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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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Microbial Retention	Bacterial Retention: ≥ 1 x 10^7 CFU/cm^2 of effective filtration area of Brevundimonas diminuta.	> 10^7 CFU/cm^2 and > 10^10 CFU/device. All analysis membranes were found to be free of the test organism (Brevundimonas diminuta).
	Bacterial Retention (Intermittent Use): Retention of Brevundimonas diminuta during typical intermittent use for a period of 35 days (using methods from ASTM F838-05 and HIMA Guidance).	All analysis membranes were found to be free of the test organism.
	Fungi Retention: Capable of retaining fungi during a period of one calendar month (maximum 31 days) when challenged with Aspergillus fumigatus.	Less than 1 CFU/500mL were recovered downstream of the filter after challenges on Day 1 (1 x 10^6 CFU), Day 15 (2 x 10^6 CFU), and Day 36 (2.4 x 10^6 CFU).
Physical Performance	Maximum Operating Temperature and Pressure: Maintain integrity when operating at a continuous maximum temperature of 60 ℃ combined with a maximum inlet pressure of 5 bar (approx. 72.5 psi). Withstand 70 ℃ for a cumulative period of 30 minutes.	Tested at 60 ℃ and 5 bar. Also tested to withstand 70 ℃ for a cumulative period of 30 minutes over the life of the filter. Filters were integrity tested and demonstrated to maintain their integrity over their simulated service life.
	Flow Rate: Documented performance at various water pressures.	Flow rate tested at water pressures of 15, 25, 45, 60, and 75 psi. (Specific flow rates were not reported in detail but stated as "Per individual model specification" which implies meeting pre-defined specifications).
	Shelf Life: Maintain integrity of packaging and filter function over specified real-time and accelerated aging periods, including bacterial challenge and burst pressure.	Three-year real-time and five-year accelerated aging Shelf Life Testing performed. All filter capsules tested retained integrity and maintained a safety margin above maximum operating pressure after both three and five-year real-time storage and five years accelerated aging.
Material Safety	Bacteriostatic Additive: Reduce external microbial contamination.	Reduction of external microbial contamination by greater than 99.5% after 24 hours contact.
	Biocompatibility: Meet ISO 10993 standards for an "External Communicating Device, Breached/compromised surfaces, Contact Duration: Limited Exposure."	Performed L929 MEM Elution - ISO, Kligman Guinea Pig Maximization Test (2 extracts) - ISO, Intracutaneous Injection (2 extracts) - ISO, and Systemic Injection Test (2 extracts) - ISO, Rabbit Pyrogen Test - Material Mediated - ISO. (The document states testing was conducted in accordance with the standards, implying the device met the criteria, though specific passing results for each test are not detailed beyond their 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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