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Peracidin™ Dialyzer Reprocessing Concentrate is indicated for the in-virro cleaning and disinfection of hollow fiber dialyzers, classified as follows:

Conventional dialyzer, 21 CFR 876.5820, product code 78 FJI High permeability dialyzer, 21 CFR 876,5860, product code 78 KDI

The product is intended for use only with reprocessing systems, automated or manual, that have been validated by the system manufacturer for use with peracetic acid. The intended use of Peracidin is identical to that of Renalin.

Peracidial Dialyzer Reprocessing Concentrate is a stabilized mixture of hydrogen peroxide 27,0% and peroxyacetic acid 4,5%; inert ingredients are 68,5% (nominal concentrations). The concentrate is a clear colorless liquid, is highly acidic, and is completely soluble in water. Peracidim breaks down to acetic acid, water, and oxygen.

The provided text is a 510(k) summary for a medical device called "Peracidin Dialyzer Reprocessing Concentrate." This document is focused on demonstrating the substantial equivalence of this new device to a legally marketed predicate device (Renalin Cold Sterilant) for the purpose of regulatory clearance.

It does not contain the type of acceptance criteria, study design, or performance metrics typically found in clinical trials or software validation studies for devices that require proof of diagnostic or treatment efficacy based on human or clinical data. Instead, it relies on the established performance of the predicate device and the chemical composition of the new device.

Therefore, most of the requested information cannot be extracted directly from this document because the study described is a demonstration of chemical equivalence and known biocidal efficacy, rather than a study involving human subjects, diagnostic accuracy, or expert adjudication.

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

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

• Not Applicable. The document describes the chemical composition of the product and references the established efficacy of its active ingredient, peroxyacetic acid, based on "extensive long-term clinical use and... well-documented in the scientific literature." It does not involve a specific test set of cases (e.g., patient data, images) for the device's performance that would require a sample size or data provenance in the typical sense of a clinical study.

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. No experts were used to establish ground truth for a test set in the context of this device's submission. The documentation relies on the established scientific literature regarding the biocidal efficacy of peroxyacetic acid.

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

• Not Applicable. No adjudication method was used, as there was no test set requiring expert review or consensus.

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 device is a chemical disinfectant, not an AI-powered diagnostic or assistance tool. Therefore, no MRMC comparative effectiveness study was conducted, and the concept of "human readers improve with AI" is irrelevant.

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

• Not Applicable. This device is a chemical disinfectant. It does not have an algorithm or human-in-the-loop component. Its efficacy is standalone chemical action.

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

• The "ground truth" for this submission is the well-established scientific literature and long history of clinical use regarding the biocidal efficacy of peroxyacetic acid and its decomposition products' low toxicity. This is an extrapolation based on chemical equivalence to a predicate device and widely accepted scientific understanding, rather than new primary ground truth derived from a specific study for this device.

8. The sample size for the training set

• Not Applicable. This is a chemical product, not a machine learning model. There is no concept of a "training set" for this type of device.

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

• Not Applicable. As there is no training set, there is no ground truth established for one.

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