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The North American Scientific Corporation's I-125 Radionuclide Brachytherapy Source Model MED3631-A is a device intended to deliver radiation by interstitial intracavity or surface application for therapy of malignant lesions.

I-125 Radionuclide Brachytherapy Source Model MED3631-A

This document is a 510(k) premarket notification letter from the FDA regarding an I-125 radionuclide brachytherapy source. As such, it does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.

The letter approves the device based on substantial equivalence to a predicate device, meaning it was determined to be as safe and effective as a device already legally marketed. It does not provide data from a specific study designed to prove new acceptance criteria for this particular device.

Therefore, I cannot provide the requested information, which typically would be found in a clinical study report or a detailed performance validation report:

1. Table of acceptance criteria and reported device performance: Not present in this document.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable or present for this type of device (a brachytherapy source, not an AI diagnostic tool).
6. Standalone (algorithm only) performance: Not applicable or present.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (no AI/machine learning involved).
9. How the ground truth for the training set was established: Not applicable.

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