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The Arisure® Closed Male Luer with Spike Adapter serves as a connector between an IV container and a standard IV set.

The Arisure Closed Male Luer with Spike Adapter, also referred to as Arisure CML with Spike Adapter or CML with Spike Adapter, is an extension of the predicate device, i.e., Closed Male Luer. The primary components of the CML with Spike Adapter include: a Closed Male Luer, a Male Luer Lock Connector, and an Extended Spike Adapter.

The subject device allows for administration set preservation when administering multiple drug therapies to the same patient. It provides a needle-free, drip-free connection between an IV bag or a rigid container and an IV administration set. The CML side provides a luer lock connection to a Bag Spike with Neutral Valve. It also gives the user a drip-free disconnect when needing to use multiple bags or bottles for the infusion. The Spike Adapter side allows for a secure connection to any ISO standard IV spike. An IV administration set can be connected safely and securely to the device through a pierceable septum.

The CML with Spike Adapter is designed to comply with ISO 8536-4:2019 as appropriate.

The Arisure® Closed Male Luer with Spike Adapter (YM060) is an extravascular administration set.
The device's performance was evaluated through a series of non-clinical tests.

Acceptance Criteria and Device Performance:

Study Details:

1. Sample Size and Data Provenance for Test Set:

   • The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., leakage, flow rate). It generally indicates that "Aged, packaged parts underwent the appropriate testing" for shelf-life, and "The following tests were completed with passing results."
   • The data provenance is not specified (e.g., country of origin). The studies appear to be non-clinical performance and laboratory tests conducted by the manufacturer, Yukon Medical, LLC. These are retrospective data in the sense that they were collected and analyzed to support the 510(k) submission.

2. Number of Experts and Qualifications for Ground Truth:

   • This information is not applicable. The device is a medical accessory, and its performance criteria are objective, based on engineering, material, and biological standards (e.g., ISO, ASTM). The "ground truth" for these tests is established by the specifications of these standards, not expert consensus in diagnostic interpretation.

3. Adjudication Method for Test Set:

   • This information is not applicable as the evaluation involves objective performance metrics against established standards, not interpretation by human experts.

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

   • No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic or imaging devices where human interpretation is involved. The Arisure® Closed Male Luer with Spike Adapter is a medical accessory with objective performance characteristics.

5. Standalone Performance Study:

   • Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently against engineering, material, and biological standards. This involved testing various mechanical, chemical, and biological attributes of the device without human-in-the-loop performance measurement related to its primary function as a connector.

6. Type of Ground Truth Used:

   • The ground truth used for performance evaluation was based on established international and national standards for medical devices, infusion equipment, and material biocompatibility. These include, but are not limited to, ISO 8536-4, ISO 80369-7, IEC 62366-1, ISO 22413, ISO 15747, ISO 10993 series, ASTM standards (e.g., D4169, F1980), and EN/SS-EN standards for sterilization. The "ground truth" is defined by the measurable parameters and acceptance limits specified within these standards.

7. Sample Size for Training Set:

   • The document describes performance testing for a medical device accessory and does not involve AI or machine learning algorithms that would typically require a "training set." Therefore, this information is not applicable.

8. How Ground Truth for Training Set Was Established:

   • As there is no AI/machine learning component described for this device, a training set and its associated ground truth establishment are not relevant to this submission.

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The 20mm SmartSite ™ Vented Vial Access Device is intended for use by healthcare professionals, patients, and/or caregivers in a wide variety of healthcare and home use environments for reconstitution or dispensing of medication. The SmartSite Vented Vial Access Device is indicated for use with standard 20 mm rubber-stopper medication vials for reconstitution or dispensing of medications.

The 20mm SmartSite™ Vented Vial Access Device is a stand-alone, sterile, single-use, disposable device which permits access to a medication vial without the use of a needle. It consists of a vial spike, the vial retention shroud, a hydrophobic filter assembly and a SmartSite™ needle-free valve.

The SmartSite™ Vented Vial Access Device is microbiologically closed. When used in a USP compliant pharmaceutical compounding and storage environment, the SmartSite™ Vented Vial Access Device is capable of maintaining the sterility of vial medications for up to 7 days.

The provided text is a 510(k) summary for the "SmartSite™ Vented Vial Access Device" and does not contain any information about a study proving the device meets specific acceptance criteria using a test set of medical images or other data that would involve ground truth established by experts.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SmartSite® Vented Vial Access Device, K151963) through comparisons of intended use, design, technology, materials, and performance characteristics.

