(224 days)
A single patient use disposable device to hold radioactive seeds, in magazine fashion, in the MICK radionuclear 200-TP applicator. This device performs the same function as the reusable magazines sold by Mick Radionuclear Instruments, Inc.
A single patient use disposable device to hold radioactive seeds, in magazine fashion, in the MICK radionuclear 200-TP applicator.
The provided documents are a 510(k) clearance letter from the FDA and an "Indications For Use" statement for the NIT Radionuclide Seed Magazine.
These documents do not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluations.
The FDA clearance is for a physical medical device (radionuclide seed magazine) under the traditional 510(k) pathway, which focuses on substantial equivalence to a predicate device rather than performance metrics from AI/ML models.
Therefore, I cannot fulfill your request for information about acceptance criteria, study details, training/test set specifics, or MRMC studies, as none of this information is present in the provided text.
§ 892.5650 Manual radionuclide applicator system.
(a)
Identification. A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.