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The HomeChoice Automated Personal Cycler Peritoneal Dialysis System is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

The HomeChoice Automated Personal Cycler, version 8.9 software is used for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis therapy. The HomeChoice Automated Personal Cycler automatically cycles peritoneal dialysis fluid in the amounts and time prescribed by a clinician.

The provided text describes a 510(k) premarket notification for the HomeChoice Automated Personal Cycler, version 8.9 software. However, it does not contain the specific details required to complete your request regarding acceptance criteria and a study proving device performance in the context of an AI/ML device.

Here's why and what information is missing:

• Device Type: The HomeChoice Automated Personal Cycler is a medical device for peritoneal dialysis, specifically its software version 8.9. This document is a regulatory submission, not a study report for an AI/ML diagnostic or predictive algorithm.
• Absence of AI/ML Specifics: The document primarily focuses on demonstrating substantial equivalence to a predicate device (K923065 and K012988) and confirming that the design requirements for controlling dialysate solution exchanges are met. There is no mention of AI, machine learning, image analysis, or any other features that would require the kind of performance metrics you've requested (e.g., sensitivity, specificity, AUC).
• "Clinical Data: N/A": This explicitly states that clinical data was "N/A," which means no clinical study, in the typical sense of evaluating patient outcomes or diagnostic performance, was deemed necessary for this particular submission. This further supports that it's not an AI/ML device requiring such studies.
• "Validation and Verification testing was successful in demonstrating that all design requirements have been met. Bench testing was performed...": This describes the type of testing done, which is functional verification and validation for a control system, not performance evaluation against ground truth data for an AI model.

Therefore, I cannot provide the requested information because the input text does not describe an AI/ML device or its performance study. The questions you've asked are pertinent to AI/ML device evaluations, which are not detailed in this 510(k) summary.

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