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The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

This FDA Submission is to include an authorization to legally market the ProSeal" Vented Universal Vial Adaptor to the existing ProSeal™ CSTD devices system of eleven (11) devices that were cleared for sales in the US, the most recent being the ToxiSeal™ Vial Adaptor (K241823).

The ProSeal™ Vented Universal Vial Adaptor is a component of the ProSeal™ CSTD system intended for connection with the interface membranes between any standard vials and ProSeal™ CSTD component devices for close system fluid transfer. When connected to a standard vial and engaged with a ProSeal™ Injector (Syringe Adaptor), fluid can be transferred to and from the connecting component device in a closed system. The ProSeal™ Vented Universal Vial Adaptor and its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component and its appropriate ProSeal™ CSTD component device reduces the risk of microbial ingress for up to 168 hours (or 7 days). when used as intended.

The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system as follows:

• A double membrane septum design utilizing self-sealing elastomeric membranes tightly fits . together when the system components engage. A cannula within the ProSeal™ Injector housing perforates the double membrane for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and also minimizing the risk of microbial contamination.

The provided text is a 510(k) summary for the ProSeal™ Vented Universal Vial Adaptor. It outlines the device description, indications for use, comparison to a predicate device, and performance data supporting substantial equivalence. However, it does not describe acceptance criteria for an AI/ML-enabled medical device performance study, nor does it provide details on the specific study that would prove such a device meets acceptance criteria.

The document pertains to a physical medical device (a vial adaptor) and its mechanical, material, and sterility performance, not a software-based AI/ML device for which metrics like sensitivity, specificity, or AUC would be relevant. Therefore, most of the requested information (sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this 510(k) submission.

The closest analogous information in this document relates to functional performance testing and biocompatibility testing for the physical device.

Here's how to interpret the available information in the context of the prompt, acknowledging the mismatch:

The document effectively describes the "acceptance criteria" and "study" for a physical medical device based on regulatory standards and comparison to a predicate, not an AI/ML device.

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

The document doesn't present a table of quantitative acceptance criteria in the typical AI/ML sense (e.g., target AUC, sensitivity). Instead, it states that the device was tested and demonstrated to be in conformance with recognized ISO and FDA standards, and that "Performance testing demonstrates that this difference [in air-vent size] does not raise new questions regarding safety and effectiveness." The acceptance criteria for this physical device are the successful completion and conformance to these standards and the demonstration of substantial equivalence to the predicate.

Here's a reinterpretation of their "acceptance criteria" based on the provided text, focusing on the functional performance tests listed:

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The ToxiSeal™ Vial Adaptor mechanically prohibits environments from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.

The ToxiSeal™ Vial Adaptor devices are single-use, sterile, non-pyrogenic CSTD drug vial adaptors that are fitted to the drug vials and are sealed against the closures of the vials. They are used as sterile interfaces between the drug vials and the ProSeal™ Injector or the ProSeal™ Injector Plus (both are syringe adaptors) for the injection of diluents into the drug vials and/or withdrawal of liquids from the vials. Changes proposed in this Special 510(k) Submission are as follow: Removed external balloon and added activated carbon filter.

The provided document is a 510(k) summary for the ToxiSeal™ Vial Adaptor (K241823). It describes the device, its intended use, a comparison to a predicate device, and performance data supporting its substantial equivalence. However, the document does not contain information about an AI/software device or a comparative effectiveness study involving human readers with and without AI assistance.

Therefore, I cannot provide information for points 5, 8, and 9 of your request as they are not present in the document.

Based on the available information regarding the medical device itself (ToxiSeal™ Vial Adaptor), here's the information related to acceptance criteria and the studies conducted:

The ToxiSeal™ Vial Adaptor is a physical medical device, not an AI/software product. Therefore, the "acceptance criteria" and "study that proves the device meets acceptance criteria" are related to its functional performance, biocompatibility, and sterility, rather than AI performance metrics.

Acceptance Criteria and Device Performance (for a physical device)

The document outlines the various tests performed to demonstrate the device's conformance to recognized standards. The "acceptance criteria" are implied by the conformance to these standards and the findings that the device "met the acceptance criteria therein" or "did not raise any new or different questions of safety or effectiveness."

Here's a table summarizing the acceptance criteria (standards/tests) and the reported device performance.

Now addressing the specific points of your request based on the provided document:

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

   • See the table above. Note that for a physical medical device, "acceptance criteria" are typically defined by conformance to established performance standards and successful completion of specified tests.

