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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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