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The m3 is intended to assist the radiation oncologist in the delivery of radiation to welldefined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In conjunction with Elekta and GE Linacs, the m3 performs the same function as customized shadow blocks or stereotactic collimators. This standard configuration is suitable for static conformal treatments and "step and shoot IMRT". The advanced m3 Siemens Integration feature available for Siemens Linacs allows additionally to perform "dynamic arc" and automated "step and shoot IMRT" treatments with the m3. The advanced Varian integration feature available for Varian Linacs allows to perform "dynamic arc" and "dynamic IMRT" treatments with the m3.

The m3 is a therapeutic X-ray Collimator. It comprises multiple motorised tungsten leafs, which are suited to shaping specific therapeutic X-ray fields, both in a static fashion as well as dynamically via leaf-movement during treatment. The subject of this submission is the use of the m3 together with Siemens Linear Accelerators for advanced treatment modalities such as Dynamic Arc and automated Step and Shoot Treatments. The correct m3 setup is controlled by the "LANTIS" Verify and Record System with PRIMEVIEW front end. In case the m3 is not correctly set-up according to the Linac settings, treatment will be aborted or not permitted.

The provided text is a 510(k) Summary for the m3 (micro-Multileaf Collimator). It describes a medical device, its intended use, and its predicate device. However, it does not contain information about acceptance criteria, device performance metrics, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

The document primarily focuses on:

• Device Description: A therapeutic X-ray Collimator with multiple motorized tungsten leaves for shaping X-ray fields.
• Intended Use: Assisting radiation oncologists in delivering radiation to target volumes while sparing normal tissue, functioning similarly to customized shadow blocks or stereotactic collimators. It supports static conformal treatments, "step and shoot IMRT", "dynamic arc", and "dynamic IMRT" depending on the Linear Accelerator integration.
• Predicate Device: micro-Multi-Leaf Collimator (K004022).
• Regulatory Information: Device classification, product code, and FDA's substantial equivalence determination.

The section titled "Verification and validation procedures" mentions that these procedures "have shown the safety and effectiveness of the m3 (micro-Multileaf Collimator) and the device can be utilized within its intended use." However, it does not provide any details about these procedures, the specific acceptance criteria, or the results of any performance tests.

Therefore, I cannot fulfill the request to describe acceptance criteria, device performance, or study details, as this information is not present in the provided text.

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