(65 days)
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.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.