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Chemfort® 28-day 20 mm Vial Adaptor is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during preparation, reconstitution, compounding and administration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

Chemfort® 28-day 20 mm Vial Adaptor prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 28 days or 10 activations.

The Chemfort® Closed System Transfer Device (CSTD) is a system of components that allows the reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion solution container. The Chemfort® CSTD prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter.

The components of the predicate Chemfort® CSTD system are:

• Vial Adaptor 20 mm with 13 mm Vial Converter
• Vial Adaptor 28 mm
• Vial Adaptor 32 mm
• Syringe Adaptor
• Syringe Adaptor Lock
• Luer Lock Adaptor
• Bag Adaptor SP

Each of the Chemfort® system components is available separately.

This submission introduces a new version of the 20mm Vial Adaptor to the Chemfort® CSTD system, called the Chemfort® 28-day 20 mm Vial Adaptor, as a range extension. This new Vial Adaptor differs from the predicate Vial Adaptor only with respect to the usage time limitation, which is extended from 7 to 28 days, but with the same limit of 10 activations. This change is reflected in the Indications for Use statement and the device labeling.

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Chemfort® is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during administration and preparation, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort® prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

The Chemfort® Closed System Transfer Device (CSTD) is developed by Simplivia Healthcare Ltd. The system is used by pharmacists, nurses or other healthcare professionals to prepare drugs, including cytotoxic drugs, and allow the safe reconstitution of powder and liquid drugs transfer for infusion containers (infusion bags, semi-rigid bottles, and collapsible plastic containers), injection, or administration. It is supplied sterile with a sterility assurance level (SAL) of 10-6.

The Chemfort® Female Luer Lock Adaptor is part of the Chemfort® system of devices. The Chemfort® Female Luer Lock Adaptor is intended for the safe drug transfer from one syringe to another and allows closed access via Chemfort® devices to any standard male Luer connection (see below in more details).

1. Syringe to Syringe connection:
   The Chemfort® Female Luer Lock Adaptor is connected to the Chemfort® Luer Lock Adaptor. The Chemfort® Luer Lock Adaptor port is connected to an empty / saline containing syringe (syringe "A"), equipped with a Chemfort® Syringe Adaptor or Chemfort® Syringe Adaptor Lock. A drug containing syringe (syringe "B"), equipped with a Chemfort® Syringe Adaptor or Chemfort® Syringe Adaptor Lock is connected to the Chemfort® Female Luer Lock Adaptor. This assembly of devices allows drug transfer from one syringe "A" to the other, syringe "B", for drug dilution (if syringe "A" contains saline) or drug dosage (if syringe "A" is empty). This procedure allows safe drug transfer from one syringe to another. The drug in Syringe "A" can then be injected to an intravenous (IV) bag through the Chemfort® spike or in a bolus through another Chemfort® Luer Lock Adaptor connected to a Y-site on an IV set.

Note that this procedure also involves the Chemfort® Vial Adaptor to allow to withdraw the drug from the drug vial to syringe "B".

2. Connection to IV sets:
   The Chemfort® Female Luer Lock Adaptor is connected to an IV set through the luer lock connection (proximal end or infusion line). The Chemfort® port can then connect to one of the Chemfort® Closed Administration (CADM) IV sets. This setup transfers an open IV set connection to a closed connection.

The Chemfort® Female Luer Lock Adaptor can be in contact with concentrated or diluted drugs.

The Chemfort® Female Luer Lock Adaptor is a single-use device intended for use on adults, children and infants.

The provided FDA 510(k) clearance letter and supporting documentation (Chemfort® Female Luer Lock Adaptor 510(k) Summary) describe the performance testing and acceptance criteria for a physical medical device, not a software or AI-driven diagnostic device.

Therefore, many of the requested categories in your prompt (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established, standalone performance) are not applicable to this type of device submission. These categories are typically relevant for AI/ML-based diagnostic devices where performance data relies heavily on expert annotations, comparative effectiveness studies involving human readers, and distinct training/test datasets.

However, I can extract the relevant acceptance criteria and performance data for the Chemfort® Female Luer Lock Adaptor based on the provided document.

Acceptance Criteria and Device Performance for Chemfort® Female Luer Lock Adaptor

This document outlines the performance data and acceptance criteria for the Chemfort® Female Luer Lock Adaptor, a physical medical device. The study performed demonstrates the device's adherence to established safety and performance standards for intravascular administration sets.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on established international standards and internal validation procedures for medical devices of this type. The "Results" column from the provided Table 2 in the 510(k) summary indicates that all tests met their acceptance criteria, demonstrating the device's compliance.

