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The MINI LAP Instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh.

The MINI LAP Instruments are a family of minimally invasive devices. The devices penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh.

Prior to insertion, the physician must depress the safety button and retract the instrument into the needle. The needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the jaws of the instrument will open. The instrument will be offered in various configurations including babcock clamp, bowel clamp, and hernia clamp. The device includes a selfactivating safety that prohibits the iaws from returning to their fully retracted position while in use. which acts as a blunt shield for the sharp needle tip.

The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for Mini Lap Technologies, Inc.'s "MINI LAP Instruments," which focuses on establishing substantial equivalence to predicate devices rather than reporting on specific performance studies against predetermined acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth was established for the training set.

The document states under "Performance Data" that "The subject device has been subjected to and passed a variety of mechanical tests and evaluations." However, it does not detail what these tests were, what the acceptance criteria for those tests were, or what the specific results were. It also mentions that the device is made of biocompatible materials, which is a material characteristic rather than a performance metric.

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