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The ModuLeaf is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The ModuLeaf is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate the radiation delivery to a target based on a treatment plan generated by planning software. The device is used to help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs.

The ModuLeaf is a conformal radiation therapy and radiosurgery device that is mounted to a standard radiation therapy linear accelerator (Linac). The ModuLeaf receives input from planning system software that determines the collimator aperture shapes at different gantry positions along the arc around the target area. Radiation is delivered at a constant rate. The ModuLeaf consists of three parts: (1) the user console, (2) the control cabinet and (3) the collimator mechanism. The control cabinet with the user console serves as the control station for the operator and is located near the Linac operator console. The control cabinet contains the PC, an interface board and the power supply. The PC consists of a specified configuration of a CPU, motherboard. RAM, VGA board and HDD. It is used as the communication interface between the operator and the planning system software or the record and verify (R&V) system that contains the treatment positioning data. The PC also serves as the master for the control and verification system. The data received from the planning system software or the record and verify (R&V) system is processed and transferred to the micro-controllers on the control and verification boards. The operator initiates position adjustment at the console or at the record and verify (R&V) system depending on the configuration. When an R&V system is involved the leaf positions are downloaded to the PC. The PC then starts all the micro-controllers simultaneously and retrieves the position of the leaves, comparing the values of the control system with those of the verification system. The collimator mechanism is fitted to the accessory holder of the Linac gantry. It consists of 80 driving units that position the tunqsten leaves via a rack and pinion mechanism. Two independent potentiometers are directly connected with each tungsten leaf to retrieve information on the leaf position, i.e. there are 80 potentiometers for leaf positioning and an additional 80 potentiometers for independent leaf position verification. They serve as feedback for the verification system that checks the correct positioning of the leaves.

The provided text is a 510(k) summary for the ModuLeaf device, a Multileaf Collimator used in radiation therapy. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it would be relevant for an AI/ML powered medical device.

Therefore, I cannot fulfill the request for information on acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details. The document is for a traditional medical device (hardware) and not an AI/ML driven one, which would typically involve such performance metrics against a defined standard or ground truth.

The only relevant information from the provided text that could be extracted is:

• Device Name: ModuLeaf
• Intended Use: "The ModuLeaf is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The ModuLeaf is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate the radiation delivery to a target based on a treatment plan generated by planning software. The device is used to help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs."
• Predicate Device: Mini Multileaf Collimator (K011816) from MRC Systems GmbH.
• Regulatory Class: Class II (21 CFR 892.5710)

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