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The ATEC® Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The ATEC® Breast Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedure.

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The provided document is a 510(k) clearance letter from the FDA for a medical device (Vacuum Assisted Core Biopsy Device, Trade/Device Name: SUROS Surgical Systems, Inc. - ATEC® Breast Biopsy System). This type of document primarily confirms substantial equivalence to a predicate device for market clearance. It does not contain the details of a study with acceptance criteria and reported device performance in the format requested.

The document states:

• Device Name: SUROS Surgical Systems, Inc. - ATEC® Breast Biopsy System
• Indications For Use: To provide breast tissue samples for diagnostic sampling of breast abnormalities, and intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

To answer your request, a detailed study report (e.g., a clinical trial report or a performance validation study report) would be needed, which is not part of this 510(k) clearance letter. The FDA clearance confirms that SUROS demonstrated substantial equivalence to a legally marketed predicate device, implying that its performance is comparable to the predicate. However, specific acceptance criteria and performance metrics from a dedicated study are not detailed in this document.

Therefore, I cannot populate the table or provide the specific study details you requested based solely on the information provided in this 510(k) clearance letter. This document is a regulatory approval notice, not a study report.

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To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, and callors on such organs as also earlier, of breast biopsy, the product is for diagnosis only.

Vacuum Assisted Spring Loaded Core Biopsy Device

I am sorry, but the provided text from the FDA 510(k) letter dated September 8, 2004, for the "Vacuum Assisted Spring Loaded Core Biopsy Device" (K034021) does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

This letter is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device. It briefly mentions the indications for use but does not delve into the underlying studies or data that would typically be included in a scientific publication or a more detailed regulatory submission summary.

Therefore, I cannot fulfill your request for the specific details about the acceptance criteria and the study that proves the device meets them based on the provided input.

Ask a specific question about this device

Ask a specific question about this device