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The Surflo Winged Infusion Set is indicated for venipuncture and intravenous administration of fluids for up to 24 hours using compatible/appropriate disposable infusion devices for medical purposes. It may be used for any patient population with consideration given to patient size.

The Surflo Winged Infusion Set consists of a protector, needle, wing, tubing, connector, and connector cap. The connector is 6% female Luer. It is primarily made from medical grade PVC (the whole device uses TOTM as plasticizer instead of DEHP) and medical grade stainless steel. The Surflo Winged Infusion Set is operated manually. The device is intended to be used by trained healthcare professionals in a healthcare facility. The Surflo Winged Infusion Set is available in different gauge sizes and tubing lengths. The Surflo Winged Infusion Set is a disposable device intended for single use only. The device is packaged and sterilized by ethylene oxide gas.

This document is a 510(k) Premarket Notification for the Surflo Winged Infusion Set, seeking substantial equivalence to a legally marketed predicate device. As such, it describes performance testing conducted to demonstrate product safety and effectiveness, rather than a study proving a device meets acceptance criteria for an AI/ML product. Therefore, several points in your requested output, such as those related to AI/ML specific criteria (e.g., sample size for training set, number of experts for ground truth establishment, MRMC study, standalone performance) are not applicable to this type of medical device submission.

However, I can extract and present the relevant information regarding acceptance criteria and performance testing for this traditional medical device:

Acceptance Criteria and Device Performance for Surflo Winged Infusion Set

The Surflo Winged Infusion Set underwent non-clinical performance testing to ensure it met predetermined specifications, conformed to applicable ISO and non-ISO standards, and demonstrated substantial equivalence to its predicate device.

1. Table of Acceptance Criteria (Standard Compliance) and Reported Device Performance

For tests conducted against specific standards, the document implies that compliance with the standard is the acceptance criterion. For additional performance tests, the acceptance criterion was "Meets acceptance criteria," established based on the predicate device's performance.

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

The document does not explicitly state the sample sizes used for each performance test. It only mentions that "Performance testing was conducted to ensure the Surflo Winged Infusion Set met the predetermined specifications." The data provenance is implied to be from the manufacturer's internal testing facilities in Hangzhou, China, as it is manufactured by "Terumo Medical Products (Hangzhou) Co., Ltd." The testing is described as non-clinical, implying a prospective testing approach conducted specifically for this 510(k) submission.

3. Number of Experts Used and Qualifications

Not applicable. This is a non-clinical performance test for a traditional medical device, not a study requiring expert readers for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical performance test for a traditional medical device, not a study requiring adjudication of expert readings.

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

Not applicable. This is a non-clinical performance test for a traditional medical device, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm Only)

Not applicable. This is a traditional medical device, not an AI/ML algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance tests were adherence to established industry standards (ISO, JIS, GB) and internal company specifications derived from the predicate device's performance.

8. Sample Size for the Training Set

Not applicable. This is a traditional medical device, not an AI/ML product requiring a training set.

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

Not applicable. This is a traditional medical device, not an AI/ML product requiring a training set.

Additional Test Information:

• Biocompatibility: Tests were conducted on non-aged and accelerated-aged devices according to ISO 10993-1, with results demonstrating biocompatibility throughout the product's shelf life.
• Sterilization: The device is sterilized to a Sterility Assurance Level (SAL) of 10^-6, validated in accordance with ISO 11135:2014.
• Clinical Tests: The 510(k) submission states that it "does not include data from clinical tests."

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The Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) is intended to access the peripheral vascular system, for single-dose or short-term intravenous administration of fluids using a syringe or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.

The 23G and the 25G Terumo Surflo Winged Infusion Sets with Filter and Needle Protection (Surshield), are sterile, single use devices consisting of a needle attached to a winged hub, microbore tubing, adapter with integrated 20 um filter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-to-wing junction. The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto the needle using a one- or two- handed technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it. The device possesses a 350 mm length microbore tubing.

The provided text describes the acceptance criteria and a summary of verification activities for the SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield®). This device is a medical product, and the study described is a series of engineering and performance tests, not a clinical study involving human patients or algorithmic performance. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set information) are not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The Surflo Winged Infusion Sets with Filter and Needle Protection (Surshield), meet all acceptance criteria as indicated in table above."

