For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices are single use disposable devices intended for the administration of fluids from a container to the patient's vascular system. The extension sets consist of a combination of the following components: PVC or PE lined PVC tubing, a clamp, female Luer with non-vented cap, male Luer with filter vented cap. The accessories consist of an anti-siphon valve, back check valve, and 1.2 µm Filter. The accessories are used in combination with IV sets to administer solutions directly from a container to a patient's vascular system.

This FDA 510(k) summary describes an intravascular extension set and accessories. The filing primarily focuses on demonstrating substantial equivalence to a predicate device (K192366) and the removal of a caution statement related to body weight. Therefore, the information provided does not detail a study involving AI or complex performance metrics as typically seen for AI/ML-enabled devices.

Based on the provided text, the acceptance criteria and study information are as follows:

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

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

The document does not specify a "test set" in the context of performance evaluation with a defined sample size for the device itself. The primary testing mentioned is biocompatibility. For biocompatibility, there is no information about sample size or data provenance provided in this summary.

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. This device is a physical medical device (intravascular extension set and accessories), not an AI/ML-enabled device requiring expert ground truth for performance evaluation of diagnostic accuracy.

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

Not applicable. This device is a physical medical device, not an AI/ML-enabled device requiring adjudication of expert interpretations.

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. No MRMC study was performed as this is a physical medical device, not an AI-assisted diagnostic tool.

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

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

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

Not applicable. For biocompatibility testing, the "ground truth" would be established by standardized testing methods and international standards (e.g., ISO 10993 series), not expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. As there is no training set mentioned, there is no ground truth established for a training set.

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The ENFit to ENFit Extension Sets are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition, fluids and medications from an enteral feeding syringe or set through to an ENFit feeding tube connector for enteral applications.

The device is single use for patients who require enteral feeding.

The ENFit to ENFit Extension Sets are sterile, single use devices. The extension sets are single and bifurcated port tubing sets with ENFit input port(s) and tethered caps, extension set tubing and clamp(s), and a single ENFit connector on the patient end. The ENFit connectors allow the extension set to be connected to other enteral devices that also have ISO 80369-3 compliant connectors. The extension sets are available in the listed lengths from 50 to 150 cm.

This document is a 510(k) Premarket Notification from the FDA for a medical device called "ENFit to ENFit Extension Sets." It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, the device in question is a physical medical device (extension sets for enteral feeding), not a software or AI-driven diagnostic tool. Therefore, the questions regarding acceptance criteria for a "study that proves the device meets the acceptance criteria" in the context of AI/software performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training data) are not applicable to this type of device submission.

The "acceptance criteria" for this device are related to its physical performance, safety, and functional equivalence to a legally marketed predicate device, as demonstrated through non-clinical testing and comparison. The "study that proves the device meets the acceptance criteria" refers to the verification and validation testing performed.

Here's the information as requested, adapted to the context of a physical medical device:

Acceptance Criteria and Device Performance (adapted for a physical medical device)

The acceptance criteria for this device are established by demonstrating compliance with recognized international standards for medical devices and particularly for enteral feeding connectors, and by showing substantial equivalence to a predicate device in terms of design, intended use, and performance.

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

The document primarily demonstrates acceptance by adherence to specific ISO standards and by direct comparison to a predicate device. The "reported device performance" is the confirmation that the device met the requirements of these standards.

