(189 days)
125 Implant Seeds are indicated for permanent interstitial treatment of selected localized tumors such as head and neck, lung, pancreas and early stage prostate. 125 Implant Seeds may be used in superficial, intraabdominal or intra-thoracic locations. 125 Implant Seeds may also be used in the treatment of residual tumors following completion of external beam radiation therapy and for other recurrent tumors.
Not Found
The provided FDA 510(k) clearance letter and Indications for Use statement do not contain the kind of detailed information about acceptance criteria, study design, and performance metrics typically expected for AI/ML-driven medical devices.
This document is for a conventional medical device (I-125 Implant Seeds) that received 510(k) clearance in 1999. The clearance process for such devices largely relied on demonstrating substantial equivalence to a predicate device, often without the need for extensive clinical studies with specific performance metrics and ground truth establishment in the way AI/ML devices require.
Therefore, I cannot provide the requested information based on the given text. The information points you've requested (such as sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are characteristic of the evidence required for AI/ML device submissions, which is not applicable to this 1999 clearance for a radioactive seed.
§ 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.