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The SAGITTL is indicated to assist in the proper positioning and re-positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments.

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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets those criteria, as requested. The document is an FDA 510(k) clearance letter for a medical device called SAGITTILTTM, indicating that it has been found substantially equivalent to a predicate device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts, their qualifications, or adjudication methods for any test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Details about a standalone algorithm performance study.
• The type of ground truth used.
• Sample size for training data or how its ground truth was established.

The document primarily focuses on the regulatory clearance for the device, its intended use (positioning and re-positioning patients for radiation therapy), and general FDA compliance information. It does not delve into the specifics of performance studies or acceptance criteria beyond indicating that it was deemed "substantially equivalent" to a legally marketed predicate device.

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