Search Results

The p.d software is used by radiation therapy professionals to assist in the treatment of cancer patients. The p.d software takes a Treatment Planning System design of a compensating filter which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. And the software converts Treatment Planning System compensator filter file into a .decimal file format.

Optionally the user may elect to design a beam shaping compensator filter based on Treatment Planning System's data which will be transferred back into the Treatment Planning System for final dose verification. The customer uses the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd and approved by a radiation therapy professional prior to use on a patient.

The p.d software is used by radiation therapy professionals to assist in the treatment of cancer patients. The p.d software takes a Treatment Planning System design of a compensating filter which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. And the software converts Treatment Planning System compensator filter file into a .decimal file format.

Optionally the user may elect to design a beam shaping compensator filter based on Treatment Planning System's data which will be transferred back into the Treatment Planning System for final dose verification. The customer uses the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd and approved by a radiation therapy professional prior to use on a patient.

This document is related to a 510(k) premarket notification for the ".decimal p.d" software, which assists in radiation therapy. The provided text does not contain acceptance criteria for device performance, nor does it detail a study proving the device meets specific acceptance criteria using statistical metrics like sensitivity, specificity, or accuracy.

The document states:

• "Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of this device." This explicitly indicates that a clinical study, as typically understood for evaluating device performance against acceptance criteria using patient data, was not performed.
• Instead, "Clinically oriented validation test cases were written and executed by in house .decimal customer support personnel including Board Certified Medical Physicists." This suggests an internal validation process focused on functional and technical correctness, rather than a statistical evaluation of clinical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment in the context of a clinical performance study. The provided text does not support such an analysis.

Ask a specific question about this device