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The Vial adapter with filter is intended for use by Healthcare Professionals for the transfer and mixing of drugs contained in vials within clinical, hospital, or healthcare environments.

The sterile device pierces the elastomeric septum of a drug vial with its integrated piercing spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the housing of the vial adapter. The connector on opposite side of the vented vial adapter is for the connection of a standard luer syringe for the reconstitution and removal of the contents of the drug vial.

The device is intended for use by Healthcare Professionals (HCPs) in a clinical, hospital, or other healthcare environment. The subject device is available by prescription use only and has no known contraindications.

The proposed vented vial adapter is available in 13mm, 20mm diameter to accommodate respective sizes of drug vials.

This document is a 510(k) Premarket Notification from the FDA regarding a Vial Adapter with Filter. It does not present information about an AI/ML medical device, but rather a physical medical device. Therefore, the request to describe acceptance criteria and a study proving an AI/ML device meets these criteria cannot be fully answered from the provided text.

The provided text details the regulatory approval process for a physical medical device (Vial Adapter with Filter) and its substantial equivalence to a predicate device. It focuses on the physical, chemical, and biological performance of the device, rather than the performance of an AI/ML algorithm.

However, I can extract the general types of performance criteria and testing mentioned for this physical device, and point out what information is missing to answer the AI/ML-specific questions.

Based on the provided text, here's what can be inferred about the physical device's "acceptance criteria" and "study" (non-AI/ML context), and why AI/ML specific questions cannot be answered:

Device: Vial Adapter with Filter (physical medical device)
Regulatory ID: K233284

1. A table of "Acceptance Criteria" and "Reported Device Performance":

For a physical device, acceptance criteria are typically defined by compliance with recognized standards and internal performance specifications. The "reported device performance" are the results of tests conducted against these standards/specifications.

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

• The document does not specify the sample sizes for any of the performance tests. It only states that "performance data were provided."
• Data Provenance: The manufacturer is Hangzhou Qiantang Longyue Biotechnology Co., LTD, based in China (implied by address and country code in phone number). The nature of the studies (retrospective/prospective) for a physical device's performance testing is implicitly "prospective" as new devices would be tested to these standards.

Regarding AI/ML specific questions (which are not applicable to this physical device):

The following points are not addressed in the provided document because it pertains to a physical medical device, not an AI/ML algorithm:

• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for a physical device is established through direct measurements, chemical analyses, and biological assays against established standards, not expert annotation of data.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a study design for AI-assisted diagnostic devices.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, ground truth is based on the results of validated physical, chemical, and biological tests according to international and internal standards (as listed in the table above).
• The sample size for the training set: Not applicable. This device is not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable. This device is not an AI/ML algorithm.

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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 Vial Adapter is indicated for the transfer of drugs contained in a vial.

The Vial Adapter (VA) 20mm is a single-use device that allows for the transfer of drugs contained in a vial. The device is a one-piece polycarbonate molded part with a standard female Luer port for the connection of a syringe. Puncturing the elastomeric closure of a drug vial is achieved by means of an integral plastic cannulated spike located in the center of the Vial Adapter component. The VA 20mm device is supplied with or without an inline filter, based on catalog number. The VA is sterilized utilizing gamma irradiation and is packaged in a Polyethylene Terephthalate Glycol (PETG) blister enclosure. The VA 20mm is packaged in either a Vial First (VF) or a Syringe First (SF) orientation. The device does not contain any medicinal substances or moving parts and is intended for use with standard drug vials having a neck diameter of 20mm.

The provided text describes a 510(k) premarket notification for a medical device called "Vial Adapter 20mm". This is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study designed to prove the device meets acceptance criteria in the typical academic or clinical trial sense.

Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable in this context, as they pertain to clinical or AI/algorithm performance studies. This document focuses on bench testing and regulatory comparisons.

Here's a breakdown of the information that can be extracted:

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

The document lists various performance tests conducted. For each test, the acceptance criteria are implicitly defined by the referenced standard or the success of the "in-house test method." The reported device performance is indicated by statements like "meets all applicable design and performance requirements," "conforms to applicable external and internal standards," and "successfully conducted." Specific numerical performance data or detailed results are not provided in this summary.

