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The SAVI Scout Reflector is intended to be placed percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

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The provided text is a 510(k) clearance letter from the FDA for the Cianna Medical SAVI Scout Reflector and SAVI Scout System. It confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for market entry.

However, the letter does not contain any information about acceptance criteria for device performance or a study proving that the device meets those criteria, as typically found in a clinical study report or a summary of safety and effectiveness data.

Therefore, I cannot provide the requested information from the given text. The document is solely a regulatory approval letter and does not include details on performance metrics, study design, or results.

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The SAVI Scout Reflector is intended to be placed percutaneously in breast tissue to mark (>30 days) a biopsy site or a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a breast biopsy site or a lumpectomy site intended for surgical removal.

Not Found

The provided documentation is an FDA 510(k) clearance letter for the Cianna Medical SAVI Scout Reflector and SAVI Scout System. It confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive submission summary.

Therefore, I cannot provide a complete answer to your request, as the critical information regarding acceptance criteria, reported device performance, study details (sample size, provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth types and establishment for training and test sets) is not present in the provided text.

The document only states the "Indications for Use" for the device:

• SAVI Scout Reflector: Intended to be placed percutaneously in breast tissue to mark (>30 days) a biopsy site or a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System), the Reflector is located and surgically removed with the target tissue.
• SAVI Scout System: Intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a breast biopsy site or a lumpectomy site intended for surgical removal.

To answer your questions, I would need access to the actual clinical study report or a more detailed summary of the performance testing that was submitted to the FDA for this device.

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The SAVI Scout Reflector is intended to be placed percutaneously in the breast to temporarily mark (

SAVI Scout Reflector and SAVI Scout System

This document is primarily a 510(k) clearance letter from the FDA for the SAVI Scout Reflector and SAVI Scout System, along with the device's Indications for Use. It does not contain the detailed study information (acceptance criteria, performance data, sample sizes, expert qualifications, ground truth establishment, etc.) that would typically be found in a clinical study report or a more comprehensive FDA submission summary.

Therefore, for the information requested in the prompt, the document provides none of the required details. It is a regulatory clearance document, not a clinical study report.

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