(166 days)
The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a radionuclide source into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.
The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a radionuclide source into the body for radiation therapy.
This looks like a 510(k) clearance letter from the FDA for a medical device called the "NIT Radionuclide Seed Applicator." This type of document declares that a device is "substantially equivalent" to a legally marketed predicate device, meaning it's considered safe and effective for its indicated use.
However, a 510(k) clearance letter does not typically contain detailed acceptance criteria or a study outlining specific performance metrics, sample sizes, ground truth establishment, or expert qualifications in the way you've described for an AI/CADe device.
The questions you've asked are highly relevant for the evaluation and clearance of AI-powered medical devices (often referred to as AI/CADx or AI/CADe). These types of devices typically undergo rigorous performance studies to demonstrate their efficacy, and the information you requested would be standard in their regulatory submissions and subsequent clearance documents.
Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria and the detailed study information. The document is a regulatory approval for a physical, manually operated medical device (a radionuclide seed applicator), not an AI-driven diagnostic or assistive technology.
To answer your questions, I would need a different type of document, specifically a regulatory submission summary or a published study for an AI/CADe device.
§ 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.