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

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 mplant 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

This is a premarket notification for I-125 Implant Seeds, which is a medical device. The provided text is a letter from the FDA determining substantial equivalence to a predicate device and a statement of indications for use.

Based on the provided documents, no acceptance criteria or a study proving the device meets acceptance criteria are present. The documents are a regulatory letter from the FDA and a statement of indications for use. They do not contain any performance data, study design, or acceptance criteria.

Therefore, I cannot provide the requested information.

Ask a specific question about this device

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.

Ask a specific question about this device