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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 EZ™ IV Administration Set is a gravity, single use, disposable, intravenous administration set designed to deliver fluids from a container into a patient's vascular system. The device includes a vented bag spike (air vent 0.1µm) integrated to a drip chamber (not made with DEHP*) featuring a 5-μm particulate filter, a roller clamp, flexible IV tubing (not made with DEHP*), and one (1), two (2) or three (3) needle-free valve (NFV) Y-site connectors. It also features a Luer connector and a priming cap with a 3-μm filter.

The EZ™ IV Administration Set may be used in combination with standard IV therapy devices commonly used throughout the healthcare settings, such as bag spike, Luer lock adaptor, syringe (MLL) (without needle), and IV extension sets. It is configured to achieve the intended use when used with these standard complementary products.

*DEHP – Di (2-ethylhexyl) phthalate (DEHP), a plasticizer to make PVC soft and flexible. It is a substance known to cause cancer or reproductive toxicity.

The provided FDA 510(k) clearance letter and summary for the EZ™ IV Administration Set (K251814) describe the device's acceptance criteria and the studies conducted to demonstrate substantial equivalence to a predicate device. However, this document primarily focuses on demonstrating substantial equivalence rather than proving the device meets specific acceptance criteria for a novel device. It also describes a medical device rather than a software or AI-driven device, so several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable.

Here's an analysis based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance for EZ™ IV Administration Set (K251814)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EZ™ IV Administration Set are primarily defined by adherence to recognized international and national standards for intravascular administration sets and specific functional performance metrics derived from these standards. The reported device performance indicates compliance with these standards.

• ISO 8536-4:2019
• ISO 22413:2021
• ISO 10993-1:2018
• ANSI/AAMI CN27:2021
• ISO 80369-7:2021
• ISO 80369-20:2015
• FDA Guidance for Intravascular Administration Sets | Comprehensive performance verification & validation testing performed; met the intended use. |
  | Air-inlet device tests | ISO 8536-4:2019 | Conformed to standard. |
  | Flow rate test | ISO 8536-4:2019 | Conformed to standard. |
  | Piercing device penetration force test | ISO 22413:2021 | Conformed to standard. |
  | Protective cap removal test | ISO 8536-4:2019 | Conformed to standard. |
  | Drip chamber and drip tube tests | ISO 8536-4:2019 | Conformed to standard. |
  | Leak integrity tests | ISO 8536-4:2019 (air leakage under positive pressure, air leakage under negative pressure and fluid leakage) | Conformed to standard. |
  | Tensile strength test | ISO 8536-4:2019 | Conformed to standard. |
  | Particulate contamination level | ISO 8536-4:2019, Annex A, A.2
  USP Particulate Matter in Injections | Met contamination index, N≤90. Conformed to standard. |
  | Drops/mL | 20 gtt/mL (as per Predicate) | 20 gtt/mL |
  | Tubing transparency | Sufficiently clear to observe air/water interface (normal/corrected vision) | Conformed to standard. |
  | Connector type | External Fitting Male Luer Lock (ISO 80369-7:2021) | Conformed to standard. |
  | Sterile barrier packaging | Medical grade paper and plastic film, heat sealed | Conformed to standard. |
  | Sterilization process | Ethylene Oxide (EO), SAL 10⁻⁶ | Ethylene Oxide (EO), SAL 10⁻⁶. Complies with ISO 11135:2014. |
  | Shelf-life validation | 3 years (36 months) via ASTM 1980-21 | 3 years (36 months) validated. |
  | Biocompatibility | ISO 10993-1:2018 (Externally Communicating Device, Blood Path Indirect, Prolonged Contact)
  (Specific ISO 10993 parts for various tests) | Met biological safety specifications. |
  | EO residues limits | ISO 10993-7:2008 & amendments | Conformed to standard. |
  | Shipping | ASTM D 4169-16 | Simulated shipping testing performed on K151650/S004. |
  | Package integrity | ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009 | Testing performed on K151650. |
  | Pyrogen tests | ANSI/AAMI ST72/2019, USP , USP , USP | Testing performed on K151650 and "will be conducted on every lot." |

