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The device is indicated for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

The device is indicated to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device is indicated for use for 6 hours or less.

KIDS Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and they can be used up to 6 hours.

The KIDS Arterial Filters are the modified version of the disposables currently marketed in the D130 PH.I.S.I.O. Dideco Kids Neonatal Arterial Filter (K063255) and the D131 PH.I.S.I.O. Dideco Kids Infant Arterial Filter (K072308).

The provided text is a 510(k) premarket notification for a medical device called "KIDS Arterial Filters." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain any information about acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test or training sets, expert review processes, or any form of AI/ML performance study.

The document explicitly states:

• "No clinical testing was conducted in support of the KIDS Arterial Filters, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use." (Page 7, Section VIII. Clinical Performance Data)
• The performance data is described as "Non-Clinical Performance Data" and states: "Sorin Group Italia S.r.l. has conducted extensive verification and validation testing of the KIDS Arterial Filters... The KIDS Arterial Filters comply with all the applicable voluntary standards related to Arterial Filters. The devices passed all the testing in accordance with national and international standards." (Page 7, Section VII. Non-Clinical Performance Data)

Therefore, based on the provided text, I cannot answer the questions related to the acceptance criteria and the study proving the device meets these criteria in the context of AI/ML device performance or clinical study results.

The device is a physical medical device (an arterial filter), not an AI/ML software device, and its approval is based on substantial equivalence to existing devices through non-clinical testing and adherence to standards, not through clinical performance metrics or AI algorithm validation.

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