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The Contura Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

The Contura MLB applicator consists of a multi-lumen catheter connected to an inflatable spherical balloon that can be attached to commercially available High Dose Rate remote afterloader equipment for passage of the radiation source delivery wire. Five radiation source wire lumens are provided; one central lumen located along the long axis of the applicator and four curved lumens symmetrically offset from the central lumen. The balloon is inflated to a 4 or 5 cm spherical shape by a controlled volume injection of physiological saline to approximately 33 or 58 ml, respectively.

This question refers to a 510(k) premarket notification for a medical device called the "Contura Multi-Lumen Balloon Source Applicator for Brachytherapy" (K080791). This submission focuses on a modification to a warning statement in the labeling and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The submission explicitly states: "The device design, materials, processes, etc. have not been changed with this application. The modification is to a warning only, therefore, the Contura Multi-Lumen Balloon Source Applicator as described in this submission is substantially equivalent to the predicate device."

Therefore, I cannot extract the requested information from the provided text for the following reasons:

*   **No Acceptance Criteria or Performance Study:** The document does not describe any acceptance criteria or any study designed to prove the device's performance against such criteria. The focus is solely on a labeling change.
*   **No AI Component:** The device is a physical medical instrument (a multi-lumen balloon source applicator for brachytherapy), and the submission does not mention any artificial intelligence or software component. Therefore, questions related to AI performance, such as MRMC studies or standalone algorithm performance, are not applicable.
*   **No Test Set or Training Set Information:** Since no performance study is described, there is no information on sample sizes for test or training sets, data provenance, ground truth establishment, or expert qualifications.

Conclusion:

The provided document K080791 does not contain the information requested regarding acceptance criteria, device performance studies, or details relevant to AI/software performance evaluation. The submission is a 510(k) for a labeling modification to an existing physical device, relying on substantial equivalence to a predicate device rather than new performance data.

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