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The Axxent Balloon Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver intracavity or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment.

The Axxent Balloon Applicator is a component of the Axxent Electronic Brachytherapy System, which utilizes a proprietary miniaturized X-ray source and does not require radioactive isotopes. The applicator allows the Axxent HDR Xray Source to deliver intracavitary or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment. The Axxent HDR X-ray Source mimics the penetration and dose characteristics of Iridium-192 within the treatment target. The Axxent Balloon Applicator is provided in five sizes to ensure proper fit into treatment areas of varying shapes and sizes. The applicators are disposable and provided sterile.

The provided text is a 510(k) premarket notification for the Axxent® Balloon Applicator. It primarily focuses on the regulatory submission and approval process, stating that the device has "No device design changes" and that "The purpose of this submission is only to expand the indications for use of the Axxent Balloon Applicator to deliver intracavitary or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment."

Critically, the document does not describe any new study proving device performance or establishing acceptance criteria. Instead, it relies on the substantial equivalence to a previously approved predicate device (K050843) and its existing technological characteristics.

Therefore, I cannot provide the requested table and study information because the provided text does not contain any new acceptance criteria or details of a study conducted to prove the device meets new acceptance criteria. The submission is purely about expanding the indications for use based on the previous approval.

To answer your request, a new study would need to have been conducted, and the details of that study, including acceptance criteria and performance data, would need to be present in the document.

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