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The Pajunk Epidural MiniFilter NRFit (ISO80369-6) and Epidural MiniFilter LUER (ISO80369-7) is an anesthesia conduction filter. An anesthesia conduction filter is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid. The anaesthesia conduction filter is intended for use for patients that weigh 10kg and above.

The Filter is a Class II medical device substantially equivalent to the predicate device (K083451, Portex Epidural Filter) as defined in 21 CFR §868.5130, product code BSN. The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to re-packagers/ medical device manufacturers. The device is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid. It has a flat housing, Female Lock and male connector with rotating locking hub, and a Filter membrane. It is available with either NRFit™ Connector according to ISO 80369-6 or LUER-Connector according to ISO 80369-7.

This document is a 510(k) summary for the PAJUNK Epidural MiniFilter NRFit and LUER, an anesthesia conduction filter. It establishes substantial equivalence to a predicate device (Portex Epidural Filter, K083451). The information provided focuses on the comparative performance with a predicate device and performance against recognized standards, rather than a standalone clinical study with acceptance criteria in the context of diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text, with many fields being "Not Applicable" (N/A) due to the nature of this submission (device performance testing against engineering standards instead of a diagnostic AI study):

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

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 describes performance testing against engineering standards, not a clinical test set with patient data. Therefore, this information is Not Applicable (N/A) in the context of this submission. The testing was conducted to demonstrate compliance with ISO standards and internal protocols.

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 is Not Applicable (N/A). The device's performance is gauged against established engineering and biocompatibility standards, not against expert interpretation of clinical data.

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

This is Not Applicable (N/A) as no expert adjudication of clinical data was involved in this type of device submission.

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 is Not Applicable (N/A). This submission is for a physical medical device (anesthesia conduction filter) and does not involve AI or human reader interpretation.

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

This is Not Applicable (N/A). This submission is for a physical medical device and does not involve an algorithm.

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

The "ground truth" for this device's performance is defined by adherence to recognized international standards (e.g., ISO 80369 series for connectivity, ISO 11135 for sterilization, ISO 10993 for biocompatibility) and internal protocols for specific performance characteristics (Burst Pressure, Bubble Point, Leak Tightness, Flow Rate).

8. The sample size for the training set

This is Not Applicable (N/A). This submission is for a physical medical device and does not involve a training set for an algorithm.

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

This is Not Applicable (N/A). No training set for an algorithm was used.

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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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An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.

The Portex® Epidural Filter is a 0.2um (micron) filter used in epidural anesthesia for the filtration of aqueous drugs and is designed to help protect the patient from injected microorganisms or particulate matter. The Filter is comprised of a 0.2 um supported membrane enclosed in a modified acrylic leak proof transparent housing with male Lucr with a rotating Locking Hub and a female Luer Lock.

The filtration area is 5.25 cm², has a flow rate of ≥ 200ml/Min @ 45 psi and can withstand a pressure of ≥ 115 psi during bolus injections.

The priming volume of the filter is 0.8 ml and the hold up volume is 0.45 ml as determined by weight. The filter has a bubble point of ≥46psi. The filter has 100% bacterial retention.

This document describes the Portex® Epidural Filter, a 0.2um filter for epidural anesthesia. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical data.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • The document states "Data submitted" for various non-clinical tests (dimensional, flow rate, bubble point, ISO 594-1 and ISO 594-2 testing, bacterial retention).
   • Specific sample sizes for each test are not provided in this summary.
   • Data Provenance: The nature of these tests (e.g., laboratory testing of device samples) indicates prospective testing performed for the purpose of this submission, likely conducted by the manufacturer, Smiths Medical ASD, Inc., located in Keene, NH, USA. There is no mention of country of origin for the data itself, but it originates from the manufacturer's testing.

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

   • Not applicable. This device is a physical filter, and its performance is evaluated through objective, quantitative non-clinical laboratory tests (e.g., flow rate measurement, bacterial retention testing) based on established engineering and medical device standards (e.g., ISO standards). Expert consensus for "ground truth" as typically understood in diagnostic AI/image analysis is not relevant here. The ground truth for these tests is the objective measurement of the filter's physical and functional properties.

