(90 days)
In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the charing In Nation Therapy, It is often nobsoad fields can be achieved by supplementing the shaping the shaping desired treatment shape. Integral shaped that system with tertiary beam blocks. These Beam Blocks are used to further collimate and contour the treatment field.
This device is intended to be used in Radiation Therapy for creating irregularly shaping treatment fields.
This looks like a 510(k) premarket notification for a medical device. The document states that the device is "substantially equivalent" to a predicate device, meaning it doesn't introduce new safety or effectiveness issues. The following information is not available in the provided text:
- Acceptance criteria and reported device performance (no specific performance metrics or testing results are provided)
- Sample size for the test set or data provenance
- Number and qualifications of experts for ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- Method for establishing ground truth for the training set
This type of submission focuses on demonstrating equivalence to an existing device rather than presenting detailed performance studies against specific acceptance criteria.
§ 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.