2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each individual test. It only states that "All necessary verification and validation tests have been performed." Data provenance is not explicitly mentioned as "country of origin," but the submission is from "TERUMO EUROPE N.V." in Leuven, BELGIUM, so the testing likely occurred in Europe. The tests are prospective in nature, as they are performed on the newly designed devices to verify their performance against established criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are engineering and performance tests of a physical medical device, not a diagnostic algorithm requiring expert interpretation of medical images or data. The "ground truth" is defined by the technical specifications and international standards (e.g., ISO 594-1, ISO 594-2, EN ISO 11135-1, EN 556-1, EN ISO 10993-7).

4. Adjudication method for the test set
Not applicable. There is no adjudication method described as these are quantitative and qualitative engineering tests against predefined specifications.

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 is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.

7. The type of ground truth used
The ground truth for these tests is established by international standards and technical specifications for sterile medical devices for intravascular administration. Examples include:

• ISO 594-1: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements
• ISO 594-2: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
• EN ISO 11135-1: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• EN 556-1: Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - I: Requirements for terminally sterilized medical devices
• EN ISO 10993-7: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• FDA General Program Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing"

8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established
Not applicable.

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The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vasular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, fuer adapter, or other compatible/ appropriate devices. Additionally, after withdrawal of the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.

The 23G and the 25G Terumo Surflo Winged Infusion Sets with Needle Protection (Surshield), are sterile, single use devices consisting of a needle attached to a winged hub, standard or microbore tubing, adapter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-towing junction. The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto the needle using a one- or two- handed technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it. The device possesses a 350 mm length standard or microbore tubing.

The document provides information on the Surflo Winged Infusion Set with Needle Protection (Surshield). It details the acceptance criteria and summarizes verification activities to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Device Performance Note: The document explicitly states: "The Surflo Winged Infusion Sets with Needle Protection (Surshield), with standard and microbore tubing, meet all acceptance criteria as indicated in table above. None of the obtained data raises any new issue of safety and effectiveness."

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual verification test. It generally refers to "all necessary verification and validation tests" having been performed.
• Data Provenance: The document was prepared by Terumo Europe N.V. in Belgium. The tests were performed to demonstrate substantial equivalence to predicate devices cleared by the FDA (K052887, K072894, K100946). The nature of these tests (e.g., physical, mechanical, functional) suggests they were conducted prospectively to evaluate the modified device's performance.

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

This information is not applicable as the verification activities are focused on the physical, mechanical, and functional performance of a medical device (infusion set) against defined engineering and safety standards (e.g., ISO standards), rather than diagnostic accuracy or interpretation by human experts. Therefore, there is no "ground truth" in the clinical diagnostic sense established by experts.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. The testing involves objective measurements against predefined acceptance criteria, not subjective interpretation requiring adjudication among experts.

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. The device is an intravenous administration set, not an AI-powered diagnostic or interpretive tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the verification activities comprises pre-defined acceptance criteria based on established engineering standards (e.g., ISO 594-1, ISO 594-2, EN ISO 11135-1, EN ISO 10993-7) and internal specifications. These criteria are objective and measurable, ensuring the device's physical, mechanical, and sterile properties.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reasons as point 8.

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The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.

The 25 Gauge Terumo Surflo Winged Infusion Set with Needle Protection (Surshield) is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-to-wing junction.

The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a one- or twohanded technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it.

The device possesses 350 mm length tubing.

The provided document is a 510(k) summary for a medical device, specifically an infusion set. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. The document primarily focuses on demonstrating substantial equivalence to a predicate device and outlining basic safety information as required for FDA clearance of a traditional medical device (like an infusion set), not an AI algorithm.

Therefore, I cannot provide the requested information from this document. The questions you've asked are typically relevant for the evaluation of AI/ML-powered medical devices, which this document does not describe.

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The Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) is intended to access the peripheral vascular system for intravenous administration of fluids using a syringe, or other compatible/appropriate devices and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.

The Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) is a sterile, single use device consisting of a needle attached to a winged hub, microbore tubing, adapter with integrated 20 um filter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-to-wing junction. The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a one- or two- handed technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it. The Surflo Winged Infusion Sets with Filter and Needle Protection (Surshield) are available with a cannula with a needle size of 23 gauge (0.6 mm) or 25 gauge (0.5 mm) and a length of 19 mm (3/4"). The device possesses 350 mm length tubing.

