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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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