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The EnSeal® Vessel Sealing and Hemostasis System is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open and laparoscopic, general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.

The SurgRx EnSeal® Vessel Sealing and Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

The EnSeal® Vessel Sealing and Hemostasis System is a bipolar electrosurgical instrument for use with an electrosurgical generator.

I apologize, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the EnSeal® Vessel Sealing and Hemostasis System. The document is a 510(k) clearance letter from the FDA, confirming the device's substantial equivalence to predicate devices and outlining its intended indications for use. It does not include details about specific performance metrics or clinical study data.

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The SurgRx EnSeal system includes bipolar electrosurgical instruments and an accessory adapter for use with standard electrosurgical generators. It is intended for use during open or laparoscopic, general and general and general to cut and seal vesses, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including unologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the Instruments.

The SurgHx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

The EnSeal Laparoscopic devices are tubular instruments with grasping jaws at the distal end, which are actuated by a handle at the proximal end of the device. The distal end contains bipolar electrodes for sealing vessels, and a mechanical cutting blade for transecting vessels. The EnSeal Open devices are reusable forceps-type devices with one snap-in single use, disposable bipolar electrode, and one permanent, reusable electrode in the jaws of the device. Connectors attached to an electrical cable connect the device to the ECA (EnSeal Controller Adapter) accessory which connects the device to a standard O.R. electrosurgical generator.

{
  "1. A table of acceptance criteria and the reported device performance": null,
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "Preclinical laboratory (bench studies) were executed, but specific sample sizes are not provided. The data provenance is described as 'preclinical laboratory (bench studies)', which typically implies prospective testing conducted in a controlled environment.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "The human factors evaluation involved 'physicians' who provided input in pre-clinical and bench testing. The specific number and qualifications of these physicians are not detailed.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The study primarily involved preclinical laboratory (bench studies) and user feedback, not a standard adjudication process for a diagnostic or AI device.",
  "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "Not applicable. This document describes a medical device for surgical procedures (vessel sealing and hemostasis system), not an AI-based diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This device is a surgical instrument that requires a human operator, not an autonomous algorithm.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "For the preclinical laboratory (bench studies), the 'ground truth' would be the objective performance metrics established by the design specifications, such as sealing strength, transection effectiveness, and tissue dissection capabilities. These are typically measured directly in a lab setting.",
  "8. The sample size for the training set": "Not applicable. This is not an AI/ML device that requires a training set in the typical sense.",
  "9. How the ground truth for the training set was established": "Not applicable. This is not an AI/ML device."
}

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