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The intended use of the i3 Membrane Water Filters i3 ONE, i3 TWO connect, i3 TWO direct is to filter EPA quality drinking water. The i3 Membrane Water Filters retain bacteria, which may aid in infection control. The filters produce water that is appropriate for washing and drinking, superficial wound cleansing (minor cuts, scrapes and abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The i3 Membrane Water Filters are not intended to provide water that can be used as a substitute for USP grade sterile water.

The i3 Point-of-Use Water Filters are supplied sterile and 100% integrity tested. The membrane within the filter cartridge is rated and validated at 0.2 µm to remove bacteria and particles in the water supply. This membrane reduces bacteria with more than 7 log levels per square centimeter filtration area. This represents the bacterial retention, the core element of infection prevention. Furthermore, a bacteriostatic additive is present in the outer housings parts of the filter, which prevents retrograde contamination of the filter. In addition, the inlet of the tap water filter is inclined to prevent the water from hitting the siphon. This also prevents retrograde contamination from the siphon, which would be caused by rising aerosols from the direct impact of the water jet. The Water Filters are designed to be used for a maximum of 50 days following initial connection. Suspending use does not extend filter life. The i3 ONE / i3 TWO connect / i3 TWO direct Water Filters are intended to be used within the healthcare environment such as hospitals, nursing homes, health care facilities or clinical settings where immunecompromised patients may be exposed to waterborne microorganisms originating from the water supply. The i3 Membrane Water Filters are disposable and designed for the use on tap or the shower.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the absence of information related to AI/ML devices as the text concerns water filters:

This document describes a medical device submission for water filters (i3 ONE, i3 TWO connect, i3 TWO direct), not an AI/ML device. Therefore, many of the requested categories related to AI/ML performance, such as test sets, ground truth establishment, expert adjudication, MRMC studies, standalone algorithm performance, and training set information, are not applicable and are absent from the provided text.

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

Since this is not an AI/ML device, the "acceptance criteria" are generally related to the physical, chemical, and microbiological performance of the water filters. The document describes several performance tests against established standards and criteria, rather than specific numerical "acceptance criteria" in a table format. However, the reported performance is presented in relation to the requirements for such devices.

The following questions are not applicable to the submitted device (water filter) as it is not an AI/ML product. The document does not contain information on these aspects.

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

   • This is not an AI/ML device. The "test set" refers to the tested filter samples, but specific sample sizes for each test are not detailed in the summary. The tests are non-clinical performance and lab-based.

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 an AI/ML device. Ground truth for the performance of a physical device like a water filter is established through standardized laboratory testing (e.g., CFU counts, integrity tests, material analysis) rather than expert consensus on medical images or patient data.

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

   • Not an AI/ML device. Adjudication methods are relevant for ambiguous cases in human interpretation, which is not applicable 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 an AI/ML device. MRMC studies are for evaluating diagnostic performance with human readers, typically in imaging.

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

   • Not an AI/ML device. This refers to algorithm-only performance, which isn't applicable.

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

   • For this device, "ground truth" is based on the results of standardized physico-chemical and microbiological laboratory tests (e.g., bacterial count reduction as per ASTM F 838 - 15a, material analysis for silver migration, physical stress tests).

8. The sample size for the training set

   • Not an AI/ML device. There is no training set mentioned or applicable.

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

   • Not an AI/ML device. Not applicable.

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The aqua-tools FILT'RAY 2G Disposable Water Filter is intended to filter EPA (Environmental Protection Agency in USA) quality drinking water. By retaining bacteria, the filters may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP grade sterile water.

The FILT'RAY 20 Disposable Water Filters are intended to produce bacteriologically controlled, purified water for general medical uses (e.g., washing of surgeon's hands, surgical instruments, and cleansing). These devices retain bacteria including opportunistic waterborne pathogenic microorganisms via a hollow fiber microfiltration technology with a corresponding pore size of 0.1 µm nominal / 0.2 µm absolute. This microfiltration technology ensures that the purified water will meets the criteria of bacteriologically controlled water that presents a higher bacteriological quality than the water of the distribution network by retaining bacteria, including Legionella spp., L. pneumophila. Pseudomonas aeruginosa and other opportunistic waterborne pathogenic microorganisms. Of note, the subject FILT'RAY 20 devices do not contain latex, nor tissues or by-product animal origins, nor derived of blood or any substance considered as a medicine. The subject FILT' RAY 20 devices are provided sterile and are designed to be used for 1 month up to 4 months after initial connection and depending on the specific model.