• Cytotoxicity per ISO 10993-5:2009
• Guinea Pig Maximization Sensitization per ISO 10993-10:2010
• Irritation per ISO 10993-10:2010
• Acute Systemic Toxicity per ISO 10993-11:2017
• Material-mediated Pyrogenicity per 10993-11:2017 | Compliant with Use of International Standard ISO 10993-1: "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." |
  | Visual Inspections:
• Verification of bonding. | Visual inspection for verification of bonding was performed and met requirements. |
  | Enteral Device Performance (per ISO 20695:2020):
• Pressure leak testing
• Tensile testing
• Flow rate testing | Found to be in compliance with design and performance requirements when tested according to ISO 20695:2020. |
  | ENFit Connector Performance (per ISO 80369-20:2019 & ISO 80369-3:2016):
• Fluid leakage
• Stress cracking
• Resistance to separation from axial load
• Resistance to separation from unscrewing
• Resistance to overriding
• Disconnection by unscrewing
• ENFit dimensional verification | Tested per ISO 80369-20 and met the standards of 80369-3 for all specified connector performance aspects. Evaluated per ISO 80369-3 for ENFit dimensional verification and met requirements. Device is compliant with ISO 80369-3. |
  | Risk Analysis (per ISO 14971:2019):
• Design Failure Modes and Effects Analysis (DFMEA). | Risk analysis per ISO 14971:2019 was performed, including DFMEA. |
  | Usability Analysis (per ISO 62366-1:2015): | Usability analysis per ISO 62366-1:2015 was performed. |
  | Substantial Equivalence to Predicate Device (K143018) for:
• Indications for Use
• Intended Use
• Environment of Use
• Intended Users
• Patient Population (differences acknowledged but deemed acceptable)
• No Reuse
• Sterility Condition
• ENFit Connector
• Lengths (differences acknowledged but deemed acceptable) | All aspects were deemed "Substantially Equivalent?", with "Yes" indicated for each. Differences in patient population (pediatric and adult vs. neonates and pediatric) and lengths were justified as not impacting safety or performance. |

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

For this type of device, "sample size" is typically not referred to in the context of data points for an algorithm's performance, but rather the number of physical devices or batches tested in laboratory settings. The document states "Verification and validation testing was performed with the ENFit Extension Sets" but does not specify the exact number of units tested for each non-clinical test. The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer, Vesco Medical, to assess the device's compliance with ISO standards. This is prospective testing carried out specifically for regulatory submission. The country of origin of the data is implicitly the country where Vesco Medical conducted its testing (Westerville, Ohio, USA).

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

This concept is not applicable. For physical medical devices, "ground truth" is established by adherence to recognized international standards and performance specifications, not through expert consensus on diagnostic images or similar. The "experts" would be the engineers and quality assurance professionals performing and evaluating the non-clinical tests according to the established protocols. Their qualifications would involve expertise in materials science, mechanical engineering, and quality systems for medical devices.

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

This concept is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus ground truth. For physical device testing, results are typically quantitative and compared against predefined pass/fail criteria from international standards.

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. MRMC studies are used for evaluating diagnostic performance of AI or imaging systems. This submission is for a physical enteral feeding extension set, not a diagnostic imaging device or AI software. There are no "human readers" interpreting data with or without AI assistance.

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

This is not applicable. This 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 is based on objective performance measurements against established international standards (e.g., ISO 80369-3, ISO 80369-20, ISO 20695, ISO 10993, ISO 14971, ISO 62366-1) and demonstrated functional equivalence to a legally marketed predicate device. There is no "pathology" or "outcomes data" in the typical sense used for diagnostic devices; rather, the device is tested for physical and material integrity, fluid dynamics, and biocompatibility.

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing processes are iterative and informed by industry standards and best practices, but there isn't a "training set" of data in the AI sense.

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

This is not applicable. Since there is no training set for an AI model, there is no "ground truth" established for it. The design specifications and performance requirements are informed by engineering principles, regulatory standards, and the performance of existing predicate devices.

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The Enteral Extension Sets with ENFit small bore connectors are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition or medication from an enteral feeding syringe through to any feeding tube which will accept a connector for enteral applications.

Not Found

The provided text is a 510(k) clearance letter from the FDA for "Enteral Extension Sets." It does not contain information about the engineering details of the device's acceptance criteria, nor does it describe any study that proves the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth establishment, or human reader effectiveness from this document.

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The MaxZero™ extension set with needle-free connector(s) is for single use only. The MaxZero™ extension set with needle-free connector(s) may be used for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids.

The MaxZero™ Extension Sets with Needle-Free Connector(s) are intravascular extension sets intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids. The MaxZero™ Extension Sets with Needle-Free Connector(s) are sterile single patient devices that can be used for up to seven (7) days and 200 activations. All extension sets included in this submission are not made from natural rubber latex or DEHP.

