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The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.

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I am sorry, but the provided text does not contain the detailed information about the acceptance criteria, device performance, or the specific study details that you requested. The document is a 510(k) clearance letter from the FDA for an "RC-115 Optional Remote Control (accessory to SR-115 Portable X-ray System)". It states that the device is substantially equivalent to legally marketed predicate devices.

The letter explicitly focuses on:

• Approval of marketing: It grants permission to market the device based on substantial equivalence.
• Regulatory classification: It identifies the device as Class II with product code IZL and regulation number 21 CFR 892.1720 (Mobile x-ray system).
• General regulatory requirements: It reminds the applicant about various FDA regulations they must comply with (registration, listing, labeling, good manufacturing practice, electronic product radiation control).
• Indications for Use: The portable X-ray system is intended for "General Purpose Portable Radiographic Applications."

It does not provide:

• A table of acceptance criteria or reported device performance.
• Details about specific studies, sample sizes, data provenance, or ground truth establishment.
• Information on expert reconciliation, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request for these specifics based on the input provided.

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