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The iDMST™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.

The subject device, iDMS™ Data Management System, is essentially the CyberKnife® Data Management System (CDMS) cleared in the predicate device, the CyberKnife® Robotic Radiosurgery System. This submission simply establishes the iDMS™ System as a stand-alone data management system and reflects its integration with Accuray's robotic radiosurgery and ring gantry systems, including but not limited to the CyberKnife® System and Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System. As such, modifications are limited to those required to integrate the iDMS™ System with the Radixact™ System which is a next generation TomoTherapy® Treatment System.

The iDMS™ System is a data management system that provides storage, applications and interfaces to access, add, modify, export, delete, and validate patient, user and system data for Accuray's radiotherapy, stereotactic radiotherapy, and stereotactic radiosurgery delivery systems, including but not limited to the CyberKnife® System and Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System, as well as treatment planning systems, including the Precision™ Treatment Planning System. The IDMS™ System can store and retrieve treatment plans and delivery data for multiple systems.

I am sorry, but the provided text does not contain detailed information about the acceptance criteria and study results for the iDMS™ Data Management System. The document is a 510(k) summary for FDA clearance and primarily focuses on establishing substantial equivalence to a predicate device.

While it mentions "Testing was completed to verify that all hardware and software perform as designed, as well as regression testing to verify the integrity of existing features. Testing demonstrated that the iDMS™ System performance is equivalent to the predicate, the CDMS features," it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states that the iDMS™ Data Management System is "essentially the CyberKnife® Data Management System (CDMS) cleared in the predicate device, the CyberKnife® Robotic Radiosurgery System," and that "modifications are limited to those required to integrate the iDMS™ System with the Radixact™ System." This suggests that the system's performance might be considered equivalent to the predicate device without requiring a new, extensive clinical study if the modifications are minor and do not alter fundamental performance characteristics.

Therefore,Based on the provided text, I cannot answer your request.

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