(188 days)
The 2.5-D and 3-D AUTIMO Systems are intended for the fabrication and positioning in radiotherapy of irregular shielding blocks, dose modifiers, and compensators.
The AUTIMO 2.5-D and 3-D models are computer-controlled cutting tool systems for producing customized shielding blocks for use in radiotherapy. The computer accepts files from existing treatmentplanning system operating on a LAN. The GE-Target, Siemens Helax, and Theratronics Theraplan systems are examples of such treatmentplanning software. The computer interprets the files from the planning system and communicates with the AUTIMO device through a serial port.
The provided document describes the 510(k) summary for the HEK AUTIMO 2.5-D and 3-D systems, which are computer-controlled cutting tool systems for producing customized shielding blocks in radiotherapy.
The document does not contain information related to software performance acceptance criteria or a study proving adherence to such criteria. Instead, it focuses on the device's substantial equivalence to a predicate device based on electrical safety and electromagnetic compatibility testing.
Therefore, I cannot provide the requested information in the format specified. The document explicitly states:
- "HEK Medizintechnik carried out testing to address the following issues: (1) electrical safety (2) eletromagnetic compatibility."
- "The results from these tests supported the safety and effectiveness of the 2.5-D and 3-D AUTIMO Systems and demonstrates that it is substantially equivalent to the predicate device."
- "The AUTIMO is simply a modification with updated hardware and cosmetic changes from the predicate device."
This indicates that the "study" mentioned in the document primarily pertains to hardware safety and EMC, rather than a clinical or performance study of an AI algorithm or software functionality that would necessitate the details requested (e.g., sample size for test/training sets, expert ground truth, MRMC study, standalone performance).
The "predicate device" mentioned is the MCP-70-SE (K844180), and the new AUTIMO system is deemed "substantially equivalent" based on its technological characteristics being the same as the predicate, with only updated hardware and cosmetic changes.
In summary, none of the specific information requested about acceptance criteria for device performance, study details (sample sizes, provenance, ground truth, expert review, MRMC, standalone), or training set data is present in this 510(k) summary because the device is a physical cutting tool system, not an AI/software-driven diagnostic or treatment planning system requiring such evaluations.
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.