(58 days)
MapRT is indicated for assisting with planning of radiation therapy by:
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Assessing which combinations of ganty/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and
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Predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.
The MapRT module is intended for use by radiotherapy professionals during the CT simulation and treatment planning stages of radiotherapy for collision avoidance and facilitating dose optimisation.
MapRT is a system which uses advanced software and couch markers to deliver a full 3D model of the patient and accessories. This model is used to calculate a clearance map for all couch and gantry angles. Plans can be imported to check beams, arcs and transition clearance.
The provided FDA 510(k) summary for MapRT does not contain acceptance criteria or a detailed study description with the requested information. It only states that "Verification tests were performed to ensure that the module works as intended and pass/fail criteria were used to verify requirements. Validation testing was performed using summative evaluation techniques per IEC 62366-1:2015. Verification and validation testing passed in all test cases."
Therefore, I cannot provide the specific tables and details requested based on the input document. The document primarily focuses on establishing substantial equivalence to a predicate device (ClearCheck Model RADCC V2) based on technological characteristics and intended use, rather than presenting a detailed performance study with quantifiable acceptance criteria.
Information Not Found in the Document:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human improvement with AI assistance.
- Whether standalone (algorithm only) performance was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.