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: The document does not specify the exact sample sizes (number of devices/batches) used for each specific performance test mentioned (e.g., flow rate, leak integrity, tensile strength). The studies are focused on product characteristics and compliance with engineering standards, not clinical patient data.
• Data Provenance: Not explicitly stated for each test. The submitter is "Epic Medical Pte. Ltd." based in Singapore, suggesting the testing data likely originated from or was managed by facilities associated with this company. The testing is for a medical device component, not a diagnostic algorithm, so there is no patient data involved in these performance tests.
• Retrospective or Prospective: Not applicable, as these are engineering and materials performance tests conducted on the physical device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device submission. The "ground truth" here is defined by objective engineering specifications and international standards, rather than expert consensus on medical images or diagnoses. Qualification involves expertise in medical device testing, engineering, and regulatory compliance.

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

Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical readings or evaluations where human interpretation introduces variability. These are objective physical and chemical tests on a medical device.

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 a physical medical device (IV administration set), not an AI-powered diagnostic tool, and therefore no MRMC studies were conducted or are relevant.

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

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 the performance tests conducted on the EZ™ IV Administration Set is based on established international and national standards and their specific test methods and acceptance criteria. This includes standards like ISO 8536-4 for infusion sets, ISO 10993 for biocompatibility, and USP for particulate matter. These standards provide objective, measurable criteria for device performance and safety.

8. The sample size for the training set

Not applicable. This pertains to the training of an algorithm or AI model. This submission is for a physical medical device.

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

Not applicable. As above, this is for a physical medical device and does not involve a training set for an algorithm.

Summary of Study that Proves Device Meets Acceptance Criteria:

The study that proves the EZ™ IV Administration Set meets its acceptance criteria is a comprehensive set of performance verification and validation tests conducted on the subject device and, in some cases, leveraging data from the predicate device (K230343/S001) or an existing device (K151650 and K151650/S004).

These tests address:

• Functional Performance: Evaluated against ISO 8536-4:2019, ISO 22413:2021, and FDA guidance documents, covering aspects like flow rate, leak integrity, piercing device penetration force, protective cap removal, drip chamber performance, and tensile strength.
• Connection Integrity: Evaluated against ANSI/AAMI CN27:2021 (for luer-activated valves) and ISO 80369 series (for small-bore connectors like Luer lock).
• Biocompatibility: Evaluated against ISO 10993 series (e.g., -5, -10, -11, -17, -18, -23) to assess cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, and chemical characterization. This classification was for "Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24 hr to 30 d)."
• Sterility and Shelf-Life: Compliance with ISO 11135:2014 for Ethylene Oxide sterilization, ASTM D 4169-16 for shipping, and ASTM F1980-21 for accelerated aging (shelf-life validation of 3 years). Package integrity, pyrogen, and EO residue tests were also part of this.
• Material Composition: Analysis and risk assessment were conducted given differences in materials between the subject and predicate devices, leveraging biocompatibility and chemical characterization data.

The submitter states that "All performance testing demonstrated and confirmed the safety and effectiveness of the Subject device" and that the results "met the intended use." They explicitly noted for material and dimension differences that "analytical and functional testing were conducted" and "the results...demonstrated that the performance of the Subject devices met the intended use. Therefore, the differences were considered not significant." This body of evidence constitutes the study proving the device meets its acceptance criteria, which are primarily compliance with the listed international and national standards.

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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) is a sterile, nonpyrogenic, single-use intravenous (IV) bag constructed from flexible, non-PVC film. It is designed for the preparation and administration of IV fluids and is intended for disposal after a single use.

Two previously cleared subgroups include:

• eZSURE™ EFC with Needle-Free Valve (NFV) Additive Port (K223674)
• eZSURE™ EFC with ProSeal™ Injection Site Additive Port (K241442)

Both subgroups are currently available in 100 mL, 250 mL, and 500 mL capacities. This Submission introduces a new 1,000 mL capacity option for each subgroup.

Each EFC consists of a flexible plastic film bag with two (2) ports:

• Additive (filling) port – for introducing compatible fluids
• Spiking (administration/access) port – for accessing the infusate using a standard IV spike

The NFV model features a self-sealing needle-free valve additive port compatible with male Luer lock syringes. The Injection Site model incorporates a closed-system injection site with a double elastomeric membrane, compatible with the ProSeal™ Injector, which is also compatible with male Luer lock syringes. Both configurations support secure medication addition and maintain a sealed system after device removal.

