(266 days)
The INTRABEAM® System is indicated for radiation therapy treatments. The INTRABEAM® Spherical Applicators are indicated for use with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments. The INTRABEAM® Balloon Applicator together with the INTRABEAM® System is intended to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.
The safety and effectiveness of the INTRABEAM® System as a replacement for whole breast irradiation in the treatment of breast cancer has not yet been established.
Not Found
This document is a 510(k) clearance letter from the FDA for the Carl Zeiss INTRABEAM® System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic or clinical accuracy (like sensitivity, specificity, etc.) for a medical imaging or AI device.
Instead, this document focuses on:
- Regulatory clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
- Intended Use: Defining the radiotherapy treatments for which the device is indicated.
- Limitations and Warnings: Explicitly stating that the "safety and effectiveness of the Carl Zeiss INTRABEAM® System with Balloon Applicators for breast brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established," and requiring this warning to be in the labeling.
Therefore, I cannot provide the requested information about acceptance criteria and a performance study based on the provided text. The traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically described for diagnostic AI/imaging devices (e.g., sensitivity, specificity, F1 score) are not present in this regulatory clearance letter. The "acceptance" here relates to regulatory clearance based on substantial equivalence, not a direct performance study like those for AI algorithms.
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.