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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 <788> 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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The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.

The eZSURE™ Empty Fluid Container (EFC) devices are empty single-use, sterile, nonpyrogenic flexible IV container devices/ bags. These are discarded after use. The Subject EFC device is composed of a flexible plastic film bag and two separate ports with closures, one for injection and another, infusion. An inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike. A transfer device with a male luer lock is used to connect to the filling-/ additive- port for filling. The additive port incorporates a needle-free valve; hence no injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the needle-free self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration. For administration to a patient, the device is then connected to an external IV set /IV line, via a bag spike. The IV bag is piped by inserting the spike point of a bag spike into the spiking-/administration- port of the IV bag, doing this by performing a twisting motion. When the bag is already filled, other medications can be added using the additive/ injection/ filling port, even during administration. Medication transfer in and out of the container is done using aseptic technique. The bags range in volume capacity of 100 mL, and 500 mL. The device has a hanger hole so it can be placed on an IV bag holder. The EFC is made of non-PVC materials and provided in a two-port configuration: The needle free additive port which is used for filling the container and the other, the spiking -/ administration port, which is used for IV therapy administration from the EFC. The EFC sub-components are externally communicating devices with no contact to the blood path. The contact duration is categorized as B-prolonged, (>24h to 30d), per ISO 10993-1 :2018 biocompatibility guidelines.

The provided text is a 510(k) Summary for a medical device called eZSURE™ Empty Fluid Container. It does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case studies, or the establishment of ground truth by experts.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for a Class II medical device (an empty IV fluid container). The "acceptance criteria" and "study" described in the document relate to physical and biological performance testing of the container itself, not the performance of an AI algorithm in diagnostic imaging.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI.
• Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for an AI test set.
• MRMC comparative effectiveness study details.
• Standalone AI performance details.
• Training set size or ground truth establishment for an AI.

The document describes the following types of acceptance criteria and studies for the physical medical device:

1. A table of acceptance criteria and the reported device performance (for the physical device, not AI):

The document does not provide a single, consolidated table directly mapping acceptance criteria to quantitative performance results for each test. Instead, it lists the types of tests performed and states that the device "met their respective acceptance criteria" or "complies with" relevant standards.

Summary of Acceptance Criteria and Reported Performance (extracted from Section VII):

2. Sample size used for the test set and the data provenance:
The document does not specify exact sample sizes for each test listed. It mentions "testing done" and "test methods" but not the number of units tested. Data provenance is not applicable here as it refers to physical testing of a manufactured device, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the "ground truth" for this device's performance relates to physical and biological properties (e.g., whether it leaks, whether materials are biocompatible, whether it is sterile), which are established through standardized laboratory testing, not by expert human readers interpreting data.

4. Adjudication method for the test set:
Not applicable for physical/biological performance testing.

5. If a Multi-reader Multi-case (MRMC) comparative effectiveness study was done:
No, this type of study is for evaluating diagnostic performance of imaging devices or AI, which is irrelevant to an empty fluid container.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as there is no AI algorithm being evaluated for this physical device.

7. The type of ground truth used:
For the physical device, the "ground truth" is defined by the technical specifications and performance limits set by various ISO, ASTM, ANSI/AAMI, EN, and USP standards (e.g., a certain burst pressure, a specific level of particulate matter, absence of microbial growth).

8. The sample size for the training set:
Not applicable, as this is not an AI model requiring a training set.

9. How the ground truth for the training set was established:
Not applicable, as there is no AI model or training set.

In conclusion, the provided FDA 510(k) summary is for a standard medical device (an empty fluid container) and demonstrates its substantial equivalence based on physical, chemical, and biological performance testing, rather than the performance of an AI algorithm.

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The SMARTeZ Pump (Long infusion time article) is intended for continuous infusions for general infusion use, including pain management.
• Routes of administration: intravenous and subcutaneous.
The SMARTeZ Pump (Short infusion time article) is intended for continuous infusions for general infusion use, including antibiotic delivery.
· Route of administration: intravenous.
The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
· Routes of administration: intravenous and intra-arterial.

The SMARTeZ Pump, is a single-use disposable, non-electric infusion pump that consists of an elastomeric fluid reservoir as energy source with an integrated administration line (see Figure 5-1). The constriction of elastomeric fluid reservoir drives the medication through the tubing and eventually through a flow restrictor out into the patient connection. Drug products should be stored in their approved containers and closures.

The SMARTeZ Pump, an elastomeric infusion pump, underwent a series of bench tests to demonstrate its performance and safety, aligning with ISO 28620:2010 standards. The study aimed to prove that the device consistently delivers medication within specified flow rate tolerances under various conditions, including nominal operation, changes in ambient temperature and solution viscosity, and after exposure to physical stresses like pressure, traction, and drops, as well as refrigeration. It also verified leak-proof integrity and the absence of retrograde flow.

Here is a summary of the acceptance criteria and the reported device performance:

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

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

The document does not explicitly state the specific sample size (number of devices) used for each individual bench test. However, it consistently refers to "All test samples" passing the criteria. It also mentions "The samples were tested."
The data provenance is from bench testing, which implies a controlled laboratory environment. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, as these types of studies are typically not applicable to physical bench tests of device functionality.

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

This information is not applicable as the study described is a series of bench tests for device performance against predefined engineering and regulatory standards (ISO 28620:2010), not a study involving expert assessment or clinical ground truth.

4. Adjudication method for the test set:

This is not applicable as the study involves objective physical measurements and functional checks against quantitative acceptance criteria, not subjective human evaluations 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:

This is not applicable as the device is a physical infusion pump, not an AI-powered diagnostic or assistive tool.

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

This is not applicable as the device is a physical infusion pump, not an algorithm. The "standalone" performance here refers to the device's inherent mechanical and fluid dynamic performance.

7. The type of ground truth used:

The ground truth for the performance tests was established by objective measurements against quantitative engineering and regulatory standards (ISO 28620:2010), specifically defined numerical tolerances for flow rate, and observable physical properties like leak-proof integrity and retrograde flow.

8. The sample size for the training set:

This is not applicable as the device does not employ machine learning or AI models that require a training set.

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

This is not applicable as the device does not employ machine learning or AI models.

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