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: Not specified in the provided text.
• Data Provenance: The tests are "non-clinical performance data" and "bench performance tests." The manufacturing facility is in Ra'anana, Israel. The data would be prospective for the purpose of this submission (i.e., new testing done for this device).

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

• Not Applicable. This is not a study relying on expert interpretation for ground truth. It's an engineering and regulatory compliance submission based on physical and chemical testing.

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

• Not Applicable. No human adjudication of results is described for these bench tests; results are objective measurements against standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This device is a passive, non-electrical, non-software-enabled mechanical component (Vial Adapter), not an AI or imaging device that would involve human readers or AI assistance.

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

• Not Applicable. As mentioned above, this is a mechanical 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 outlined is defined by the specified international and in-house standards (e.g., ISO, USP, ASTM) that the device must comply with. For biocompatibility and sterilization, it's compliance with safety thresholds and validation standards.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning study, so there is no training set.

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

• Not Applicable. As there is no training set, this question is irrelevant.

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The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials.

The Vial Adapter consists of luer connector, housing and piercing spike, all of which are made of polycarbonate (PC). The sterile device pierces the elastomeric septum of a drug vial with its integrated piercing spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the housing of Vial Adapter. The connector on opposite side of the Vial Adapter is for the connection of a standard Luer needle free syringe for the reconstitution and removal of the contents of the drug vial.

The proposed Vial Adapter is available in 13mm, 20mm and 28mm diameter configurations to accommodate respective size of drug vials. The device is intended for use in healthcare facilities or in the home environment by the patient or care-giver to aid and support prescribed treatment and therapy.

This document is a 510(k) summary for a medical device (Vial Adapter) and describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. It does not describe a study involving an AI/Machine Learning (ML) algorithm or human readers.

Therefore, many of the requested details, such as those pertaining to AI/ML acceptance criteria, ground truth establishment for AI/ML, human reader studies (MRMC), number of experts for ground truth, and training/test set sample sizes for AI/ML models, are not applicable to this document.

However, I can extract information related to the performance testing of the device itself and its acceptance criteria, as well as the overall study design of the non-clinical testing.

Here's the information that can be extracted from the provided text:

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

The document lists various performance tests conducted. The acceptance criteria are implicitly "Pass" for each item, indicating that the device met the required standards for each test.

Biocompatibility Testing:

The following tests were performed with acceptance criteria implicitly being "conforming" to the respective ISO standards.

Sterilization and Shelf Life Testing:

The acceptance criterion for sterilization is a minimum SAL 10-6. The shelf life testing acceptance is that the device performs as intended over its 3-year proposed shelf life.

Simulated Transportation Testing:

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

• Test Set Sample Size: The document does not specify the exact sample size (the number of units tested) for each of the performance tests. It states that "The following data were provided in support of the substantial equivalence determination," indicating tests were conducted. Standard practice for such tests involves using a statistically relevant sample size, but the specific number is not disclosed in this document.
• Data Provenance: The tests were performed by the manufacturer, Shanghai Ling Fu Technology Co., Ltd. The document is silent on the specific country of origin for the data collection (beyond the manufacturer's location in China) or whether the data was retrospective or prospective. Given the nature of performance validation, it would be prospective testing of newly manufactured devices.

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

• Not Applicable. This document describes the device performance testing (e.g., sterilization, leakage, material properties) of a physical medical device (Vial Adapter), not a diagnostic or AI/ML-based device that requires expert interpretation for ground truth. The "ground truth" here is the physical measurement or outcome of the prescribed test.

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

• Not Applicable. As this is physical device performance testing, there is no "adjudication" in the sense of resolving discrepancies between human readers or AI outputs. The "adjudication" is inherently built into the testing protocol and measurement against a standard.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI/ML device. Therefore, no MRMC study with human readers was performed.

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

• No. This is not an AI/ML device. Therefore, no standalone algorithm performance was assessed.

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

• The "ground truth" for this device's testing is based on objective measurements and adherence to established engineering and medical device standards (e.g., ISO, ASTM, internal performance standards). For example, a "Pass" for Luer Connector leakage means it met the leakage requirements specified in ISO 80369-7. For biocompatibility, the ground truth is conformance to the biological response defined by ISO 10993 series.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device. There is no "training set" in this context.

