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The Pain Care™ 4200 is indicated to provide continuous infusion for the post-operative management of pain.

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I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a medical device. The document is an FDA 510(k) clearance letter for a device called "Pain Care 4200," indicating that it has been found substantially equivalent to a predicate device.

The clearance letter primarily states:

• Device Name: Pain Care 4200
• Regulation Number: 880.5725 (Infusion Kit)
• Regulatory Class: II
• Product Code: MEB
• Indications For Use: To provide continuous infusion for post-operative management of pain.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies.
6. Results of standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request with the given input.

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