(164 days)
Ethos Treatment Management is indicated for use in managing and monitoring radiation therapy treatment plans and sessions.
Ethos Treatment Planning is indicated for use in generating and modifying radiation therapy treatment plans.
Halcyon and Ethos Radiotherapy System are indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated for adults and pediatric patients.
Ethos Treatment Management is software designed for radiation therapy medical professionals to support them in managing radiation treatments for patients.
Ethos Treatment Planning is software that is designed generate treatment plans, modify treatment plans, and guide users within adaptive treatment sessions.
Halcyon and Ethos Radiotherapy System are single energy linacs designed to deliver Image Guided Radiation Therapy and radiosurgery, using Intensity Modulated and Volumetric Modulated Arc Therapy techniques. They consist of an accelerator and patient support within a radiation shielded treatment room and a control console outside the treatment room.
I am sorry, but the provided text does not contain the specific information required to answer your request regarding acceptance criteria and a study proving device performance. The document describes a premarket notification for several medical devices and confirms their substantial equivalence to predicate devices, but it does not detail specific performance metrics, clinical studies, or acceptance criteria with reported device performance against those criteria.
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether an MRMC comparative effectiveness study was done or its effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document mentions that "Hardware and software verification and validation testing was conducted" and "Test results showed conformance to applicable requirements specifications," but it does not provide the details of these tests or their results against specific criteria. It also states, "No animal studies or clinical tests have been included in this pre-market submission," which indicates that the information you requested about clinical performance studies is not present in this document.
§ 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.