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The UltraClip Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

A sterile, single patient use device comprised of a disposable introducer and applier in addition to the marker itself. The set includes an introducer needle comprised of a plastic molded hub, a needle with 1 cm depth marks, and an ultrasound enhancement on the distal end to aid in needle placement. The applier consists of a stainless steel rod with plastic hub, and the marker, located at the distal end of the introducer needle, is made of stainless steel or . titanium. A plastic safety connector holds the applier and introducer needle in the appropriate position and helps prevent premature deployment of the marker.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the Inrad UltraClip Tissue Marker, primarily focusing on its substantial equivalence to a predicate device (Micromark Clip).

Here's a breakdown of why this information isn't present in the provided text:

• 510(k) Pre-Market Notification: This type of submission to the FDA (510(k)) focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design principles, materials, energy used, and intended use.
• Substantial Equivalence vs. De Novo Approval: When a device is deemed substantially equivalent, it generally means that safety and effectiveness are established through the predicate device, and new clinical studies specifically demonstrating performance against acceptance criteria are often not required. If a device were entirely new (de novo), then detailed clinical trials and established acceptance criteria would be a core part of its approval process.
• "Non-Clinical Performance Data Assessment": The document mentions "Comparison of non-clinical performance data between the Inrad UltraClip Tissue Marker and the Biopsys Medical Micromark Clip indicates the devices are substantially equivalent." This implies that testing was done to ensure the new device performed similarly to the predicate in non-human scenarios (e.g., mechanical tests, material compatibility), but it does not specify performance acceptance criteria or report on specific outcomes from a study designed to meet those.

Therefore, I cannot populate the requested table or answer the specific questions because the provided text does not contain the necessary information regarding acceptance criteria or a study proving the device meets them.

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