(32 days)
TrackLeaf-10 is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
TrackLeaf-10 is a tertiary Micro Multi Leaf Collimating (MMLC) system. It performs the same functions as beam shaping blocks, circular or cut blocks collimators for Conformal and "step and shoot IMRT" treatments, and it also performs "dynamic arcs" and "dynamic IMRT" treatments.
TrackLeaf is a LINAC based Micro-Multi-Leaf-Collimator (MMLC), used in radiation treatment.
It enables shaping the Linac beam according to target geometrical and clinical requirements.
The device is composed of the MMLC modules the Linac interface modules the v Workstation (with TrackLeaf. Control. Software), and the Power Distribution module. »
The device operates in conjunction with a Linac, a treatment couch, a data file that contains the desired aperture parameters, and any additional equipment required in radiation treatment. In addition, means are provided to receive aperture offset data from an Image Guided Radiation Therapy (IGRT) system in order to perform leaves position adjustments.
MMLC apertures are generated by positioning the motor-driven leaves. TrackLeaf software operates as a sequential process of forming apertures.
TrackLeaf operation modes are: Step-and-Shoot, Dynamic Arc, and dynamic IMRT (DIMRT).
- Step-and-Shoot: TrackLeaf forms apertures while irradiation is off and gantry is stationary.
- Dynamic Arc: TrackLeaf forms apertures while irradiation is on and the gantry rotates.
- DIMRT: TrackLeaf forms apertures while irradiation is on and the gantry is stationary.
There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text.
The document is a 510(k) summary for a medical device (TrackLeaf-10, a Micro Multi-Leaf Collimator) that focuses on its substantial equivalence to predicate devices. It discusses the device's intended use, description, and classification, as well as regulatory compliance.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
§ 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.