(89 days)
In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the desired shape of the treatment volume. Irregular shapes can be achieved by supplementing the shaping ability of the treatment machines collimation system with tertiary beam blocks. These Beam Blocks are used to further collimate and contour the treatment field and are often custom formed from low metling alloys containing lead and other high density metals. In order to be used, beam blocks must be supported in the path of the incident beam so that the resultant treatment field is properly defined at the patient Shadow Trays provide a simple system for holding the blocks in surface. position for treatment with pre-defined geometry.
This device is intended to be used as a support for beam shaping or beam defining blocks in the delivery of external beam (photon) radiation therapy. This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices.
The provided text is a 510(k) summary for a medical device called "Shadow Trays" (beam block trays), which are used in radiation therapy. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel performance against acceptance criteria derived from a study.
Therefore, the document does not contain information about:
- Acceptance criteria and reported device performance in a table.
- Sample sizes, data provenance, number of experts, adjudication methods for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm-only) performance.
- Types of ground truth.
- Training set sample size or how its ground truth was established.
Explanation based on the document's content:
The submission focuses on establishing equivalence to a predicate device, not on presenting a performance study against specific acceptance criteria. The key statements from the document are:
- "This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices." (Page 1, section 7)
- "No new issues of safety or effectiveness are introduced by using this device." (Page 1, section 7)
This indicates that the "study" for this type of submission is a comparison to a legally marketed predicate device rather than an independent performance study with predefined acceptance criteria. The FDA's review letter confirms this by stating: "We have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (Page 2).
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.