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Indicated for cutting, coring and extracting tissue in operative laparoscopy, including gynaecologic procedures such as hysterectomy and myomectomy.

The LiNA Xcise Laparoscopic Morcellator is a single use, fully disposable, device that is supplied sterile. It has a self contained motor-unit and battery power-supply in a pistol grip housing with a trigger to control blade rotation and an integrated adjustable trocar housing containing a rotating cylindrical tube 15mm in diameter sharpened on the distal end to a cutting blade. The trocar housing is manually retractable to expose the cutting blade. The device includes duckbill housing with valve to restrict gas leakage. The morcellator is to be used with standard tissue graspers that are extended through the cylindrical tube to grasp the tissue to be morcellated by pulling it through the rotating blade in a coring action. The device is single packed in blister package with tyvek lid. The package includes an obturator.

The provided text contains information about a 510(k) submission for the LiNA Xcise Laparoscopic Morcellator. However, it does not include detailed "acceptance criteria" and "study results" in the format commonly found for AI/ML device performance evaluations. The document focuses on performance testing related to the physical device's functionality and safety, rather than statistical performance against a clinical endpoint with a ground truth.

Specifically, there is no mention of:

• A table of acceptance criteria with numerical targets (e.g., sensitivity, specificity, accuracy).
• A test set with sample size or data provenance for evaluating device performance against clinical outcomes.
• The number or qualifications of experts establishing ground truth.
• Any adjudication method.
• A multi-reader multi-case (MRMC) study.
• A standalone algorithm performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical performance evaluation.
• Training set sample size or how ground truth was established for it.

Instead, the document lists various performance tests related to the mechanical and electrical aspects of the device, such as:

• Test of cutting tube
• Test of trocar and trocar function
• Test of gearing/toothed wheels lifetime
• Test of motor, torque, motor-lifetime and morcellation functionality
• Test of ergonomics and trigger function
• Test of battery lifetime and electronics
• Test of battery post gamma sterilization
• Test of environment: Heat, vibration and noise
• Test of pull strength cutting tube
• Test of torque
• Test of speed (RPM)
• Test of EMC per EN 60601-1-2: 2007 FCC 47 CFR part 18
• Test cut rate g/minute

The document explicitly states: "No clinical data was deemed necessary to support this premarket notification. However, published literature is provided to demonstrate the safe and effective use of morcellation devices used for tissue removal during hysterectomy."

Given this, I cannot provide the requested table and information as it is not present in the provided text. The device described is a physical surgical instrument, not an AI/ML diagnostic or assistive device that would typically have the kind of clinical performance acceptance criteria and studies you've inquired about.

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