The "testing" mentioned in the document refers to engineering and biocompatibility tests for the physical device, not an AI/algorithm-based performance study. For example:

• Human Factors Engineering/Usability Engineering Study: This relates to how users interact with the physical device, not an algorithm's performance on data.
• Particulate Contamination Testing, Fragmentation Testing, Attachment force, Flow rate, Shelf life, etc.: These are physical performance tests of the device itself.
• Chemical Characterization Testing: Relates to the material properties of the device.
• Biocompatibility Testing: Relates to the device's interaction with the body (e.g., cytotoxicity, irritation).

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they pertain to an AI/algorithm-based device and its performance metrics against a ground truth. The document does not describe such a study.

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Arisure® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of drugs in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

Arisure® Closed System Drug Transfer Device (CSTD) uses three primary components to prevent the escape of drug and ingress of microbes: Closed Vial Adapter, Closed Male Luer, and Dry Spike. The Closed Vial Adapter attaches to the drug vial allowing access to the vial contents while preventing vial pressurization by capturing displaced vapor and allowing filtered air into the vial. The Dry Spike attaches to an IV container allowing drug to be injected into the container while a separate port accepts the spike of an administration set. The Closed Male Luer syringe adapter provides a means of closed fluid transfer from the drug vial to the IV container. The Closed Male Luer was designed specifically to access the needle-free valve (neutral valve) on the Closed Vial Adapter and Dry Spike. The fluid path of the Closed Vial Adapter, Dry Spike, and Closed Male Luer is normally closed, opening only when the Closed Male Luer is connected to the neutral valve.

The Yukon Medical, LLC Arisure Closed System Drug Transfer Device (CSTD) (K201422) demonstrates substantial equivalence to its predicate device (TEVADAPTOR® Closed Drug Reconstitution and Transfer System, K141448) based on a comprehensive set of non-clinical performance data.

1. Acceptance Criteria and Reported Device Performance:

The document provides a table of various tests conducted to support the substantial equivalence of the Arisure CSTD. The reported device performance is indicated by its compliance with the specified standards or by direct statements of outcome (e.g., "Non-pyrogenic," "Single use"). Where acceptance criteria are implicitly stated through comparison with standards, the device is reported to have met these. Explicit performance metrics are provided for certain aspects.

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The SmartSite® Vented Vial Access Device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The 20mm SmartSite® Vented Vial Access Device is a stand alone, sterile, single-use, disposable device which permits access to a medication vial without the use of a needle. It consists of a spike, locking shroud, hydrophobic filter, and SmartSite® needle-free access valve for Luer access.

The SmartSite® Vented Vial Access Device is microbiologically closed. When used in a USP compliant pharmaceutical compounding and storage environment, the SmartSite® Vented Vial Access Device is capable of maintaining the sterility of vial medications for up to7 days.

This document is a 510(k) summary for the SmartSite® Vented Vial Access Device, which is a medical device for accessing medication vials. The summary primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve AI/ML performance evaluation. Therefore, many of the requested categories related to AI/ML studies are not applicable.

Here's the information extracted and categorized based on your request, with "Not Applicable" for sections where the document does not provide the requested AI/ML related details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which a device's AI/ML performance is measured, as this is a traditional medical device submission, not an AI/ML one. However, it lists various tests performed to demonstrate the device's functional and safety characteristics, primarily against a predicate device.

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

Not Applicable (This is a traditional medical device; no "test set" in the context of AI/ML data). The document refers to "tests conducted" on the device itself and the predicate device. The specific sample sizes for these engineering and biological tests are not detailed in this summary. Data provenance is not described as it relates to physical device testing rather than clinical data.

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

Not Applicable (No AI/ML system involved in a clinical study to establish ground truth).

4. Adjudication method for the test set

Not Applicable (No AI/ML system involved in a clinical study requiring 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 a physical medical device, not an AI/ML diagnostic or assistive tool).

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

Not Applicable (No AI/ML algorithm involved).

7. The type of ground truth used

Not Applicable (No AI/ML system requiring a ground truth in the context of expert consensus, pathology, or outcomes data). The "ground truth" for this device would be its adherence to established engineering, safety, and performance specifications as measured by laboratory testing and previous FDA clearances for its components.

8. The sample size for the training set

Not Applicable (No AI/ML model with a training set).

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

Not Applicable (No AI/ML model with a training set).

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The SmartSite® VialShield is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® VialShield is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The SmartSite® VialShield is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® VialShield is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The SmartSite® VialShield is a mechanically closed device, designed to retain vapors produced from medications in the attached vial.

The SmartSite® VialShield is microbiologically closed. When used in a USP compliant pharmaceutical compounding and storage environment, the VialShield is capable of maintaining the sterility of vial medications for up to 7 days.

