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The disposable AdvanCE® capsule endoscope delivery device is a 2.5 mm single sheathed device indicated for transendoscopic delivery of Capsules (with the dimensions of 10.5mm - 11.5mm in diameter and 23.5mm in length), to the stomach or duodenum. This device is intended for patients who are either unable to swallow the capsule, or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.

The disposable AdvanCE® capsule endoscope delivery device is a 2.5 mm single sheathed device.

I am sorry, but based on the text provided, I cannot fulfill your request. The document is a 510(k) clearance letter for a medical device called "Advance - Capsule Endoscope Delivery Device." This letter grants clearance for the device based on substantial equivalence to a predicate device but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document discusses:

• The device name and regulation number.
• The indication for use of the device.
• General regulatory requirements for marketing the device.

It explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the device was found to be as safe and effective as a legally marketed predicate device, but the details of how that safety and effectiveness were demonstrated through performance studies are not included in this particular document.

Therefore, I cannot extract the specific information you requested, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or their provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC study details or effect sizes.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

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