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The AKTINA Medical Physics Corporation Tilt Board is intended for use in Radiation Therapy as an aid in patient positioning for breast treatments.

Tilt Boards are also commonly known as Breast Boards and are intended for use in Radiation Therapy to facilitate patient positioning in irradiation of the breast.

The AKTINA Medical Physics Corporation Tilt Board is intended for use in Radiation Therapy as an aid in patient positioning for breast treatments.

This device is similar in design and construction, and identical in materials, intended use and performance characteristics to the predicate devices.

The provided text describes a 510(k) submission for a medical device called the "Tilt Board" (also known as a Breast Board). This submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

However, the provided document does not contain acceptance criteria for device performance or any study data proving the device meets specific performance criteria. The submission primarily focuses on:

• General Provisions: Trade name, applicant, predicate devices, classification, and performance standards (not established by FDA).
• Intended Use and Device Description: Used for patient positioning in radiation therapy for breast treatments.
• Biocompatibility: No studies undertaken as no patient contact and no new materials.
• Summary of Substantial Equivalence: States similarity in design, construction, materials, intended use, and performance to predicate devices, introducing no new safety or effectiveness issues.
• FDA Response Letter: Confirms substantial equivalence based on the provided information and allows marketing.
• Indications for Use: Reiterates the intended use.

Therefore, I cannot provide the requested information as it is not present in the given text.

The document is a regulatory submission for a Class II medical device, where the primary path to market is often through demonstrating substantial equivalence to a predicate device rather than presenting new clinical performance data against specific acceptance criteria. For devices like a "Tilt Board" which are positioning aids and not directly diagnostic or therapeutic in themselves, the "performance" often refers to basic functional safety (e.g., structural integrity, ease of use, stability) and alignment with the intended use of patient positioning, rather than a quantifiable clinical outcome requiring extensive studies with ground truth.

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