Here's an analysis of the provided text regarding the "SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield™)":

It's important to note that the provided 510(k) summary does not contain details about specific acceptance criteria or a dedicated study proving performance against those criteria in the way one might expect for a software or AI/ML device. This document is for a physical medical device (an infusion set), and the "study" mentioned is primarily focused on demonstrating substantial equivalence to previously cleared devices through material compatibility, sterilization validation, and shelf-life testing, rather than an AI-driven performance study.

Therefore, many of the requested fields regarding AI/ML-specific performance metrics (like sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to this document.

However, I can extract the information that is present and explain why other requested details are absent.

Analysis of SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield™) 510(k) Summary

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, this document does not present explicit performance acceptance criteria in the format typically seen for novel diagnostic or AI devices (e.g., sensitivity, specificity thresholds). Instead, the "performance" demonstrated is through substantial equivalence and compliance with relevant standards.

2. Sample Size for the Test Set and Data Provenance

• Not Applicable in the context of an AI/ML device's "test set."
• For the physical device, "testing" would involve laboratory evaluations for sterility, material properties, and shelf-life. The sample sizes for these types of tests are not specified in this summary but would typically follow established validation protocols for manufacturing and quality control.
• Data Provenance: The studies (sterilization, biocompatibility, shelf-life) are conducted by the manufacturer, Terumo Europe N.V. The country of origin of the data is implicitly Belgium (where Terumo Europe N.V. is located). These are more akin to prospective laboratory or manufacturing validation studies rather than retrospective clinical data analysis.

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

• Not Applicable. This is not a device that relies on expert interpretation for its "ground truth" performance in a clinical context (like image analysis). Ground truth relates to objective measurements for sterility, chemical residuals, and material compatibility standards.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "adjudication" in the sense of resolving discrepancies between expert opinions on a test set, as this is not an interpretive device.

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

• No. An MRMC study is relevant for diagnostic devices where human readers interpret outputs (e.g., radiologists reading images with and without AI assistance). This device is an intravenous administration set, not a diagnostic tool requiring human interpretation for its primary function.

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

The ground truth used for relevant testing includes:

• Standardized Sterility Assurance Level (SAL): Defined by international standards (EN 550, ISO 11135) to be 10⁻⁶.
• Reference Limits for Chemical Residues: Defined by international standards (ISO 10993-7) for ethylene oxide residuals.
• Biocompatibility Standards: Defined by international standards (ISO 10993-1).
• Performance Specifications: The core "ground truth" for the device's functionality and safety features is its ability to meet the design specifications and be substantially equivalent to predicate devices that have already demonstrated safety and effectiveness for their intended use.

8. The Sample Size for the Training Set

• Not Applicable. This refers to AI/ML model training, which is not relevant for this device.

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

• Not Applicable. See point 8.

Summary of Device and Regulatory Context:

The 510(k) for the SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield™) is a submission for a Class II physical medical device. The primary goal of this type of submission is to demonstrate substantial equivalence to predicate devices already on the market. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

The "studies" referenced are primarily:

• Comparison to Predicate Devices: Demonstrating similarity in design and function to previously cleared infusion sets.
• Compliance with International Standards: Validation of manufacturing processes (sterilization), material safety (biocompatibility, chemical residuals), and performance (shelf-life).

This is distinctly different from the type of information requested for a software as a medical device (SaMD) or AI/ML-powered diagnostic device, where performance metrics like sensitivity, specificity, and results from clinical studies (often involving human readers) are central to the submission.

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The Surflo Winged Infusion Set is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimans using a syringe, luer adapter, or other compatible/appropriate devices.

The Terumo Surflo Winged Infusion Set is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap. The device possesses 300 mm length tubing.

This 510(k) premarket notification (K070362) for the SURFLO® Winged Infusion Set does not contain the level of detail typically found in a clinical study report for AI/software-based medical devices. This submission pertains to a physical medical device (an infusion set) and focuses on demonstrating substantial equivalence to a predicate device rather than evaluating the performance of an algorithm or AI system.

Therefore, many of the requested categories like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable or not provided in this document.

However, I will extract and present applicable information based on the provided text, primarily focusing on the regulatory and performance aspects that are discussed for this physical device.

Acceptance Criteria and Device Performance (SURFLO® Winged Infusion Set)

This submission is a 510(k) for a physical medical device, not an AI/software product. Therefore, the "acceptance criteria" discussed are primarily related to general performance, safety, and manufacturing standards for such devices. The "reported device performance" refers to the demonstration of compliance with these standards and substantial equivalence to a predicate device.