This document is a 510(k) submission for the aqua-tools FILT'RAY 2G Disposable Water Filters. It describes the device, its indications for use, and the performance data that demonstrates its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes (number of filters) used for each specific test described in the "Performance Data" section. However, it indicates that testing was conducted on "all tested filters" for microbial retention and "new filters and on aged filters" for bacteriostatic agent effectiveness. "All filter models" were subjected to flow rate testing.

The data provenance is from non-clinical performance testing (bench testing) and specifically refers to a "manufacture the housing components" for the bacteriostatic agent. The origin of the data is not specified by country, but it's likely from the manufacturer's internal testing or contract labs. It is retrospective in the sense that the testing was performed on the finished device before submission.

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

This section is not applicable to this document. The device in question is a water filter, and its performance criteria are objective, based on physical and microbiological measurements (e.g., bacterial retention, chemical concentration, temperature, pressure, flow rate). There is no "ground truth" established by human experts in the way that it would be for an AI diagnostic device evaluating medical images. The ground truth for performance claims is established by adherence to recognized standards (e.g., ASTM F838-15a, ISO 22196, ISO 11737-1, ISO 11137-1).

4. Adjudication Method for the Test Set

This section is not applicable. Since the performance of the water filter is assessed through objective laboratory tests against pre-defined standards, there is no need for expert adjudication of results.

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 section is not applicable. The device is a physical water filter, not an AI diagnostic device. Therefore, no MRMC study involving human readers and AI assistance was performed.

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

This section is not applicable. The device is a physical water filter and does not involve any algorithms or AI for its function.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this device is established through:

• Objective laboratory measurements and adherence to recognized international and national standards/protocols. Examples include:
  • Bacterial retention: ASTM F838-15a
  • Antibacterial activity: ISO 22196
  • Silver ion limits: World Health Organization (WHO) guidelines
  • Sterility: ISO 11737-1, 11737-2, ISO 11137-1, ISO 11137-2
  • Biocompatibility: FDA Guidance on the "Use of International Standard ISO 10993-1"

These standards define the expected performance metrics and the methods to verify them.

8. The Sample Size for the Training Set

This section is not applicable. As a physical water filter, this device does not use machine learning or AI, and therefore does not have a "training set" in the computational sense. The design and manufacturing processes are informed by engineering principles, materials science, and regulatory requirements.

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

This section is not applicable for the same reason as point 8.

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The Ecolab POU Water Filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. Ecolab POU Water Filters are suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta. The POU Filters are suitable for general point of use infection control for procedures such as superficial wound cleansing, cleaning of equipment, washing of surgeon's hands and bathing where the reduction of such microorganisms in the water is desired.

The Ecolab POU Filters are not intended for use in the production of USP sterile water for use in infusion, injection or production of fluids for use in dialysis treatments.

The Ecolab POU Water Filter is a disposable Polyethersulfone (PES) membrane filter sealed in a white polypropylene housing designed to be installed by facility personnel at point of use locations where the control of bacteria in EPA quality drinking water is desired for hand- washing, bathing, showering and instrument cleaning applications. These filters are designed to be installed as attachments to faucets or as a handheld shower head attached to a water outlet.

This document describes the 510(k) premarket notification for the Ecolab POU Water Filter, which is a medical device. The document focuses on demonstrating substantial equivalence to a predicate device, rather than a de novo approval or an AI/ML powered device. As such, many of the requested criteria related to AI/ML device testing (e.g., training set size, human-in-the-loop studies, multi-reader multi-case studies, expert adjudication) are not applicable to this submission.

However, I can extract the information relevant to this medical device's performance and the testing conducted to support its claims.

Device Name: Ecolab POU Water Filter

Regulation Number: 21 CFR § 876.5665 (Water Purification System for Hemodialysis)

Product Code: NHV

Predicate Device: Ecolab POU Water Filters, K173164

Purpose of Submission: To demonstrate substantial equivalence of new Ecolab POU Water Filter models with a longer useful life (up to 62 days) to previously cleared 31-day models.

