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stay•safe® catheter extension set with Safe-Lock, 12 inch:
The stay•safe catheter extension set with Safe-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay•safe PIN technology.

stay•safe® catheter extension set with Luer-Lock, 6 inch;
stay•safe® catheter extension set with Luer-Lock, 12 inch;
and stay•safe® catheter extension set with Luer-Lock, 18 inch:
The stay•safe catheter extension set with Luer-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Luer-Lock is used to connect a PD catheter with Luer-Lock catheter adapter to PD systems that use stay•safe PIN technology.

stay•safe® to Luer-Lock Adapter, 4 inch:
The stay•safe to Luer-Lock adapter is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe to Luer-Lock adapter is used to connect a stay•safe catheter extension set to medical devices with a Luer-Lock connection.

The stay•safe® catheter extension set with Safe-Lock, 12 inch (Safe-Lock extension set) stay•safe® catheter extension set with Luer-Lock, 6 inch, stay•safe® catheter extension set with Luer-Lock, 12 inch, and stay•safe® catheter extension set with Luer-Lock, 18 inch (Luer-Lock extension sets), and stay•safe® to Luer-Lock adapter, 4 inch (Luer-Lock adapter), hereinafter collectively referred to as the "Catheter Extension Sets" are the subject devices of this 510(k).

The Safe-Lock extension set is a single-use device designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Safe-Lock extension set is provided sterile and non-pyrogenic. The Safe-Lock extension set is sterilized using ethylene oxide (EO).

The Luer-Lock extension sets are single-use devices designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Luer-Lock extension sets are provided sterile and non-pyrogenic. The Luer-Lock extension sets are sterilized using EO.

The Luer-Lock adapter is a single-use device designed to connect a stay•safe catheter extension set to a medical device with a Luer lock connector. The Luer-Lock adapter is provided sterile and non-pyrogenic. The Luer-Lock adapter is sterilized using EO.

The provided FDA 510(k) clearance letter (K250404) for Fresenius Medical Care Renal Therapies Group's stay•safe® catheter extension sets and adapter pertains to a Class II medical device (Peritoneal Dialysis System and Accessories, Product Code KDJ).

Crucially, this document details the substantial equivalence of the new device to a legally marketed predicate device (K173593), based on non-clinical performance testing and biocompatibility. It explicitly states that "No clinical studies were performed for the Catheter Extension Sets." This means the type of study typically associated with assessing an AI/Software as a Medical Device (SaMD) to meet acceptance criteria through human reader performance (like MRMC studies) or standalone algorithmic performance was not conducted because this is a physical medical device, not AI/SaMD.

Therefore, I will describe the acceptance criteria and supporting studies based on the provided document, acknowledging that they are for a physical medical device and not an AI/SaMD.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The acceptance criteria for the stay•safe® catheter extension sets and adapter are based on demonstrating substantial equivalence to a legally marketed predicate device (K173593) in terms of safety and efficacy. This is primarily achieved through non-clinical performance testing and biocompatibility assessments, rather than clinical efficacy studies involving human patient outcomes or AI performance metrics.

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

The document doesn't provide a direct "table of acceptance criteria" with specific numerical targets and performance results for each test. Instead, it lists the types of performance tests conducted to support the determination of substantial equivalence. The implication is that the new devices met the predefined specifications for each test, which would be deemed "acceptable" for equivalence.

Based on the provided text, the categories of performance testing serve as the basis for acceptance. The "Reported Device Performance" is implicitly that the device met the requirements of each test, demonstrating substantial equivalence.

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

• Sample Size: The document does not specify the exact sample sizes (number of units tested) for each of the performance or biocompatibility tests. This information is typically detailed in the engineering test reports or biocompatibility reports submitted as part of the 510(k) package, but not in the summary letter itself.
• Data Provenance: The data originates from non-clinical laboratory testing conducted by Fresenius Medical Care Renal Therapies Group, LLC, the device manufacturer. This is by nature prospective testing, as it is performed specifically to support the 510(k) submission for the new devices. The country of origin of the data is implied to be within the US, given the submission is to the US FDA.

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

• Not Applicable: For a physical medical device cleared via substantial equivalence based on non-clinical performance and biocompatibility testing, there are no "experts" in the sense of clinicians establishing a "ground truth" for a test set in the way one would for an AI/SaMD (e.g., radiologists annotating images). The "ground truth" for these tests is defined by engineering specifications, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and established test methods. The "experts" involved are engineers and scientists responsible for designing, conducting, and interpreting these tests according to predefined protocols and standards. Their qualifications would be in relevant fields such as biomedical engineering, materials science, and toxicology.

