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The intended use of this device is to sheild healthy tissue from radiation. The MED-TEC, INC. MT-MX3 thermoplastic shield MATRIX operates in the same manner as other personnel protective shields. or The intended use of the MED-TEC, INC. MT-MX3 MATRIX thermoplastic shield is to shield healthy tissue from radiation.

MED-TEC, INC. has a Personnel Protective Shield System to be manufactured by MED-TEC, INC.

I am sorry, but the provided text from the FDA 510(k) letter and the indications for use document for the Med-Tec Corporation Matrix MT-MX3 device does not contain the kind of detailed information requested about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications.

The documents indicate that the Matrix MT-MX3 is a "Personnel Protective Shield System" (thermoplastic shield) intended to "shield healthy tissue from radiation." The 510(k) letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on a de novo clinical study with pre-defined acceptance criteria for performance metrics in the same way a novel AI or diagnostic device might. The provided documents are administrative and regulatory approvals, not clinical study reports.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based on the given information.

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