The provided text describes a 510(k) premarket notification for a medical device, the MaxZero™ Extension Sets with Needle-Free Connector(s). This type of submission relies on demonstrating "substantial equivalence" to a predicate device, rather than proving independent effectiveness through clinical trials in the same way a new drug or novel medical device might.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance tests performed to demonstrate that the new device (subject device) is as safe and effective as the previously cleared predicate device, despite some differences.

Here's an analysis of the provided information within the framework of your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table with corresponding numerical results in the provided document. Instead, the document discusses various performance tests conducted according to established ISO standards and FDA guidance, with a general statement that "All test results met their acceptance criteria." The table provided on pages 5-6 outlines various characteristics of the subject device and compares them to the predicate device, indicating "Equivalence" or "Different" with explanations.

Based on the information, the acceptance criteria are implicitly derived from the relevant ISO standards and FDA guidance documents, which define the expected performance metrics for intravascular administration sets. The "reported device performance" refers to the fact that the device passed these tests.

Implied Acceptance Criteria and Reported Performance (extracted from comparison and performance discussion):

Note: The document explicitly states "Design Control activities have been conducted and have confirmed the different technological characteristics of the proposed device do not raise different questions of safety and effectiveness" for the characteristics where the subject device differs from the predicate (e.g., device length, materials, configurations, physical specifications, filter size, tubing bore, bonding agent, priming volume, vacuum integrity, maximum pressure, shelf life, light resistance of amber tubing). This indicates that the differences were evaluated and found to be acceptable for substantial equivalence.

Study Details (as applicable to a 510(k) for a Class II device)

1. Sample sized used for the test set and the data provenance:

• Sample Size: Not explicitly stated in the provided abstract for each specific test. However, typical non-clinical performance testing for medical devices involved in 510(k) submissions would use a predetermined number of samples for each test type (e.g., n=3, n=5, n=10, or more, depending on the test and statistical rationale).
• Data Provenance: The data is from non-clinical bench testing ("CareFusion performed design verification performance testing"). There is no mention of country of origin for the testing itself, but given it's an FDA submission, the testing would be expected to adhere to international and potentially US-specific standards. The nature of the testing is prospective as it's part of design verification for a new device.

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

• Not applicable in this context. This is a non-clinical, engineering/performance study assessing a physical medical device's functional characteristics (e.g., leakage, tensile strength, flow rate, material compatibility). "Ground truth" established by human experts (like radiologists for image analysis) is not relevant to this type of device and study. The "ground truth" here is the pass/fail criteria defined by the recognized consensus standards (e.g., ISO, ASTM, USP) and the device's design specifications.

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

• None. This is not a study involving human interpretation or subjective assessment that would require an adjudication method. The test results are quantitative physical measurements or qualitative pass/fail outcomes against pre-defined engineering and material standards.

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 is a medical device (intravascular administration set), not an AI/imaging device. Therefore, MRMC studies are not applicable.

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

• Not applicable. As stated, this is a physical medical device, not an algorithm.

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

• The "ground truth" (or more accurately, the acceptance criteria) for this type of device performance study is based on recognized consensus standards (like various ISO standards for medical devices, ASTM standards, USP for particulate matter) and the predicate device's established performance and safety profile. The testing verifies that the subject device meets these established engineering, material, and functional benchmarks.

7. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this traditional 510(k) submission for a physical medical device. This is not an AI/machine learning product. The design and manufacturing process are subject to Quality System (QS) Regulation (21 CFR Part 820), which involves process validation and quality control, but not a "training set" in the computational sense.

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

• Not applicable. (See point 7).

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BD UniVia™ RightFit enteral extension set is indicated for use in neonatal, pediatric and adult patients in connection with nasogastric enteral feeding tube to provide nutrition via nasal or oral gastric tube placements.

BD UniVia™ RightFit transition adapter allows connection of BD UniVia™ RightFit Extension Sets to non-BD UniVia™ RightFit enteral systems.

