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The USFilter/lonpure Med-RO™ Reverse Osmosis System is intended to supply water for use in the preparation of dialysate for hemodialysis patients and for other hemodialysis-related procedures such as cleaning, rinsing of equipment, and reprocessing of dialyzers. 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 RD 62:2001[RD-5: 1992 if Treatment Equipment for Temodiarysle Applications RD & LES T.(RE ST 1000 in conjunction with other components of a water treatment system as necessary with compatible input and output water requirements.

The Med-RO™ Reverse Osmosis System is a machine used to purify water.

The provided text describes a 510(k) submission for a medical device called the "Med-RO™ Reverse Osmosis System." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way one might find for a diagnostic or therapeutic device.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically seen in clinical trials for diagnostic algorithms is not explicitly present in this document. The submission is for a water purification system used in hemodialysis. For such devices, acceptance criteria would likely relate to specific water quality parameters (e.g., conductivity, levels of specific contaminants) and performance would be measured against those parameters.

The closest the document comes to this is in the "Indications For Use" section, which states: "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 RD 62:2001 [RD-5: 1992 if Treatment Equipment for Temodiarysle Applications RD & LES T.(RE ST 1000 in conjunction with other components of a water treatment system as necessary with compatible input and output water requirements."

Therefore, the acceptance criteria for this device are implicitly tied to the ANSI/AAMI standards for water quality in hemodialysis. The document does not report specific measurements of water quality from the Med-RO™ system in a table format. It states that non-clinical tests were performed and that "Based on the testing performed as well as the information provided, there are no changes in the performance, safety or effectiveness of the modified device." This implies that the device meets the functional requirements for water purification, and thus, by extension, the ANSI/AAMI standards, but no concrete data is presented here.

Table of Acceptance Criteria and Reported Device Performance:

Study Information as per Request:

1. A table of acceptance criteria and the reported device performance
   (See table above. Specific numerical data is not provided in the document.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • N/A. The document explicitly states "Discussion of Clinical Test Performed: N/A." This indicates that no clinical test set was used for evaluating the device's performance in humans. The testing mentioned is "non-clinical." The submission is based on engineering design and performance verification, demonstrating that the modified device performs equivalently to the predicate device.

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)

   • N/A. There was no clinical test set, and therefore no ground truth established by medical experts in this context. The "ground truth" for a water purification system would be the objective measurement of water quality against established engineering and medical standards (like ANSI/AAMI), not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • N/A. No clinical test set.

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

   • N/A. This device is a water purification system, not an AI-assisted diagnostic or therapeutic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • N/A. This is not an algorithm. The "standalone" performance here would refer to the Med-RO™ system's ability to purify water independently. The submission indicates non-clinical testing was done to verify this, but details of those tests are not provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • The "ground truth" for this device's performance would be the direct measurement of water quality parameters (e.g., conductivity, total dissolved solids, specific ion concentrations, microbiological counts) against the specifications set by the ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications RD 62:2001 (or RD-5:1992).

8. The sample size for the training set

   • N/A. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

   • N/A. Not an AI/ML device.

Summary of the Study (as described in the document):

The submission describes a non-clinical study (or more accurately, a comparison based on non-clinical testing and engineering assessment) to demonstrate substantial equivalence of the Med-RO™ Reverse Osmosis System to a previously cleared predicate device (USFitter/lonpure, Inc. M-Series Reverse Osmosis Water Purification System).

The primary "study" performed was an engineering assessment and non-clinical testing to ensure that modifications to the device "will not negatively affect performance, safety, or effectiveness." The core argument for substantial equivalence is that the new device "contains the same fundamental scientific technology as the predicated device."

The study did not involve human subjects or clinical data in the manner often seen for diagnostic or therapeutic devices. Its "acceptance criteria" are implied to be adherence to the performance and safety characteristics of the predicate device and the relevant ANSI/AAMI water quality standards for hemodialysis. The document explicitly states "Discussion of Clinical Test Performed: N/A."

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