(129 days)
GammaTileTM is intended to deliver radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms.
The GammaTile™ is a device, intended for the treatment of recurrent intracranial neoplasms that uses cesium-131 radioactive sources embedded in a collagen matrix. The GammaTile™ is designed to provide "adjuvant" radiation therapy therapy to eliminate any remaining neoplastic cells - to patients who require surgical resection of recurrent brain neoplasms. GammaTile™ is positioned within the resection cavity immediately after surgical excision of the brain neoplasm to deliver radiation therapy to any neoplastic cells that remain in proximity of the resection cavity.
The provided text is a 510(k) summary for the GammaTile™ device, which is a brachytherapy source. It does not describe a study involving an AI/ML device or its performance criteria, but rather a regulatory submission for a medical device. Therefore, I cannot extract the requested information as it pertains to AI/ML device performance and studies.
Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (Proxcelan™). The "Assessment of Non-Clinical Performance Data" section mentions "simulated clinical use testing, characterization of the radionuclide source and source spacing during bench testing," but these are not studies that fit the criteria of evaluating an AI/ML device's diagnostic or predictive performance in a clinical setting with human readers.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria for an AI device, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.
§ 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.