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125I Brachytherapy Seeds are intended for permanent interstitial implantation in selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.

The 125I Brachytherapy Seeds consist of 125I absorbed onto the surface of a spherical polymeric substrate sealed in a welded titanium casing. A typical Brachytherapy Seed is shown below. For higher activity levels the number of beads with absorbed 1431 may be increased from 2 to 4.

Typically, the 1351 Brachytherapy Seeds are placed within or in close to the turnor to be treated utilizing guidance. The devices are delivered using an 18 gauge or greater diameter hypodermic needle.

The provided text describes the Prostec 125I Brachytherapy Seed and its substantial equivalence to a predicate device, rather than a study with detailed acceptance criteria and performance metrics in the typical sense of a clinical trial or algorithm validation. This submission is for a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device.

However, I can extract the "acceptance criteria" as implied by the comparison to the predicate device and the reported "device performance" as stated in the document.

Here's an interpretation based on the provided text, recognizing that this is a technical equivalence comparison, not a performance study in the context of diagnostic algorithms or clinical outcomes:

1. Table of Acceptance Criteria and Reported Device Performance

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