(98 days)
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.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.