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The 2008K2 Hemodialysis Machine is indicated for acute and chronic hemodialysis therapy in a healthcare facility.

Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg and ≤ 40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing

The 2008K2 Hemodialysis machines is used for dialysis therapy. The machine pumps blood from the patient through an extracorporeal circuit containing a semi-permeable membrane (dialyzer). This membrane acts as an artificial kidney to transport toxins (diffusion) and excess water (ultrafiltration) from the blood into a separate fluid (dialysate) circuit. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood. In the dialysate circuit, the dialysate concentrates are mixed with purified water, heated, degassed, and delivered to the dialyzer. Balancing chambers control the incoming flow and outgoing flow of the dialysate fluid during ultrafiltration.

This looks like a 510(k) Pre-Market Notification for a medical device, specifically a hemodialysis machine. Based on the provided text, the document describes modifications to an existing device (the 2008K2 Hemodialysis Machine) and argues for its substantial equivalence to a predicate device.

The document does not contain the detailed information required to fill out your request about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device.

Here's why and what information is missing:

• This is not an AI/ML device: The document describes a physical medical device (hemodialysis machine) with software controls. It is not an AI/ML system that makes diagnostic or treatment decisions. Therefore, the concepts of "test set," "ground truth," "experts," "adjudication," "MRMC study," "standalone performance," or "training set" as they relate to AI/ML model validation are not applicable here.
• Focus is on Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use and technological characteristics, or that any differences do not raise new questions of safety or effectiveness.
• Performance Data is for Mechanical/Electrical/Software Functionality: The "Performance Data" section (5.8) outlines various tests conducted, such as Biocompatibility, Electrical Safety, Software Verification and Validation, Mechanical and Acoustic Testing, and Other Bench Testing (microbiological purity, risk-based analysis of software updates). These tests confirm the engineering and software functionality of the hemodialysis machine itself, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested table or answer the specific questions about AI/ML device validation.

If you were to adapt your request to the type of device described, the document would contain:

• Acceptance Criteria: These would be functional specifications for the hemodialysis machine (e.g., blood flow rates, fluid removal accuracy, dialysate flow rates, temperature control, alarm functionality, electrical safety standards compliance).
• Study Proving Acceptance: This would refer to the various verification and validation tests listed in section 5.8 (e.g., "Software Verification and Validation Testing," "Mechanical testing included net fluid removal accuracy evaluations," "Simulated dialysis testing at the full range of dialysate and blood flow rates").

Since your questions are specifically tailored for AI/ML devices, and this document does not describe one, I cannot fulfill the request as stated.

Ask a specific question about this device