4. Adjudication method for the test set:

• Not Applicable: As there are no human-read interpretations or clinical assessments requiring reconciliation, there is no "adjudication method" in the context of clinical expert consensus. Test results are objectively measured against predefined acceptance criteria (e.g., a leak test either passes or fails, a tensile strength measurement is or is not within specification). Any discrepancies in test results would be handled through standard quality control and engineering investigation procedures.

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 was not done. This type of study is specifically relevant for software/AI devices that assist human readers in diagnosing or interpreting medical images/data. The device in question is a physical catheter extension set and adapter, not an AI or imaging device. The document explicitly states: "No clinical studies were performed for the Catheter Extension Sets."

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

• No, a standalone performance study was not done. This is also relevant for AI/SaMD devices. The Catheter Extension Sets do not contain any software or algorithms. The document explicitly states: "Not applicable. The Catheter Extension Sets do not contain software."

7. The type of ground truth used:

• Engineering Specifications and Standardized Test Methods: The "ground truth" for the performance tests relies on established engineering specifications, mechanical properties of materials, and successful adherence to recognized industry standards (e.g., ISO for biocompatibility testing). For instance, a "leak test" has an objective pass/fail criterion based on absence of fluid leakage under defined pressure, not a clinical interpretation. Biocompatibility results are compared against toxicological limits and biological responses as defined by ISO 10993-1.

8. The sample size for the training set:

• Not Applicable: This pertains to machine learning models. As this is a physical medical device, there is no "training set."

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

• Not Applicable: There is no training set for this type of device.

In summary, the FDA's clearance for the stay•safe® catheter extension sets and adapter is based on a demonstration of substantial equivalence to an existing predicate device, supported by a comprehensive battery of non-clinical performance tests and biocompatibility assessments, validating its physical and material properties for its intended use, rather than clinical efficacy studies or AI/SaMD specific evaluations.

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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 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 device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. The intended populations include adults and pediatrics except neonates.

The proposed device is a single used device. It includes 30 models. For the 30 different models, each configuration comprises of various components which may include: Male luer lock and protector, Female luer lock and protector. Tube, Flow regulator, Clamp, multiple ways connector, Precision Liquid filter, Needle free connector, Check valve, Graduated flow regulator. Injection site and stopcock. The detail description of models is provided in Table 1.

The proposed devices are sterilized by EO to achieve a SAL 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

The provided text is a 510(k) summary for a medical device (Disposable Extension Set) seeking FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. This document does not include information about AI/ML algorithm performance, comparative effectiveness studies, or the types of ground truth typically associated with such studies.

Therefore, many of your requested items cannot be extracted from this document, as they pertain to studies on intelligent algorithms rather than a physical medical device like an extension set.

However, I can provide the available information:

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

The document doesn't explicitly state "acceptance criteria" for each test in a numerical format. Instead, it states that the device "complies with the following standards" or that "test results demonstrated that the proposed device complies with the following standards." The "reported device performance" is implicitly that it met the requirements of these standards.

Regarding the other points, as per medical device clearance context:

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

  • This document does not specify sample sizes for the performance tests as it's a summary of a physical device's compliance with standards, not an AI/ML study.
  • Data provenance (country of origin, retrospective/prospective) is not applicable or specified for these types of engineering/material tests.

• 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. "Ground truth" in the context of an AI/ML study does not apply to the regulatory clearance of a physical medical device like an extension set.

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

  • Not applicable.

• 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 device.

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

  • Not applicable. This is a physical medical device.

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

  • Not applicable. The "ground truth" for this device is its adherence to established engineering and biological safety standards (e.g., seal strength, biocompatibility, flow rates) through laboratory testing.

• 8. The sample size for the training set:

  • Not applicable. There is no AI/ML component; therefore, no "training set."

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

  • Not applicable.

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Extension Sets are intended to be used with a vascular access device for direction, intermittent infusion, continuous infusion or aspiration. The Extension Sets may be used with power injector procedures to a maximum pressure of 200 kPa (2 bar).

The subject device, Extension sets are single use, sterile, non-pyrogenic, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration. The device is to connect the infusion device through the luer lock connector to add length and provide clamping capacities, or added to an intravascular catheter hub as a conduit for flow to and from the catheter. It is available in various lengths and tube dimensions, and may be comprised of various generic components such as connectors, clamps, flow regulators, filters, check valves and needleless injection ports. It can be used for gravity infusion and pressure infusion with pressure up to a maximum of 200 kPa (2 bar).