The provided FDA 510(k) clearance letter describes a medical device, the eZSURE™ Empty Fluid Container, which is an IV bag. The submission primarily focuses on the device's technical characteristics and performance, particularly concerning the introduction of a new 1,000 mL capacity option.

Based on the provided document, the device in question (eZSURE™ Empty Fluid Container) is a Class II medical device (an I.V. container). The validation described heavily relies on bench testing and conformance to established international and national standards rather than clinical studies involving human patients or complex AI algorithms requiring extensive ground truth establishment and multi-reader studies.

Therefore, the acceptance criteria and study that proves the device meets them are focused on these engineering and biocompatibility aspects.

Here's the breakdown as requested, tailored to the information available in the 510(k) letter:

Acceptance Criteria and Device Performance for eZSURE™ Empty Fluid Container

The acceptance criteria for this device are primarily based on meeting the requirements of various recognized national and international standards related to IV containers, fluid transfer, and biocompatibility. The "study" proving acceptance consists of a series of bench tests and evaluations against these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device (an IV container) with an extension of capacity, the performance criteria are primarily related to its physical and material properties, and its ability to safely contain and dispense fluids. The provided document details a comprehensive set of tests performed.

• Accelerated aging of above tests (ASTM F1980-21)
• Resistance to dropping (ISO 15747:2018, Annex A.4)
• Accelerated aging of above test (ASTM F1980-21)
• Hanger tensile strength (ISO 15747:2018, Annex A.11)
• Accelerated aging of above tests (ASTM F1980-21) | Conformant: All specified tests were performed on the Subject device (1000 mL capacity) and leveraged data from predicate devices. The Submitter's Comment indicates that functional testing was conducted and data summarized, concluding that performance results met intended use, and determined the difference in volume to be insignificant. |
  | Additive Port (Common) | - Infusion container transparency (ISO 15747:2018)
• Water vapor impermeability (ISO 15747:2018)
• Access port cover test (ISO 15747:2018)
• Access port penetration ability of insertion point (ISO 15747:2018)
• Access port adhesion strength of infusion device and impermeability of insertion point (ISO 15747:2018)
• Access port liquid tightness of insertion point (ISO 15747:2018)
• Identification test (ISO 15747:2018)
• Raw container and test fluids requirements (ISO 15747:2018)
• Impermeability to microorganism and migration (ISO 15747:2018)
• 7-day microbial ingress (FDA guidance and AAMI CN27:2021) | Conformant: These tests were performed with the NFV filling port version (under K223674) or demonstrated to be equivalent. Results implied conformance, as the submission states no substantial differences raised concerns and performance met intended use. |
  | Additive Port (ProSeal™ Specific) | - Additive port air and liquid tightness (ISO 15747:2018)
• Impermeability to microorganism (ISO 15747:2018)
• Additive port positive pressure fluid leakage (ISO 80369-7:2021)
• Sub-atmospheric pressure air leakage (ISO 80369-7:2021)
• Stress cracking (ISO 80369-7:2021)
• Resistance to separation from axial load (ISO 80369-7:2021)
• Resistance to unscrewing (ISO 80369-7:2021)
• Resistance to overriding (ISO 80369-7:2021)
• Device leakage integrity (ISO 8536-4:2019)
• Vapor containment test (NIOSH 2016 draft protocol)
• Microbial ingress (FDA guidance and AAMI CN27:2021) | Conformant: These tests were performed with the Injection Site filling port version (under K241442 and K240433) or demonstrated to be equivalent. Results implied conformance, as the submission states no substantial differences raised concerns and performance met intended use. |
  | II. Biocompatibility | - Cytotoxicity (ISO 10993-5:2009)
• Sensitization (ISO 10993-10:2010)
• Intracutaneous reactivity (ISO 10993-23:2021)
• Acute systemic toxicity (ISO 10993-11:2017)
• Subacute/subchronic systemic toxicity (ISO 10993-11:2017)
• In-vitro hemolysis (ISO 10993-4:2017)
• Material mediated pyrogenicity (ISO 10993-11:2017)
• Chemical characterization and toxicological risk assessment (ISO 10993-18:2020 & ISO 10993-17:2002)
• Particulate matter testing (ISO 15747:2018 & USP )
• EO residues limits (ISO 10993-7:2008, Amd.1:2019) | Acceptable Biological Risks Established: Testing was conducted under predicate devices (K223674/S001, K241442, K240433) and the Subject device. The Submitter's Comment explicitly states: "The biocompatibility testing and chemical characterization as well as risk analysis data on cleared device were evaluated for the Subject device... The difference was determined to be insignificant as results were determined to have met the device's biological safety specifications." Testing also confirmed compliance with EO residue limits for special patient populations. |
  | III. Sterility, Shipping, and Shelf-Life | - Sterilization validation (ISO 11135:2014)
• Simulated shipping testing (ASTM D 4169-16)
• Package integrity (ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009)
• Pyrogen tests (ANSI/AAMI ST72/2019, USP 42-NF 37 , , )
• Shelf-life validation (3 years, ASTM 1980-21) | Conformant: The Subject device complies with ISO 11135:2014. Shipping and package integrity tests leveraged data from prior submissions (K151650/S004, K223674/S001, K151650). Pyrogen tests performed under K151650 will be conducted on every lot. A 3-year shelf-life was validated on the Subject device. |