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

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each test conducted (e.g., number of filters tested for bacterial retention, flow rates, or cyclic pulse testing). It refers to "All Ecolab POU Water Filters" undergoing the Brevundimons diminuta challenge.

• Data Provenance: The tests appear to be conducted by the manufacturer (Ecolab) in a laboratory setting, likely in the US, as the company is based in St. Paul, MN, USA. The data is prospective, generated specifically for this 510(k) submission to demonstrate the performance of the new filter models.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to the testing of a water filter's physical and microbial retention properties. The "ground truth" here is established by standardized test methods (e.g., ASTM F838-15) and laboratory measurements, not by human expert consensus or clinical interpretation.

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

Not applicable. This type of adjudication is relevant for studies involving human interpretation (e.g., radiologists interpreting medical images), not for objective physical and microbial performance testing of a water filter.

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 a water filter, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a physical water filter, not an algorithm. The performance is "standalone" in the sense that the filter itself is tested, but there is no algorithm involved.

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

The "ground truth" for the device's performance is established by:

• Standardized Test Methods: Specifically, ASTM F838-15 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration for microbial retention.
• Physical Measurements: Flow rates, pressure tolerance, and other engineering specifications.
• Sterilization and Packaging Standards: ISO 11137-1, ISO 11137-2, ISO 11607-1, ISO 11607-2.
• Biocompatibility Standards: ISO 10993-1.

These are objective, reproducible, and quantitative measurements based on established scientific and engineering principles, not subjective expert consensus or clinical outcomes data in the usual sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The ECOLAB POU Water Filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. ECOLAB POU Water Filters are suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta. The POU Filters are suitable for general point of use infection control for procedures such as superficial wound cleansing, cleaning of equipment, washing of surgeon's hands and bathing where the reduction of such microorganisms in the water is desired.

The POU Filters are not intended for use in the production of USP sterile water for use in infusion, injection of fluids for use in dialysis treatments.

The Ecolab POU Water Filter is a disposable Polyethersulfone (PES) membrane filter sealed in a white polypropylene housing designed to be installed by facility personnel at point of use locations where the control of bacteria in EPA quality drinking water is desired for hand- washing, bathing, showering and instrument cleaning applications. These filters are designed to be installed as attachments to faucets or as a handheld shower head attached to a water outlet.

The request is about a water filter, not an AI/ML medical device. Therefore, questions 2, 3, 4, 5, 8, and 9 are not applicable to this document. The document describes a traditional medical device (water filter) and its performance characteristics, not an algorithm, so terms like "ground truth," "training set," "test set," and "human-in-the-loop" performance are not relevant.

However, I can extract information related to acceptance criteria and performance studies for the Ecolab POU Water Filter based on the provided text.

Here's the information derived from the provided document, addressing the relevant parts of your request:

Device: Ecolab POU Water Filter (K173164)

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable as the device is a physical water filter, not an algorithm. The "performance" assessment is based on the filter's physical and biological filtration capabilities.

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

For this physical device, "ground truth" equates to laboratory testing against established standards and known microbial challenges.

• Microbial Retention: The "ground truth" was the Brevundimonas diminuta challenge ≥ 10^7^ organisms/cm², with the effectiveness judged by the absence of bacterial grow-through. This is a direct measurement of the device's capability.
• Sterility: The "ground truth" for sterility was verification against ISO 11137-1 and ISO 11137-2 standards for sterilization processes.
• Package Integrity: The "ground truth" for package integrity was verification against ISO 11607-1 and 11607-2 standards.
• Biocompatibility: The "ground truth" for biocompatibility was verification against ISO 10993 series standards and GLP 21 CFR Part 58 Regulations.

There are no concepts of "training sets" or "ground truth establishment" for a training set as would apply to machine learning models. The tests were performed to directly demonstrate the specified physical and biological performance characteristics of the manufactured device.

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The Pall® QPoint™ Water Filter Capsule is intended to be used within the healthcare environment such as hospitals, nursing homes, healthcare facilities or clinical setting where immunecompromised patients may be exposed to waterborne microorganisms originating from the water supply.

The Pall QPoint™ Water Filter Capsule is intended to filter EPA (Environmental Protection Agency in USA) quality drinking water. By retaining bacteria, fungi and protozoa the filters may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes or abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP grade sterile water.

