(24 days)
The microMLC is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The microMLC 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 assist the clinician in the delivery of well-defined target volumes of radiation while sparing the surrounding tissues and organs.
The microMLC is a conformal radiation therapy and radiosurgery device that is mounted to a standard radiation therapy linear accelerator (Linac). The microMLC receives input from planning system software that determines the collimator aperture shapes at different gantry positions along the target area. Radiation is delivered at a constant rate. The microMLC consists of three parts: (1) the user console, (2) the control cabinet and (3) the collinator mechanism. The control cabinet with the user console serves as the control station for the operator and is located near the Linac operator console. If the system fails or the patient is endangered, the operator can push the emergency stop button that immediately cuts the power supply to all motors. 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 tungsten leaves. Eighty independent potentiometers for the verification system are included that serve as feedback for the verification system and checks the correct positioning of the leaves.
This 510(k) summary (K032790) describes a new medical device, the microMLC, and asserts its substantial equivalence to a predicate device (K000349). However, it does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the provided text is a regulatory submission for premarket notification (510(k)), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing the full technical details of performance testing and acceptance criteria.
Therefore, I cannot extract the following information from the provided text:
- 1. A table of acceptance criteria and the reported device performance
- 2. Sample sized used for the test set and the data provenance
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- 4. Adjudication method for the test set
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- 8. The sample size for the training set
- 9. How the ground truth for the training set was established
The document states that "The Siemens Medical Solutions Oncology Care Systems, microMLC, is substantially equivalent to the cleared predicate device, Motorized Micro Multileaf Collimator K000349." This implies that the device's performance would be considered acceptable if it is comparable to the predicate device, but the specific metrics and acceptance thresholds for "substantial equivalence" in terms of performance are not included in this summary.
In summary, the provided K032790 document is a 510(k) summary for regulatory clearance and does not contain the detailed study information you are requesting.
§ 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.