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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.

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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:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Whether an MRMC comparative effectiveness study was done or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. 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.

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