The Pall QPoint™ Water Filter Capsule is a disposable filter capsule comprised of polyester, polypropylene, and polyethersulphone. The product is not made with natural rubber latex. The filter does not come into direct contact with patients, but indirect contact occurs as the water flowing through the filter is used by patients and by surgeons operating on patients.

Every device batch is integrity tested prior to release, and the filter capsules are supplied sterile. The Qpoint™ filter is a single-use device, i.e., it should not be removed and then re-used; however, a filter capsule can be used for up to two calendar months (maximum 62 days) following initial connection. A double layer Supor® membrane within the filter capsule is rated and validated at 0.2 µm to remove bacteria, fungi, protozoa and particles in the water supply. The filter membrane also has a high-technology integrated pre-filtration layer to provide extended use with higher dirt capacity for better flow rates.

The Filter Capsule is designed to be used with a fixed reusable Docking Station (i.e., Shower or Faucet Assembly, also called a Filter Capsule holder). The fitter capsule must be connected to a docking station in order to be used, but it can be exchanged when required without discarding the holder, which have separate reorder codes. The Docking Station need only be exchanged if obvious functional damage is found (e.g., a leak) or when aesthetic wear leads the user to prfer replacing this component.

The provided text is a 510(k) summary for the Pall® QPoint™ Water Filter Capsule device. It describes the device's intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text.

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

The document does not explicitly state "acceptance criteria" in a numerical or comparative table format for each performance test as would be typical for an AI/ML device. Instead, it describes various performance tests and states whether the device passed or performed adequately.

Here's an attempt to extract the implied "acceptance criteria" (which appear to be successful completion of the test) and the reported 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 does not specify exact "sample sizes" for the test sets in terms of number of filters or specific data points for each performance test. It refers to "testing" or "per ASTM F838-05," which would imply adherence to the standard's recommended sample sizes.

• Sample Size: Not explicitly stated as a number of devices for each test. Phrases like "All analysis membranes" or "All filter capsules tested" suggest that a sufficient number was used to meet the requirements of the standards cited (e.g., ASTM F838-05, ISO 11137, ISO 10993).
• Data Provenance: Not explicitly stated. The manufacturer is Pall International Sàrl, Fribourg, Switzerland, with a U.S. contact. The testing appears to be laboratory-based performance validation, likely conducted internally or by contract labs following international standards. It's not clinical data (retrospective or prospective) from specific countries, but rather engineering/microbiological performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device and study. This device is a water filter, and its performance is evaluated through physical, chemical, and microbiological testing (e.g., bacterial retention, flow rates, integrity tests). It does not involve human expert interpretation of medical images or other data that would require "ground truth" established by human experts like radiologists.

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

Not applicable. As the device is a physical water filter and the studies are performance tests (e.g., microbial challenges, material integrity), there is no "adjudication method" in the context of human interpretation or disagreement resolution for a test set.

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 pertains to AI/ML software devices that assist human readers (e.g., radiologists interpreting images). The Pall® QPoint™ Water Filter Capsule is a physical medical device, and its approval involves demonstrating its physical and biological performance against established standards, not a comparative effectiveness study involving human interpretation.

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

Not applicable. This also pertains to AI/ML algorithms. The performance studies described are for the physical filter itself, operating as a standalone filtration device.

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

The "ground truth" for the performance of this device is established through:

• Standardized Microbiological Challenge Testing: Using well-characterized reference organisms (e.g., Brevundimonas diminuta, Legionella pneumophila, Aspergillus fumigatus) at specified concentrations to challenge the filter and then quantitatively measuring the presence or absence of these organisms in the filtrate. This is a direct measurement based on established scientific principles.
• Physical and Chemical Measurement Standards: For flow rates, pressure ratings, temperature tolerances, and material integrity, the "ground truth" is based on precise measurements against design specifications and existing industry standards.
• ISO and ASTM Standards: Compliance with relevant International Organization for Standardization (ISO) and American Society for Testing and Materials (ASTM) standards (e.g., ASTM F838-05 for microbial retention, ISO 11137 for sterilization, ISO 10993 for biocompatibility) serves as the basis for "ground truth" for these tests.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the context of machine learning. The term "training set" refers to data used to train a statistical or machine learning model. This is a physical product.

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

Not applicable. As there is no AI/ML component or "training set," this question does not apply. The "ground truth" for the device's design and manufacturing is derived from engineering principles, material science, and microbiology, validated through the performance tests mentioned above.