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., "n=X units") for each specific test conducted on the 1000 mL subject device. It lists the types of tests performed and the standards they adhere to. For physical device testing, sample sizes are typically defined by the standards themselves (e.g., a certain number of units per lot, or a statistical sampling plan to achieve confidence). The statement "functional testing have been conducted and their data are summarized in section VII.A" implies sufficient samples were used to meet the standards' requirements.
• Data Provenance: The data provenance is primarily from bench testing conducted by the manufacturer or authorized test labs. The document mentions leveraging "relevant testing data from the Predicate devices and the existing device: K223674/S001, K241442 and K230343/S001" for many of the functional and biocompatibility tests, with specific tests performed "On Subject device" (the new 1000 mL version). The country of origin of the data is not specified beyond the company being in Singapore. All data is retrospective in the sense that it's historical data generated for the submission, but the tests themselves were designed to prospectively evaluate the device's performance against defined criteria.

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

This type of device (an IV container) does not typically involve expert "ground truth" establishment in the way AI/radiology devices do. The "ground truth" is established by adherence to pre-defined, internationally recognized engineering and scientific standards (e.g., ISO, ASTM, USP) and their associated test methods. Experts involved would be engineers, material scientists, and quality assurance professionals responsible for designing, executing, and interpreting these standardized tests. Their qualifications would be in engineering, chemistry, biology, or related fields, with experience in medical device testing and regulatory compliance. The document does not specify the number or specific qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is based on established technical standards, not on subjective human interpretation requiring adjudication. Performance is measured against quantitative or qualitative acceptance criteria defined by these standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those involving image interpretation (e.g., AI in radiology), where human performance (with and without AI assistance) needs to be assessed. This device is a physical IV container and does not involve human readers for diagnostic interpretation.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used is primarily based on:

• Engineering and Performance Standards: The device's ability to meet specified physical, mechanical, and chemical properties as defined by ISO, AAMI, ASTM, and USP standards.
• Biocompatibility Standards: The device's materials and their extracts demonstrating acceptable biological compatibility as per ISO 10993 series.
• Sterility Assurance: Validation of the sterilization process and maintenance of sterility as per ISO 11135.

This is fundamentally different from ground truth for AI algorithms which might use expert consensus or pathology results.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

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The ProSeal™ 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™ Bag Spike with Additive Port (or "and Seal Tab" (suffixed ST model no.)) serves as an adaptor between I.V. bags and ProSeal™ CSTD components, facilitating closed system fluid transfer. The spiking port of this device is compatible with generic I.V. spikes. Additionally, the additive port (injection site) allows medication to be added to the bag using the cleared ProSeal™ Injector or Injector Plus (both Syringe Adaptors).

The injection site of the ProSeal™ Bag Spike with Additive Port (or "and Seal Tab") and all corresponding interface membranes ensure a dry connection during fluid transfer. Utilizing this component and its appropriate ProSeal™ CSTD connecting component reduces the risk of microbial ingress for up to 168 hours (7 days).