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

• Sample Size: The document does not explicitly state the numerical sample sizes for each performance test (e.g., number of units tested for particulate analysis, bidirectional flow, etc.). However, it indicates that "Simplivia conducted several performance tests to demonstrate that the Chemfort® Female Luer Lock Adaptor is safe and effective..." implying a sufficient number of samples were tested to meet the requirements of the listed standards and internal procedures.
• Data Provenance: The tests were conducted by Simplivia Healthcare LTD. (an Israeli company) for regulatory submission to the FDA. The data provenance is laboratory testing performed by the manufacturer, rather than clinical data from human subjects. The tests are prospective in nature, as they involve testing newly manufactured devices against predetermined specifications.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This question is not applicable to the type of device being cleared. The "ground truth" for the performance of a physical device like the Chemfort® Female Luer Lock Adaptor is established by adherence to validated engineering specifications, material properties, and functionality defined by international standards (e.g., ISO, USP) and internal quality control procedures. It does not involve expert interpretations of images or signals for diagnostic purposes.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert annotations or interpretations, typically in studies involving human readers or AI outputs for diagnostic tasks. For a physical device, performance is evaluated against objective, measurable criteria with pass/fail outcomes, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are specific to evaluating the diagnostic performance of medical imaging devices or AI algorithms, often comparing human reader performance with and without AI assistance across multiple cases. This device is an intravascular administration set, not an imaging or diagnostic AI device.

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

This question is not applicable. There is no "algorithm" to be evaluated in a standalone manner for this physical device. Its function is mechanical and fluidic.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications, material science, and compliance with recognized international standards (e.g., ISO 80369-7, ISO 10993 series, USP monographs). These standards define the acceptable performance characteristics, physical properties, and safety profiles for devices of this type. For example, for "Luer Test," the ground truth is defined by the dimensional and functional requirements of ISO 80369-7:2021. For "Biocompatibility," the ground truth is defined by the specific tests and acceptance criteria within the ISO 10993 series.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical product, not an AI/ML model that requires a training set.

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

This question is not applicable for the same reason as #8.

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Chemfort® Catheter Adaptor is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during administration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort® Catheter Adaptor prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

The Chemfort® Catheter Adaptor enables drug transfer to the catheter, thus allowing drug administration to the patient's urinary bladder. The use of elastomeric seals of the Chemfort® Catheter Adaptor prevents hazardous drug contamination of healthcare professionals, the patient, and the environment.

The Chemfort® Catheter Adaptor is an addition to the cleared Chemfort® system (K192866). The Catheter Adaptor provides closed system protection during the following procedures:

• a) Drug transfer from a standard luer lock syringe to the Catheter Adaptor through the Chemfort® Syringe Adaptor (K192866).
• b) Closed system drug administration to the urinary bladder, through a urinary catheter. The Catheter Adaptor fits a wide range of standard catheter sizes and converts an open catheter connection to a closed Chemfort® connection.

The Chemfort® Catheter Adaptor allows the healthcare professional to have the option for safe drug administration to the urinary catheter and safe disconnection of the Chemfort® Syringe Adaptor (K192866) from the patient's urinary catheter.

The provided text describes a medical device submission (K231286) for the Chemfort® Catheter Adaptor. This document is a 510(k) summary submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, the provided text does NOT contain information about acceptance criteria for a study, nor does it detail a study that proves the device meets specific performance criteria in the way requested.

The text mentions several performance tests were conducted to demonstrate compliance with standards and intended function, but it does not present the acceptance criteria for these tests or the reported device performance against those criteria. It lists various ISO standards and USP tests that the device complies with, but this is different from presenting specific acceptance criteria and detailed study results.

Therefore, I cannot fulfill all parts of your request based on the provided text. I can, however, extract relevant information about the device and the nature of its evaluation.

Here's what can be extracted based on the provided document:

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

• Cannot be provided. The document states that "Simplivia Healthcare conducted several performance tests to demonstrate that the Chemfort® Catheter Adaptor complies with the following standards and that it functions as intended." However, it does not present a table with specific acceptance criteria (e.g., "Drug leakage must be less than X mg") and the quantitative reported device performance for these criteria. It only lists the standards against which various tests were performed (e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization, USP tests for endotoxins and particulate matter).

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

• Cannot be provided definitively. The document mentions "performance tests" but does not detail their methodology, including sample sizes, nor does it specify the provenance (country of origin, retrospective/prospective nature) of the data from these tests.

