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The Sensus Healthcare TVM Balloon Applicator is intended to support the delivery of high-dose-rate X-ray radiation in support for brachytherapy.

The Sensus TVM Balloon Applicator is indicated for use with the Sensus IORT System to deliver intracavity or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment.

The Sensus Healthcare TVM Balloon Applicator is a component of the Sensus Healthcare IORT system, which utilizes an X-ray source and does not employ radioactive isotopes. The TVM Balloon Applicator supports the Sensus Healthcare IORT System's ability to deliver intraoperative brachytherapy wherever the physician chooses to delivery radiation therapy. The Sensus Healthcare TVM Balloon Applicator is provided in one size (variablevolume balloon) to support the achievement of proper fit within the varying patient anatomies. The applicator is a single-use disposable device that is provided sterile. Product sterility is achieved through the use of Gamma radiation (reference ISO 11137-1).

The provided text is a 510(k) summary for the Sensus Healthcare TVM Balloon Applicator. It describes the device, its intended use, and the non-clinical performance and safety testing conducted to demonstrate substantial equivalence to a predicate device.

However, it does not contain information regarding the acceptance criteria, the study design, or the performance results of an AI/ML-based medical device as typically outlined in the request. The Sensus Healthcare TVM Balloon Applicator is a physical medical device (a balloon applicator for brachytherapy) and the testing described is related to its physical and functional integrity, sterility, and biocompatibility, not its performance as an AI/ML algorithm.

Therefore, I cannot extract the information required to populate the table and answer the questions about AI/ML device study parameters (such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) from the provided text.

The closest relevant information, though not for an AI/ML device, would be in the "Non-Clinical Performance Testing" and "Non-clinical Safety Tests" sections which list the types of tests performed (e.g., System Level Verification Test, Pull Testing, Cytotoxicity) and the associated report numbers. However, these are mechanical and biological tests, not statistical performance metrics for an AI algorithm.

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