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The AccuFix Tilting Radiotranslucent Headholder is designed to be used with a head rest or prone pillow and Aquaplast RT Thermoplastic (K 935067) masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Headholder attaches to the treatment table, a Silverman brand head rest (for supine treatment) or prone pillow (for prone treatment) is attached to the Headholder and a custom fit mask attaches to the Headholder in such a way that patient head movement is minimized and the patient's head can be accurately repositioned for subsequent treatment sessions.

The AccuFix Tilting Radiotranslucent Headholder is designed to be used with a head rest or prone pillow and Aquaplast RT Thermoplastic (K 935067) masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Headholder attaches to the treatment table, a Silverman brand head rest (for supine treatment) or prone pillow (for prone treatment) is attached to the Headholder and a custom fit mask attaches to the Headholder in such a way that patient head movement is minimized and the patient's head can be accurately repositioned for subsequent treatment sessions.

The provided documents do not contain any information regarding acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The documents are a 510(k) clearance letter from the FDA for a device called "AccuFix Tilting Radiotranslucent Headholder". This letter confirms that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed.

Key information from the documents:

• Device Name: AccuFix Tilting Radiotranslucent Headholder
• Manufacturer: WFR/AQUAPLAST Corporation
• Regulatory Class: II
• Product Code: 90 IYE
• Indication for Use: To be used with a head rest or prone pillow and Aquaplast RT Thermoplastic masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. Its purpose is to minimize patient head movement and allow for accurate repositioning for subsequent treatment sessions.
• FDA Decision Date: July 2, 2002

Since the documents are a notification of substantial equivalence and not a detailed study report, they do not include the specific technical performance data or study methodologies typically required to answer your questions.

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