This document describes a 510(k) clearance for a medical device called "ProSeal™ Bag Spike with Additive Port." 510(k) clearances are for medical devices that are substantially equivalent to a legally marketed predicate device. This process primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Important Note: The provided FDA 510(k) clearance letter and summary do not describe a study involving a medical device with Artificial Intelligence (AI) or machine learning (ML) capabilities. The document pertains to a physical medical device (an intravascular administration set) and its mechanical and material properties. Therefore, the questions related to AI/ML specific criteria (e.g., sample size for training set, number of experts for ground truth, MRMC studies, AI assistance) are not applicable to this specific clearance.

I will focus on the acceptance criteria and performance data provided for this physical medical device.

Acceptance Criteria and Device Performance for ProSeal™ Bag Spike with Additive Port

Since this 510(k) is for a physical medical device and not an AI/ML device, the "acceptance criteria" are based on meeting established national and international standards for medical device safety and performance, as well as demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

The device performance is demonstrated by conformance to various ISO standards and validation testing. The table below summarizes the key performance areas and the general nature of the reported performance, as specific quantitative acceptance criteria or detailed results are not explicitly listed in this type of summary document, but rather conformance to the standards is stated.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual functional, biocompatibility, sterility, shipping, or shelf-life test. This level of detail is typically found in the full test reports, not in the 510(k) summary. For device clearances, compliance is often demonstrated by testing a statistically significant number of units to ensure performance within specifications, but the exact number isn't usually summarized here.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter is Epic Medical Pte. Ltd. based in Singapore, suggesting the testing could have been conducted there or by affiliated labs. The testing refers to "bench performance verifications and validations" and "existing 510(k) cleared referred-to devices (K222929, K223674, K241988)" for leveraging data. This indicates the data is retrospective, drawing from previous tests on related and cleared devices, as well as specific new tests for the subject device. There is no indication of prospective clinical studies.

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

• Not Applicable: This criterion relates to AI/ML model validation, where human experts (e.g., radiologists) establish ground truth for image interpretation. For a physical medical device like an intravascular administration set, "ground truth" is established through engineering and biological testing against predefined performance standards and specifications, not through expert consensus on qualitative data. The "experts" would be the engineers, microbiologists, and other scientific and quality control personnel conducting the rigorous lab tests and validations.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or AI/ML model validation to resolve discrepancies in expert interpretations of data. For a physical device, performance is objectively measured against quantifiable technical specifications and standards (e.g., no leaks observed, flow rate within X range, microbial ingress count below threshold).

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 the diagnostic performance of AI-assisted systems where human readers interpret medical images or data. This device is a physical product, not an AI system.

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

• Not Applicable: This criterion is for AI/ML algorithms. The performance of this device is inherently its standalone physical function.

7. The Type of Ground Truth Used

• Objective Test Results / Conformance to Standards: The "ground truth" for this device's performance is established by objective engineering measurements, chemical analyses, and biological assays that demonstrate compliance with recognized industry standards (ISO, ASTM, ANSI, USP) and the device's design specifications. Examples include:
  • Absence of leaks under specified pressure.
  • Maintaining sterility and preventing microbial ingress for 7 days.
  • Meeting pre-defined flow rates.
  • No evidence of cytotoxicity, sensitization, or pyrogenicity in biocompatibility tests.
  • Successful vapor containment.

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" in the context of a physical medical device. This term applies to machine learning models.

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

• Not Applicable: As there is no training set for a physical device, this question is not relevant.

Summary of Study that Proves the Device Meets Acceptance Criteria for this Physical Device:

The study proving the device meets acceptance criteria is a comprehensive set of bench performance verifications and validations, along with biocompatibility, sterility, shipping, and shelf-life testing.

