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The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.

The Tissue Site Marking System is supplied as a sterile device and is intended for single patient use only. The Tissue Site Marking System is composed of two elements: 1) an implantable device (marker) including a bioabsorable component and a permanent component and 2) a deployment device. The Tissue Site Marking System is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, nuclear, computed tomography, and direct visualization.

The provided text does NOT contain information about acceptance criteria, device performance, or any studies involving AI, human readers, or ground truth establishment.

The document is a 510(k) summary for a "Tissue Site Marking System," which is a medical device for marking sites in soft tissue. It primarily focuses on the regulatory aspects of the device, including:

• Classification Information: Device name, common name, proprietary name, classification, and regulation number.
• Owner/Operator Information: Company details and contact person.
• Device Description: Two components (implantable marker and deployment device) and its intended use with various imaging modalities.
• Indications for Use: Permanent radiographic marking of sites in soft tissue.
• Contraindications: None known.
• FDA Communication: A letter from the FDA confirming substantial equivalence to predicate devices and outlining regulatory responsibilities.
• Indications for Use Form: A standard FDA form reiterating the indications for use.

Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

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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.

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