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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 (Bacterial Endotoxins Test)
  • USP (Transfusion and Infusion Assemblies and Similar Medical Devices)
  • USP (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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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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