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

   • Sample Sizes: The document does not specify the exact sample sizes used for each performance test (e.g., number of devices tested for leak integrity, biocompatibility, etc.). It mentions that tests were "performed on the Subject devices," "on devices under K241476," or "on device under K222929," implying samples were used from these device types.
   • Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission to the FDA, the data would typically be generated by the manufacturer or contract labs following international and US standards. The studies, being part of device verification and validation prior to market clearance, are generally prospective in nature for the tests conducted on the subject device.

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

   • This question is not applicable to this type of medical device submission. Ground truth established by experts (like radiologists for imaging AI) is relevant for diagnostic accuracy studies of software/AI. For a physical device like a vial adaptor, the "ground truth" is based on objective measurements against established engineering and biological standards. There are no human "experts" establishing a diagnostic ground truth here.

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

   • This question is not applicable as there is no diagnostic test set or human interpretation being adjudicated. The tests are quantitative and involve laboratory measurements.

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 document describes a physical medical device, not an AI software. No MRMC study was conducted or is relevant for this device.

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

   • Not applicable. This is not an algorithm/AI device. The device's performance is standalone in the sense that its mechanical and biological properties are tested independently.

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

   • The "ground truth" for this medical device is the objective measurement of physical properties, chemical properties, and biological safety against predefined engineering, material, and biocompatibility standards. Examples include:
     • Meeting specific leakage rates.
     • Absence of fragmentation.
     • Demonstrating specified penetration force.
     • Absence of microbial ingress.
     • Absence of cytotoxicity, sensitization, systemic toxicity, pyrogenicity, and meeting particulate matter limits.
     • Maintaining sterility over shelf-life.
   • It's based on quantitative laboratory testing results compared to acceptance criteria defined by recognized standards (ISO, ASTM, USP, NIOSH).

8. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device; 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 an AI model, this question does not apply.

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The ToxiSeal™ Vial Adaptor with External Flip Balloon mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.

The ToxiSeal™ Vial Adaptor with External Flip Balloon devices are single-use, sterile, nonpyrogenic CSTD drug vial adaptors that are fitted to the drug vials and are sealed against the closures of the vials. They are used as sterile interfaces between the drug vials and the ProSeal™ Injector or the ProSeal™ Injector Plus (both are syringe adaptors) for the injection of diluents into the drug vials and/or withdrawal of liquids from the vials. In addition, the ToxiSeal™ Vial Adaptor with External Flip Balloon devices equalize the pressure difference which occurs when fluid or air is added to or removed from the drug vial. This neutral pressure is maintained utilizing an external balloon/ expansion chamber.

This is a 510(k) summary for a medical device called "ToxiSeal™ Vial Adaptor with External Flip Balloon". This submission seeks to demonstrate that the new device, which has some material and design changes compared to a previously cleared predicate device, is substantially equivalent and does not require a new premarket approval application.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a comparative format for each specific criterion. Instead, it lists the standards and types of tests performed, implying that the device met the requirements of these standards. The "Reported Device Performance" in this context refers to the affirmation that testing was conducted and demonstrated conformance with the cited standards and previously cleared devices' performance.

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

• Sample Sizes: The document does not explicitly state the specific number of units or samples used for each individual test. It mentions that testing was performed "on the Subject device" or "on test samples in their finished form aged to the intention i the Subject device validation lots."
• Data Provenance: The document does not specify the country of origin of the data. The studies are described as "bench performance verifications and validations" and refer to past clearances (K222929, K240433, K192075) for much of the leveraged data, implying these were laboratory-based tests. The submission originates from Singapore.

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

This information is not applicable to this type of device submission. The device is a physical medical device (vial adaptor), not an AI/ML-based diagnostic or prognostic tool that would require expert-established ground truth for a test set. The validation relies on technical performance standards and biocompatibility.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable. This is not an AI/ML-based diagnostic device where reader studies would be relevant.

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

This information is not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by conformance to recognized industry standards (ISO, ASTM, USP, ANSI/AAMI) for mechanical, chemical, biological, and sterility properties. For example:

• Mechanical Integrity: Conformance to ISO 22413, ISO 8536-4.
• Biocompatibility: Conformance to ISO 10993 series.
• Sterility: Conformance to ISO 11135.
• Particulate Matter: Conformance to USP .
• Shelf-life: Conformance to ASTM 1980-16.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI/ML system that utilizes a training set.

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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The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days, when used as intended.