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 / Cannot be provided. This type of information is relevant for studies involving human interpretation (e.g., diagnostic imaging studies). The Chemfort® Catheter Adaptor is a physical medical device (Closed System Transfer Device - CSTD), and its performance evaluation would typically involve laboratory testing rather than expert-established ground truth on diagnostic cases.

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

• Not applicable / Cannot be provided. As above, adjudication methods are typically used in studies where human readers are involved in making subjective assessments or interpretations, which is not the nature of the device testing described here.

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 not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

• Not applicable. This device is not an algorithm. Its "performance" refers to its mechanical and biological integrity, and its ability to prevent contamination and drug release.

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

• Not applicable / Implicitly based on technical standards. For a physical device like this, "ground truth" refers to meeting established engineering, chemical, and biological specifications defined by standards (e.g., a device must be sterile, meaning it passes a sterility test; it must not leak hazardous drugs, meaning it passes a containment test). The document indicates compliance with various ISO and USP standards which define quantitative and qualitative benchmarks for device performance.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that requires a training set.

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

• Not applicable. This device is not an AI algorithm that requires a training set.

Summary of what the document does provide regarding the device's evaluation:

The document states that the Chemfort® Catheter Adaptor has similar indications for use, technological characteristics, and principles of operation as its predicate device, Tevadaptor® Catheter Adaptor (K180489).

It highlights one specific difference in claims:

• Predicate Device (Tevadaptor®): Tested and proved to prevent contaminants from entering the drug or fluid path for up to 3 days.
• Proposed Device (Chemfort® Catheter Adaptor): Has been tested and approved for 7 days regarding the prevention of microbial and airborne contaminants into the drug or fluid path.

The document lists the following standards against which performance tests were conducted (but does not provide the specific acceptance criteria or results for each):

• Biocompatibility:
  • ISO 10993-1:2018 (Biological Evaluation - General)
  • ISO 10993-4:2017 (Interactions with blood)
  • ISO 10993-5:2009 (In vitro cytotoxicity)
  • ISO 10993-10:2021 (Irritation and skin sensitization)
  • ISO 10993-11:2017 (Systemic toxicity)
  • ISO 10993-18:2020 (Chemical characterization)
• Sterilization:
  • ISO 10993-7:2008/Amd 1:2019 (Ethylene oxide sterilization residuals)
  • ISO 11135:2014 + Amd.1:2018 (Ethylene oxide sterilization requirements)
• Packaging:
  • ISO 11607-1:2019 (Packaging for terminally sterilized medical devices)
• Risk Management:
  • ISO 14971:2019 (Application of risk management to medical devices)
• Pharmacopeial Tests:
  • USP <85> (Bacterial Endotoxins Test)
  • USP <161> (Transfusion and Infusion Assemblies and Similar Medical Devices)
  • USP <788> (Particulate Matter in Injections)

The conclusion is that "Performance data demonstrated that the Chemfort® Catheter Adaptor is as safe and as effective as its predicate and does not raise any new safety and effectiveness issues." However, the specifics of these performance data (acceptance criteria, methodologies, sample sizes, and quantitative results) are not provided in this 510(k) summary.

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The OnGuard®2 Chemfort™ Closed Administration is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during administration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

OnGuard®2 Chemfort™ Closed Administration prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

The OnGuard®2 Chemfort™ Closed Administration (CADM) devices allow drug transfer to the IV bag and drug administration to the patient. The use of elastomeric seals in CADM prevents hazardous drugs contamination of healthcare professionals, the patient and the environment.

The OnGuard®2 Chemfort™ Closed Administration contains four devices that connect between infusion containers and primary sets:

• Bag Adaptor Chemfort™ Port (BACP)
• Closed Y Inline Set (Y-Set)
• Closed IV Secondary Set (Secondary)
• Closed Adaptor Spike Port (CASP)

CADM devices are an addition to the cleared Chemfort™ system (K192866). CADM provides closed system protection during the following procedures:

• 1. Drug transfer to a container (e.g. IV bag) through the Chemfort™ Syringe Adaptor (K192866) and CADM Bag Adaptor Chemfort™ Port (BACP).
• 2. Drug administration, with one of the CADM sets after it is attached to the BACP and creates a closed system.