4. Adjudication Method for the Test Set:

   • Not applicable. As the "ground truth" is established via objective laboratory measurements, there is no need for expert adjudication.

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

   • No. This is a physical medical device (anesthesia conduction filter), not a diagnostic algorithm or image analysis tool, so MRMC studies involving human readers or AI assistance are not relevant. Clinical data was explicitly stated as "Not required."

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

   • Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

   • The ground truth for the performance was established through objective laboratory testing and measurements based on scientific and engineering principles (e.g., measuring flow rates, bubble points, determining bacterial retention through microbial challenge tests, and adherence to ISO standards for Luer fittings). Comparisons were made against the technological characteristics of a legally marketed predicate device and implied industry standards for filter performance.

8. The Sample Size for the Training Set:

   • Not applicable. This is a hardware device (filter), not a machine learning algorithm. Therefore, there is no "training set."

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

   • Not applicable. As there is no training set for a hardware device, this question is not relevant.

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Intended for use as a syringe filter to sterilize, ultraclean, or clarify low volume solutions in direct patient care and pharmacy admixture applications.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Millex®- HV, VV, GV Syringe Filter Unit." It is an approval for the device to be marketed, based on its substantial equivalence to a legally marketed predicate device.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) is a premarket notification process that demonstrates a new device is as safe and effective as a legally marketed device (predicate device). It primarily focuses on comparing the new device to an existing one. It does not typically include detailed performance study results, acceptance criteria, or ground truth establishment in the way that would be seen for a new, novel device requiring a PMA (Premarket Approval) or for AI/ML-driven devices.

Therefore, I cannot provide the requested information from this document. The document confirms that the device is intended for use as a syringe filter to sterilize, ultraclean, or clarify low volume solutions in direct patient care and pharmacy admixture applications, and that it has been deemed substantially equivalent to a predicate device.

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Intended for use as a syringe filter to sterilize or ultraclean low volume solutions in direct patient care and pharmacy admixture applications.

Millex- GP Sterilizing Filter Unit

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria for device performance, a study proving the device meets those criteria, or any details related to AI/algorithm performance.

Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment based on the provided text.

The document primarily focuses on:

• Device Name: Millex- GP Sterilizing Filter Unit
• Regulation Number/Name: 868.5130, Anesthesia Conduction Filter
• Regulatory Class: II
• Product Code: BSN
• Indications for Use: Intended for use as a syringe filter to sterilize or ultraclean low volume solutions in direct patient care and pharmacy admixture applications.
• FDA's finding: Substantially equivalent to legally marketed predicate devices.

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For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications.

Millex - MP Sterilizing Filter Unit

I am sorry, but based on the provided document excerpts, there is no information available regarding acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the "Millex® - MP Filter Unit," which primarily addresses the substantial equivalence of the device to a predicate device for its intended use.

The letter and the enclosed "Indications for Use Statement" do not contain details about:

• Specific performance metrics or acceptance criteria for the filter.
• Any performance study results (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
• Details about training sets or their ground truth establishment.

The document states the device's indications for use: "For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications." The FDA's clearance is based on its determination of substantial equivalence, which implies that the device performs as intended and is as safe and effective as a legally marketed predicate device, but the specific data proving this from a primary study are not included in these excerpts.

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The intended use is the same.

The revised Arbor Medical Syringefilter is as safe and effective as the original. The proposed plastic housings and membrane have passed Class VI testing as did the original housings and membrane. The proposed product is manufactured the same as the original. The method of sterilization is the same as the original version.

Given the input, there is no information about acceptance criteria, device performance, specific studies, sample sizes, expert involvement, or any of the detailed aspects requested in the prompt.

The provided text is a very brief "Summary of Safety and Effectiveness" for a device called "Arbor Medical Syringefilter" (K960928) from 1997. It makes general statements about the revised product being "as safe and effective as the original" and mentions some basic tests like "Class VI testing" and "HIMA Challenge" for a 0.2um filter. However, it does not provide any quantitative data, specific study designs, or detailed methodologies.

Therefore, I cannot fulfill your request based on the provided text. I can only report that:

• No acceptance criteria or reported device performance are present in the text.
• No studies proving the device meets acceptance criteria are described.
• No information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details is available in the provided document.

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