The provided text is a 510(k) Summary for a medical device called "Extension Set." This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and biocompatibility assessments, rather than presenting a performance study with acceptance criteria in the context of an AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance with AI) are not applicable to this document.

However, I can extract information related to the device's performance based on the non-clinical tests performed to ensure its safety and effectiveness.

Acceptance Criteria and Device Performance (Derived from Non-Clinical Tests)

The document lists numerous non-clinical tests performed to demonstrate that the device meets its design input requirements and applicable standards. The "reported device performance" in this context refers to the affirmation that the device met the requirements of these tests. Specific quantitative acceptance criteria are generally not explicitly stated in this summary but are implied by adherence to the referenced standards and guidance documents (e.g., ISO, ASTM, FDA guidance).

Here's the relevant information based on your numbered questions, with explanations for why some information is not present:

1. A table of acceptance criteria and the reported device performance: See the table above. The acceptance criteria are implicitly defined by the referenced international standards (e.g., ISO 8536 series, ISO 80369-7, ASTM F838-20) and FDA guidance documents, which specify performance requirements (e.g., maximum leakage, tensile strength thresholds, bacterial retention rates). The "reported device performance" is a blanket statement that the device met the requirements of these standards for all 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: Not explicitly stated in the summary document. For medical device bench testing, sample sizes are typically determined by statistical methods for quality control or standard requirements, but these details are not provided here.
   • Data Provenance: The tests were conducted by MEDCAPTAIN LIFE SCIENCE CO., LTD. which is based in Shenzhen, Guangdong, China. The document does not specify if external labs were used or the specific origin of materials if different. Tests are non-clinical (bench tests).

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 (Extension Set), not an AI diagnostic tool. Ground truth for its performance is established through adherence to engineering specifications and performance standards via bench testing, not through expert consensus on medical images or diagnoses.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (often of images) where there can be disagreement, typically in AI/diagnostic studies. Bench testing of a physical device is a direct measurement against defined specifications, not subject to subjective 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. MRMC studies are specific to evaluating diagnostic systems, especially those involving AI and human readers. This document concerns a physical "Extension Set" device.

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

   • Not applicable. There is no algorithm or AI component in this medical device.

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

   • The "ground truth" for the device's performance is established by the specifications defined in international standards (e.g., ISO, ASTM) and FDA guidance documents. These standards dictate acceptable ranges for physical, chemical, and biological properties (e.g., acceptable leakage rate, minimum tensile strength, non-cytotoxicity). The device's performance is measured directly against these pre-defined, objective criteria.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not applicable, as there is no 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 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 NP Medical Extension Set with stabilizing base is a sterile single patient use device.

The NP Medical Extension Set is intended for direction, intermittent infusion, continuous infusion or aspiration for all patients for which IV therapy is prescribed.

The NP Medical Extension Set incorporates a normally closed bidirectional pressure-activated valve that prevents low pressure retrograde flow and is intended for power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.

The NP Medical Extension Set with Stabilizing Base is a sterile, single use, nonpyrogenic intravenous administration extension set comprised of a side repositionable tube bonded to a connector hub on one end and a female luer on the other end with a clamp in between. The connector hub has a locking male luer and a rotating tube connection joint. The hub houses a bidirectional Pressure-Activated Valve (PAV) and an integral stabilizer under the connector hub. The stabilizing base component (along with IV tape / adhesive) is intended to help anchor the extension set to the patient. This device is not made with plasticizers Diethylhexylphthalate (DEHP). The NP Medical Extension Set with Stabilizing Base may be used with compatible Vascular Access Devices (VAD), Needle Free Connectors, and other commercially available devices.

Based on the provided text, the device in question is the "NP Medical nCompass Extension Set with Stabilizing Base," which is an intravascular administration set. The document is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.

The acceptance criteria and study proving the device meets these criteria are primarily based on bench performance testing and biocompatibility testing, as no clinical data was required or provided.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document doesn't provide specific numerical acceptance criteria for each test with their corresponding reported performance values. Instead, it states that the device "met all requirements" and "satisfy the acceptance criteria specified by the above applicable standards."

However, we can infer some criteria and the general reported performance:

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

• Sample Size for Test Set: The document does not specify the sample size for any of the performance tests. It states that tests were conducted using "appropriate methodology" and "NP Medical established test protocols."
• Data Provenance: The data is generated from bench testing conducted by NP Medical. The country of origin for the testing itself is not explicitly stated, but NP Medical is based in Clinton, Massachusetts, USA. The studies appear to be prospective in nature, as they were conducted specifically for the purpose of demonstrating substantial equivalence for this 510(k) submission.

