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The Capiox RX15 is intended to be used during open-heart surgical procedures requiring cardiopulmonary bypass for period up to 6 hours. The Capiox RX15 is for use with patients when required blood flow rate will not exceed 5 L/min (4 L/min if using the CXRX15RW30 product code or CXRX15RE30 Product code).

The Capiox RX15 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures, in post-operative chest drainage, and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement.

The design of the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir provides a semi-integral device whereby the oxygenator and heat exchanger are joined together, while the hardshell reservoir can be detached from the device assembly.

Here's a breakdown of the acceptance criteria and study information for the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document does not specify explicit sample sizes for each "in-vitro performance evaluation." Instead, it refers to "comparisons of the performance of the CAPIOX® RX15 Hollow Fiber Performance Oxygenator with/without Hardshell Reservoir and the predicate devices were conducted."
   • The origin of the data is not explicitly stated as "country of origin," but the submitter information lists "Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya city, Shizuoka Pref. Japan 418-0015," suggesting the tests were likely conducted in Japan or under the supervision of the Japanese entity.
   • All performance evaluations listed are described as "in-vitro performance evaluations," and there is an additional "in-vivo animal study" for the polymer coating. These would be considered prospective studies for the purpose of this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. The studies performed are primarily objective engineering and biological performance tests, not subjective evaluations requiring expert interpretation of results for ground truth.

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

   • This information is not applicable/provided as the performance evaluations are objective measurements (e.g., gas transfer rates, pressure drops, etc.) rather than subjective assessments that would require adjudication.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a medical oxygenator, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

   • Yes, the performance evaluations listed are standalone device evaluations. The device's performance is measured directly against predefined criteria or compared to predicate devices, without human in-the-loop performance as part of the primary evaluation.

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

   • The "ground truth" for the in-vitro performance evaluations is based on engineering and biological performance specifications and measurements. For example, gas transfer is measured quantitatively, and biocompatibility is assessed against established ISO standards.
   • For the biocompatibility of the polymer coating, an in-vivo animal study was conducted, where the "ground truth" would be the observed biological response or lack thereof in the animal model.

7. The sample size for the training set:

   • This is not applicable as the device is a medical hardware device (oxygenator) and not an AI/machine learning algorithm that requires a training set.

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

   • This is not applicable as there is no training set for this type of medical device submission.

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