations. The results are quantitative measurements against predefined pass/fail criteria.

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. This submission is for a conventional medical device (I.V. Administration Set), not an AI/Software as a Medical Device (SaMD) that assists human readers. No MRMC study was performed, and human readers are not involved in the "reading" or "interpretation" of data generated by this device in a diagnostic sense.

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

This is not applicable. This is not an AI/Software as a Medical Device (SaMD). The "standalone performance" here would refer to the device's ability to meet its technical specifications independently, which is what the non-clinical bench testing demonstrated.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance is objective laboratory and bench test results against pre-defined specifications and compliance requirements of recognized international standards (e.g., ISO, ASTM, USP).

• Examples include measured flow rates, leakage rates, material properties (tensile strength, seal strength), biological responses (cytotoxicity, hemolysis), and sterility assurance levels.
• It is not based on expert consensus, pathology, or clinical outcomes data in the usual sense, as no clinical study was performed (or required for this type of 510(k)).

8. The Sample Size for the Training Set

This is not applicable. This is not an AI/machine learning device that requires a "training set" of data. The device's performance is based on its physical design, manufacturing processes, and materials, which are verified through the non-clinical testing described.

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

This is not applicable, as there is no training set for this type of medical device submission.

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The AMSINO® I.V. ADMINISTRATION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

The AMSINO® I.V. ADMINISTRATION SET is a single use, latex-free, Non-DEHP, gravity feed, sterile device sterilized with Ethylene Oxide Gas. It is used to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein. It is comprised of various components such as: bag, spike, drip chamber (vented and non-vented), Y-site, burette, tubing, flow controller, drip selector, clamp, check valve, latex-free injection site, needleless injection site, flashbulb, filter, manifold, stopcock, flash bulb, luer connectors and bag hanger.

This submission is an extension of the original approval (K973107) and covers the following AMSINO Product Line:

AMSINO® STANDARD I.V. ADMINISTRATION SET AMSafe® I.V. ADMINISTRATION SET (identical to the Amsino Standard I.V. Administration set, except it is marketed for Emergency Medical Services group/personnel)

AMSafe3® I.V. ADMINISTRATION SET (identical to AmSafe I.V. Administration Set, with the exception of the drip selector option.)

AMSINO offers both standard and custom sets with tubing of various sizes and lengths with a choice of 10, 15, 20 and 60 drops per ml to meet customer requirements and specifications. Customers may request I.V. Administration sets with varying configuration containing any combination of the parts per the table:

Tubing
Drip Chamber
Needleless injection site
Split Septum Injection Site
Bag Spike
Clamp
Flow Controller
Drip Selector
Filter
Rotating male luer lock
Male or Female luer lock
Check Valve
Bag Hanger
Y-site
stopcock
manifold

The provided document describes a Special 510(k) Premarket Notification for a modification to the AMSINO® I.V. ADMINISTRATION SET. This submission primarily focuses on demonstrating substantial equivalence to a previously cleared device (K973107) rather than a de novo device requiring extensive clinical studies to establish safety and effectiveness.

Therefore, the "study that proves the device meets the acceptance criteria" in the traditional sense of a human clinical trial is not applicable here. Instead, the submission relies on bench performance testing, biocompatibility, and sterilization validations to show that the modified device performs as intended and is as safe and effective as the predicate device.

Here's an analysis of the provided information based on your requested categories:

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

The document lists several performance criteria the device meets, primarily referencing ISO standards and/or AMSINO's internal testing criteria. However, specific quantitative acceptance criteria values and corresponding reported device performance values are generally not provided in this summary document. Instead, it makes statements of compliance.

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 explicitly state the sample sizes for the various bench tests, biocompatibility tests, or microbial ingress tests. It only states that these tests were conducted and the device "meets requirements" or "demonstrates a 4-log reduction." The data provenance is internal to Amsino International, Inc. (Pomona, CA, USA) and the testing would be considered prospective for the purpose of this submission, meaning the tests were conducted specifically to support this application.

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 section is not applicable to this type of device and submission. The "ground truth" for the performance criteria is established by recognized international standards (like ISO) and internal engineering/quality specifications, not expert consensus in the medical image interpretation sense. The experts involved would be the engineers and quality assurance personnel at Amsino International responsible for designing, testing, and validating the device and its manufacturing processes. Their qualifications are not detailed.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., images) by multiple readers. This is not applicable to the bench testing, biocompatibility, or sterilization validation performed for this I.V. administration set.

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. The device is an I.V. administration set, not an AI-powered diagnostic tool requiring human readability studies.

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

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

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

The "ground truth" for this device's performance is based on established engineering and materials science principles, international standards (e.g., ISO 8536-4, ISO 10993-1, ISO 11135-1), and Amsino's internal product specifications. This would involve:

• Physical/Mechanical Properties: Measured values against predefined tolerance ranges.
• Biocompatibility: Laboratory test results (e.g., cell viability, irritation scores) compared against acceptable limits derived from ISO 10993.
• Sterility: Sterility assurance levels (SAL) achieved through validated processes per ISO 11135-1.
• Microbial Ingress: Measured reduction in microbial count against a defined log reduction target.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI/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 reasons stated above.

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The Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein.