• Purpose: To demonstrate that the ProSeal™ Bag Spike with Additive Port is safe and effective for its intended use as an intravascular administration set component, and that any differences from its predicate device (ProSeal™ Closed System Bag Access, K241988) do not raise new questions of safety or effectiveness.
• Methodology:
  • Functional Testing: The device was subjected to various mechanical and functional tests based on ISO standards (e.g., ISO 8536-4, ISO 22413, ISO 15747, ANSI AAMI CN27), including leak integrity, tensile strength, flow rate, protective cap strength, IV bag spike penetration force, and impermeability to microorganisms (demonstrated for 7 days). Vapor containment was also assessed using a NIOSH CSTD draft protocol.
  • Biocompatibility Testing: In accordance with ISO 10993-1:2018 for externally communicating devices (blood path indirect, prolonged contact), various biocompatibility tests were performed on the device's materials, leveraging data from previously cleared predicate and similar devices (K222929, K223674, K241988). These included cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, chemical characterization, and particulate matter analysis.
  • Sterility Validation: Compliance with ISO 11135:2014 for Ethylene Oxide sterilization (SAL 10⁻⁶) was demonstrated, along with pyrogen testing.
  • Shipping and Shelf-Life Validation: Simulated shipping (ASTM D 4169-16) and package integrity tests (ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009) were conducted. Shelf-life of 3 years was validated using accelerated aging (ASTM 1980-21).
• Data Sourcing: Data was obtained from new tests performed on the subject device and by leveraging data from previously cleared devices (K222929, K223674, K241988) that share similar components or materials, indicating a retrospective data approach for certain aspects.
• Conclusion: The results of these tests and validations confirmed that the subject device meets all relevant performance standards and does not raise new questions of safety or effectiveness compared to the predicate device, thus demonstrating substantial equivalence.

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The ZeroClear™ Bag Access is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ 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 ZeroClear" Bag Access is a part of the ProSeal™ Closed System drug Transfer Device (CSTD), used for injecting and infusing IV fluids and drug solutions from a standard IV bag to a patient. It features a bi-directional Luer lock connector, compatible with ISO 80369-7:2021 male Luer connectors and an ISO 8536-4:2019 compliant IV bag spike, including the applicant's eZSURE™ Empty Fluid Container (cleared K223674) and eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (cleared K241442).

This sterile, single-use device used with the appropriate connecting devices, ensures dry connections, minimizes exposure to contaminants and drug vapors, and reduces microbial ingress for up to 7 days. It is intended for use by health care professionals in clinical settings for handling hazardous drugs.

The Subject device will be a part of a grouping of currently, twelve (12) cleared component device offerings, to the ProSeal™ CSTD system together with Epic Medical's most recently FDA cleared CSTD devices (K241988).

The provided FDA 510(k) summary (K243976) for the ZeroClear™ Bag Access details the device and its intended use as a component of a Closed System Drug Transfer Device (CSTD). However, it does not contain the specific information requested regarding acceptance criteria and the comprehensive study details as outlined in the prompt (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, ground truth establishment, training set size).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (ProSeal™ Closed System Bag Access, K241988), primarily through functional performance, biocompatibility, and sterility testing against recognized standards. It highlights that no animal or clinical tests were deemed applicable for this submission.

Therefore, many of the requested fields cannot be directly populated from the provided text. Based on the document, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text for individual tests. The document mentions "testing data" but does not give specific numbers of devices or samples tested.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the tests were retrospective or prospective. The manufacturer is Singapore-based, but testing could occur elsewhere.

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 to the types of performance and safety tests conducted for this device (bench testing, biocompatibility, sterility). These tests do not involve expert interpretation or "ground truth" in the diagnostic or AI sense.

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

• Not applicable. Adjudication methods are typically used for studies involving human interpretation or subjective assessment, which is not the case for the physical and biological tests described.

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. The device is a physical medical device (component of a CSTD), not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant here.

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

• Not applicable. The ZeroClear™ Bag Access is a physical component, not an algorithm or software. Its performance is inherent to its design and materials, not a standalone algorithmic output. The performance tests mentioned (e.g., airtightness, microbial ingress) evaluate the device itself.

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

• For the functional, biocompatibility, and sterility tests, the "ground truth" is defined by the pass/fail criteria of the referenced international and national standards (ISO, ANSI AAMI, ASTM, USP, NIOSH). For example, a device either leaks or it doesn't, based on predefined measurable thresholds in the standards.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

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

• Not applicable. No training set is involved.

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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 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.

The ProSeal™ CSTD is a sterile, single-use, pyrogen-free CSTD for the preparation, reconstitution, compounding, and administration of antineoplastic and hazardous drugs, intended for use in clinical settings by trained health care professionals and/or pharmacists.

