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The Rotaflow Centrifygal Pump is a device that uses a method other to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

· Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels: or

· Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The RotaFlow Centrifugal Pump is is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

This document is a 510(k) premarket notification summary for the RotaFlow Centrifugal Pump with Bioline Coating. It focuses on demonstrating substantial equivalence to pre-existing devices. This type of regulatory submission does not contain the detailed study results and acceptance criteria typically used to prove a device meets specific performance metrics in the way a clinical study for a novel diagnostic or treatment would.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the manner you've requested for a device that involved clinical performance testing with metrics like sensitivity, specificity, or AUC. The "acceptance criteria" here are based on demonstrating that the new device (with Bioline coating) performs similarly to the predicate devices and meets relevant safety standards (integrity, performance, biocompatibility, sterility) for a medical device of its class.

Here's an attempt to answer your questions based on the provided text, recognizing the limitations:

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

As explained above, this document describes a special 510(k) for a coating modification. The "acceptance criteria" are implied to be substantial equivalence to predicate devices regarding safety and effectiveness, demonstrated through evaluation of integrity, performance, biocompatibility, and sterility. The document does not provide quantitative performance metrics or a detailed acceptance criteria table as might be found in a clinical trial report.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" sample size in the context of clinical or diagnostic performance. The evaluations mentioned (integrity, performance, biocompatibility, sterility) would typically involve laboratory testing. The provenance of this data (e.g., country of origin, retrospective/prospective) is not provided in this summary.

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

This type of information is not relevant to a 510(k) submission for a device change related to a coating, particularly when the submission focuses on substantial equivalence through non-clinical testing (integrity, performance, biocompatibility, sterility). There isn't a "ground truth" established by human experts in the context of a diagnostic test set described here.

4. Adjudication method for the test set

Not applicable for this type of submission.

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 medical pump, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a mechanical pump, not an algorithm.

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

For the evaluations of integrity, performance, biocompatibility, and sterility, the "ground truth" would be established by validated scientific methodologies and standards relevant to each of these areas (e.g., ISO standards for biocompatibility, engineering specifications for integrity and performance, validated sterilization methods). It does not involve expert consensus, pathology, or outcomes data in the way a diagnostic device would.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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