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The Baxter AK 98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or home use.

The AK 98 Dialysis Machine is a standalone hemodialysis machine intended for use as a single patient dialysis machine to perform HD treatments of patients with renal failure or fluid overload. The Vantive AK 98 Dialysis Machine is intended to be used in a chronic dialysis or hospitale care environment for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 Dialysis Machine is intended to be used on patients with a body weight of 25 kg or more.

To perform hemodialysis therapy, the AK 98 system needs a high purity water source and the appropriate consumables for treatment, including but not limited to: cleaning products, ultrafilters, acid and base dialysate concentrates, bloodlines, and dialyzers.

In hemodialysis therapies, the AK 98 is used to pump the blood through the extracorporeal circuit and to monitor the arterial and venous pressure, but the blood directly contacts only the disposable bloodline and dialyzer, not the monitor itself.

The fluid unit of the AK 98 Dialysis Machine is used to produce the dialysis fluid (with the correct temperature, flow, and composition) from reverse osmosis water and concentrates (dry or liquid) and to transport the dialysis fluid through the dialyzer. The fluid unit offers Profiling of Ultrafiltration and/or conductivity, it also offers isolated Ultrafiltration. The fluid unit also includes "Clearance Measurement" (Diascan). The fluid unit maintains the dialysis fluid flow through the dialyzer and controls ultrafiltration. If a fault occurs, the machine enters a patient safe state, which, depending upon the fault, can include actions such as bypassing the dialyzer.

The fluid path of the AK 98 is composed of a variety of different materials, including silicone tubing.

The provided FDA 510(k) clearance letter and summary for the AK 98 Dialysis Machine (K250508) do not contain the details typically associated with Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for AI/ML-driven medical devices.

The document describes a submission for a dialysis machine, and the key changes and testing detailed focus on physical components and performance attributes of a medical device (e.g., changes in silicone tubing curing process, ultrafiltration accuracy, blood flow rate accuracy). It specifically highlights non-clinical tests rather than clinical studies with human subjects or AI-specific validation.

Therefore, many of the requested categories in the prompt (e.g., sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance) are not applicable to this type of device and submission as described in the provided text.

The information that can be extracted relates to the device's functional performance and how it maintains equivalence to its predicate.

Here's an attempt to address the prompt based only on the provided text, while noting the limitations:

Acceptance Criteria and Device Performance for AK 98 Dialysis Machine

Based on the provided 510(k) summary for the AK 98 Dialysis Machine (K250508), the device is demonstrated to be substantially equivalent to its predicate device (AK 98 Dialysis Machine, K232467). The assessment of differences focuses on ensuring the proposed device maintains similar performance and safety characteristics despite a material change in its silicone tubing.

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to maintaining the performance specifications of the predicate device. The "reported device performance" is implicitly that the proposed device performs identically to the predicate device for all listed features, having passed non-clinical functional testing. The key change evaluated was the transition from peroxide-cured and platinum-cured tubing to solely platinum-cured tubing.

Note on Silicone Tubing Difference: The crucial "acceptance criteria" here for the tubing change was that "Performance, biocompatibility, and extractables testing demonstrates that the difference in the curing process does not impact the performance or safety of the AK 98 Hemodialysis System." The reported performance is that this testing was successfully conducted, confirming no impact.

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

The provided document describes non-clinical functional performance testing, biocompatibility testing, and extractables and leachables assessment. It does not mention a "test set" in the context of patient data or clinical trials. Therefore, sample sizes for such data are not applicable here. The data provenance would be laboratory testing results from the manufacturer.

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

This submission pertains to a physical medical device and primarily relies on engineering and laboratory testing for equivalence, not AI/ML-driven analysis of medical images or patient data requiring expert adjudication. Thus, this information is not applicable.

4. Adjudication Method for the Test Set

As there is no mention of a clinical test set requiring human interpretation or AI output evaluation, an adjudication method is not applicable.

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

No, an MRMC study was not done, as this device is a physical hemodialysis machine, not an AI/ML diagnostic or assistive tool for human readers.

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

No, a standalone algorithm performance study was not done, as this device does not contain a discrete AI/ML algorithm whose performance is being evaluated in isolation. Its "performance" refers to the mechanical and fluid dynamic functions of the dialysis machine itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation lies in established engineering standards, device specifications, and the performance characteristics of the legally marketed predicate device. The change in the silicone tubing's curing process required "Performance, biocompatibility, and extractables testing" to demonstrate continued safety and effectiveness. This testing serves as the "ground truth" method for verifying that the new component does not negatively impact the device's adherence to its established specifications.

8. The Sample Size for the Training Set

This concept is not applicable to the submission of this physical medical device. There is no AI/ML model being trained with a dataset.

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

This concept is not applicable as there is no training set for an AI/ML model.

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