The subject SmartSite® Vialshield device is constructed of polymeric components:

• Upper and Lower Housings: Polycarbonate
• Check Valves: Silicone
• Lubricant: Silicone
• Hydrophobic Filter Membrane: PTFE, Polyester
• Loctite 3341: UV adhesive
• Barrier Film: Polyether Polyurethane
• SmartSite® valve, including:
  • Body: Acrylic
  • Cap: Polyurethane
  • Piston: Silicone
  • Lubricants: Silicone

The subject SmartSite® Vialshield device is provided with a molded polyethylene cap, considered part of the packaging, made using low density polyethylene.

The subject SmartSite® Vialshield materials do not contain natural rubber latex.

This document describes Yukon Medical's SmartSite® VialShield, a vial access device, and its successful 510(k) submission to the FDA. The submission demonstrates substantial equivalence to a predicate device through a comparison of technical and performance characteristics.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" as a separate table with quantified values. Instead, it describes performance tests conducted and states that the device "meets all specified requirements" and "is as safe and effective as the legally marketed devices designated as predicate device."

However, we can infer some of the performance criteria based on the tests conducted. The table below outlines the tests and the general reported outcome:

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

• Sample Size for Test Set: The document does not specify the exact sample size used for each individual performance test. It mentions that "some performance characteristics of the predicate device were tested along with the subject SmartSite® Vialshield device," implying comparative testing was done.
• Data Provenance: The studies were conducted by Yukon Medical, LLC, and Gilero, LLC for regulatory submission in the USA. The studies are prospective as they were specifically conducted to demonstrate the device's performance for this 510(k) application.

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

The document does not explicitly state that experts were used to establish "ground truth" for the performance tests in the way it might be for a diagnostic AI device. The tests described are laboratory-based performance and safety tests (e.g., leak tests, filter integrity, biocompatibility). The "ground truth" in this context would be the objective measurement against established standards (e.g., ISO, USP guidelines) rather than expert consensus on diagnostic interpretations. Therefore, this question is not directly applicable in the same manner as it would be for AI-driven diagnostic imaging.

4. Adjudication Method for the Test Set

Given the nature of the performance tests (e.g., physical integrity, biological compatibility), an "adjudication method" in the sense of resolving discrepancies between expert opinions is not applicable or detailed in the document. The tests involve objective measurements and adherence to pre-defined protocols and acceptance criteria, likely performed and verified by trained technical personnel.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for diagnostic devices, especially those incorporating AI to assess human reader performance with and without AI assistance. The SmartSite® VialShield is a mechanical medical device for drug preparation and administration, not a diagnostic imaging or AI-driven diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study was not done. This question is also primarily relevant for AI-driven diagnostic devices. The SmartSite® VialShield is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for the performance characteristics was established by:

• Objective Measurements against Established Standards: For tests like Biocompatibility (ISO 10993), ISO-594 compliance for the Luer valve, and other physical performance tests, the "ground truth" is adherence to predefined specifications, industry standards, and regulatory requirements.
• Approved Protocols and Acceptance Criteria: For some tests, like "maintains drug sterility for 7 days," the document explicitly mentions "Approved protocol and acceptance criteria."

8. Sample Size for the Training Set

Not applicable. The SmartSite® VialShield is a mechanical medical device, not an AI or machine learning algorithm. Therefore, 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 this mechanical device, the concept of establishing ground truth for a training set does not apply.

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The Vented Single Vial Access Device is a stand-alone, singleuse, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies.

The Vented Single Vial Access Device is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.

The Vented Single Vial Access Device (ViaLokTM / Universal) is a sterile, stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. These devices are inserted into a stopper of a medication vial. The healthcare provider uses the Vented Single Vial Access Device to transfer and mix drugs contained in standard medication vials. The Vented Single Vial Access Device includes three product configurations in this submission:

• ViaLok™ 20 mm Single Vial Access Device, Vented, Female Luer .
• . ViaLok™ 13 mm Single Vial Access Device, Vented, Female Luer
• . Universal Single Vial Access Device, Vented, Female Luer

The 20mm and 13mm product configurations are intended to mate with standard medication vial enclosure sizes (20mm and 13mm, respectively). The Universal device does not contain a shroud and can be used independent of enclosure size. Each Vented Single Vial Access Device configuration is offered with a female luer.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" with pass/fail values. Instead, it lists various performance tests conducted to demonstrate equivalency to predicate devices. The reported device performance for each test is generally stated as "meets all specified requirements" or "is as safe and effective as the legally marketed devices."