Enteral Extension Sets are intended to provide access from a feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in two configurations:

• Standard enteral extension sets, with a variation in tube length and diameter
• Bifurcated extension sets, which allow for medication or additional delivery without disrupting the feeding line with a variation in tube length

Enteral Extension Sets consists of flexible tubing with a purple strip on the tubing. The enteral connectors are purple in color for ease of identification of enteral feeding lines. The female connector has a tethered cap to cover the connector when not used to prevent fluid leakage. A clamp is present over the tube to stop the fluid flow as needed. Transitional Adapters allow for the connection of RightFit Enteral Extension Sets to non-enteral systems. The Transitional Adapters are available in two configurations:

• Enteral female to enteral female
• Enteral male to enteral male

The document you provided is a 510(k) summary for a medical device called "BD UniVia™ RightFit Extension Sets and Transitional Adapters." This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and it typically relies on non-clinical (bench) testing rather than clinical studies.

Therefore, many of the requested categories related to clinical trials, expert adjudication, and AI performance will not be applicable or present in this context.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them:

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

The document states: "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, specific numerical acceptance criteria and reported device performance values are not provided in this summary. It only lists the types of tests performed.

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

• Sample Size for Test Set: The document does not specify the sample sizes used for each of the in vitro tests.
• Data Provenance: The studies were in vitro (bench testing), not clinical. The document does not specify the country of origin of the data beyond stating the submitter (MPS Medical, Inc.) is located in Brea, CA, USA. This would be considered prospective bench testing conducted specifically for this submission.

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. This device is not an AI/imaging device requiring expert interpretation for ground truth. It is a physical medical device. Ground truth for its performance is established through measured physical and chemical properties in controlled lab settings against established standards.

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

Not applicable. This device is not an AI/imaging device requiring expert adjudication.

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

Not applicable. This device 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 device is 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 pre-determined product specifications and external standard requirements (e.g., ISO standards for biocompatibility, sterilization, and transportation/shelf life, as well as internal functional specifications for physical properties).

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model, 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 for a machine learning model, there is no ground truth to establish for it in this context.

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For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices consist of IV Extension sets and IV set accessories. They are single use disposable devices intended for the administration of fluids from a container into the patient's vascular system. They are non-pyrogenic, sterile devices that can be used with or without a syringe. The extension sets consist of PVC tubing or polyethylene lined PVC tubing, a notch clamp, female luer, non-vented cap, male luer, and filter vented cap. They are used to administer solutions, drugs, antibiotics, lipids to the patient. The accessories consists of an anti-siphon valve, back check valve, and 1.2 µm Filter. They attach to the proposed sets to add a specific feature to facilitate the administration of fluid when used with a syringe. The anti-siphon valve reduces the risk of free flow from the syringe and backflow into the primary infusion line. The back check valve prevents backflow into the primary infusion line. The 1.2 um Filter prevents particulate matter and eliminates air bubbles.

The provided document is a 510(k) Summary for Baxter Healthcare Corporation's Intravascular Extension Sets and Accessories (K192366). It describes a Class II medical device intended for the administration of fluids into a patient's vascular system.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests conducted and generally states that "All tests met the acceptance criteria" without providing specific numeric results for each test. The acceptance criteria themselves are primarily referenced by external standards, not internal performance metrics.

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

The document does not specify the sample sizes used for the individual performance tests (e.g., Luer tests, tensile strength, leak test, etc.). It only states that tests were conducted.

The data provenance is retrospective testing performed by Baxter Healthcare Corporation to verify the functional performance of the proposed devices. No information about the country of origin of the data is provided beyond the submitting company being U.S.-based (Illinois).

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

This section is not applicable to this type of device submission. The tests are bench tests verifying physical and chemical properties of the device, not clinical performance requiring expert medical review or ground truth establishment in a diagnostic context.

4. Adjudication Method for the Test Set

This section is not applicable. As mentioned above, the tests are primarily bench tests against engineering standards, not subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The device in question is an intravenous extension set and accessories, which are physical medical components.

