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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.

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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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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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