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The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleaning of equipment used in medical procedures and washing of surgeon's hands. Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.

Not Found

The provided document is a 510(k) clearance letter for the HydraGuard 10" UltraFilter. It does not contain information about acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of clinical or diagnostic accuracy. Instead, it describes the indications for use and the regulatory classification of the device as a water purification system.

The "Indications for Use" section (page 2) describes what the device is intended for:

• To filter EPA quality drinking water.
• To retain bacteria, viruses, and endotoxin.
• To provide ultrapure water for patient washing and drinking, aiding in infection control.
• To produce water suitable for patient wound cleaning, cleaning of equipment used in medical procedures, and washing of surgeon's hands.

It explicitly states, "The filter is not intended to provide water that can be used as a substitute for USP sterile water."

Based on the provided text, the specific details regarding acceptance criteria, device performance metrics (other than the qualitative statements above), and information about a "study that proves the device meets the acceptance criteria" in the context of clinical effectiveness or diagnostic accuracy are not available. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on a detailed performance study with specific quantitative acceptance criteria as would be found for a diagnostic or AI-driven device.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert involvement, adjudication, MRMC studies, or ground truth establishment based solely on the text provided. This document is a regulatory approval letter, not a clinical study report.

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The NOSOGARD line of filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. NOSOGARD filters are available in models suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta and models for microbial removal equal to or greater than Legionella pneumophila. The NOSOGARD is suitable for general point of use infection control for procedures such as cleaning, rinsing of equipment, hand washing and bathing where the reduction of such microorganisms in the water is desired.
The Nosogard is not intended for use in the production of USP sterile water for use in infusion, injection of fluids for use in dialysis treatments.

Nosogard Filters are disposable Polyethersulfone (PES) membrane filters sealed in a polypropylene housing designed to be installed by facility personnel at point of use locations where the control of bacteria in the drinking water supply is desired for device cleaning, handwashing and bathing applications. These filters are designed to be installed as attachments to faucets or as a handheld shower head.

The Evoqua Water Technologies Nosogard Filters are intended as microbial retention filters for EPA quality drinking water sources, for general point-of-use infection control in procedures like cleaning, rinsing equipment, hand washing, and bathing. They are not intended for producing USP sterile water for infusion, injection, or dialysis treatments.

Here's an analysis of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally focused on bacterial retention (no grow-through), flow rate, structural integrity (housing burst pressure, pulse testing, drop testing), and shelf-life, along with biocompatibility and sterilization efficacy.

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

The document does not explicitly state the exact sample size for each test. However, it indicates that "All filter designs were placed in test assemblies and operated continuously for a period at least equal to the useful life of the model with repetitive inoculations of the subject microbe." This implies that a sufficient number of units representing each filter design were tested.

• Sample Size: Not explicitly quantified with a specific number for each test across all models. It implies a representative sample of "all filter designs."
• Data Provenance: The studies are described as "Non-Clinical Performance Testing" and "Bench Testing," which are laboratory-based studies conducted by the manufacturer (Evoqua Water Technologies, LLC.) to evaluate device performance against established standards. The data is retrospective in the sense that the results are being reported after the tests were conducted for the 510(k) submission. There is no mention of country of origin for the data, but it is submitted to the FDA in the USA.

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

This information is not applicable to this type of device. The ground truth for device performance, such as bacterial retention or physical integrity, is established through standardized laboratory testing methods (e.g., ASTM F838 for bacterial retention, pressure tests). These tests rely on objective measurements and established scientific protocols rather than expert consensus on interpretation of, for example, medical images.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of data by multiple human experts (e.g., radiologists interpreting images) to establish a consensus ground truth. For the laboratory-based performance testing of a water filter, the results are derived from objective measurements per defined testing protocols.

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. MRMC studies are used to evaluate AI systems that assist human readers in tasks like medical image interpretation. The Nosogard Filter is a physical water filtration device, not an AI-powered diagnostic tool. Therefore, human reader performance or AI assistance effects are irrelevant to its evaluation.

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

This information is not applicable. The Nosogard Filter is a physical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the performance evaluation of the Nosogard Filters is based on objective, quantifiable measurements derived from standardized laboratory bench testing.