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

The document does not explicitly state the specific sample sizes used for each performance test. It only mentions that "samples of the predicate device were tested along with the Vented Single Vial Access Device" where performance data for a predicate was unavailable.

The data provenance is from Yukon Medical, LLC's internal testing as part of their 510(k) submission. It is a prospective study in the sense that the new device was manufactured and then subjected to these performance tests. The country of origin of the data is not specified, but the submission is to the US FDA, implying US regulatory standards and potentially US-based testing.

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

This information is not applicable as the device is a physical medical device (Vented Single Vial Access Device), not an AI/software-based diagnostic tool. Ground truth in this context refers to objective physical and chemical properties and performance, not expert interpretation of data. The "ground truth" is established by the specifications and standards for medical device performance.

4. Adjudication Method for the Test Set

This is not applicable for a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation (e.g., of medical images) needs consensus. For device performance, the results are objectively measured against established 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. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use the AI to improve their performance. The Vented Single Vial Access Device is a physical, non-AI medical device.

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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The Vented Single Vial Access Device is a physical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted on the Vented Single Vial Access Device is primarily based on:

• Established industry standards: Such as ISO 594-2 for luer connections and ISO 10993 series for biocompatibility.
• Performance characteristics of legally marketed predicate devices: The new device's performance is compared to that of existing, cleared predicate devices (Yukon Medical's ViaLok™ Non-vented and Medimop Medical Projects' Vented Vial Adapter Transfer Device). The implicit ground truth is that the predicate devices are safe and effective.
• Engineering specifications and design requirements: While not explicitly detailed in the summary, underlying the tests are specific engineering targets for flow rates, leak resistance, etc., which define acceptable performance.

8. The Sample Size for the Training Set

This is not applicable. A "training set" refers to data used to train an AI algorithm. The Vented Single Vial Access Device is a physical medical device and does not involve AI.

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

This is not applicable for the reasons stated in point 8.

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The ViaLok™ is a stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies.

The ViaLok™ is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.

The ViaLok™ Non-vented (ViaLok™) is a sterile, stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The ViaLok™ is inserted into a stopper of a medication vial. The healthcare provided uses the ViaLok™ to inject or withdrawal fluid from the vial. The ViaLok™ includes four product configurations in this submission:

• ViaLok™ Non-vented, 20mm with female luer .
• ViaLok™ Non-vented, 20mm with male luer .
• ViaLok™ Non-vented, 13mm with female luer
• ViaLok™ Non-vented, 13mm with male luer .

The ViaLok™ is offered in two sizes: 20mm and 13mm. The ViaLokTM is configured to mate with standard medication vial enclosure sizes (20mm and 13mm). Each ViaLok™ size configuration is offered in female and male luer versions.

The ViaLok™ device is made up of a spike, luer access and a shroud. The spike is used to penetrate a standard medication vial stopper and provide a fluid path.

The purpose of the ViaLok™ shroud is to secure the device to a standard medication vial after the stopper is penetrated.

The ViaLok™ is molded methyl methacrylate acrylonitrile butadiene styrene copolymer (MABS). The ViaLok™ may be provided with a cap which is molded from a low density polyethylene (female luer) or a high density polyethylene (male luer). The ViaLok™ and protective caps do not contain natural rubber latex.

This document describes the acceptance criteria and study proving the device meets said criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details performance characteristics that were tested for the ViaLok™ device to demonstrate its substantial equivalence to a predicate device. While specific quantitative acceptance criteria (e.g., minimum attachment force, maximum leak rate) are not explicitly stated, the text implies that the ViaLok™ met all specified requirements. The performance data is presented as a comparative study against a predicate device.

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual test or the overall test set. It mentions "samples of the predicate device were tested along with the ViaLok™."

The data provenance is implicit: the studies were conducted as part of a 510(k) submission to the FDA, indicating that the testing was carried out by or for Yukon Medical, LLC, likely in the United States, as the submission is to the U.S. regulatory body. The studies are prospective in nature, as they involve testing newly manufactured devices and a predicate device for the purpose of regulatory clearance.

3. Number of Experts and Qualifications for Ground Truth

This type of information is not applicable to the described study. The tests performed are objective, quantitative performance characteristic evaluations (e.g., force measurements, leak tests, biocompatibility assays). They do not involve subjective interpretation or decision-making by experts to establish a "ground truth" for a diagnosis or classification.

4. Adjudication Method

This information is not applicable for the same reason as point 3. Adjudication methods (like 2+1, 3+1) are used in studies where there is a need for expert consensus on a subjective interpretation, such as image reading or clinical diagnosis. This study relies on objective physical and chemical measurements.

