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The Habib 4X Laparoscopic is intended to be used to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures

The Habib 4X Laparoscopic is a bipolar radiofrequency (RF) device that consists of a handle, an instrument shaft, and an array of four needles at the distal end of the instrument. The instrument has an attached cable which connects the device directly to the RITA Medical 1500X RF generator. The device electrodes are inserted into tissue is coagulated using the RF power. The Habib 4X Laparoscopic is designed for use in laparoscopic surgery and the instrument shaft fits through a standard 10mm laparoscopic port. The handle includes an RF on/off switch which can be operated with either the left or right hand. The Habib 4X Laparoscopic is a single use device.

The provided text does NOT contain information about acceptance criteria, device performance metrics, or a detailed study proving the device meets specific criteria. It is a 510(k) summary for a medical device (Habib 4X Laparoscopic) seeking substantial equivalence to existing predicate devices.

The document states:

• "Performance testing was done to ensure that the Habib 4 X Laparoscopic functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes, data provenance, ground truth establishment, or expert qualifications for any specific study.
• Information about MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill the request for a table of acceptance criteria and study details based on the provided text. The document focuses on establishing substantial equivalence based on technological characteristics and intended use compared to predicate devices, rather than presenting a detailed performance study with specific quantitative acceptance criteria.

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The Habib 4X is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.

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The provided text is a 510(k) clearance letter from the FDA for the Habib 4X device, an electrosurgical cutting and coagulation device. This type of document does not typically contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications for AI/ML device studies.

The letter focuses on:

• Confirming substantial equivalence to a predicate device.
• Indicating that the device can be marketed subject to general controls.
• Outlining relevant regulations.
• Providing the stated Indications for Use.

Therefore, based solely on the provided text, I cannot reconstruct the specific information you requested. The document does not describe a study, acceptance criteria, or performance metrics in the way your questions demand for an AI/ML device.

Ask a specific question about this device