(125 days)
The AmeriWater Centurion 1500+ Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAM and Federal (U.S.) standards. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAM and Federal (U.S.) standards. The Centurion 1500+ Reverse Osmosis System is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The device includes an integrated heat sanitization process.
The AmeriWater Centurion 1500+ Reverse Osmosis System is a water treatment system intended for use in hemodialysis applications. The system is designed to remove organic and inorganic substances and contaminants from potable water. The purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate. The AmeriWater Centurion 1500+ Reverse Osmosis System is intended to be used in hospitals, clinics, dialysis centers, and for home care use. There is no direct contact between the patient and any part of the device invasive. Materials that contact that contact the product water include: Nylon, Polypropylene, Stainless Steel, EPDM, and Thin Film Composite Membrane (Polyamide). The Centurion 1500+ Reverse Osmosis System purifies water by applying pressure (greater than the osmotic pressure difference) to the feed water to reverse the water flow through a semi-permeable membrane so that the water moves from a more concentrated solution to a less concentrated solution resulting in purified permeate flow. The feed water enters the Centurion through an inlet solenoid valve filling the feed water tank. A high pressure pump forces water from the feed tank through the RO membrane where it is split into permeate which has passed through the membrane and the concentrate which passes over the membrane and carries the contaminants to drain. The AmeriWater Centurion 1500+ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications. The AmeriWater Centurion 1500+ Reverse Osmosis System also includes a built in heat sanitization feature. Heat sanitization can be activated manually using the HEAT SANITIZATION function from the controller's main menu. The frequency of thermal sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content should be conducted at regular intervals to determine the optimum frequency for thermal sanitization.
The provided text describes a medical device, the "AmeriWater Centurion 1500+ Reverse Osmosis System," and its performance relative to existing standards and predicate devices. However, it does not describe an AI/ML powered medical device, nor does it contain a study with acceptance criteria related to typical AI/ML performance metrics (like sensitivity, specificity, AUC).
The document is a 510(k) summary for a Class II medical device, which is a water purification system for hemodialysis. The "acceptance criteria" and "study" mentioned in the document relate to the device's ability to purify water to specific physical, chemical, and microbiological standards, and its safety.
Therefore, many of your requested points are not applicable to the provided document. I will extract the information that is present and indicate where the requested information is not available due to the nature of the document.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "The AmeriWater Centurion 1500+ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications." and "Results of performance testing indicate that the device produces water that meets current AAM and Federal (U.S.) standards. Microbiological testing results show evidence that the heat sanitization function is effective in the reduction of bacteria. Clinical studies show evidence that the device, when used in accordance with the instructions for use, will produce water that meets current AAMI and Federal (U.S.) standards for hemodialysis."
The table provided in the document compares the new device with predicate devices across several specifications, which could be interpreted as performance metrics. The implicit acceptance criteria are that the device meets AAMI and Federal (U.S.) standards for water used in hemodialysis applications. The table below presents the comparative performance aspects mentioned.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (AmeriWater Centurion 1500+) |
|---|---|---|
| Water Quality | Meets current AAMI and Federal (U.S.) standards for hemodialysis. | Produces water that meets current AAMI and Federal (U.S.) standards. |
| Microbiological Impact | Effective reduction of bacteria by heat sanitization. | Heat sanitization function is effective in the reduction of bacteria. |
| Total Dissolved Salts | Superior to predicate devices (e.g., >96% or >94% rejection). | > 98% rejection rate. |
| Permeate Flow Rates | Appropriate for hemodialysis applications. | 1.5 l/min at 10°C. |
| Drain Requirements | Manageable for intended use. | Max 3.0 l/min. |
| Biocompatibility | Safe for body contact indirectly through purified water. | Test results indicate device is safe and effective. |
| Software Validation | Software functions as intended. | Test results indicate device is safe and effective. |
| Electrical Safety | Complies with IEC 60601-1. | Test results indicate device is safe and effective (in accordance with IEC 60601-1). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for specific tests (e.g., how many water samples, how many bacteria cultures). The text refers to "Non-clinical testing" and "Microbiological testing" and "Clinical studies" generally.
- Data Provenance: Not specified.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: This document concerns a physical device that purifies water, not an AI/ML algorithm that interprets medical images or data requiring expert human-established ground truth. Water quality standards (AAMI, Federal U.S. standards) are objective chemical and microbiological measurements, not expert consensus opinions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used for reconciling disagreements among human experts in cases where subjective interpretation is involved, common in image review. This is not relevant for objective water quality testing.
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 is not an AI/ML device, so no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is not an AI/ML algorithm. The device operates as a standalone water purification system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth Type: Physical and chemical measurements against established AAMI and Federal (U.S.) standards for water used in hemodialysis. This includes specific limits for various contaminants (e.g., total dissolved salts, bacteria count) and functional parameters (e.g., permeate flow rates).
8. The sample size for the training set
- Not Applicable: This is not an AI/ML device that requires a "training set." The device is engineered and then tested against established physical standards.
9. How the ground truth for the training set was established
- Not Applicable: No training set or associated ground truth as this is not an AI/ML device.
§ 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.