• Bacterial Reduction: Measured according to ASTM F838 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration, using specific bacterial challenges (Brevundimonas diminuta, Legionella pneumophila) at defined concentrations. The "ground truth" is the quantitative reduction in colony-forming units (cfu) to demonstrate "no grow through" or a >10^7 reduction.
• Physical Integrity (Flow Rate, Burst Pressure, Pulse Testing, Drop Testing): The ground truth is adherence to specified physical parameters (e.g., specific flow rates, resisting a certain pressure, maintaining integrity after cycles/drops) as verified by direct measurement and observation under controlled conditions.
• Biocompatibility: Adherence to established standards (e.g., USP Class VI, ISO 10993) which define acceptable biological responses.
• Sterilization: Demonstrated efficacy according to ANSI/AAMI/ISO 11137-2:2012.
• Shelf Life: Demonstrated sterile barrier integrity for a specified period (3 years) based on ISO 11607:2009.

8. The Sample Size for the Training Set

This information is not applicable. The Nosogard Filter is not an AI or machine learning device that requires a "training set" for model development. Its performance is based on its physical design and material properties.

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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The Pall-Aquasafe™ Water Filter is intended to be used to filter EPA (Environmental Protection Agency in USA) quality drinking water. By retaining bacteria, the filters may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP grade sterile water.

The Pall-Aquasafe™ Water Filter is supplied sterile and integrity tested. The Supor® membrane within the filter cartridge is rated and validated at 0.2 micron to remove bacteria, protozoa, fungi and particles in the water supply. It is designed to be used for a maximum of one calendar month (31 days) following initial connection. Suspending use does not extend filter life. The Pall-Aquasafe Water Filter is intended to be used within the healthcare environment such as hospitals, nursing homes, health care facilities or clinical settings where immune-compromised patients may be exposed to waterborne microorganisms originating from the water supply.

The document provided describes the Pall-Aquasafe™ Water Filter and its performance testing. Below is an attempt to structure the information according to your request. However, please note that the document is a 510(k) summary for a medical device (water filter), not an AI/ML medical device. Therefore, many of the requested categories (e.g., test set, training set, number of experts, adjudication, MRMC study, standalone performance) are not applicable or cannot be fully answered as they relate to AI/ML model validation, which is not covered in this type of document for a physical filter.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated with a single number for a "test set" as is common for AI/ML studies. The testing described (microbial retention, shelf life, temperature/pressure, biocompatibility) involves different quantities of filter units and biological samples specific to each test. For instance, microbial retention validation using Brevundimonas diminuta refers to "All analysis membranes" being free of the organism, but the total number of membranes/filters tested is not given. Shelf life testing mentions "All filter capsules tested" but doesn't quantify them.
• Data Provenance: The studies are non-clinical (laboratory-based) performance tests conducted by the manufacturer (Pall Medical) to demonstrate the physical performance and safety of the filter. The data is prospective, generated specifically for this 510(k) submission. Country of origin of the testing is not specified, but the applicant's contact information is in Port Washington, NY, USA, while the submitter is in Fribourg, Switzerland, and Pall Medical is the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable as this is a physical medical device (water filter) and not an AI/ML diagnostic or predictive algorithm requiring expert interpretation of results for ground truth. Verification is based on objective laboratory measurements and standardized protocols (e.g., ASTM, HIMA, ISO).

4. Adjudication method for the test set

• Not applicable for a physical device. Test results are objective measurements (e.g., colony forming units, pressure readings, chemical analysis) rather than subjective assessments requiring adjudication.

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 a water filter, not an AI/ML system.

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

• Not applicable. This device is a water filter, not an AI/ML system. The performance evaluated is the standalone performance of the filter itself in retaining microorganisms and maintaining integrity under specified conditions.

7. The type of ground truth used

• The "ground truth" for this device's performance is established through:
  • Microbiological assays: Direct measurement of microbial (bacteria, fungi) presence/absence downstream of the filter.
  • Physical measurements: Pressure, temperature, flow rate, burst pressure, and integrity testing.
  • Chemical analysis: For bacteriostatic additive effectiveness and biocompatibility.
  • Standardized protocols: Adherence to established industry standards like ASTM F838-05, HIMA Guidance, and ISO 10993 for biocompatibility ensures that the 'ground truth' is based on scientifically accepted methods for evaluating filter performance and material safety.