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

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

7. The Type of Ground Truth Used

For the performance tests, the "ground truth" or reference is established by the acceptance criteria outlined in various international standards (e.g., ISO, BS EN ISO) and Baxter's internal test methods. For biocompatibility, it's the biological response against established toxicology and biocompatibility standards. For sterility, it's the validation against a specified Sterility Assurance Level (SAL).

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical device. There is no "training set" in the context of an algorithm or AI system. The manufacturing process and quality control would involve ongoing sampling and testing, but not in the sense of a machine learning training set.

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

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

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Pressure Rated: The MaxZero™ Extension Set with Needle-Free Connector(s) is for single use only. The MaxZero™ Extension Set with Needle-Free Connector(s) may be used for direct injection, intermittent infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10mL per second.

The MaxZero™ Extension Set with Needle-Free Connector(s) are intravascular extension sets intended for single patient use, including pediatrics (neonates, infants, children, adolescents) and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids, All MaxZero™ Extension Set with Needle-Free Connector(s) include the previously cleared zero reflux MZ1000 needleless Connector bonded to the extension set tubing. The MZ1000 needleless connector allows thorough and easy disinfection due to a solid, flat smooth surface and eliminates the risk of needle stick injuries. The MaxZero™ needleless connectors are sterile single patient devices that can be used for seven (7) days and 200 activations. All extension sets included in this submission are not made from natural rubber latex or DEHP.

The provided document is a 510(k) summary for the MaxZero™ Extension Set with Needle-Free Connector(s). It details the device's technical characteristics, its substantial equivalence to a predicate device, and the non-clinical testing performed to support its safety and effectiveness.

Here is a breakdown of the requested information based on the provided text:

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

The document states: "All test results met their acceptance criteria and support that the MaxZero™ Extension Set with Needle-Free Connector(s) are appropriately designed for their intended use." However, specific numerical acceptance criteria and the exact reported performance results for each test are not provided in this summary. The summary only lists the types of tests performed.

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 individual non-clinical tests. It refers to "design verification performance testing" and lists various standards and additional tests. The data provenance is not specified, but the submission is from CareFusion, Inc., located in San Diego, CA, USA. The testing would have been conducted by or for a US-based company, likely in the US or in a facility adhering to international standards for medical device testing. The data is prospective, as these are engineering and laboratory tests conducted to qualify the device.

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 as the document is discussing a non-clinical evaluation of a medical device (intravascular administration set) rather than diagnostic or imaging software requiring expert interpretation for ground truth establishment. The "ground truth" here is defined by engineering specifications and recognized performance standards.

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

This section is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies or evaluations of diagnostic systems where there might be disagreement in expert interpretations.

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

There is no MRMC comparative effectiveness study mentioned. The submission is for a physical medical device (extension set) and not an AI-assisted diagnostic tool.

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

This section is not applicable as the device is a physical medical device, not an algorithm or AI system.

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

For this medical device, the "ground truth" is established through:

• Engineering specifications and design requirements: The device must meet specific physical and performance parameters (e.g., pressure resistance, flow rates, bond strength).
• Recognized consensus standards: The device performance is evaluated against international standards such as ISO and ASTM for medical devices, luer connectors, sterilization, packaging, and biocompatibility.
• Biocompatibility guidelines: Specific ISO standards define acceptable biological responses and toxicity.
• Regulatory guidance: Adherence to FDA guidance documents for intravascular administration sets.

8. The sample size for the training set

This section is not applicable as there is no machine learning or AI component requiring a training set. The device is a physical product.

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

This section is not applicable as there is no machine learning or AI component requiring a training set and its associated ground truth establishment.

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The Q2 and CheckMate Multiport IV Administration Sets and Extension Sets are indicated for use for the following: For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Sterile, single use non-pyrogenic intravenous fluid administration sets which may include a multiport IV manifold, integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps. The subject devices for this Premarket Notification are manufactured with tubing and drip chamber materials not made with the plasticizer Diethylhexylphthalate (DEHP).

