Search Results

The RenaPure filter is a bacterial and endotoxin retentive filter intended for use in a centralized loop as the final step of a water purification cascade to provide standard dialysis water to machine servicing multiple patients. This filter is not intended to service as the sole means of water purification and therefore must be used in conjunction with other water treatment equipment.

The RenaPure filter is a 20" cartridge style filter in a polypropylene casing that contains dual-layered, 0.22 micron polyethersulfone (PES) pleated membranes which are separated by polypropylene screen layers. The PES membrane is charge modified with a positive charge coating, similar to the predicate device, that aids in removal of endotoxin by charge attraction. Filter configurations are based on an industry standard 222 header design with silicone O-rings at the open end of the filter and flat or fin end caps at the closed end. The filter cartridge is installed in a durable filter housing and operates in a dead-end mode. The filter is designed to remove bacteria and endotoxin from water used in hemodialysis with similar water flow characteristics as the predicate device. The filter provided non-sterile.

The provided text describes the regulatory clearance of the RenaPure Endotoxin Retentive Filter and includes a summary of non-clinical performance assessment, but it does not contain information about:

• Acceptance criteria expressed as specific quantitative thresholds for device performance.
• A comparative study with human readers (MRMC study) or effect sizes of AI assistance.
• Standalone algorithm performance.
• Sample sizes for test sets or training sets in the context of an AI/algorithm study.
• Data provenance, number of experts for ground truth, or adjudication methods for an AI/algorithm study.
• Ground truth type for training data.

The document focuses on the physical and functional performance of a medical device (a filter) through bench testing and biocompatibility assessment, not on the performance of a diagnostic AI algorithm.

Therefore, I cannot fulfill your request as the necessary information regarding acceptance criteria, study details, and AI performance metrics (including expert involvement, sample sizes, and ground truth establishment) is not present in the provided text.

The "Performance (bench) testing" section within the "Non-clinical Performance Assessment" is the closest to describing a study, but it lacks the specific details requested concerning acceptance criteria, ground truth, and expert involvement usually associated with AI algorithm evaluation.

What the document does state about performance assessment:

• Study type: Non-clinical bench testing.
• Tests performed:
  • Flow/Pressure Drop measurements
  • Endotoxin Retention
  • Bacterial Retention
  • Compatibility to Hot Water and Chemical Disinfections
  • Housing Fit tests
  • Compatibility with Deionized water
• Results: "Testing demonstrated that the RenaPure filter met the intended design requirements and will operate as a drop-in replacement to the predicate device."
• Biocompatibility: A series of biocompatibility tests, including exhaustive extraction and toxicological risk assessment, were performed. "All biocompatibility testing passed and the risk of any toxic leachates from the RenaPure filter were considered negligible."
• Ground Truth: For these physical device tests, the "ground truth" would be established by the physical measurements and chemical analyses themselves, validated against engineering specifications and regulatory standards. There are no "experts" in the sense of clinical readers establishing ground truth for perception tasks.

Ask a specific question about this device

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.

Ask a specific question about this device