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The Xoft Axxent Electronic Brachytherapy System is intended to provide brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.

The safety and effectiveness of the Axxent Electronic Brachytherapy System as a I he salely and chectryedies of the ristion in the treatment of breast cancer has not been established.

The three components of the Axxent Electronic Brachytherapy System include the Controller, Balloon Applicators-BR and X-ray Source.

The Controller is a mobile platform that is responsible for the overall operation of the device. The radiation is delivered by a disposable, microminiature X-ray source located at the end of a flexible cable. The X-ray source at the distal tip of the cable is inserted into the central lumen of the appropriately-sized Balloon Applicator. The System is designed to deliver doses of X-ray radiation directly to the excised tumor bed when the physician desires to deliver intracavitary or interstitial radiation to the surgical marqins following lumpectomy for breast cancer.

The Axxent Electronic Brachytherapy System does not utilize a radioactive isotope, or require an HDR isotope afterloader, and thus does not require the heavily-shielded treatment rooms necessary for the delivery of isotope-based HDR brachytherapy.

The provided text is a 510(k) Summary for the Axxent Electronic Brachytherapy System (K050843), focusing on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The 510(k) summary primarily addresses:

• Device Name: Axxent™ Electronic Brachytherapy System
• Predicate Devices: Photoelectron Corporation Photon Radiosurgery System (PRS), Varian VariSource Remote Afterloader, Proxima Therapeutics MammoSite Radiation Therapy System (RTS).
• Device Description: Three components - Controller, Balloon Applicators-BR, and X-ray Source. It describes its function as delivering X-ray radiation directly to the excised tumor bed for intracavitary or interstitial radiation following lumpectomy for breast cancer, without using a radioactive isotope.
• Intended Use: To provide brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.
• Technological Characteristics: Claims similarity and equivalence to predicate devices in design, materials, principles of operation, product specifications, and sterilization.
• Summary of Equivalence: Argues substantial equivalence to predicate devices based on design, materials, function, and intended use.
• FDA Communication: Includes a letter from the FDA stating the determination of substantial equivalence and a critical warning that “The safety and effectiveness of the Axxent Electronic Brachytherapy System as a sole or adjunctive form of breast irradiation in the treatment of breast cancer has not been established.” This warning was required to be presented in a black box in the device's labeling.

In summary, this 510(k) submission is a regulatory document focused on demonstrating substantial equivalence to already cleared devices, not on providing a study with acceptance criteria and performance data as you've requested for an AI/ML device. The device described is a physical medical device (X-ray radiation therapy system), not an AI/ML system, which would require different types of performance evaluation.

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