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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 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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