Search Results

The SeedLinks™ are indicated for use in brachytherapy source spacing and linking in brachytherapy procedures.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets them in the format requested. The document is a 510(k) clearance letter from the FDA, which confirms that the SeedLinks™ device is substantially equivalent to a legally marketed predicate device.

Specifically, the text does not include:

• A table of acceptance criteria and reported device performance.
• Details about the sample size used for the test set or its data provenance.
• Information about the number or qualifications of experts used for ground truth.
• The adjudication method.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document primarily focuses on the regulatory clearance and the intended use of the device, which is "for use in brachytherapy source spacing and linking in brachytherapy procedures." It confirms that the device is classified as a radionuclide brachytherapy source (21 CFR 892.5730, Class II, Product Code 90 KXK) and can be marketed based on its substantial equivalence to a predicate device, subject to general and special controls.

Ask a specific question about this device