The provided text describes the OnGuard®2 Chemfort™ Closed Administration (CADM) device, a single-use, sterile Closed System Transfer Device (CSTD). It focuses on demonstrating its substantial equivalence to a predicate device (K192866) by comparing indications for use, technological characteristics, and performance data.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" versus "reported device performance." Instead, it lists the performance tests conducted and states that the device "comply with the following standards and that they function as intended" or "met the USP acceptance criteria," or "All tests passed according to the predetermined acceptance criteria." It implies compliance rather than detailing specific numerical criteria and results for each test.

However, based on the Performance Data and Biocompatibility sections, we can infer the tested areas and the general outcome:

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

• Sample Size for Test Set: The document explicitly mentions a sample size only for the Bacterial Endotoxins Test, where "10 samples (in pool)" were used. For other performance tests and biocompatibility, specific sample sizes are not provided in the summary.
• Data Provenance: The document does not specify the country of origin of the data. It's a regulatory submission from Simplivia Healthcare LTD. located in Israel. The studies appear to be device performance and laboratory tests rather than clinical studies on human subjects, so the "retrospective or prospective" designation is not directly applicable in the typical sense of clinical data. These are prospective engineering and biological tests conducted for regulatory compliance.

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

This information is not applicable to the type of studies described. The "ground truth" for these tests (e.g., whether a device leaks, its tensile strength, or if it is cytotoxic) is established by adherence to recognized international standards (ISO, USP, ASTM) and validated laboratory methods, not by expert consensus in interpreting complex data like medical images.

4. Adjudication Method for the Test Set

Not applicable. As noted above, these are objective performance and laboratory tests against predefined standards, not subjective assessments requiring adjudication.

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

No. The document describes laboratory and engineering performance tests of a medical device, not a comparative effectiveness study involving human readers or AI algorithms.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a physical medical device (Closed System Transfer Device), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable.

7. Type of Ground Truth Used

The ground truth used for these studies is defined by:

• International Standards: e.g., ISO 8536-4, ISO 80369-7, ISO 10993-1, ISO 10993-7, ISO 14971.
• Pharmacopeial Standards: e.g., USP <788>.
• Industry Standards: e.g., ASTM F1980-16, ASTM F88/F88-15, ASTM F1929-15, ISTA 3A.
• Predetermined Acceptance Criteria: The document frequently refers to tests passing "according to the predetermined acceptance criteria," implying established limits or thresholds for each test based on these standards.

8. Sample Size for the Training Set

Not applicable. This document is about a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. As above, there is no AI algorithm training set mentioned.

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Tevadaptor® is a Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during preparation, compounding and administration, minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system.

The I.V. Administration set is comprised of various components such as: Spike, tubing, clamp, ULTRASITE® needless injection site (Y-site), 'twist-off' and Luer connection.

The I.V. Administration set is part of the Tevadaptor® closed system transfer device (CSTD) and is intended to interact with Tevadaptor® and/or Chemfort™ system's Syringe Adaptor (SA), Syringe Adaptor Lock (SAL) and Luer Lock Adaptor (LLA) components that were cleared under K192866. The Tevadaptor® and Chemfort™ CSTD are intended to protect the healthcare professional, the patient and the environment during preparation, reconstitution, compounding and administration of hazardous drugs in the form of liquid, vapor or aerosol.

The Tevadaptor® and/or Chemfort™ SA connects to the Tevadaptor® port located on the I.V. Administration set's Spike component. After the connection is made, a fluid path is opened which allows to inject of the drug to the patient's IV bag. The Tevadaptor® and/or Chemfort™ LLA connects to any female luer connection located on the I.V. Administration set to create a Tevadaptor® port connection that enables the Tevadaptor® and/or Chemfort™ SA to administer the drug directly to the patient.

The purpose of this submission is to add five new designs of I.V. Administration Sets to the Tevadaptor® and/or Chemfort™ Closed System Transfer Device (CSTD) that was cleared for sale in the US under K192866, the descriptions of the added sets, subject of this submission:

• Tevadaptor® IV Secondary Safety Set with ULTRASITE®
• Tevadaptor® IV Secondary Safety Set .
• Tevadaptor® Bag Adaptor LL ●
• Tevadaptor® Bag Adaptor LL with ULTRASITE® .
• . Tevadaptor® Bag Adaptor SP with ULTRASITE®

All of the components used in the five new I.V. Administration Sets were previously used in the predicate device cleared under K121269, except for the Spike component which has been redesigned in comparison to the predicate's Spike component that was cleared under K121269. The redesigned Spike component is substantially equivalent to the reference device, Chemfort™ Bag Adaptor SP's Spike component, which was cleared under K192866. The Spike component of both the IV Administration Set and of the reference device are identical in terms of design and raw material.