The ProSeal™ Injection Site Extended Male Luer Lock (ProSeal™ Injection Site) is a new component device for the ProSeal™ Closed System (drug) Transfer Device (CSTD) system. It is intended for connection with interface membranes between any standard female Luer lock port and ProSeal™ CSTD component devices for closed system fluid transfer. It is a variant of the cleared ProSeal™ Connector, a component of the ProSeal™ CSTD system. When connected to a female Luer lock port and engaged with a ProSeal™ Injector or a ProSeal™ Injector Plus (K240171) (Syringe Adaptor), fluid can be transferred to the connecting device in a closed system. The ProSeal™ Injection Site and its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component and its appropriate ProSeal™ CSTD component device reduces the risk of microbial ingress for up to 168 hours of 7 days, when use as intended. The closed transfer of liquid utilizes a double membrane septum design with self-sealing elastomeric membranes. Modifications from the existing ProSeal™ Connector include a geometric design change and a material change of the membrane from TPE to polyisoprene.

This is a 510(k) premarket notification for a medical device, specifically the ProSeal™ Injection Site Extended Male Luer Lock (model 422140). The document asserts "substantial equivalence" of this device to a previously cleared predicate device, the ProSeal™ CSTD's Connector (K240171).

The provided text does not contain any information about a study proving the device meets acceptance criteria related to AI/algorithm performance (e.g., sensitivity, specificity, or human reader improvement with AI assistance). This document concerns a physical medical device (an intravascular administration set component) and its functional, biocompatibility, and sterility performance, comparing it to an already cleared similar device.

Therefore, the requested information regarding acceptance criteria and a study proving an AI/algorithm device meets these criteria cannot be extracted from this document. The concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC study," and "standalone algorithm performance" are not applicable to the type of device and submission described in this FDA clearance letter.

The document discusses "functional performance acceptance criteria" for the physical device, which are met through conformance to various ISO and FDA recognized standards.

Here's an interpretation of the document's content relevant to "acceptance criteria" for this physical device:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

Regarding the other requested points (not applicable to this document's content):

2. Sample size used for the test set and data provenance: Not applicable. This document refers to bench testing of a physical device, not a performance study on an ML model's test set.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for an AI model is not relevant to the evaluation of this physical medical device.
4. Adjudication method 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/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML model for this device. For the physical device, "ground truth" would be the objective measurement against established ISO/FDA standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminants into the drug or fluid path for up to 168 hours or 7 days, when used as intended.

The ProSeal™ Injector Plus is a component of the ProSeal™ CSTD system intended for connection to a standard Luer lock syringe. It is one variant of the cleared ProSeal™ Injector, a component device of the ProSeal™ CSTD system. Just like the ProSeal™ Injector, a nonlatex elastomeric membrane covers the liquid transfer cannula tip of the ProSeal™ Injector Plus. It incorporates a clamp mechanism that reversibly connects to the other component devices of the ProSeal™ CSTD system. The ProSeal™ Injector Plus, like the ProSeal™ Injector includes a stainless steel cannula that is always shielded: during preparation, use and disposal. The ProSeal™ Injector Plus is supplied with a protective cap.

The provided text is a 510(k) premarket notification for a medical device called "ProSeal™ Injector Plus (Model no. 421050)". It details the device's description, indications for use, comparison to a predicate device, and performance data supporting substantial equivalence.

However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML model for medical image analysis, which is what your request is about. The device is an "Intravascular Administration Set" and does not appear to involve AI.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance (for an AI/ML model): This is a hardware device, not an AI/ML model.
2. Sample size used for the test set and data provenance: No AI/ML test set is described.
3. Number of experts used to establish ground truth and qualifications: No ground truth establishment for AI/ML is mentioned.
4. Adjudication method for the test set: Not applicable for a hardware device.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable for a hardware device.
6. Standalone (algorithm-only) performance: Not applicable for a hardware device.
7. Type of ground truth used: Not applicable for a hardware device.
8. Training set sample size: No AI/ML training set is mentioned.
9. How ground truth for the training set was established: No AI/ML training set is mentioned.

The document focuses on:

• Functional performance: Bench performance verifications and validations against ISO standards (e.g., fluid leakage, air leakage, stress cracking, resistance to separation, drop test, flexural force test, tensile force test, compression force test, sharps access, device leakage integrity, needle bonding strength, sharps injury protection, cap removal force).
• Biocompatibility: Conformance to ISO 10993-1, with tests like cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, and chemical characterization.
• Sterility, Shipping, and Shelf-Life: Conformance to ISO 11135 and other standards for sterilization, endotoxin testing, accelerated aging, seal strength, and ethylene oxide residuals.

These are standard hardware device tests, not related to AI/ML performance.

