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Diasol -- Additives are used in conjunction with Diasol acid concentrate, AAMI standard water and Sodium Bicarbonate as Dialysate solution for concentralia, 2011 homodialysis in 3 stream homodialysis machines allowing the physician to customize the dialysate to meet the patient's needs .

puysesan additives, Infusates and Infusate additives are for use with sorbent regenerated Dulysis and allows physicians to customize the dialysate to meet the patient's needs.

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This is a response to the prompt based on the provided text, however, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically understood in the context of AI/ML-powered medical devices (performance metrics, test sets, ground truth establishment, etc.) does not apply to this document.

The document is a 510(k) clearance letter from the FDA for a conventional medical device, "Diasol - Additives," which are used in hemodialysis. The FDA's review for such devices primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than performance against predefined acceptance criteria for an AI algorithm.

Therefore, the requested information cannot be extracted from this document in its current form. The document does not describe any acceptance criteria, device performance metrics, study design, sample sizes, expert involvement, or ground truth for an AI/ML device.

However, if we were to interpret "acceptance criteria" and "device performance" in the context of a conventional medical device clearance (even though it's not explicitly about AI/ML), it would be related to meeting the standards of the predicate device and the safety and effectiveness for its intended use.

Given this limitation, I will respond by stating that the information requested for AI/ML device performance is not present in the provided document.

Analysis of the Provided Document Regarding AI/ML Device Performance:

The provided document is a 510(k) clearance letter from the FDA for a device named "Diasol - Additives," referenced under K020231. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The "Statement of Intended Use" describes "Diasol - Additives" as components used in conjunction with other materials (Diasol acid concentrate, AAMI standard water, and Sodium Bicarbonate) to form a dialysate solution for hemodialysis machines. It also mentions their use with sorbent regenerated dialysis to customize dialysate for patient needs.

Crucially, there is NO mention of any AI or Machine Learning component, algorithm, or software in this document. The device appears to be a chemical additive product used in a medical procedure, not an AI/ML powered diagnostic or therapeutic device.

Therefore, the questions regarding acceptance criteria, study data, sample sizes, ground truth, expert opinions, and MRMC studies, which are pertinent to the evaluation of AI/ML medical devices, are not applicable to the information contained in this FDA clearance letter.

Conclusion:

The provided document does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML powered medical device. The device described, "Diasol - Additives," is a conventional medical product used in hemodialysis, and its clearance process, as reflected in this 510(k) letter, does not involve the type of AI/ML specific evaluations outlined in your prompt.

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