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The D731 MICRO Ph.I.S.I.O. with 27 micron screen with phosphoryIcholine coating and the D733 MICRO Ph.I.S.I.O. with 40 micron screen with phosphoryIcholine coating are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that may be 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 D731/D733 MICRO Ph.I.S.I.O. Arterial Filters are sterile, non-pyrogenic disposable filter for use in the arterial line of the cardiopulmonary bypass circuit with flow rate not exceeding 6.0 liters/minute. The D731/D733 MICRO Ph.I.S.I.O. are Arterial Filters with 27 and 40 micron filters screen, respectively. The devices are designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris, greater than the pore size, from the arterial line perfusate.

Here's an analysis of the acceptance criteria and study information for the D731/D733 MICRO Ph.I.S.I.O. Arterial Filters, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or detailed reported device performance values in a table format. Instead, it refers to broad compliance with guidance documents and established specifications. The main "acceptance criteria" appear to be meeting the performance of the predicate device and relevant industry standards.

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

• Sample Size: Not explicitly stated. The document mentions "Applicable tests were carried out," "In vitro testing was carried out," and "Testing supplied... includes performance testing that demonstrates compliance with performance specifications." It does not provide the number of devices tested.
• Data Provenance: The device manufacturer is Sorin Group Italia S.r.l., based in Italy. The tests were likely conducted by the manufacturer or a contract research organization on their behalf. The document does not specify the country of origin of the data beyond the manufacturer's location. The tests are described in the "NON CLINICAL TEST RESULTS" and "IN VITRO TEST RESULTS" sections, suggesting a retrospective approach where existing data or newly generated lab data was compiled for the 510(k) submission, rather than a prospective clinical trial.

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

This information is not provided in the document. The tests described are non-clinical and in-vitro, focusing on device performance specifications rather than expert-derived ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the described tests are non-clinical and do not involve human interpretation or adjudication in the way a clinical study with expert readers would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The document describes a medical device (arterial filter) and its non-clinical performance, not an AI or imaging device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical arterial filter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be established performance specifications and regulatory guidance.

• For biocompatibility: ISO 10993-1 and FDA May 1st, 1995 Memorandum.
• For in vitro performance: "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" (November 29, 2000), and comparison to the predicate device (AF 620/640 Ph.I.S.I.O. Arterial Filters).
• For sterility and non-pyrogenicity: Effectiveness of production techniques to assure these properties.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable. See point 8.

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