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Source Production & Equipment Cc., Inc. (SPEC) Model M-31 198 Ytterbium Brachytherapy Sources, with individual activities up to 5 mCi (185 MBq), are indicated for temporary or permanent interstitial. intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors such as for lung cancer. Model M-31 Brachytherapy Source may be used concurrently with or following treatment with other interventions, such as external beam therapy, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.

SPEC Model M-31 is a singly-encapsulated 18° vtterbium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive 19° tterbium pellet. The capsu the pellet consists of a titanium tube which is closed on each end with titanium wires which are laser-welded to the tubing.

This document is a 510(k) summary for a medical device (Radionuclide Brachytherapy Source) and does not contain information about studies conducted to prove device performance against acceptance criteria. Instead, it describes the device, its intended use, and its technological characteristics, and declares substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria and study details.

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