(28 days)
The Accuray Precision® Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.
The Accuray Precision® Treatment Planning System is a radiation therapy planning system used for the creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
The radiation treatment plan is developed by using diagnostic CT (primary image series) and/or secondary images (MR and PET) of the patient previously acquired prior to treatment and saved into the central database server (iDMS Data Management System). The images are imported from the database server into the Accuray Precision® Treatment Planning System to register/ fuse for dose calculation, and to accurately define/contour regions of interest (target) and the surrounding critical anatomical structures to avoid.
The user (dosimetrist/ medical physician) then specifies the treatment delivery machine (CyberKnife or TomoTherapy systems, Radixact systems), treatment delivery mode (e.g., 3DCRT, IMRT) and the patient alignment at the treatment machine. This is followed by specifying the radiation dose criteria for the identified regions of interest, as well as the number of fractions over which this dose is to be administered. After the relevant data has been entered, the user initiates the treatment plan calculation or optimization process. When the treatment plan has been calculated, the user may refine the plan with adjustments to the regions of interest, avoidance structures, and dose criteria and re-optimize the plan.
Once an optimized treatment plan is produced that meets the requirements of the intended therapy, the prescribing physician approves the plan for delivery and the plan is saved on the database server as a treatment delivery plan. The plan reports are also printed for the patient record.
The provided text describes a 510(k) submission for the Accuray Precision® Treatment Planning System. It states that the subject device, with modifications, is substantially equivalent to its predicate device. However, the document does not contain the specific details regarding acceptance criteria, reported device performance in a table, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance data for an AI/ML component.
The document only generally mentions:
- "Software verification and validation was conducted, and documentation is provided as recommended by FDA's Guidance for Industry and FDA staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'."
- "The results from testing included in the premarket notification demonstrate that the performance characteristics of the subject device are substantial equivalent to the predicate device."
- "The performance test data for subject device... confirms that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as compared to the treatment plans created using the predicate device."
Without specific numerical performance data or detailed study descriptions, it's impossible to fill out the requested information. The text indicates that these performance data exist and were submitted to the FDA, but they are not included in this public summary.
Therefore, I cannot provide the requested information from the given text. A typical 510(k) summary (public version) does not usually include the granular details of the V&V studies, especially for features like "dose calculation algorithms" which are mentioned as having "minor enhancements." If these enhancements involved an AI/ML component, the detailed study would be in a separate, non-public section of the submission.
§ 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.