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The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, plastic and reconstructive, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tissue bundles is performed (e.g. bowel resections, hysterectomies, gall bladder procedures, Nissen Fundoplication, adhesiolysis, and oophorectomies). 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 ENSEAL X 1 Tissue Sealers have 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 X1 Tissue Sealer, Curved Jaw Articulating instrument is a sterile, single patient use surgical instrument to coagulate and transect vessels up to and including 7 mm in diameter, tissue and/or vascular bundles. This device is for soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable iaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The instrument shaft, normally in the straight position, can be articulated using the articulation wheel to gain additional access to tissue and facilitate additional angles across tissue and/or vascular bundles. The jaws are in a normally-opened position and can be partially or fully closed by squeezing the closing handle. The jaws are designed for grasping and holding targeted tissue when clamped. The ENSEAL X1 Tissue Sealer, Curved Jaw Articulating has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer, Curved Jaw Articulating can be used in the open or closed position to deliver energy based on the electrode configuration and jaw design. Bipolar energy is delivered when the SEAL button or the MIN foot pedal is pressed. Pressing the CUT button advances the knife the length of the jaws to cut the targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL X1 Tissue Sealer, Curved Jaw Articulating instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.

Here's a breakdown of the acceptance criteria and study information for the ENSEAL X1 Tissue Sealer, Curved Jaw Articulating, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Bench Testing: The document states "Porcine arteries were used in this testing" but does not specify the sample size (number of arteries/vessels tested). The data is likely prospective, as it's part of a device validation study. The country of origin is not specified, but typically such studies are conducted in the country of the manufacturer or a contract research organization.
• Acute Animal Study: "an acute porcine study" was conducted. Specific sample size (number of animals or applications) is not provided. The data is prospective.
• Survival Animal Study: "a chronic survival study" was conducted. Specific sample size (number of animals or applications) is not provided. The data is prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of human experts to establish ground truth for the test sets in the traditional sense of diagnostic AI. The ground truth for this medical device (electrosurgical sealer) is established through technical measurements (e.g., burst pressure, mechanical force) and biological outcomes (e.g., tissue effects, vessel patency/occlusion, healing) observed in the animal studies. These evaluations are typically performed by veterinarians, histopathologists, and engineers, whose qualifications are implied by their roles in such studies, but not explicitly stated.

4. Adjudication Method for the Test Set

Not applicable in the context of this device study. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in image interpretation or clinical diagnosis, not for physical device performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for assessing the diagnostic performance of AI algorithms in medical imaging, usually comparing human readers with and without AI assistance. This document describes the validation of a surgical electrosurgical device, not a diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Again, this question is not applicable. The device is a physical electrosurgical instrument, not an algorithm. Its performance is inherent to its design and how it interacts with tissue.

7. The Type of Ground Truth Used

• Biocompatibility: Compliance with established biological safety standards (ISO 10993-1).
• Electrical Safety & EMC: Compliance with international electrical safety and electromagnetic compatibility standards (IEC 60601 series).
• Sterilization/Shelf-Life: Achieved sterility assurance level (SAL).
• Mechanical Testing: Measured physical properties (e.g., force, dimension) against engineering specifications and comparison to the predicate device.
• Bench Testing: Measured burst pressure of sealed vessels (a quantitative biological outcome) and qualitative assessment of vessel division, compared against predetermined acceptance criteria.
• Acute Animal Study: Histopathological and gross evaluation of tissue effects (e.g., seal integrity, thermal damage) in live porcine models, compared to the predicate device.
• Survival Animal Study: Long-term histopathological and gross evaluation of tissue effects and healing after 30 days in live porcine models, compared to the predicate device. The "ground truth" here is the biological response and healing process observed by experts.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that undergoes "training." Its design and performance are based on engineering principles, materials science, and preclinical testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of medical device.

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