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The Adjustable Multi-Catheter Source Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy of breast cancer.

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I am sorry, but the provided text from the FDA letter regarding the Adjustable Multi-Catheter Source Applicator (K062241) does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.

The letter is a 510(k) substantial equivalence determination. It primarily:

• Confirms the device is substantially equivalent to a legally marketed predicate device.
• States the device's indications for use.
• Imposes a specific labeling limitation (a "black box warning") about the device's safety and effectiveness not being established for use as a replacement for whole breast irradiation in the treatment of breast cancer. This explicitly indicates a lack of such evidence for this specific use case.
• Outlines general regulatory requirements for the manufacturer.

Therefore, I cannot fulfill your request to describe acceptance criteria and the study proving device performance using the provided text. The document does not contain this type of information.

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The North American Scientific, Inc Brachytherapy Preloaded Needle Kit is indicated for interstitial implantation of select localized tumors with low to medium radiosensitivity. They are used either as primary treatment for tumors such as those in the head, neck, lung, pancreas, breast, cervix and prostate and unresectable turnors or for residual disease after excision of the primary turnor. North American Scientific Brachytherapy Preloaded Needle Kit implants are indicated for use with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

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I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a medical device called the "Surtrak® Implantation Kit". It primarily addresses regulatory aspects, substantial equivalence to predicate devices, and indications for use.

It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the type of study conducted.
• Information on ground truth establishment, expert qualifications, or adjudication methods.
• Data on Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
• Training set details or how their ground truth was established.

Therefore, I cannot fulfill your request using the provided input.

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The North American Scientific, Inc Brachytherapy Preloaded Needle Kit is indicated for interstitial implantation of select localized tumors with low to medium radiosensitivity. They are used primarily for treatment for tumors such as those in the head, neck, lung, pancreas, breast, cervix and prostate and unresectable tumors or for residual disease after excision of the primary tumor. Preloaded implants are used with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy.

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I apologize, but this document is a 510(k) clearance letter from the FDA for a medical device called the "nStrand Implantation Kit." It confirms that the device is substantially equivalent to legally marketed predicate devices.

This document specifies the indications for use of the device but does NOT contain any information regarding:

• Acceptance criteria or reported device performance. The letter is an administrative approval, not a performance study report.
• Study details such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set information.

Therefore, I cannot provide the requested information based on the content of this document. To answer your request, I would need a clinical study report or a performance evaluation document for the nStrand Implantation Kit.

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Ask a specific question about this device