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The Boehringer Laboratories Liver Retractor is indicated for use in laparoscopic surgical procedures to elevate the liver, improve access to surgical sites, and provide visualization of target anatomy.

The Boehringer Laboratories Liver Retractor is comprised of three components: a Suction Delivery Assembly, a Positioning Clip, and an Integral Suction Regulator. The suction delivery assembly is composed of a Flexible Tube with a proximal Suction Cup and a distal Grasping Suture.

The suction delivery assembly is introduced into the abdomen via a standard laparoscopic trocar. A standard suture passer is then used to grip the grasping suture and pull the upper portion of the flexible tube percutaneously through the abdominal wall. The now externalized tip of the flexible tube is cut off and the open end is connected to the integral suction regulator. The conformable suction cup can then be applied laparoscopically to the liver and the external portion of the flexible tube manipulated to adjust liver position. Once at the desired height, the positioning clip is placed around the external portion of the flexible tube and against the skin to lock the device in place. The suction cup can be efficiently repositioned via laparoscopic technique to accommodate the evolving requirements of a procedure. The device is inserted, manipulated, and removed by or under the direct supervision of a surgeon.

The provided FDA 510(k) clearance letter and summary for the Boehringer Laboratories Liver Retractor (K243399) does not describe an AI device. It's a physical medical device (a liver retractor) and the clearance is based on substantial equivalence to a predicate device, supported by non-clinical testing (bench testing, animal studies, biocompatibility, sterilization, packaging, shelf-life).

Therefore, the information requested in your prompt (AI-specific acceptance criteria, test sets, ground truth establishment, MRMC studies, etc.) is not applicable to this specific medical device clearance. The document does not contain any reference to AI, machine learning, or software performance studies that would require the details you've asked for.

To reiterate:

• No AI device: This is a physical liver retractor.
• No AI acceptance criteria: The device's performance is demonstrated through physical properties and functionality (retraction times, regulator functionality, integrity) and safety (biocompatibility, animal safety).
• No test sets, ground truth, or MRMC studies for AI: These concepts are relevant for AI/ML-driven medical devices, which this device is not.

If you have a document for an AI/ML-driven medical device, I would be happy to analyze it against your criteria.

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