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device. Instead, it is a 510(k) premarket notification summary for an "Intravascular Administration Set" (TEVADAPTOR Bag Adaptor) that has an "ONB" product code, indicating it is a Closed System Transfer Device (CSTD).

The document mentions that the proposed device (TEVADAPTOR Bag Adaptor LL, etc.) was tested according to NIOSH guidelines and "proved to be a CSTD." This is stated as a comparison point to the predicate device, which was cleared before the NIOSH draft protocol for CSTD was issued.

Therefore, I cannot extract the requested information, such as:

1. Table of acceptance criteria and reported device performance: Not present for an AI/ML device. The document lists performance tests against ISO standards for medical devices and biocompatibility.
2. Sample size used for the test set and data provenance: Not mentioned.
3. Number of experts used to establish ground truth and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. MRMC comparative effectiveness study effect size: Not mentioned.
6. Standalone (algorithm only) performance: Not applicable as it's not an AI/ML device.
7. Type of ground truth used: Not applicable as it's not an AI/ML device.
8. Sample size for the training set: Not applicable as it's not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable as it's not an AI/ML device.

The document discusses the substantial equivalence of the proposed device to a predicate device (K121269) based on intended use, technological characteristics, and principles of operation, and compliance with various ISO standards for medical devices, specifically for an intravenous administration set. The key change highlighted is that the proposed device now meets the NIOSH and ISOPP definition of a CSTD.

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Chemfort™ is a Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during preparation, reconstitution, compounding and administration, minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
Chemfort™ prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

The Chemfort™ Closed System Transfer Device (CSTD) is a system of components that allows the reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion container. The Chemfort™ CSTD prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron.

The components of the Chemfort™ CSTD system are:

• . Vial Adaptor 20 mm with 13 mm Vial Converter
• Vial Adaptor 28 mm
• Vial Adaptor 32 mm
• Syringe Adaptor
• Syringe Adaptor Lock
• Luer Lock Adaptor
• Bag Adaptor SP

Each of the Chemfort™ system components is available separately.

The acceptance criteria for the Chemfort™ Closed System Transfer Device (CSTD) and the study that proves it meets these criteria are detailed through various non-clinical performance tests. The device aims to mechanically prohibit the release of drugs (including antineoplastic and hazardous drugs) in vapor, aerosol, or liquid form during preparation, compounding, and administration, thereby minimizing exposure to hazardous drugs. It also prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted to demonstrate equivalence with the predicate device (TEVADAPTOR®) and to support the new indication concerning microbial ingress. While specific quantitative acceptance criteria are not explicitly detailed in the provided text for each test, the general reporting indicates that the device "successfully passed" or "has been carried out" with tests demonstrating equivalence or functionality. The conclusion states that the device "does not raise new types of safety and effectiveness questions" and is "substantially equivalent" to the predicate.

Here's a table summarizing the tests and the reported performance:

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

The document does not specify the exact sample sizes used for each test. It generally refers to "bench testing" and "biocompatibility tests" being "carried out on the Chemfort™ system components." The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given that it's bench testing for a medical device submission, it would typically be prospective testing conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention the use of experts or their qualifications for establishing ground truth for the test set. All mentioned studies are non-clinical bench tests performed according to recognized standards (e.g., ISO, USP, ASTM). These types of tests typically rely on standardized protocols and quantitative measurements rather than expert consensus on subjective evaluations.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned. This is consistent with non-clinical performance testing where results are objective measurements against predefined specifications, rather than subjective interpretations requiring adjudication.

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

A MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI/radiology devices where human interpretation is a key component. The Chemfort™ CSTD is a mechanical device, and its performance is evaluated through bench testing against physical and chemical criteria.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study for an algorithm was not conducted as the Chemfort™ CSTD is a mechanical medical device, not an AI/software device. The performance data presented are for the device itself.

7. Type of Ground Truth Used:

The ground truth for the device's performance is based on objective measurements and results from standardized non-clinical bench tests. These tests evaluate physical properties, chemical integrity, microbial barrier efficacy, and other performance characteristics against established industry standards (e.g., ISO, USP, ASTM) and the specifications of the predicate device. For example, "microbial ingress tests (7 days)" would confirm the device's ability to prevent contamination, which is a measurable outcome.

8. Sample Size for the Training Set:

This question is not applicable. The Chemfort™ CSTD is a mechanical device, not an AI or machine learning model that requires a training set.

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

This question is not applicable, as there is no training set for a mechanical device.

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