The 3 in 1 IV Administration Set is a single use, sterile, device sterilized with Ethylene Oxide gas. The 3 in 1 set is used to administer fluids from an IV container or syringe to a patient's vascular system through a needle or catheter. A choice can be easily made between 10, 15, or 60, drops/cc volume without breaking the line. This feature allows the healthcare provider the flexibility to treat the patient condition by turning the selector. The device may include a flow regulator, a drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set, needleless injection site, Y port, extension set, and a hollow spike to penetrate and connect the tubing to an IV bag or other infusion fluid container. VitalCare Group Inc. will offer standard sets and custom sets to meet customer requirements and specifications.

The provided text describes a medical device, the "3 In 1" I.V. Administration Set, and its 510(k) summary for clearance. However, it does not detail a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/ML device would.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K925465). This is a different type of validation process.

Here's an analysis based on the information provided, addressing your requested points where applicable, and noting where the information is not present for this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (an IV administration set), the "acceptance criteria" are generally tied to demonstrating that the device performs as intended and is as safe and effective as a legally marketed predicate device. The performance data presented are primarily engineering bench tests to ensure the physical integrity and functionality of the set.

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

• Sample Size: Not specified. For bench testing of physical properties, specific sample sizes are typically used for each test (e.g., n=30 for tensile strength). This information is not provided in the 510(k) summary.
• Data Provenance: The tests were performed internally by VitalCare Group, Inc., or by a contracted lab. The country of origin of the data is implicitly the USA (where the company is based and the submission was made). The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to demonstrate device performance and safety.

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

Not applicable. For a device like an IV administration set, "ground truth" as it relates to expert consensus in image analysis or clinical diagnosis is not relevant. The "ground truth" for performance is established by engineering specifications, material standards, and industry best practices. The "experts" would be the engineers and quality control personnel designing and testing the device, but their specific numbers and qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists, pathologists) when establishing ground truth for diagnostic or AI performance studies. This is not a human-in-the-loop or diagnostic device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is for evaluating human performance, often with and without AI assistance, typically in diagnostic or screening contexts. It is not relevant for an IV administration set.

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

No. This device does not have an "algorithm" or AI component. It is a physical medical device.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications, material standards, and functional requirements for IV administration sets. This would include:

• Physical specifications (e.g., dimensions, flow rates)
• Material properties (e.g., tensile strength, chemical compatibility)
• Biocompatibility standards (e.g., ISO 10993)
• Sterility assurance (e.g., ISO 11135 for EO sterilization)
• Leakage and connection integrity standards.

The 510(k) summary indicates that "Pull testing, pressure testing, joint strength testing, and drop testing has been performed," which are standard engineering tests to verify these aspects.

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 training set.

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

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

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is for a physical medical device (I.V. Administration Set) and not an AI/software device, so many of the requested fields are not applicable:

Acceptance Criteria and Device Performance

Study Details (Relevant to K023469 - Victus IV Administration Sets)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document mentions "performance and safety testing" and "biocompatibility testing," but does not specify the sample size for these tests or the data provenance (e.g., country, retrospective/prospective). This information is typically found in detailed testing reports, which are not included in the provided 510(k) summary.

2. 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. This device is a physical IV administration set. Ground truth establishment by medical experts (like radiologists) is relevant for diagnostic or image-based AI devices, not for the functional testing of a physical product like this. Testing would involve engineering, microbiology, and biocompatibility specialists.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. This refers to consensus methods for establishing ground truth, typically in the context of expert review of images or data for AI studies. For a physical device, testing outcomes are objective (e.g., pass/fail for sterility, flow rate, material strength).

4. 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 device is an IV Administration Set, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No. This device is a physical medical product, not an algorithm or AI. Standalone performance refers to the accuracy of a digital algorithm on its own.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for this device would be established through:

   • Engineering specifications and standards: Verification that the device meets defined physical, mechanical, and functional requirements (e.g., flow rates, connection integrity, material strength).
   • Microbiological testing: Confirmation of sterility.
   • Biocompatibility testing: Verification that materials are non-toxic and do not induce adverse biological responses, often following standards like ISO 10993.
   • Comparison to predicate device: The fundamental "ground truth" for FDA clearance here is substantial equivalence to a legally marketed predicate device (BBraun-McGaw IV Administration Sets), implying that if it performs comparably to a safe and effective predicate, it too is considered safe and effective.

7. The sample size for the training set:
   Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established:
   Not applicable. As above, this is not an AI/machine learning device.

Summary of the Study:

The provided document describes a 510(k) premarket notification for the Victus IV Administration Set. The study primarily involves demonstrating substantial equivalence to existing predicate devices (BBraun-McGaw IV Administration Sets).

The evidence for this substantial equivalence is based on:

• Technological characteristics: The Victus IV Administration Sets have the "same technological characteristics" as the predicate device.
• Performance and safety testing: The device "undergone performance and safety testing to verify mechanical properties and biocompatibility using FDA recognised standards, where applicable." This testing would rigorously assess physical integrity, flow rates, sterility, material safety, and other critical performance attributes against established standards and the performance profile of the predicate device.

The FDA's decision to clear the device (K023469) signifies that they found the data presented by Victus, Inc. sufficient to demonstrate that the Victus IV Administration Set is as safe and effective as the predicate device already on the market. The specific details of the individual tests (e.g., how many units were tested for sterility, details of biocompatibility studies) are not in the provided summary but would have been part of the full 510(k) submission.

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The CODAN IV Administration Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding an I.V. Administration Set. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to legally marketed predicate devices, not on the performance metrics of the device itself.

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