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The Lockado™ Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult populations only via a straight or side viewing flexible endoscope for the purpose of :
(1) Endoscopic marking;
(2) Hemostasis for
(a) Mucosal / sub-mucosal defects

The proposed device Lockado™ Repositionable Hemostasis Clip is a sterile, single-use endoscopic clipping device in adult patients only via a straight or side viewing flexible endoscope, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

The provided text is a 510(k) summary for the Lockado™ Repositionable Hemostasis Clip and does not contain information about studies involving acceptance criteria and device performance evaluation in the context of an AI/human reader study. Instead, it focuses on bench testing, sterilization, and biocompatibility to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from the provided text.

The closest relevant section is "9. Performance Data," which lists various bench tests conducted to demonstrate the device's essential performance. However, it does not provide specific acceptance criteria or the results of these tests in a quantifiable manner as you might expect for an AI/human reader comparative effectiveness study. It merely states that the tests "were tested and evaluated as substantially equivalent to the predicate device."

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