Study Details (Not Applicable for AI/Software)

As this submission is for a physical medical device and not an AI/software product, the following requested information regarding AI/algorithm performance studies is not provided or not relevant to this document.

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

• Not Applicable / Not Provided: This information is not relevant for the type of device and submission. Performance is demonstrated through compliance with standards (sterility, biocompatibility) and comparison of physical characteristics to a predicate device, rather than a data-driven test set.

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

• Not Applicable / Not Provided: No "ground truth" in the context of expert labels for data is established in this type of submission. Performance is assessed through engineering testing and regulatory compliance.

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

• Not Applicable / Not Provided: No adjudication method for a test set is used.

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

• Not Applicable / Not Provided: This is not an AI-assisted device.

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

• Not Applicable / Not Provided: This is not an algorithm.

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

• Not Applicable / Not Provided: No "ground truth" in the context of data labeling is used. Performance relies on established engineering and biological standards.

8. The sample size for the training set

• Not Applicable / Not Provided: Not an AI/ML device requiring a training set.

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

• Not Applicable / Not Provided: Not an AI/ML device.

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The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.

The Terumo Surflo Winged Infusion Set with Needle Protection (Surshield) is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-towing junction. The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a one- or two- handed technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it. The device possesses 350 mm length tubing.

The provided 510(k) summary (K052887) describes the "Surflo® Winged Infusion Set with Needle Protection (Surshield™)", which is an intravascular administration set. The primary focus of the submission is to demonstrate substantial equivalence to a previously cleared device (K031266). The document does not describe a study involving detailed performance data with acceptance criteria for the new device itself, but rather relies on the substantial equivalence to the predicate device and standardized testing for sterility and biocompatibility.

However, based on the information provided, we can infer some "acceptance criteria" related to critical safety aspects (sterility, ETO residuals, and biocompatibility) and the "study" that proves the device meets these criteria. The device's primary novel feature is the needle protection mechanism, for which performance is described qualitatively rather than with quantitative metrics and acceptance criteria in this specific document.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information

The document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence rather than a detailed report of a single, comprehensive clinical or performance study for the new device. The "studies" mentioned are largely compliance with established standards and tests.

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

• Needle Protection Mechanism: No specific sample size or data provenance is detailed for verification of the needle protection mechanism's performance in this summary. The description of its function (manual activation, audible click, finger protection) implies engineering testing and validation, but quantitative data (e.g., success rate of activation, force required, etc.) and associated sample sizes are not provided.
• Sterility, ETO Residuals, Biocompatibility, Expiration Dating: These are typically evaluated using laboratory testing on specific batches of the device components or finished product. The sample sizes would depend on the specific validation protocols for each standard (EN 550, ISO 11135, ISO 10993-7, ISO 10993-1, internal aging studies). These are typically prospective laboratory tests. The country of origin for the data is not explicitly stated, but the manufacturer is Terumo Europe N.V., and the predicate device was manufactured in Hangzhou, China. The standards cited (EN, ISO, European Pharmacopeia) are international/European.

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 in the context of this 510(k) summary. The "ground truth" for the tests mentioned (sterility, biocompatibility, ETO residuals, expiration dating) is defined by objective, measurable laboratory standards and predetermined thresholds, not by expert consensus in the typical sense for diagnostic or prognostic devices. For the needle protection mechanism, its functional "truth" would be established through engineering tests and user validation, but no details are provided here.

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

• Not applicable. The tests described are objective, laboratory-based physical and chemical tests, not clinical evaluations requiring adjudication of subjective outcomes.

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 device is an intravascular administration set, not a diagnostic imaging device using AI.

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

• Not applicable. This device is a medical instrument (hardware), not an algorithm.

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

• Sterility: Achieved SAL of 10⁻⁶, as measured by microbiological testing and adherence to validated sterilization cycles (objective laboratory measurement against a standard).
• ETO Residuals: Measured levels of Ethylene Oxide and Ethylene Chlorohydrin (objective chemical analysis against a standard).
• Biocompatibility: Response to biological tests (e.g., cytotoxicity, irritation, sensitization), showing no adverse reaction (objective laboratory measurement against a standard).
• Expiration Dating: Stability testing data showing maintenance of device properties over time (objective physical/chemical measurement against specifications).
• Needle Protection Mechanism: Functional activation and covering of the needle (objective observation of mechanism function).

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning product and does not involve a "training set."

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

• Not applicable.

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