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

• This device, being a physical medical device (extension set), does not involve diagnostic interpretations or algorithms that would require expert human review for ground truth establishment in the traditional sense of AI/imaging studies.
• The "ground truth" for its performance is established through adherence to recognized consensus standards (e.g., ISO, USP) and validated bench testing protocols. The experts involved would be technical professionals (engineers, quality assurance personnel, lab technicians) performing the tests and interpreting results against the objective criteria of these standards, rather than clinical experts establishing a "truth" from patient data. Their qualifications would be in metrology, engineering, and quality systems for medical devices. The document does not specify the number or specific qualifications of these individuals.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations where multiple human readers interpret data, and a consensus or tie-breaking mechanism is needed for ground truth. For bench testing of physical device performance against objective criteria, such methods are not used. The results are quantitative measurements 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:

• No. An MRMC comparative effectiveness study is not applicable as this is a physical medical device (extension set), not an AI algorithm for diagnosis or interpretation. The document explicitly states: "VIII. CLINICAL DATA: Not applicable."

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

• Not applicable. This relates to AI/software as a medical device. This product is a physical medical device.

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

• The ground truth for the performance of this device is established by:
  • Objective measurements against physical and chemical standards (e.g., flow rate, burst pressure, particulate count, material composition).
  • Adherence to recognized consensus standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607-1 for packaging) and FDA guidance documents.
  • Comparison to the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set:

• Not applicable. This device is a physical product and does not involve machine learning or AI, and therefore no "training set" in the context of data for algorithm development.

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

• Not applicable. See point 8.

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

The proposed device consists of an IV Extension Set (Light Resistant Extension Set). It is a single use disposable, non-pyrogenic, sterile device intended for the administration of fluids from a container into the patient's vascular system. This IV extension set can be directly attached to a syringe but also used as an extension set to a primary set that is connected to a syringe (primarily to add length). The Light Resistant Extension Set consists of non-DEHP (

The provided text describes the regulatory clearance of the Baxter Healthcare Corporation's Intravascular Extension Set (Light Resistant Extension Set) (K210430). The focus is on demonstrating substantial equivalence to a predicate device (K192366) through non-clinical testing.

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

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

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The Velano ExT™ Extension Set with needle-free connector is for single use only. Each port of the Velano ExT™ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The pressure rated port of the Velano ExT™ Extension Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.

The Velano ExT™ Extension Set is a sterile, single use, non-pyrogenic intravenous administration extension set comprised of an approximate 5" inch tube bonded to a T-connection port on one end and a female luer on the other end with a clamp in between. The T-connection port has a swabable, needle-free port on one side and a locking male luer on the other side. The device contains and integrated stabilizer under the swabable needle-free port. This component (along with IV tape / adhesive) is intended to help anchor the extension set to the patient. This device is not made with the plasticizer Diethylhexylphthalate (DEHP). The Velano ExT™ Extension Set is compatible with Velano Vascular PIVOT™ devices.

The provided text is a 510(k) premarket notification for a medical device called the "Velano ExT™ Extension Set". This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on a clinical trial or algorithm performance study as you might find for an AI/ML medical device.

Therefore, the document does not contain the information required to answer questions 1 through 9, as it does not describe an acceptance criteria table, a study proving the device meets these criteria, or details regarding algorithm performance, ground truth establishment, or expert reviews.

The document details the following regarding the device and its testing:

• Device Name: Velano ExT™ Extension Set
• Intended Use: Administration of intravenous fluids, and use with low-pressure power injectors up to 325 psi and a maximum flow rate of 10 mL/second.
• Predicate Device: Velano Vascular Q2® Low Power Injector Extension Set (K182897)
• Functional and Safety Testing Performed: This section lists various tests conducted to verify the device's design meets functional and performance requirements. These tests are physical and mechanical in nature, not related to an algorithm's diagnostic performance.
  • Visual inspection
  • Simulated shipping
  • Priming volume
  • Microbial ingress
  • Particulate
  • Backpressure leak under normal use and power injection
  • Flow rate for normal use and power injection
  • Spin collar height and spin collar angle
  • Simulated use
  • Tubing bond strength
  • Multiple Engagement
  • Continuous Engagement
  • Activation Force
  • Tubing kink resistance
• Standards Applied: The document lists several ISO, USP, ASTM, and AAMI standards related to medical device sterilization, biological evaluation, particulate matter, packaging, and accelerated aging.

In summary, this document is a regulatory submission for a physical medical device (an extension set), not an AI/ML-driven device. Thus, the concepts of acceptance criteria for algorithm performance, test set size, expert adjudication, MRMC studies, standalone algorithm performance, or training set details are not applicable or present in this document.

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