Acceptance Criteria and Device Performance for Q2 and CheckMate Multiport IV Administration Sets and Extension Sets

This document describes the acceptance criteria and the studies performed to demonstrate that the Q2 and CheckMate Multiport IV Administration Sets and Extension Sets (with non-DEHP tubing and drip chamber) meet these criteria, thereby proving substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample sizes used for each of the test sets (e.g., how many units were subjected to high pressure testing, how many for biocompatibility). However, it indicates that testing was performed on "the proposed IV Administration Sets" and "a fully assembled representative IV Administration Set" and "devices manufactured with the proposed non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber."

The data provenance is internal to Quest Medical, Inc. The studies appear to be prospective as they were conducted specifically for this 510(k) submission to demonstrate the performance of the modified device. The country of origin of the data is implicitly the USA, where Quest Medical, Inc. is located.

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

This document describes performance testing for medical devices (IV administration sets), not diagnostic or interpretative studies requiring expert ground truth establishment for a test set. Therefore, this section is not applicable in the context of this submission. The "ground truth" for these tests is defined by established international standards (e.g., ISO 10993) and engineering specifications.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1, none) are typically used in clinical studies or studies involving human expert interpretation to resolve discrepancies in diagnoses or assessments. Given that this is a submission for an IV administration set based on functional and biocompatibility bench testing, an adjudication method for a "test set" in this context is not applicable. The results are quantitative measurements against predetermined specifications or qualitative observations of performance according to established test protocols.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically conducted for diagnostic imaging devices or algorithms where human readers interpret medical cases, and the effectiveness of an AI system, with or without human assistance, is evaluated. This submission pertains to an IV administration set, a non-diagnostic medical device.

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

This question is geared towards AI/algorithmic devices. Given that the device is an IV administration set, there is no algorithm involved, and thus, no standalone (algorithm-only) study was performed. The performance evaluation focuses on the physical and chemical properties of the device components.

7. The Type of Ground Truth Used

For this device, the "ground truth" for evaluating its performance is based on established industry standards, regulatory guidelines, and scientific protocols. Specifically:

• Bench Testing: Performance specifications derived from engineering principles and comparison to predicate devices.
• Sterilization: Compliance with ISO 10993-7:2008 for Ethylene Oxide residuals.
• Shelf Life: Internal validation protocols to confirm stability over time.
• Biocompatibility: Adherence to ISO 10993-1:2009 for material biocompatibility. Specific tests like Hemocompatibility, Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Subchronic Toxicity, and Material-mediated Pyrogenicity are part of this standard.
• Pyrogenicity: Compliance with established guidelines for endotoxin levels, measured using the kinetic chromogenic LAL method.

8. The Sample Size for the Training Set

This document does not describe a machine learning algorithm, and therefore, there is no training set in the conventional sense. The "training" or development of the device itself would involve engineering design and prototype testing, but not a dataset for training an algorithm.

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

As there is no training set for an algorithm, this question is not applicable. The development of the device relies on design inputs, engineering specifications, and adherence to quality system regulations, rather than ground truth established from a training dataset.

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Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.

The Hospira Extension Sets are intended for use as gravity sets. Hospira Extension sets are comprised of various components including the following: male luer adapter with cap, tubing, female luer adapter, flow control device, in-line adapter, injection site assembly, and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Extension sets are intended for the delivery of fluids from a container to a patient's vascular system. The sets are disposable devices for single patient use.

The provided text describes a 510(k) premarket notification for Hospira Extension Sets, which are intravascular administration sets. The document focuses on demonstrating substantial equivalence to predicate devices, primarily due to changes in tubing material and a needleless valve component.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international standards for medical devices, specifically those relating to biocompatibility and mechanical/functional performance of IV administration sets. The reported device performance indicates that the new Hospira Extension Sets meet these standards.

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

The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., number of devices tested for liquid leakage, number of samples for cytotoxicity). It broadly states that "new data has been generated" and "all testing is acceptable."

The data provenance is not specified in terms of country of origin. The studies are non-clinical (laboratory testing) rather than studies on human subjects, so the retrospective or prospective nature isn't directly applicable in the same way it would be for clinical trials. The focus is on demonstrating compliance with recognized international standards for device performance and safety.

