(88 days)
The SMD Sr90-1 Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy of tumors and benign growths.
The SMD Sr90-1 RBS device is intended for use within a manual brachytherapy applicator system.
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This document is a 510(k) clearance letter for the Salutaris Medical Devices, Inc. SMD Sr90-1 Radionuclide Brachytherapy Source. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding specific acceptance criteria, device performance metrics, or the details of a study (test set, training set, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) that proves the device meets any such criteria.
The letter focuses on regulatory approval and compliance, not on performance evaluation studies. Therefore, I cannot construct the requested table or answer the specific questions about sample sizes, data provenance, expert ground truth, or study methodologies based on the input provided.
The document only indicates the "Indications for Use" for the device: "The SMD Sr90-1 Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy of tumors and benign growths. The SMD Sr90-1 RBS device is intended for use within a manual brachytherapy applicator system."
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.