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The Terumo Circuit Connectors are intended to be used to interconnect tubing and other devices within a circuit during extra-corporeal bypass procedures. The devices can be used in procedures lasting up to 6 hours in duration.

The connectors that are the subject of this premarket notification are of various designs (quick I he connection, etc.), each of which provides for the flow of blood and extracorporeal fluids through the bypass circuit. Each of the connectors is made from various plastics - all of which are common in medical devices that are already on the market. There are no new and/or exotic materials used in the manufacturing of the proposed devices.

Here's a breakdown of the acceptance criteria and study information for the Terumo Circuit Connectors, based on the provided text:

Acceptance Criteria and Device Performance

The provided text details that clinical studies were not necessary. Instead, substantial equivalence was demonstrated through in-vitro performance evaluations. The "acceptance criteria" are implied by the successful completion of these tests without raising new safety or effectiveness concerns compared to the predicate device.

Study Details

The provided document describes in-vitro performance evaluations to demonstrate substantial equivalence, rather than a traditional clinical study or AI-related study. Therefore, several points are not applicable.

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

   • The document does not specify the exact sample sizes for each in-vitro test (e.g., how many connectors were tested for leakage or circulation).
   • Data provenance is not specified, but it's implied to be from Terumo's internal testing. The tests are "in-vitro," so country of origin for patient data is not relevant. The nature of the tests (attribute evaluations, comparative testing) makes them prospective in design for the purpose of the submission.

2. 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. Ground truth in this context is established by engineering specifications and objective test results, not expert interpretation of diagnostic images or patient outcomes.

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

   • Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which are not described here.

4. 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 is a medical device submission for physical connectors, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a medical device submission for physical connectors, not an algorithm.

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

   • The ground truth for these in-vitro studies is based on engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and standardized testing protocols designed to verify physical and chemical properties. The predicate device's established performance also serves as a comparative ground truth for the 6-hour circulation test.

7. The sample size for the training set:

   • Not applicable. There is no machine learning or AI component requiring a training set.

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

   • Not applicable. There is no machine learning or AI component requiring a training set.

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