The ProSeal™ Closed System Bag Access is a component of the ProSeal™ CSTD system which is intended for connection to a standard I.V. bag and appropriate ProSeal™ CSTD component devices for the injection and infusion of I.V. infusion fluids. It is an adaptor between IV bags and ProSeal™ CSTD components for closed system fluid transfer into and out of the I.V. bag. The Subject bag access is compatible with the ProSeal™ Injector or the ProSeal™ Injector Plus (cleared K240171) and other ProSeal™ component devices, e.g. ProSeal™ Closed System Administration Set (for infusion from the I.V. bag). The ProSeal™ Closed System Bag Access and all its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component device and its appropriate ProSeal CSTD connecting 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 Plus housing perforates the double membranes 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 spills, and also minimizing the risk of microbial contamination, when used as intended.

Based on the provided FDA 510(k) summary for the ProSeal™ Closed System Bag Access (K241988), here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Disclaimer: This document is a 510(k) summary, which provides an overview of the substantial equivalence determination. It does not contain the full details of all the studies performed. Therefore, specific quantitative performance metrics beyond what is explicitly stated for acceptance and observed results are not available in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes functional performance, biocompatibility, sterility, shipping, and shelf-life testing. While specific quantitative acceptance criteria are not explicitly listed in a single table with corresponding numerical results, the document states conformance to various ISO and FDA recognized standards. The "Comment/Discussion" column in the comparison table indicates "Same" or "Similar" for many characteristics, implying that the acceptance criteria are met by demonstrating equivalence to the predicate device and adherence to standards.

For functional performance, the document lists the following tests and their corresponding standards, implying that meeting these standards constitutes the acceptance criteria. The performance data "supporting substantial equivalence" suggests that the device met these criteria.

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

The document does not explicitly state the specific sample sizes used for each of the functional performance, biocompatibility, or sterility tests. It refers to various ISO and ASTM standards, which typically prescribe minimum sample sizes for such tests.

• Data Provenance: The document states "Bench performance verifications and validations referred-to and performed" and "testing data on devices cleared under K222929." This indicates that the testing was primarily benchtop testing (laboratory-based) and retrospective, leveraging data from previously cleared devices within the ProSeal™ CSTD system (specifically K222929). There is no mention of data provenance by country of origin or specific patient data since the studies are physical/chemical rather than clinical.

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

This section is Not Applicable to this 510(k) submission. The device is a physical medical device (intravascular administration set component), not an AI/ML diagnostic or image analysis device that requires expert human interpretation to establish ground truth from medical images or clinical data. Its performance is evaluated through physical, mechanical, and biological testing against established standards.

4. Adjudication Method for the Test Set

This section is Not Applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies involving human interpretation or subjective assessments, especially for AI/ML devices where ground truth might be derived from multiple expert opinions. For a physical device undergoing performance and safety testing against objective engineering and biological standards, such adjudication is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of how much Human Readers Improve with AI vs. without AI Assistance

This section is Not Applicable. An MRMC study is relevant for diagnostic or AI-assisted diagnostic devices that evaluate human reader performance. The ProSeal™ Closed System Bag Access is a hardware component for drug transfer and does not involve human readers interpreting medical cases.

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

This section is Not Applicable. This concept applies to AI/ML software. The ProSeal™ Closed System Bag Access is a physical device component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by conformance to internationally recognized performance standards (e.g., ISO, ASTM, USP, ANSI/AAMI) for medical devices, specifically for intravascular administration sets and closed system transfer devices. This includes:

• Engineering/Physical Standards: Defining acceptable ranges for leak integrity, tensile strength, penetration force, package integrity, etc.
• Biological Standards: Defining acceptable levels for biocompatibility (cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity) and sterility.
• Functional Claim Validation: Demonstration of preventing microbial ingress and vapor containment as defined by specific test protocols (e.g., microbial ingress test, vapor containment test).

8. The Sample Size for the Training Set

This section is Not Applicable. The product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the machine learning sense. The design and manufacturing processes are validated through engineering principles and compliance with quality systems (e.g., 21 CFR Part 820).

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

This section 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 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™ CSTD devices are single-use, sterile, non-pyrogenic CSTD component devices that are fitted to each other. They are used as sterile interfaces for the closed injections and withdrawals of liquids into and from the ProSeal™ CSTD component devices and external transfer devices. The ProSeal™ In Line Pump Set is a closed system in-line IV infusate/drug transfer adapter/ connector for providing closed system protection during hazardous drug administration when connected to a standard IV set at its distal end, with the proximal end attached to a mating ProSeal™ Injection Site (K240433) of a ProSeal™ CSTD component device such as the eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (K241442).

