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The indications for use of the device are to provide hemodialysis treatments in the acute and chronic setting including high flux hemodialysis.

• The device is intended to be used by trained operators when . prescribed by a physician.
• The device is intended to be used in conjunction with a hollow fiber or parallel plate dialyzer.
• The auto start option is intended to allow up to a three day . delayed start of the fluid path heat clean or rinse cycle.

The Drake Willock® System 1000® Single Patient Dialysate Delivery System is a dialysate proportioning system for hemodialysis. The system fulfills the following functions:

• Mixes concentrate with water in the appropriate proportions to produce dialysate .
• Delivers dialysate at the appropriate temperature and ionic concentration to the . dialyzer,
• Removes the appropriate amount of liquid from the patient's blood .
• Along with the dialyzer and blood pump acts as a total artificial kidney. .
  The following option is the subject of this submission that will be implemented with FDA approval.
  The fundamental modification is to provide the patient care provider with a means to delay the start of fluid path rinse or heat clean up to 3 calendar days.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is a 510(k) summary for a modification to a dialysate delivery system, focusing on its substantial equivalence to a predicate device.

Here's why I cannot provide the requested information:

• No Acceptance Criteria or Performance Study: The document primarily discusses the "AutoStart" feature, which is a software change to delay the start of heat clean or fluid path rinse. It explicitly states that "The machine and patient safety systems are the same as the predicate devices" and "The only difference is a software change." It does not mention any specific acceptance criteria or an independently designed study to prove the performance of this new software feature. The focus is on demonstrating that the modification itself is safe and effective through design and testing, rather than a standalone performance study as would be described for a new diagnostic or prognostic AI device.
• Focus on Substantial Equivalence: The entire submission is built around demonstrating "substantial equivalence" to existing predicate devices (K910215 and K954987). This means the manufacturer is arguing that the modified device is as safe and effective as devices already on the market, not necessarily presenting novel performance data against a specific set of criteria as might be expected for an AI-powered diagnostic product.
• No AI Component: The device described is a dialysate delivery system, a piece of medical hardware with a software modification. There is no mention of any Artificial Intelligence (AI) component, machine learning algorithms, or image analysis involved. Therefore, questions related to AI performance, such as MRMC studies, standalone algorithm performance, or ground truth for training sets, are not applicable.
• Information Not Present: The document does not contain information on:
  • Sample sizes for test sets or data provenance.
  • Number of experts or their qualifications for ground truth establishment.
  • Adjudication methods.
  • MRMC comparative effectiveness studies or effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used (pathology, outcomes data, etc.).
  • Sample size for training sets.
  • How ground truth for training sets was established.

In summary, the provided text describes a regulatory submission for a minor software modification to an existing medical device, emphasizing its substantial equivalence to predicate devices. It does not contain the kind of detailed performance study information, particularly in the context of AI, that your request anticipates.

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