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The HemoCare® Hemodialysis System is indicated for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare Hemodialysis System is indicated for use in chronic dialysis facilities, self-care dialysis facilities, and the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed with the assistance or observation of an individual who has been trained and is considered competent in the use of the device. The HemoCare Hemodialysis System is not indicated for solo hemodialysis in the home setting.

The HemoCare® Hemodialysis System is a self-contained, software-controlled device that provides hemodialysis treatments, including short daily and nocturnal hemodialysis, for patients with renal failure. The device is intended for use by a single patient in chronic dialysis facilities, self-care dialysis facilities, and the home setting. The HemoCare® Hemodialysis System is composed of the following components:

• The HemoCare® Treatment Device is a hemodialysis delivery system. When provided a source of water for dialysis, it produces infusion grade dialysate using liquid acid and powder bicarbonate concentrates. The Treatment Device provides secure, 2-way communication with the cloud for transmitting patient registration, physician-prescribed dialysis treatments, patient monitoring, and device status information.
• The HemoCare® Water Device is a water purification system that produces water for dialysis through distillation of EPA drinking water. The Water Device interfaces with the Treatment Device.
• The Blood Treatment Set connects to the patient access site and interfaces with the Treatment Device to provide extracorporeal blood flow through a dialyzer for dialysis treatment. The Blood Treatment Set is terminally sterilized and includes displacement blood pumps, a heparin delivery system, and an access disconnect sensor. The Blood Treatment set can be used for up to 16 treatments.

The provided text describes the HemoCare® Hemodialysis System, a medical device. However, it does not contain the specific information required to complete the detailed table about acceptance criteria and device performance results as requested, nor does it detail a study proving the device meets acceptance criteria in the context of an AI/ML algorithm.

The document is a 510(k) summary for a hemodialysis system, focusing on its substantial equivalence to predicate devices. It outlines performance data categories like Biocompatibility, Electrical Safety, Software Verification and Validation, Bench Performance Testing, Sterilization and Shelf Life, Human Factors, and Clinical Testing.

Importantly, the document does not describe an AI/ML algorithm that would have "acceptance criteria," "test sets," "ground truth," "expert readers," or "MRMC studies" in the context typically associated with an AI/ML medical device submission. The "Software Verification and Validation Testing" section states that "Testing results demonstrate that the device meets all software performance requirements," but it does not specify what those requirements are, nor does it indicate these requirements relate to an AI/ML diagnostic or predictive function.

Therefore, I cannot fulfill the request as the type of information sought (related to AI/ML algorithm performance) is not present in the provided text. The document is about a physical medical device (hemodialysis system) and its regulatory clearance as substantially equivalent to existing devices, not about a software-as-medical-device (SaMD) or AI-enabled medical device performance study with the detailed metrics requested.

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