Search Results

Stereotactic Body Frame Cod. 70-1A is patient localization system for use in stereotactic radiosurgery. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning and conduct of 3 dimensional radiation therapy.

Stereotactic Body Frame is a spatial reference system external to the body of a patient undergoing radiotherapy treatment that provides accurate positioning of the patient in spatial registration with diagnostic images and a radiotherapy treatment plan.

The provided text is a 510(k) summary for the Stereotactic Body Frame, focusing on its substantial equivalence to a predicate device. It specifies the intended use and compares characteristics, but it does not contain information about studies proving the device meets specific acceptance criteria related to its performance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
• If a standalone study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to a previously cleared device (Elekta Instrument AB's Stereotactic Body Frame, K960338) based on similarities in intended use, design, and materials, rather than presenting a performance study with acceptance criteria.

Ask a specific question about this device