(187 days)
The USFilter MedRO - SPD is a single/acute care patient reverse osmosis unit intended to supply water that is used for hemodialysis treatments. The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD5:1992 and RD62:2001) and the CSA Water Treatment Equipment and Water Quality Requirements for Hemodialysis (CSA-Z364.2.2-03) when used as directed. Dependent on feed water quality this unit may be used in conjunction with other approved water treatment components.
MedRO™-SPD is a reverse osmosis unit used to purify water in hemodialysis applications.
The provided document describes the MedRO™-SPD, a water purification unit for hemodialysis, and its performance testing. However, it does not include information about a study proving the device meets acceptance criteria in the context of a medical AI device, as implied by the structure of the requested output.
Specifically, the document pertains to hardware validation and water quality testing of a physical device, not an AI algorithm. Therefore, many of the requested fields are not applicable.
Here's an analysis based on the provided text, highlighting the differences:
The document describes performance testing for a physical medical device (a reverse osmosis unit), not an AI algorithm. Thus, questions related to AI-specific terms like "test set," "training set," "ground truth experts," "MRMC study," and "standalone AI performance" are not applicable.
Here's an attempt to answer the questions based on the provided content, acknowledging the difference in device type:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (AAMI Standards) | Reported Device Performance |
|---|---|
| AAMI quality water (chemical contaminants) | Unit was able to significantly reduce chemical contaminants to amounts below the FDA recognized standard and AAMI requirements. |
| Bacteria reduction (AAMI requirements) | Unit was able to reduce bacteria in the product water. |
| Endotoxin reduction (AAMI requirements - not FDA recognized at time of submittal) | Unit was able to reduce endotoxin in the product water. |
| Components installed according to design (IQ) | Passed (after correction of two discrepancies: electrical drawing and tubing material). |
| Unit operates according to design specifications (OQ) | Passed (tested for power failure response, operating sequences, switch/button/indicator functions, alarm conditions). |
| Unit operates as specified during failures (FAT) | Passed (tested for low quality alarm, low water pressure shutdown, accurate rejection/quality readings). |
| Alarms operational when preset requirements aren't met | Alarms were given forced conditions and were operational. |
| Product water meets AAMI RD5 quality water | Both systems are designed so the product water will meet AAMI RD5 quality water. (Verified through sampling). |
2. Sample size used for the test set and the data provenance
- Sample Size: For water quality testing (chemical, bacteria, endotoxin), "Two samples were drawn for the water testing to assure reproducibility of these results." Other tests (IQ, OQ, FAT) involved functional testing of the single unit.
- Data Provenance: The testing was conducted on the MedRO™-SPD unit itself, installed to a potable water source. This is a prospective, in-house validation of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the "ground truth" here refers to objective measurements against established engineering specifications and AAMI water quality standards, not expert interpretations of medical images or data. The "experts" would be the engineers performing the validation and laboratory technicians analyzing water samples according to standard protocols.
4. Adjudication method for the test set
- Not applicable in the context of a physical device validation. Results were determined by direct measurement against pass/fail criteria (e.g., AAMI standards, functional test outcomes).
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 for a physical water purification device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is for a physical water purification device, not an AI algorithm.
7. The type of ground truth used
- The "ground truth" was based on:
- Engineering Design Specifications: For Installation Qualification (IQ), Operational Qualification (OQ), and Failure Analysis Test (FAT).
- ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD5:1992 and RD62:2001): For chemical contaminants, bacteria, and endotoxin levels in the product water.
8. The sample size for the training set
- Not applicable. This is for a physical water purification device, not an AI system. There is no "training set" in the AI sense. The device's design and manufacturing are based on established engineering principles and prior experience (e.g., the predicate device MedRO™ Reverse Osmosis System).
9. How the ground truth for the training set was established
- Not applicable. As noted above, there is no AI training set. The "ground truth" for the device's design and operation comes from engineering best practices, regulatory requirements, and industry standards like AAMI.
§ 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.