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

• Not Applicable. This is not an AI/ML device. There is no "training set."

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The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials.

The Vial Adapter consists of luer connector, housing and piercing spike, all of which are made of polycarbonate (PC). The sterile device pierces the elastomeric septum of a drug vial with its integrated piercing spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the housing of Vial Adapter. The connector on opposite side of the Vial Adapter is for the connection of a standard Luer syringe for the reconstitution and removal of the contents of the drug vial. The proposed Vial Adapter is available in 13mm, 20mm and 28mm diameter to accommodate respective size of drug vials.

This is a 510(k) Premarket Notification for a medical device called "Vial Adapter". The document describes the device, its intended use, and the evidence provided to demonstrate its substantial equivalence to a legally marketed predicate device.

Here's the breakdown of the acceptance criteria and study information, as requested:

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

The document doesn't explicitly define "acceptance criteria" in a quantitative format for specific performance metrics in the way a clinical trial might, but rather lists various tests performed and reports a "Pass" result for each. These effectively serve as the acceptance criteria for ensuring the device's functional integrity and safety.

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

The document does not specify the sample size for individual performance tests (e.g., how many devices were tested for leakage or puncture force). The tests are described generally and report a "Pass" result. Data provenance is not explicitly stated beyond being "internal performance standards" and compliance with international standards (ISO, ASTM). It is implied these are lab-based tests, not human/patient data.

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 document describes non-clinical performance testing of a physical medical device. Ground truth, in the sense of expert consensus on medical conditions or image interpretation, is not relevant here. The "ground truth" for the performance tests would be the established scientific and engineering principles and standards against which the device's physical properties and functionality are measured.

4. Adjudication method for the test set:

This information is not applicable as the document describes non-clinical performance testing. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human readers.

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. This submission is for a physical medical device (Vial Adapter) and does not involve AI or any form of human-in-the-loop performance evaluation. A MRMC comparative effectiveness study would not be relevant in this context.

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 Vial Adapter; there is no algorithm or software component for which standalone performance would be relevant.

7. The type of ground truth used:

For the performance tests, the "ground truth" implicitly refers to:

• Established industry standards: Such as ISO 80369-7 for Luer connectors, ISO 11137-1/2 for sterilization, ISO 10993-1/4/5/10/11 for biocompatibility, and ISO 11607-1/2 and ASTM F1980-16 for shelf life and packaging.
• Internal performance standards: These are criteria developed by the manufacturer to ensure the device meets its design specifications, based on engineering principles and intended use.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML product.

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

This information is not applicable. Since there is no training set, there is no ground truth to establish for it.

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Transfer of drugs contained in a vial.

The Vented Vial Adapter HU, is a single use, sterile, non-pyrogenic medical device intended for the transfer of drugs contained in a vial. The device is intended for use in the preparation of drugs for home use, in hospitals, or outpatient nursing units as used/administered by the patient, caregiver, or Healthcare Professionals (HPCs). The subject device is by prescription use only and does not have contraindications. The device does not contain any medicinal substances and there are no additional accessories provided for use with the product. The device has a 3-year shelf life.

The Vented Vial Adapter HU allows for the connection of a standard accessory with a female Luer lock to be connected to a vial. The vial adapter body with tight grip hold ("wings") is intended to be attached to a standard drug vial with a neck diameter of 20mm. The device contains a piercing spike, cap with air filter, vent and a female Luer lock connector for attachment to a standard accessory. This dual lumen spike design facilitates rapid withdrawal of the drug/solution without pressurizing the vial by allowing inbound air aspiration through the air filter.

The materials of construction of the VVA HU body and cap are polycarbonate, with a 0.2um hydrophobic air filter comprised of 100% expanded PTFE membrane over non-woven polyester membrane support.

The provided document is a 510(k) premarket notification for a medical device called the "Vented Vial Adapter 20mm". This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than requiring a full clinical trial for safety and efficacy. Therefore, the information typically found in a study proving acceptance criteria for AI/ML devices, such as sample sizes for test sets, expert consensus, and comparative effectiveness studies, is not present here.

Instead, the document focuses on non-clinical performance data and biocompatibility testing to demonstrate that the new device meets relevant standards and is substantially equivalent to a previously cleared predicate device.

