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Cathivex®-GV filter units are in-line 0.22um, sterilizing-grade filters for use with intravenously administered aqueous solutions. The filters remove particulates, microbial contamination, and air bubbles in applications where venting and low protein binding membranes are required or desired.

Cathivex®-GV filter units are sterile, non-pyrogenic, single-use filter devices intended for sterile filtration of aqueous solutions for intravenous infusions. Cathivex®-GV filter units are designed with a Female Luer Lok™ inlet and a Male Luer Lok™ outlet. Cathivex®-GV filter units contain a 0.22um Durapore® hydrophilic filter membrane constructed from polyvinylidene fluoride (PVDF) and a 0.03um hydrophobic vent membrane constructed from polytetrafluoroethylene (PTFE). The filter membrane is designed to remove particles, microorganisms, microprecipitates and undissolved powders which are larger than 0.22 um. The vent membrane is designed to prevent air locks and air emboli by automatically venting air introduced upstream. The filter housing material is molded from PVC.

The provided text describes the regulatory clearance of a medical device, the Cathivex®-GV Filter Units, not an AI/ML powered device. As such, the requested information regarding AI/ML-specific acceptance criteria, study methodologies, and expertise for ground truth is not applicable to this document. The document focuses on performance data for a non-AI medical device.

However, I can extract the information relevant to a traditional medical device's performance criteria and testing, as presented in the document:

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

The document states: "The following performance data were provided in support of the substantial equivalence determination. All specified performance requirements were met." It then lists the tests performed, implying that meeting the requirements of these tests constitutes the acceptance criteria. Specific numerical acceptance criteria values are not provided in this summary, only the categories of tests.

2. Sample size 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 the exact sample sizes for each test in the summary. It mentions that Merck Millipore Ltd. is located in Ireland, implying that the testing was conducted either there or overseen by them, but doesn't explicitly state the country of origin of the raw data. The studies are described as "bench testing" and "performance data provided in support of the substantial equivalence determination," which generally implies prospective testing conducted for regulatory submission.

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 as this is a physical medical device, not an AI/ML powered device where expert ground truth is typically established for image or data interpretation. The "ground truth" for this device would be defined by validated physical and biological measurement standards and laboratory procedures.

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

Not applicable as this is a physical medical device. Decisions would be based on objective passes/fails against pre-defined test specifications, not on expert adjudication of interpretations.

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 not an AI-powered device, so MRMC studies and human reader improvement with AI assistance are irrelevant.

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

Not applicable. This is not an AI-powered device. The device's performance (e.g., filtration efficacy, burst strength) is tested directly, not via an algorithm.

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

The "ground truth" for this device's performance testing would be based on established scientific and engineering standards, physical measurements, and biological assays. For instance:

• Bacterial Retention Test: Ground truth is defined by the sterility assurance level (SAL) of 10^-6, determined by standard microbiological methods.
• Filter Integrity/Bubble Point/Water Intrusion tests: Ground truth based on physical principles and instrument readings (e.g., pressure, flow rates) against pre-defined specifications.
• Biocompatibility: Ground truth from standardized assays (e.g., cytotoxicity assays, sensitization studies) following ISO 10993 standards and a comprehensive risk assessment.
• Endotoxin LAL Test: Ground truth from laboratory quantification of endotoxins using Limulus Amebocyte Lysate (LAL) reagents against established limits.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model, so there is no "training set."

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

Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment for a training set.

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Vented Millex®-GV filter units are syringe filters for sterilization of low volume aqueous solutions for direct patient injection, filtration of laboratory solutions, and filtration of clinical solutions where venting and low protein binding membrane are required or desired.

Cathivex®-GV filter units are in-line gravity fed filters for the sterilization of aqueous solutions for administration via the neuraxial route, filtration of laboratory solutions, and filtration of clinical solutions where venting and low protein binding membrane are required or desired.

Vented Millex®-GV and Cathivex®-GV filter units are sterile, non-pyrogenic, single-use filter devices intended for sterilizing aqueous solutions for medical applications. Vented Millex®-GV is designed with a Female Luer Lok™ inlet and a Male Luer slip outlet, and Cathivex®-GV is designed with a Female Luer Lok™ inlet and a Male Luer Lok™ Both devices contain a 0.22um Durapore® hydrophilic filter membrane outlet. constructed from polyvinylidene fluoride (PVDF) and a 0.03um hydrophobic vent membrane constructed from polytetrafluoroethylene (PTFE). The filter membrane is designed to remove particles, microorganisms, microprecipitates and undissolved powders which are larger than 0.22 um. The vent membrane is designed to prevent air locks by automatically venting air introduced upstream. The filter housing material is molded from PVC.

The provided document is a 510(k) summary for Vented Millex®-GV and Cathivex®-GV filter units, which are medical devices. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various tests conducted and generally states that "All specified performance requirements were met." However, it does not provide specific quantitative acceptance criteria or the numerical results (reported device performance) for each test. For example, for a "Flow Rate Test," it doesn't state what the acceptable flow rate range was or what the measured flow rate actually was.

Therefore, a table with specific acceptance criteria and reported device performance cannot be fully constructed from the provided text. The document summarizes the tests and their successful outcomes in a qualitative manner.

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

The document does not specify sample sizes used for the individual tests (e.g., how many units were subjected to the Burst Test or Bacterial Retention Test).

The data provenance is from Merck Millipore Ltd., located in Co. Cork, Ireland. The studies are non-clinical design verification and validation tests, meaning they were performed in a lab setting rather than on human subjects. This is retrospective in the sense that the testing was completed prior to submission for 510(k) clearance, but it's not data collected from prior clinical use.

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

This information is not applicable as the document describes non-clinical performance testing of a physical medical device (filter units) rather than an AI/ML-based device that requires expert-established ground truth for performance evaluation. The "ground truth" for these tests would be objective measurements against established engineering and sterilization standards.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to resolve discrepancies in expert opinions.

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 a physical filter unit, not an AI/ML system. Therefore, no MRMC study involving human readers or AI assistance would have been performed or would be relevant.

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 filter unit, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical testing would have been based on established engineering standards, laboratory measurement techniques, and regulatory guidelines for sterility, physical integrity, flow rates, and biocompatibility. For example:

• Bacterial Retention Test: Ground truth would be the known bacterial challenge concentration and the measured post-filtration concentration, compared against a sterility assurance level (SAL).
• Filter Integrity Test/Bubble Point Test: Ground truth would be the physical principles governing membrane pore size and integrity, measured by standardized pressure tests.
• Biocompatibility Testing: Ground truth would be established through compliance with ISO 10993-1, which guides biological evaluation of medical devices.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical filter unit, not a machine learning model. Therefore, no "training set" in the context of AI/ML was used.

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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