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Klarity Bolus is indicated for radiation therapy clinical treatments as a tissue equivalent aid to correct for anatomical irregularities and deliver a prescribed dose to the skin and underlying tissue. Target population is Adult, Child and Infant, and Federal (USA) law restricts this device to sale by, or on the order of a physician.

Klarity Bolus has been tested for tissue equivalency at 6 MV and 10 MV photon and at 6 MeV electron energy levels. Further testing will be required to confirm performance with proton therapy systems.

Klarity Bolus is a moldable gel sheet material to be used by trained radiation therapy professionals as an aid to radiation treatment of uneven areas of a patient, such as at the nose or ears, to make up for missing tissue, or to provide build-up of radiation dose to the skin surface. The use of bolus is decided by a doctor or professional on a case by case basis, deciding if bolus is needed or appropriate, and deciding the amount and shape of the bolus material to be used.

During radiation therapy treatments there can often be a "build up" of radiation dose a few millimeters beneath the surface of a patient's skin. Bolus material can be used to create a simulated layer of tissue that will raise the depth of the "build up" to be closer to actual skin level. This can benefit the accuracy and dose level for treating a skin cancer, for example. Bolus materials have been used for this purpose for many years.

Klarity Bolus is provided as a non-sterile 30x30cm sheet in various thicknesses from 0.5cm to 4cm. Klarity Bolus incorporates a thin mesh netting in the sheet to enhance dimensional stability and prevent easy tearing. In clinical use a therapist will use scissors to cut the sheet into a desired shape. Klarity Bolus is tacky and self-adherent, so it can be layered to a desired thickness. The shaped piece will be placed on the patient's skin in a chosen location, where it will adhere enough to stay in place but can be easily removed. Klarity Bolus has less tackiness than other bolus materials, a manufacturing choice made in response to clinician complaints about the oily and overly tacky surface of other bolus materials. Sheets are semi-transparent, allowing a therapist to see the underlying treatment area.

Klarity Bolus is for single patient use only, and can be discarded with normal hospital waste. For cleanliness reasons, gloves should be worn when working with bolus sheets.

Klarity Bolus has been tested for tissue equivalency at 6 MV and 10 MV photon and at 6 MeV and 12MeV electron energy levels. Results compare favorably with the predicate device and other bolus materials. Further testing will be required to confirm performance with proton therapy systems.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria or any of the other requested information related to an AI/ML device study. The document is an FDA 510(k) premarket notification for a medical device called "Klarity Bolus", which is a physical bolus material used in radiation therapy.

It describes:

• The indications for use of the Klarity Bolus.
• Its physical characteristics and how it is used.
• A comparison to a predicate device.
• Non-clinical performance data, specifically:
  • Biocompatibility testing (Cytotoxicity, Skin Sensitization, Skin Irritation).
  • Tissue equivalency testing at specific photon and electron energy levels.
  • Element content and Zeff values.

It explicitly states that "Klarity Bolus has been tested for tissue equivalency at 6 MV and 10 MV photon and at 6 MeV and 12 MeV electron energy levels. Results compare favorably with the predicate device and other bolus materials." This refers to physical testing of the bolus material itself, not the performance of an AI/ML device or algorithm.

Therefore, I cannot provide the requested information.

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