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The CT/MR Tandem and Ovoid Set is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR Brachytherapy.

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This FDA clearance letter describes a new device, the "CT/MR Tandem and Ovoid Set," but it does not describe a study involving AI or software performance evaluation. The document focuses on the substantial equivalence of this physical medical device (an applicator for brachytherapy) to a predicate device, primarily through mechanical, material, and compatibility testing.

Therefore, I cannot extract information related to acceptance criteria for AI model performance or a study proving that an AI device meets acceptance criteria, as the provided text doesn't contain such a study.

The document discusses:

• Biocompatibility Testing: Ensuring the materials are safe for patient contact.
• Magnetic Resonance Testing (MR): Confirming the device is MR safe/compatible.
• Cleaning, Disinfection, and Sterilization Testing: Verifying the device can be properly cleaned and sterilized for repeated use.
• Human Factors Validation Study: To ensure the device is user-friendly and performs as intended for its users and environment.
• Mechanical and Acoustic Testing: To demonstrate the device performs as intended and meets design specifications.

These tests are for the physical device's safety and effectiveness, not for an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fill in the requested table and details for AI-related performance.

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