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This device is intended to be used for taking biopsy sample, must be used on soft tissues and I has device is intended to be about to taming copies to obtain biopsies of various tissues, including those from Breast, Kidney, Liver, Prostate, Lung , Bladder, Thyroid, Abdomen and Pancrease

SecurcutTM Aspiration Biopsy Needle

The provided text describes a 510(k) premarket notification for the "Securcut™ Aspiration Biopsy Needle." This document is not a study report and therefore does not contain the information required to answer the questions about acceptance criteria and device performance evaluation.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The document is a regulatory submission for premarket clearance, primarily focused on establishing substantial equivalence to a predicate device. It briefly mentions the intended use but does not outline specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or present any study results demonstrating the device meets such criteria.
• No Study Details: There is no description of any clinical or performance study, nor details about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set specifics.

Therefore, I cannot provide the requested information based on the given input.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the 510(k) process relied on demonstrating equivalence to an existing device, rather than presenting a performance study with acceptance criteria.

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