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The Rivetti-Levinson Intraluminal Shunt is indicated for use in preventing ischemia during the construction of coronary artery bypass grafts (either saphenous vein or of mammary artery) in the non-arrested heart.

Intraluminal shunting is indicated for temporary perfusion of the distal coronary lumen as an adjunct to the surgical technique and as a mechanism to prevent myocardial ischemia while the target coronary artery is opened and surgically grafted to a donor vessel.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device called the "Rivetti-Levinson Intraluminal Shunt". It states that the device is substantially equivalent to legally marketed predicate devices.

The document discusses:

• The trade name of the device.
• Regulatory class and product code.
• The FDA's determination of substantial equivalence.
• General controls provisions and other regulations the device is subject to.
• Indications for use of the device.

However, it does not include details about:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or its provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Multi reader multi case (MRMC) comparative effectiveness study or its effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for the training set was established.

This document is a regulatory approval notice, not a clinical study report or a technical performance evaluation.

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