(29 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.
Ethos Treatment Management is a standalone software device designed to help radiation therapy medical professionals manage treatments for their patients. It allows the physician to do initial planning, review and approve candidate plans, and monitor ongoing treatments.
Ethos Treatment Planning is a standalone software device designed to generate and modify radiation therapy treatment plans and manage treatment sessions. The device supports the traditional and adapted treatments, in which the scheduled plan is adapted to the patient's anatomy at the time of treatment.
The provided text is a 510(k) summary for Varian Medical Systems' Ethos Treatment Management 2.1 and Ethos Treatment Planning 1.1. It details the regulatory review and clearance of these devices. However, the document explicitly states:
"No data from animal studies or clinical tests have been included in this pre-market submission." (page 4)
And later:
"Since the predicate devices were cleared based only on the results of non-clinical testing, no animal or clinical studies were conducted for the subject devices." (page 5)
This means that the submission does not contain information about studies involving human or animal subjects to prove the device meets specific acceptance criteria related to its performance in a clinical setting. The "performance data" section (page 4) refers only to "Software Verification and Validation Testing" and "Standards Conformance," which are non-clinical forms of testing.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor answer questions related to sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth types as these would pertain to clinical performance studies.
The document focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical software verification and validation, and conformance to relevant industry standards.
§ 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.