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

This information is not applicable and not provided in the document. The "ground truth" for non-clinical performance and biocompatibility testing is established by the specified standards (ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4), rather than expert consensus on interpretive data. The tests themselves are objective measurements against defined parameters.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective assessment (e.g., image interpretation by multiple readers). For objective bench testing against defined standards, the outcome is determined by whether the device's performance falls within the specified acceptance limits for each test.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

No MRMC comparative effectiveness study was done. This type of study is not relevant for the evaluation of an invasive medical device like an extension set, which does not involve human interpretation of diagnostic data or AI assistance in a clinical workflow.

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

No standalone algorithm performance study was done. This device is not an AI/ML-based diagnostic or therapeutic algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the device's performance is defined by adherence to objective, quantitative and qualitative criteria set forth in recognized international standards (ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4, ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11737-1). For example, for "liquid leakage," the ground truth is whether the device leaks or not under specified test conditions, as defined by the ISO standard. For "cytotoxicity," it's whether the materials cause a cytotoxic reaction above a defined threshold.

8. The Sample Size for the Training Set

This information is not applicable. The development of this medical device (Hospira Extension Sets) does not involve a "training set" in the context of machine learning or AI. The design and validation are based on engineering principles, materials science, and compliance with established performance standards.

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

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

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For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps. The reason for the submission was a material change to the male luer component.

The acceptance criteria and study proving device performance are described below for the Q2® Multiport IV Administration Sets and Extension Sets.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each individual test (sterilization residuals, shelf life, bench testing, biocompatibility). It generally refers to "the proposed IV Administration Sets" and "the materials of construction of a fully assembled IV Administration Set."

The data provenance is from bench testing and laboratory testing performed by Quest Medical, Inc., the device manufacturer. No specific country of origin for the data is mentioned beyond the company's US address. The nature of these tests suggests they are prospective in relation to the submission, as they were conducted to support the substantial equivalence claim for the modified device.

3. Number of Experts and Qualifications for Ground Truth:

This device is an IV administration set, not an AI or diagnostic imaging device that typically requires human expert consensus for ground truth. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of medical image interpretation or clinical diagnosis does not apply directly here.

Instead, the "ground truth" for the performance criteria is established by:

• Industry standards and regulations: ISO 10993-7:2008 for sterilization residuals, and general biocompatibility testing principles per ISO 10993-1:2009.
• Engineering and materials science principles: For bench testing (high pressure, bond strength, solvent exposure) to ensure functional integrity.

The "experts" involved would be the engineers, toxicologists, and quality assurance personnel who designed, executed, and interpreted these technical tests according to established protocols and standards. Their qualifications would stem from their expertise in relevant engineering, materials science, and regulatory compliance fields.

4. Adjudication Method for the Test Set:

Not applicable in the human-in-the-loop sense. The "adjudication" is based on objective measurements against predetermined specifications and accepted industry standards (e.g., meeting ISO limits, specified bond strengths, no adverse reactions in biocompatibility tests). There is no mention of a human adjudicator reviewing conflicting interpretations of results, as the tests produce objective data.

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

No. This is a medical device (IV administration set), not a diagnostic algorithm or AI-assisted diagnostic tool. Therefore, a MRMC study to compare human reader performance with and without AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance:

No. This device does not involve an algorithm or AI. It is a physical medical device.

7. Type of Ground Truth Used:

The ground truth is established through:

• Objective laboratory measurements and tests: For physical performance (e.g., pressure resistance, bond strength).
• Compliance with recognized international standards: Such as ISO 10993-7:2008 for Ethylene Oxide Residuals and ISO 10993-1:2009 for Biocompatibility.
• Comparison to the legally marketed predicate device: Demonstrating that the modified device performs "similarly to the predicate device" in functional tests.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for such a device effectively comes from the established engineering principles, design specifications, and manufacturing processes, rather than a data-driven model.

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

Not applicable, as no training set (in the AI/ML sense) is involved. The "ground truth" for the design and manufacturing of such a device is established through:

• Historical performance of predicate devices.
• Industry best practices and engineering standards.
• Regulatory requirements.
• Material properties and scientific understanding of their behavior.

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