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Advanced Neuromodulation Systems Spinal Cord Stimulation Accessory Kit is for use during the implantation or revision of an ANS spinal cord stimulation (SCS) system, which is indicated for the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

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The provided text is a 510(k) clearance letter from the FDA for an "ANS SCS Accessory Kit." This type of document does not contain information about acceptance criteria, study designs, or device performance data.

510(k) clearances are based on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical trials proving safety and effectiveness from scratch. Therefore, the document indicates:

• No acceptance criteria or device performance report. The letter states that the device is "substantially equivalent" to predicate devices, meaning it has similar technological characteristics and is intended for the same use, raising no new questions of safety or effectiveness.
• No specific study details such as sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies are mentioned.

In summary, the provided document does not contain the information requested in your prompt. This information would typically be found in the 510(k) submission itself, not in the FDA's clearance letter.

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