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

A MRMC comparative effectiveness study was not done. The study is focused on the device's physical and biological performance characteristics, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was done in the sense that the ViaLok™ device's performance was evaluated independently against defined standards (like ISO 594-2 and ISO 10993) and through direct comparison with a predicate device. This is not an "algorithm-only" study as it pertains to a physical medical device, but it evaluates the device's inherent performance characteristics without human-in-the-loop interaction in the context of interpretation, but rather human interaction for use.

7. Type of Ground Truth Used

The "ground truth" for this study is based on objective, verifiable measurements against established engineering standards and performance benchmarks, as well as a direct comparison to a legally marketed predicate device. This includes:

• Established industry standards: ISO 594-2 for luer components and ISO 10993 for biocompatibility.
• Performance metrics: Measurable parameters like attachment force, flow rate, leak rates, and priming volume.
• Predicate device performance: The performance of the predicate device (ALARIS Medical Systems, Inc. Single Dose Dispensing Pin) served as a benchmark for comparison.

8. Sample Size for the Training Set

This information is not applicable. The ViaLok™ is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of supervised learning. The testing described is for verification and validation of the device's design and manufacturing.

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

This information is not applicable as there is no training set for a physical medical device as described in this document.

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The Arisure™ Neutral Valve is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or artery. The Arisure™ Neutral Valve may be used with low-pressure power injectors up to 300 psi.

The Arisure™ Neutral Valve is a sterile, single-use, swab-able, normally closed, luer-activated, valved connector. The Arisure™ Neutral Valve consists of five primary components: lower housing, upper housing, retention ring, pre-slit silicone piston, and lubricating silicone oil. The lower housing, made of polycarbonate, consists of a male luer and a long feature that provides support for the silicone piston to move upon. The pre-slit silicone piston attaches to the lower housing. A series of round protrusions on the inside of the silicone piston provides sliding seals over the long feature on the lower housing. These sliding seals allow fluid to travel through the silicone piston when the piston is accessed with a male luer. The retention ring, made of polycarbonate, fits over the silicone piston and provides extra rigidity. The silicone piston and top housing together comprise the female end of the needle-free valve. The top housing, made of polycarbonate, fits over the top of the piston and is permanently affixed to the bottom housing. When pressed downward by a male luer, the slit in the piston opens, and the sliding seal on the inside of the piston opens a fluid pathway through the device. Silicone oil is used to lubricate the silicone piston. The Arisure™ Neutral Valve does not contain any natural rubber latex.

The provide text is a 510(k) summary for the Arisure™ Neutral Valve. As such, it describes the device's intended use, comparison to predicate devices, and a list of non-clinical tests conducted. The document demonstrates substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with the detailed parameters requested in the prompt. While non-clinical tests are mentioned, the document does not provide the specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert-related details required in the prompt.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document lists non-clinical tests performed (e.g., Microbial Ingress Testing, Liquid Leak, Flow Rate) but does not provide the specific acceptance criteria for each test or the reported performance values. It only states that the testing met "pre-determined acceptance criteria."
• Sample sizes used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a medical device, not an AI/diagnostic study with a "ground truth" derived from expert consensus.
• Adjudication method 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, as this is a medical device, not an AI system being evaluated for diagnostic accuracy or human-in-the-loop performance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For the device, "ground truth" would relate to its physical performance meeting specifications, rather than a diagnostic accuracy truth. The document mentions "hemolytic testing" where "hemolytic percentages below 2% are considered nonhemolytic (ASTM F 756-00)" as a general threshold, but this is a standard, not internally established ground truth from experts.
• The sample size for the training set: Not applicable; this device does not use a training set as it is not an AI/machine learning product.
• How the ground truth for the training set was established: Not applicable.

The document primarily focuses on demonstrating substantial equivalence to an existing predicate device (MicroCLAVE® Connector and CLAVE® Connector) by comparing technical and performance characteristics and conducting non-clinical tests to ensure safety and effectiveness.

The only specific performance data mentioned related to criteria is about hemolysis:

• Acceptance Criteria for Hemolysis (General Threshold): Hemolytic percentages below 2% are considered nonhemolytic (ASTM F 756-00).
• Reported Device Performance (Hemolysis): Both the 21GA needle (comparator) and the Arisure™ Neutral Valve had hemolytic percentages below 2%. The Arisure™ Neutral Valve had less hemolysis compared to blood withdrawn using a 21GA needle.
• Study Details for Hemolysis (Limited): It was an "additional testing" conducted on the Arisure™ Neutral Valve. Compared to blood withdrawn using a 21GA needle. No sample size, data provenance, ground truth establishment, or expert involvement details are provided for this specific test, beyond the standard mentioned.

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