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The North American Scientific Corporation's Pd-103 Radionuclide Brachytherapy Source is a device intended to deliver radiation by interstitial, intracavity or surface application for therapy of malignant lesions.

Pd-103 Radionuclide Brachytherapy Source

This is a clearance letter from the FDA for a medical device called the "Pd-103 Radionuclide Brachytherapy Source." The letter indicates that the device has been found substantially equivalent to pre-amendment devices and can be marketed.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document is a regulatory approval letter, not a scientific study report. It states that the device is "intended to deliver radiation by interstitial, intracavity or surface application for therapy of malignant lesions," but does not provide any data on its effectiveness or safety from specific studies.

Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text.

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