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The Bio-Probe blood flow monitoring system is to be used with an appropriate model Bio-Console® extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.

The Trillium™ Bio-Probe Disposable Blood Flow Probe is a single-use insert designed to be used in the Bio-Probe Blood Flow Monitoring System.

The provided text describes a Special 510(k) submission for a modification to an existing device, the Bio-Probe Disposable Blood Flow Probe. The modification involves coating the blood contact surfaces with Trillium™. The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria or conduct a new clinical study with acceptance criteria in the traditional sense typically associated with new device approvals.

Therefore, the information requested in your prompt related to specific acceptance criteria, studies proving those criteria, sample sizes, expert involvement, and ground truth establishment, is largely not applicable in the context of this specific 510(k) submission.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable. This 510(k) is for a modification (adding a coating) to an already cleared device. The submission focuses on demonstrating that the modification does not affect safety or effectiveness and that the new device remains substantially equivalent to the predicate. There are no explicit "acceptance criteria" for novel performance metrics discussed. Instead, the focus is on comparability.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Provided. The text mentions "biocompatibility and in vitro bench testing" but does not specify sample sizes for these tests, nor does it provide details on data provenance (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable/Not Provided. The testing described is "biocompatibility and in vitro bench testing," which typically involves laboratory analyses rather than interpretation by human experts to establish ground truth in the way a diagnostic AI might.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. The described testing does not involve human adjudication in the context of diagnostic interpretation.

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 blood flow probe, not an AI-powered diagnostic tool, and the submission is not for a clinical effectiveness study.

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

• Not Applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable/Implied by testing. The "ground truth" for the in vitro bench testing would be established by the defined analytical methods for "Coating Characteristics," "Physical Characteristics," and "Performance Characteristics," and comparing those to established specifications or predicate device characteristics.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not Applicable.

Summary of Device Performance (as stated in the 510(k) for substantial equivalence):

The submission concludes that:

• "The biocompatibility and in vitro bench testing demonstrated that when compared to the ... predicate devices, the Trillium™ Bio-Probe Disposable Blood Flow Probe does not [present new questions of safety or effectiveness] and are substantially equivalent to other [legally marketed] extracorporeal cardiopulmonary devices."
• The in vitro bench testing included analysis of:
  • Coating Characteristics
  • Physical Characteristics
  • Performance Characteristics

This 510(k) is an example of a "Special 510(k)" which is used for modifications to a manufacturer's own legally marketed device where the modification does not raise new questions of safety and effectiveness, and where established methods exist to assess the impact of the change. In such cases, the "study" is often a series of bench tests and biocompatibility assessments to confirm that the modified device performs comparably to the predicate and does not introduce new risks.

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