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This device is intended solely for processing (e.g., in vitro rinsing) of hemodialyzers. Any subsequent clinical use of the dialyzer processed by this machine is the sole responsibility of the patient's physician.

The Seratronics DPS 4 Dialyzer Preparation System is an automatic four-station rinsing machine for removing formaldehyde, glutaraldehyde or peracetic acid from reused dialyzers. Dialyzers are stored filled with the germicide and with the venous and arterial blood ports connected by a filled tubing segment that includes a sample site. This provides a blood side circuit that can be recirculated while the germicide is removed by the process of diffusion across the membrane. The system removes the germicide from the dialyzer by delivering AAMI quality (RD5. 1992) water to the dialysate side of the dialyzer at a controlled temperature and flow rate while the blood side fluid is recirculated by a tubing pump. The germicide is diffused from the blood compartment of the dialyzer to a final concentration prescribed by the physician. The blood side of the dialysis circuit is never opened during the rinsing process on the DPS 4 rinse machine. At a predetermined time in the recirculation cycle (selected on the front panel), an alarm sounds, indicating that the rinse time has been completed. The blood and dialysate side flow continue when this end-of-cycle alarm occurs. A proprietary buffering agent, RINSE-QUICK concentrate, can be added to the rinse solution to reduce rinse out times with formaldehyde only.

The provided text describes the Seratronics DPS 4 Dialyzer Preparation System, an automatic four-station rinsing machine for removing germicides (formaldehyde, glutaraldehyde, or peracetic acid) from reused dialyzers. The core of the submission focuses on demonstrating the effectiveness of a proprietary buffering agent, RINSE-QUICK concentrate, in reducing formaldehyde rinse-out times.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the DPS 4 system itself in terms of numerical thresholds that must be met for device approval. Instead, the study aims to demonstrate the effectiveness of the Rinse-Quick concentrate in reducing rinse times to achieve physician-prescribed final germicide concentrations.

The "acceptance criteria" can be inferred as the ability to reduce germicide (specifically formaldehyde) to a safe level, which is then verified by a manual test by medical professionals prior to patient connection. The reported performance is the reduction in rinse time with the use of Rinse-Quick concentrate compared to rinsing with RO water alone.

Detailed Reported Device Performance for Formaldehyde Rinse-out Rate (with Rinse-Quick concentrate):

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The table lists 6 different dialyzer types. For each dialyzer type, rinse times are reported for two target concentrations (5 PPM and 1 PPM) and two conditions (with and without Rinse-Quick). The exact number of individual dialyzers tested to generate these average rinse times is not specified.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given the context of a 510(k) submission, it would typically be a prospective, controlled study conducted in a laboratory or clinical setting within the US, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The "ground truth" here is the measured formaldehyde concentration in the dialyzers after rinsing. This would typically be established by laboratory analysis, not by expert consensus.

4. Adjudication Method for the Test Set

Since the ground truth is a direct measurement of chemical concentration (not an interpretation), an adjudication method like 2+1 or 3+1 typically used for subjective assessments (e.g., image review) is not applicable and therefore, not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to assess the performance of diagnostic devices where human readers interpret results, often with and without AI assistance. This device is a rinsing machine, and the study focuses on germicide removal effectiveness, not diagnostic interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

While the device operates automatically, the study described is a performance test of the device's ability to remove germicide, not an "algorithm-only" performance in the sense of a software-driven diagnostic tool. The "human-in-the-loop" equivalent for this device is the ultimate requirement for medical professionals to manually test each dialyzer for residual germicide and pH just prior to connection to the patient, as explicitly stated in the warnings. The device facilitates the rinse, but the final safety check remains a human responsibility.

7. The Type of Ground Truth Used

The ground truth used for the study described is quantitative chemical measurement of formaldehyde concentration in the dialyzer effluent or internal fluid. This is implicit in the "5 PPM" and "1 PPM" values reported in the table.

8. The Sample Size for the Training Set

The document describes a study demonstrating effectiveness of Rinse-Quick concentrate. It does not describe the development or training of an algorithm in the AI sense. Therefore, there is no training set in this context. The device is a mechanical system with a chemical additive, not an AI/ML product.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML algorithm, this question is not applicable.

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