This document does not contain the information required to populate a table of acceptance criteria and reported device performance for a medical device that would involve AI or machine learning. The provided text is a 510(k) summary for a physical medical device (ProSeal™ In Line Pump Set), which is an intravascular administration set, and does not mention any AI components, software, or algorithms.

Therefore, questions related to:

1. Acceptance criteria and reported device performance (with AI metrics)
2. Sample size for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study and effect size
6. Standalone (algorithm only) performance
7. Type of ground truth used (for AI)
8. Sample size for the training set
9. How ground truth was established for the training set

cannot be answered from the provided text.

The document focuses on the substantial equivalence of the ProSeal™ In Line Pump Set to a predicate device (ProSeal™ Injector Plus) based on:

• Intended use and indications for use
• Technological characteristics (materials, design, sterilization, shelf-life)
• Performance data from bench testing demonstrating compliance with ISO standards for mechanical, fluidic, and safety aspects.
• Biocompatibility testing (per ISO 10993)
• Sterility, shipping, and shelf-life testing.

The performance data listed pertains to physical device attributes such as leak integrity, flow rate, Luer lock connection tests, sharps injury protection, needle bonding strength, resistance to temperature/pressure/dropping, water vapor impermeability, spiking port ability and adhesion, particulate non-contamination, and impermeability to microorganisms. These are standard engineering and biomedical tests for physical medical devices, not performance metrics for AI algorithms.

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The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.
· Routes of administration: intravenous and subcutaneous.

The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications 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™ Elastomeric Infusion Pump (SMARTeZ™ Pump) is a sterile, single-use, mechanical (non-electric, non-electronic) infusion pump that consists of an elastomeric fluid reservoir as an energy source and an administration line. The constriction of the elastomeric fluid reservoir drives the fluid through the administration tubing and eventually through a flow restrictor, into the patient connection.

The SMARTeZ™ Pump is intended to administer infusion therapies only, and not for fluid storage.

This Special 510(k) Submission is to inform FDA of the addition to the thirty-nine (39) existing SMARTeZ™ Pump offerings, four (4) new models of different nominal volumes, flow rates and time: 498111: 100 ml, 0.5 ml/h, 200 h; 498121: 100 ml, 1 ml/h, 100 h: 498131: 50 ml, 0.5 ml/h, 100 h: 498141: 50 ml. 1 ml/h, 50 h. with KVO (Keep Vein Open) infusion pump labeling.

This document describes the FDA clearance for the SMARTeZ™ Elastomeric Infusion Pump (K242152), which identifies it as substantially equivalent to a previously cleared device (K151650). This submission is a "Special 510(k)" for the addition of new models with different nominal volumes, flow rates, and infusion times, along with a change to a detachable administration tube.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to recognized international standards. The document doesn't provide a direct "table" of acceptance criteria values alongside specific performance metrics for each, but rather states that tests were performed in conformance with these standards.

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

The document does not explicitly state the numerical sample size for each specific test in the "test set". It mentions "bench performance verifications and validations performed on the Subject device (pump and administration tubing connected) and referred-to existing devices (K151650)". The provenance of the data is not specified in terms of country of origin. The studies are described as "bench performance verifications and validations," indicating controlled laboratory testing, and would be considered prospective for the specific tests performed on the Subject device to support this 510(k).

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

This information is not provided in the document. The document describes bench testing and compliance with standards for a medical device. Ground truth, in the context of expert review, is not applicable here as these are performance tests and biocompatibility assessments, not diagnostic or interpretive tasks.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes objective performance testing and compliance with standards, not a case-based review where expert adjudication would be needed.

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 information is not applicable. The device is an elastomeric infusion pump, a hardware device for fluid delivery, not a software device or an AI application that assists human readers.

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

This information is not applicable. The device is a physical medical device, an elastomeric infusion pump, not an algorithm.

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

The concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The ground truth for this device's performance is objective measurements against established engineering and biocompatibility standards (e.g., flow rate accuracy within specifications, confirmation of sterility, absence of cytotoxicity).

8. The Sample Size for the Training Set

This information is not applicable. This document describes the clearance of a physical medical device (an elastomeric infusion pump) based on engineering performance and biocompatibility testing, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable as there is no training set for this device.

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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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