(90 days)
The AmeriWater Portable RO+ Model MROS09 is a stand-alone water treatment system for use in hemodialysis applications. It is designed to pretreat and purify potable water for use in making dialysate for hemodialysis. The AmeriWater Portable RO+ with Onboard Pretreatment System is intended to be used in hospitals, clinics, home-care, and dialysis centers. It provides quiet operation for bedside use and may be used for acute care cases, small dialysis wings in hospitals, or to handle extra patients at dialysis centers.
The AmeriWater Portable RO+ Model MROS09 is a portable, stand-alone water treatment system for use in hemodialysis applications. It is designed to pre-treat and purify potable water for use in making dialysate for hemodialysis. The water treatment components for the AmeriWater Portable RO+ Model MROS09 consist of a temperature-blending valve, two backwashing carbon filters, regenerating water softener with brine tank, a micron prefilter, and a reverse osmosis membrane. The components are conveniently packaged in ABS cabinets designed to fit in a standard washing machine pan. All components are constructed of materials that meet FDA and/or NSF standards.
The provided text describes the AmeriWater Portable RO+ Model MROS09, a water purification system for hemodialysis. However, it does not contain information about specific acceptance criteria and a study proving the device meets those criteria in the way typically expected for a medical device efficacy trial (e.g., performance metrics like sensitivity, specificity, or adverse event rates). Instead, the document focuses on demonstrating substantial equivalence to existing devices.
Here's an analysis based on the information provided and addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit table of acceptance criteria with corresponding performance data (e.g., sensitivity, specificity, accuracy, or similar quantitative metrics) is provided in this 510(k) summary. The primary performance claim is that the device "is designed to produce water that meets or exceeds ANSI/AAMI RD62 requirements." And "Contaminants are removed from the water at a rejection rate greater than or equal to 94% to achieve product water that meets or exceeds ANSI/AAMI RD62 standards."
| Acceptance Criteria (Inferred from Text) | Reported Device Performance |
|---|---|
| Produce water that meets or exceeds ANSI/AAMI RD62 requirements. | The device is designed to produce water that meets or exceeds ANSI/AAMI RD62 requirements. |
| Carbon filtration meets AAMI standards. | The backwashing carbon filtration has been designed to meet all standards for carbon filtration as defined by AAMI. |
| Reverse Osmosis (RO) membrane rejection rate. | Removes contaminants at a rejection rate ≥ 94%. |
| Water produced meets or exceeds ANSI/AAMI RD62 standards (post-RO). | The 94%+ rejection rate achieves product water that meets or exceeds ANSI/AAMI RD62 standards. |
| Functional equivalence to predicate device (K924695). | "The AmeriWater Portable RO+ Model MROS09 is the same in function and design as the AmeriWater Portable RO+ currently approved for market under the 510(k) number K924695." |
| Performance specifications remain same as predicate device (K924695). | "The basic design, intended use, and performance specifications remain the same for the new model of the RO+ product line." |
| Design/specifications of backwashing carbon filters as predicate K991519. | "The design and performance specifications for the backwashing carbon filters are the same as those used for the carbon filters currently marketed with the AmeriWater Purification System for Hemodialysis under 510(k) number K991519." |
| Design/specifications of regenerating water softener as predicate K991519. | "The design and performance specifications for the regenerating water softener are the same as those used for the water softeners currently marketed with the AmeriWater Purification System for Hemodialysis under 510(k) number K991519." |
2. Sample Size for Test Set and Data Provenance
The document does not describe a "test set" in the context of an efficacy study as one might expect for a diagnostic or AI device. Instead, the "testing" described is related to the design and performance specifications of the component parts and the overall system's ability to meet industry standards. There is no explicit mention of a sample size (e.g., number of patients, water samples evaluated over a period) for a clinical or in-use performance test to confirm the acceptance criteria for the entire device.
The data provenance for the claims is largely implied to be based on the design specifications and testing performed by AmeriWater to ensure compliance with ANSI/AAMI RD62 standards and internal design parameters, as well as the proven performance of the predicate devices. This would be considered retrospective in the sense that it relies on established designs and standards, not a new prospective clinical trial. There's no country of origin of data explicitly stated, but it's an FDA submission, implying compliance for the US market.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The "ground truth" for this type of device is defined by engineering specifications and compliance with recognized industry standards (ANSI/AAMI RD62). It does not involve expert medical readers establishing ground truth for diagnostic decisions.
4. Adjudication Method for the Test Set
This is not applicable as there is no "test set" in the context of expert review or diagnostic assessment. Performance is measured against engineering specifications and documented compliance with standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or is mentioned. This type of study is typically performed for diagnostic devices where human interpretation is involved, often comparing human performance with and without AI assistance. This device is a water purification system, not a diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable here. The device is a physical water purification system, not an algorithm. Its performance is measured by the quality of the water it produces, not by an algorithm's output.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering/design specifications and compliance with recognized industry standards, specifically ANSI/AAMI RD62 for water quality in hemodialysis. This also includes the proven performance of the predicate devices (K924695 and K991519) on which the new design's components are based.
8. Sample Size for the Training Set
This is not applicable. The device is a physical system, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
§ 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.