(119 days)
The DSU-H and SSU-H Ultrafilters are intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP sterile water.
The DSU-H and SSU-H Ultrafilters are hollow fiber ultrafilters that retain bacteria, viruses, endotoxin and particulate from water used for washing and drinking.
The provided text describes a medical device, the DSU-H and SSU-H Ultrafilters, but it does not include information about AI algorithms, reader studies, ground truth establishment for AI, or training/test sets for AI. Therefore, I cannot fulfill most of your request regarding acceptance criteria and studies that prove the AI device meets acceptance criteria.
However, I can extract the acceptance criteria for the Ultrafilters themselves as stated in the submission documents, which are based on their filtration performance.
Here's what I can provide based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance (for the Ultrafilters)
The document primarily performs a substantial equivalence comparison to a predicate device (MainStream™ Water Purification Device – K012716) and refers to its own reference device (DSU and SSU Filters – K110285). The "acceptance criteria" can be inferred from the "Retention" section of the comparison table, where the device must demonstrate at least equivalent or superior reductions for various contaminants.
| Characteristic | Acceptance Criteria (Inferred from Predicate/Reference) | Reported Device Performance (Subject Device: DSU-H and SSU-H Ultrafilters) |
|---|---|---|
| Bacteria Reduction | > 10^7^ (Predicate) / > 10^11^ (Reference) | > 10^11^ |
| Virus Reduction | > 10^4^ (Predicate) / > 10^8^ (Reference) | > 10^8^ |
| Endotoxin Reduction | > 10^4^ (Predicate) / > 10^5^ (Reference) | > 10^5^ |
| Organic Reduction | 10^3^ dissociable ions (Predicate) | N/A (Not designed for ion reduction) |
Explanation of Inference:
The submission states "Based on non-clinical performance testing, the DSU-H and SSU-H Ultrafilters have been found to be substantially equivalent to the predicate PrisMedical MainStream Filter (K012716)." For the characteristics where the subject device also performs, it must meet or exceed the predicate's performance. Furthermore, the subject device's performance aligns with its own reference device (K110285), which indicates its expected retention capabilities.
The following points cannot be answered as the provided text pertains to a physical water purification device and does not involve AI or a diagnostic algorithm evaluated through an AI specific study:
- Sample size used for the test set and the data provenance: Not applicable. This is for a physical filter, not an AI algorithm. The performance data would come from laboratory testing of the filter medium with controlled contaminant challenges.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical filter's performance is established through standard microbiological and chemical testing, not expert consensus on medical images or diagnoses.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance data presented (bacteria, virus, endotoxin reduction), the ground truth would be established by quantitative laboratory analysis of contaminant levels before and after filtration, using validated assays (e.g., CFU counts for bacteria, TCID50 for viruses, LAL test for endotoxin).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.