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The ToxiSeal™ Vial Adaptor with External Balloon mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.

The ToxiSeal™ Vial Adaptor with External Balloon devices are single-use, sterile, nonpyrogenic CSTD drug vial adaptors that are fitted to the drug vials and seal against the closures of the vials. They are used as sterile docking interfaces between the drug vials and the ProSeal™ Injectors for injection of diluents into the drug vials and/or aspiration of liquid drug from the vials.

In addition, the ToxiSeal™ Vial Adaptor with External Balloon devices equalize the pressure difference which occurs when fluid or air is added to or removed from the drug vial. This neutral pressure is maintained utilizing an external balloon/ expansion chamber.

The ToxiSeal™ Vial Adaptor with External Balloon devices, designed to be used with the cleared ProSeal™ Injector within the ProSeal™ CSTD system (K192075), are additions of CSTD vial adaptor component device offerings to the ProSeal™ CSTD system. The additions enhance the completeness of the portfolio of ProSeal™ CSTD devices system.

The provided text is a 510(k) summary for the Epic Medical ToxiSeal™ Vial Adaptor with External Balloon. It addresses the substantial equivalence of the device to a predicate device but does not contain information about a study that uses a test set, ground truth established by experts, or acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for a diagnostic or AI-driven device.

The "acceptance criteria" discussed in the document refer to:

• Compliance with recognized standards: The device was tested to conform with various ISO standards (ISO 22413:2010, ISO 8871-5:2016, ISO 8536-2:2010, ISO 8536-4:2019) and a draft NIOSH CSTD Test Protocol for functional performance.
• Biocompatibility: Testing was conducted according to ISO 10993-1:2018 for cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subacute/subchronic systemic toxicity, hemocompatibility, chemical characterization, and toxicological risk management. Particulate matter testing met USP acceptance criteria.
• Sterility, Shipping, and Shelf-Life: Compliance with ISO 11135:2014 for sterilization, package integrity (ASTM F88), and shelf-life validation (ASTM 1980-16).

Since the device described is an "Intravascular administration set" (specifically a vial adapter) and not a diagnostic or AI-driven device, the detailed information typically requested for AI/diagnostic devices (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone performance) is not applicable and therefore not present in this document.

The document focuses on demonstrating substantial equivalence through comparison of technological characteristics and performance testing against established safety and performance standards for medical devices, rather than a clinical study evaluating diagnostic accuracy against a ground truth.

Therefore, I cannot provide the requested table and information as it pertains to AI/diagnostic device performance because the provided document does not describe such a study or device.

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The Administration Sets are intravenous administration sets intended for delivery of medications and fluids from a container into a patient's vascular system.

The ProSeal™ Closed System Administration Set is a single use-, disposable-, intravenousadministration set used to deliver fluids from a container into a patient's vascular system. The device comprises an injector, a drip chamber* with a 15-um particulate filter, a roller clamp, flexible IV tubings*, a luer connector and a priming cap with a 3-um air filter. ProSeal™ Closed System Administration Set may be used in combination with standard IV therapy devices widely used throughout the health care industry, e.g. luer lock adaptor and IV extension sets. ProSeal™ Closed System Administration Set is configured to achieve the intended use when used in combination with these aforementioned standard complementary products. Based on the approved microbial testing in K192075, the ProSeal injector can be accessed/used for up to maximum of 5 times in 7 days. * Both the drip chamber and the IV tubings are not made with DEHP (Di (2-ethylhexyl) phthalate (DEHP)).

The provided text is a 510(k) summary for the ProSeal™ Closed System Administration Set. It provides information for a medical device that administers fluids intravenously, and demonstrates its substantial equivalence to a predicate device.

However, the request asks for details related to acceptance criteria, test set, ground truth establishment, MRMC studies, and training set information for an AI/Software as a Medical Device (SaMD).

The provided document does NOT contain information about an AI/SaMD device. It describes a physical medical device (an intravenous administration set). Therefore, it does not include the specific types of data, studies, and performance metrics that would be relevant to an AI model, such as:

• Acceptance criteria in terms of AI performance metrics (e.g., sensitivity, specificity, AUC).
• Test set/training set sizes and provenance for AI model development.
• Number and qualifications of experts for AI ground truth labeling.
• Adjudication methods for ground truth in an AI context.
• MRMC studies for AI assistance.
• Standalone performance of an algorithm.
• Types of ground truth for AI (e.g., pathology, outcomes data).

Therefore, I cannot fulfill the request as the source document pertains to a physical medical device, not an AI/SaMD.

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