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The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.

The expanded indications for use are also applicable as previously presented for pReference Treatment System (K983793), including hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.

The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

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I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "pReference IMRT Treatment Planning Module" and its indications for use. It primarily focuses on the regulatory approval and substantial equivalence to predicate devices.

The document does NOT contain information about specific acceptance criteria, a study proving the device meets those criteria, or the detailed methodology of such a study.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported performance, nor can I answer questions about:

• Sample sizes (test, training) or data provenance
• Number of experts or their qualifications
• Adjudication methods
• MRMC comparative effectiveness study or effect size
• Standalone performance
• Type of ground truth used
• How ground truth for training was established

The letter only states that the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use. This means the FDA determined it performs as safely and effectively as existing, legally marketed devices, but it does not detail the specific performance metrics or studies that would typically be associated with defined acceptance criteria.

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• The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.
• The indications for use of pReference Treatment System are expanded to include lesions requiring extracranial stereotactic radiotherapy or radiosurgery. These include hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.
• The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

Not Found

The provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. This document is an FDA 510(k) clearance letter for the "pReference Treatment System," which is a treatment planning system. It outlines the device's indications for use and confirms its substantial equivalence to a predicate device.

Therefore, I cannot populate the requested information. The document focuses on regulatory clearance rather than a detailed performance study.

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The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.

The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

Not Found

I am sorry, but the provided text from the FDA 510(k) summary does not contain the specific information required to answer your request about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document is a clearance letter for a device called "Explorer 3D Stereotactic Irradiation Software" (K991815) and an "Indications For Use" statement. It primarily focuses on the substantial equivalence determination to a predicate device (pReference TPS, K970464) and the regulatory classification.

To answer your questions, I would need a more detailed study report or a different section of the 510(k) submission that specifically addresses the performance testing and validation of the device.

Ask a specific question about this device