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The hygh-tec drainage is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liguid stools and to provide access for the administrations. The device is not intended for use on pediatric patients.

The hygh-tec drainage is sold as a kit to include a main catheter component, collection bag, inflation syringe, and closure strap. The catheter component consists of a retaining and sealing balloon element, a trans-anal segment, drainage shaft, an elastically deformable tip, a colored positioning ring, a stool irrigation tube, an irrigation line, and an air filling line.

I am sorry, but the provided text does not contain information regarding acceptance criteria and a study that proves the device meets the acceptance criteria for an AI/ML powered device. The document is a 510(k) premarket notification for a medical device called "hygh-tec drainage," which is a fecal management system, not an AI/ML powered device.

Therefore, I cannot provide the requested information, which includes:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth.
• Sample size for the training set.
• How the ground truth for the training set was established.

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