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The INTRABEAM® System is indicated for radiation therapy treatments. The INTRABEAM® Spherical Applicators are indicated for use with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments. The INTRABEAM® Balloon Applicator together with the INTRABEAM® System is intended to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.

The safety and effectiveness of the INTRABEAM® System as a replacement for whole breast irradiation in the treatment of breast cancer has not yet been established.

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This document is a 510(k) clearance letter from the FDA for the Carl Zeiss INTRABEAM® System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic or clinical accuracy (like sensitivity, specificity, etc.) for a medical imaging or AI device.

Instead, this document focuses on:

• Regulatory clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Intended Use: Defining the radiotherapy treatments for which the device is indicated.
• Limitations and Warnings: Explicitly stating that the "safety and effectiveness of the Carl Zeiss INTRABEAM® System with Balloon Applicators for breast brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established," and requiring this warning to be in the labeling.

Therefore, I cannot provide the requested information about acceptance criteria and a performance study based on the provided text. The traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically described for diagnostic AI/imaging devices (e.g., sensitivity, specificity, F1 score) are not present in this regulatory clearance letter. The "acceptance" here relates to regulatory clearance based on substantial equivalence, not a direct performance study like those for AI algorithms.

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