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The MammoSite RTS is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

The MammoSite is a radiation therapy system that includes the MammoSite Catheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite Catheter Tray includes the MammoSite catheter and accessories to assist with the implantation of the catheter. The MammoSite is a catheter shaft with an inflatable balloon mounted on its distal end that positions the radiation source within the resected cavity for radiation delivery. The MammoSite Afterloader Accessories Tray contains the items needed to connect the afterloader to the MammoSite.

The provided text describes a 510(k) summary for the MammoSite Radiation Therapy System (RTS) and outlines its intended use and substantial equivalence to previously cleared predicate devices. It also briefly mentions preclinical and clinical studies. However, the document does not contain specific acceptance criteria, reported device performance metrics in a quantitative manner, nor detailed information about a specific study that proves the device meets (or met) those criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Details of a standalone performance study.
7. Type of ground truth used for the test set.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document mentions "Extensive pre-clinical studies were performed to support the MammoSite" and that these studies "included in vitro laboratory studies to demonstrate that the MammoSite device, accessories, and packaging, performed as intended under simulated use and challenge conditions." It also states, "Biocompatibility testing was performed to demonstrate that the materials meet the biocompatibility requirements. The dosimetry of the MammoSite was characterized and is similar to the predicate MammoSite devices."

Regarding clinical data, it notes: "The multi-center phase clinical study initially done to evaluate the safety and effectiveness of the MammoSite supports the modified MammoSite. The clinical study included breast cancer patients who were undergoing tumor resection. Assessment methods used to evaluate safety and effectiveness included radiological and clinical measures. Brachytherapy was successfully delivered to the patients."

Crucially, none of these descriptions provide the specific quantitative data needed to answer your questions about acceptance criteria or study methodologies. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety/effectiveness, rather than providing detailed study results and performance metrics against specific acceptance criteria.

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