Here's an analysis of the provided information within the context of your request:

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

The document does not explicitly provide a table of acceptance criteria alongside reported device performance in the typical sense of a clinical study measuring a specific outcome (e.g., sensitivity, specificity for an AI diagnostic). Instead, it lists various performance tests conducted and indicates that the device "met the applicable design and performance requirements" and that "all product design requirements are verified."

Below is a table summarizing the types of tests conducted, which implicitly serve as criteria for performance, and the general statement of their success:

Regarding the other requested information:

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

  • The document does not specify sample sizes for each non-clinical performance test. It mentions that an "in-house test method" was often used.
  • The data provenance is not explicitly stated in terms of country of origin for the non-clinical tests. The manufacturer is West Pharma. Services IL, Ltd. in Ra'anana, Israel. The tests are non-clinical bench tests, not involving human data.

• 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 question is not applicable to a device submission of this nature. The "ground truth" for these tests are objective measurements against defined standards or specified functional parameters, not subjective expert interpretations.

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

  • This is not applicable. The performance testing is based on objective measurements against engineering and biological standards, not on human adjudication of subjective findings.

• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • No MRMC or comparative effectiveness study was done. This device is a passive medical device (a vial adapter), not an AI/ML diagnostic or assistive technology.

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

  • Not applicable, as this is not an AI/ML algorithm or software device.

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

  • For performance testing, the "ground truth" refers to the established specifications, international standards (e.g., ISO, BS EN ISO), or in-house defined criteria for mechanical properties, fluid dynamics, and biological safety. For biocompatibility and sterilization, the ground truth is defined by specific ISO standards and their associated pass/fail criteria (e.g., for cytotoxicity, sensitization, sterility assurance level).

• 8. The sample size for the training set:

  • Not applicable, as this is not an AI/ML device that requires training data.

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

  • Not applicable, as this is not an AI/ML device that requires a training set or associated ground truth.

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Vials Adapters Ø20 mm and Ø13mm are indicated for the transfer and mixing of drugs contained in vials.

The vial Adapters (VA) Ø20mm and Ø13mm are sterile polycarbonated devices which allows easy transfer of fluids into and out of drug vials. It incorporates a siliconized hollow spike for puncturing the stopper in the neck of a vial and a luer fitting that allows connection of a syringe on opposite side. After puncturing the hollow spike seats securely around the ferrule of drug vial utilizing the "legs" of the vial adapter. The opposite side of the vial adapter contains a Luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the contents of the drug vial. The proposed VA is available in two Ø20 mm and Ø13mm diameter to accommodate respective size of drug vials and is available in 3 configurations, no filter, in-line 5-micron or 15-micron disc filter sub- assembly for particulate filtration.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Vial Adapter Ø20 mm, Vial Adapter Ø13 mm". It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device.

However, the request asks for information relevant to the acceptance criteria and study proving a device meets those criteria for an AI/ML-enabled medical device. The document provided pertains to a traditional physical medical device (Vial Adapter) and, as explicitly stated in section "10. Clinical Testing", no clinical testing was required or performed, and the device is not an AI/ML-enabled device.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable to this document.

The document focuses on non-clinical performance testing (mechanical, flow, packaging, filtration, Luer Lock) and biocompatibility for a physical device.

N.B.: Since the core premise of the request (AI/ML device testing) is not met by the provided document, I cannot fulfill most of the specific numbered points. The below response will address only what is present in the document related to acceptance criteria and testing for this physical device.

Acceptance Criteria and Study for Vial Adapter (Physical Device)

The document describes non-clinical performance testing for the Vial Adapter to demonstrate substantial equivalence to a predicate device, rather than an AI/ML system's performance. The acceptance criteria for these tests are implicitly that the device performs as expected according to the specified standards or internal performance criteria.

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

The document provides a "Non-Clinical/Performance testing Summary" table listing various tests and the testing standards used. It then states in section "9. Summary of Non-Clinical Testing" and "Performance Testing Summary" that:

• "All testing met the required acceptance criteria."
• "The performance testing of the filters met required acceptable criteria."

The specific quantitative acceptance criteria values (e.g., minimum snapping force, maximum leak rate) and the reported device performance values (e.g., actual snapping force measured, actual leak rate) are not detailed in this summary document. Only the statement that they "met the required acceptance criteria" is provided.