8. The sample size for the training set

• Not applicable. As a physical medical device, there is no "training set" in the context of AI/ML model development.

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

• Not applicable. There is no AI/ML training set for this physical device.

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The S100 Point of Use Filter is intended to be used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP sterile water.

The S100 Point of Use Filter is a hollow fiber microfilter that retains bacteria from water used for washing and drinking.

Here's a breakdown of the acceptance criteria and study information for the Nephros S100 Point of Use Filter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document directly compares the S100 filter to the DSU-H and SSU-H Ultrafilters (K141731) as predicate devices. The "Acceptance Criteria" here are derived from the performance specifications of these predicate devices as presented in the "SUBJECT TO PREDCATE DEVICE COMPARISON TABLE." The S100's performance is considered "substantially equivalent" to these predicates.

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

The document does not explicitly state the sample size for the test set (number of S100 filters tested for performance). It only mentions "The S100 Point of Use Filter has been tested for performance."

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

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

This information is not provided in the document. The testing described for the filter's performance (Flow Rate, Simulated Use Life, Bacteria Challenge, Biocompatibility) are typically lab-based tests with objective measurements, not requiring expert consensus for "ground truth" in the way a clinical study for diagnosis might.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the performance tests described are objective, laboratory-based measurements rather than subjective assessments requiring adjudication.

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

An MRMC study is not applicable to this type of device. The S100 Point of Use Filter is a physical water filter, not an AI-powered diagnostic tool. The document describes performance testing for filtration capabilities.

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

This is not applicable to this device. As mentioned, the S100 Point of Use Filter is a physical filter, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the performance testing (e.g., bacteria removal, flow rate) would be established through laboratory-based measurements and validated testing methods. For example:

• Bacteria Removal: Direct enumeration of bacteria in the influent and effluent water (e.g., colony-forming units, turbidity measurements) using standard microbiological laboratory practices.
• Flow Rate: Direct measurement of water volume passed over time at a given pressure.
• Use Life: Controlled flow and pressure conditions over an extended period, with periodic performance checks for bacteria removal and flow.

8. The Sample Size for the Training Set

This is not applicable/provided. As the S100 Point of Use Filter is a physical device and not an AI/machine learning model, there is no "training set" in the computational sense.

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

This is not applicable as there is no training set for this type of device.

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The DSU-H and SSU-H Ultrafilters are intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP sterile water.

The DSU-H and SSU-H Ultrafilters are hollow fiber ultrafilters that retain bacteria, viruses, endotoxin and particulate from water used for washing and drinking.

The provided text describes a medical device, the DSU-H and SSU-H Ultrafilters, but it does not include information about AI algorithms, reader studies, ground truth establishment for AI, or training/test sets for AI. Therefore, I cannot fulfill most of your request regarding acceptance criteria and studies that prove the AI device meets acceptance criteria.

However, I can extract the acceptance criteria for the Ultrafilters themselves as stated in the submission documents, which are based on their filtration performance.

Here's what I can provide based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance (for the Ultrafilters)

The document primarily performs a substantial equivalence comparison to a predicate device (MainStream™ Water Purification Device – K012716) and refers to its own reference device (DSU and SSU Filters – K110285). The "acceptance criteria" can be inferred from the "Retention" section of the comparison table, where the device must demonstrate at least equivalent or superior reductions for various contaminants.

Explanation of Inference:
The submission states "Based on non-clinical performance testing, the DSU-H and SSU-H Ultrafilters have been found to be substantially equivalent to the predicate PrisMedical MainStream Filter (K012716)." For the characteristics where the subject device also performs, it must meet or exceed the predicate's performance. Furthermore, the subject device's performance aligns with its own reference device (K110285), which indicates its expected retention capabilities.

The following points cannot be answered as the provided text pertains to a physical water purification device and does not involve AI or a diagnostic algorithm evaluated through an AI specific study:

2. Sample size used for the test set and the data provenance: Not applicable. This is for a physical filter, not an AI algorithm. The performance data would come from laboratory testing of the filter medium with controlled contaminant challenges.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical filter's performance is established through standard microbiological and chemical testing, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance data presented (bacteria, virus, endotoxin reduction), the ground truth would be established by quantitative laboratory analysis of contaminant levels before and after filtration, using validated assays (e.g., CFU counts for bacteria, TCID50 for viruses, LAL test for endotoxin).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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