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This versatile Treatment Chair provides upright positioning for specialty treatment cases of head, neck, thorax, breast and lung or for patients who have difficulty lying supine for treatments. The seated patient has improved comfort increased lung volume and reduced respiratory motion. The treatment chair will be used on Medical Linear Accelerator treatment couch located in a hospital or clinic. A physician and physicist will prescribe its use for a treatment on a patient.

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I am sorry, but the provided text from the FDA 510(k) letter for the "Radio Therapy Treatment Chair" (K150382) does not contain the detailed information needed to answer your request regarding acceptance criteria and study particulars for device performance.

The document is a general communication from the FDA stating that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements such as annual registration, labeling, and good manufacturing practices. It also includes the official "Indications for Use" for the device.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details of any specific study (e.g., sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The FDA 510(k) summary (which is a separate document often submitted with or referenced by the 510(k) clearance letter) or the actual study reports themselves would contain the kind of detailed information you are seeking. This particular document serves as the regulatory clearance notice, not a detailed technical report of performance studies.

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