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: Not specified in the provided summary for any of the non-clinical tests.
• Data Provenance: Not applicable in the context of this physical device's non-clinical performance testing. The tests are laboratory-based. The submitter is Avenir Performance Européenne Medical (APEM), located in France, suggesting the testing likely occurred in France or a European testing facility.

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

• Not applicable. This device is a physical product, not an AI/ML system requiring expert interpretation for ground truth.

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

• Not applicable. Ground truth and adjudication methods are not relevant for these non-clinical performance tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a physical device, and no AI/ML component is involved.

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

• No. This is a physical device, not an algorithm.

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

• Not applicable. The "ground truth" for a physical device's performance tests would be the established scientific/engineering standard for what constitutes acceptable performance (e.g., maximum allowable leak rate, minimum force for a secure connection). These are determined by regulatory standards (e.g., ISO) or internal specifications.

8. The sample size for the training set

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

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

• Not applicable. There is no training set.

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Vial Adapter Ø20mm are indicated for the transfer and mixing of drugs contained in vials.

The vial adapter (VA) are sterile polycarbonate molded devices that allows easy transfer of fluids into and out of drug vials. It incorporates a siliconized hollow spike for puncturing the stopper in the neck of the vial and a luer fitting that allows connection of a syringe on opposite side. After puncturing the hollow spike seats securely around the ferrule of drug vial utilizing the "legs" of the vial adapter. The opposite side of the vial adapter contains a luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the contents of the drug vial. The proposed VA is available in Ø20mm to accommodate Ø20 drug vials and is available in 3 configurations, no filter, inline 5-micron or 15-micron disc filter sub- assembly for particulate filtration.

Based on the provided document, the device in question is a "Vial Adapter Ø20 mm", which is a medical device for transferring and mixing drugs contained in vials. The document is a 510(k) summary submitted to the FDA for market clearance.

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing to demonstrate performance and substantial equivalence to a predicate device. There are no specific "acceptance criteria" presented in a table with numerical goals and actual performance values for each, but rather the document states that "All testing met the required acceptance criteria." The tests performed are primarily related to mechanical function, fluid dynamics, filter performance (for some configurations), and Luer lock characteristics.

Here is a table summarizing the tests, standards, and the general statement of performance:

Study Details:

This document describes a 510(k) submission for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy trials. The "study" here refers to the non-clinical testing performed to support this claim.

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

   • The document does not specify the exact sample sizes (N) for each of the non-clinical tests performed. It only lists the types of tests conducted.
   • Data Provenance: The submitter is Avenir Performance Européenne Medical (APEM), located in Château Landon, France. The testing standards are international (ISO, ASTM) and US-based (USP). The document does not explicitly state whether the data is retrospective or prospective, but for device testing, it would generally be prospective (tests conducted specifically for this submission).

2. 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 submission. The "ground truth" for the non-clinical performance of a device like a vial adapter is established through standardized engineering and laboratory testing protocols, not through expert consensus or clinical interpretation of data. The "acceptance criteria" are derived from these standards or internal specifications, not expert diagnostic agreement.

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

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, typically for establishing ground truth in image analysis or diagnostic tasks where human interpretation is involved and subject to variability. For engineering performance testing of a physical device, the outcome is measured against predefined physical/chemical standards, not adjudicated by experts.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This is not applicable. An MRMC study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a mechanical vial adapter, not an AI diagnostic tool.
   • The document explicitly states: "There was no clinical testing required to support the medical device as the Indications for Use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing."

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

   • This is not applicable. This device is a mechanical adapter, not an algorithm or AI. The tests performed are on the physical device itself.

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

   • The "ground truth" for this device's performance is based on established engineering and medical device standards (ISO, USP, ASTM) and internal performance specifications. For example, "Leak Spike/Vial" is tested against ISO 8871-5:2016(F), and "Particulate Testing" against USP . Biocompatibility is tested against ISO 10993. These standards define the acceptable range or limits for specific performance parameters.

7. The sample size for the training set:

   • This is not applicable. The concept of a "training set" is relevant for machine learning algorithms. This device is a mechanical medical device, not an AI.

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

   • This is not applicable for the same reason as point 7.

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