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D130 Ph.I.S.I.O. Dideco Kids with 40 micron screen phosphoryIcholine coated is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardidpulmony in the altenal life of the extraction of our dailing any processions particulate debrish that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The D130 Ph.I.S.I.O. is a sterile, non-pyrogenic disposable filter for use in arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 0.7 liters/minute. The D130 Ph.I.S.I.O. is a Neonatal Arterial Filters with 40 micron filter screen designed to remove potentially harmful gaseus embeli, aggregated blood constituents, and particulate debris greater than 40 microns from the arterial line perfusate. The overall dimensions have been reduced in the modified version of the D736 Ph.I.S.I.O. unmodified device resulting in decreased priming volume and maximum blood flow to 0.7 liters/minute. The internal modifications which mainly involve the filter screen geometry, make the new filter esently a downscaled and simplified version of the D736 Ph.I.S.I.O.. The modifications to some of the external features result in enhanced ergonomics.

D130 Ph.I.S.I.O. Dideco Kids Neonatal Arterial Filter Study Summary

This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the D130 Ph.I.S.I.O. Dideco Kids Neonatal Arterial Filter to its predicate device, the D736 Ph.I.S.I.O. The study focused on in vitro evaluations and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated against established specifications, primarily demonstrating equivalence or improvement compared to the predicate device, the D736 Ph.I.S.I.O.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test set. However, it indicates that "A complete battery of tests were carried out" and "Testing was performed on the D130 Ph.I.S.I.O." and "all tests, when applicable, were performed on sterilized aged devices comparing the D130 Ph.I.S.I.O. vs. the D736 Ph.I.S.I.O." This implies a sufficiently representative number of devices were tested to draw conclusions on performance, aging, and comparison.

The data provenance is from in vitro testing and laboratory experiments conducted by Sorin Group Italia S.r.l. in Italy. The results likely represent prospective data generation specifically for this 510(k) submission, as these tests were carried out to meet current regulatory guidance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of medical device (arterial filter) relies on objective, measurable physical and chemical properties rather than subjective interpretation of diagnostic images or clinical assessments by human experts. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists interpreting images) is not directly applicable here. The "ground truth" or "established specifications" were likely based on:

• Engineering and Biomedical Scientists: Professionals with expertise in fluid dynamics, materials science, biocompatibility, and medical device design.
• Regulatory Standards: ISO 10993-1:2002 and FDA 1995 Memorandum, and "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" Final Guidance for Industry, dated November 29, 2000. These standards themselves are developed through expert consensus and scientific validation.
• Predicate Device Performance: The established performance of the D736 Ph.I.S.I.O. served as a benchmark for substantial equivalence.

No specific number or qualifications of individual human experts for ground truth establishment are provided because the evaluation method is primarily objective testing against predefined technical standards.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements (e.g., flow rate, pressure drop, particle count, chemical analysis) that do not require human adjudication in the typical sense of a clinical or image-based study. The results are compared directly to pre-established specifications or the predicate device's performance.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical device (an arterial filter) and not an AI or software-as-a-medical-device (SaMD) that involves human readers interpreting data.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an arterial filter and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used was a combination of:

• Quantitative measurements and physical properties: Measured values for operating blood volume, pressure drop, flow rate, filtration efficiency, and integrity tests.
• Biological and chemical assays: Results from biocompatibility tests (hemolysis, cytotoxicity, etc.), sterility tests, pyrogenicity, and leaching tests.
• Established Regulatory Standards: Compliance with ISO 10993-1:2002, FDA Guidance documents, and the D736 Ph.I.S.I.O. 510(K) (K002493) data.

This represents objective scientific and technical data, often rooted in established scientific principles and regulatory benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical product designed through engineering principles.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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