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The ENSEAL® 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 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® 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 Ethicon Endo-Surgery ENSEAL® Tissue Sealers are sterile, biopolar electrosurgical instruments for single patient use. They are designed to seal and cut vessels, and to cut, grasp and dissect soft tissue during open and laparoscopic surgery. The instrument shaft can be rotated using the rotation knob to facilitate visualization and enable easy access to targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The devices are offered in different shaft lengths with curved or straight blade geometries to accommodate the needs of the surgeon.

Here's an analysis of the provided text regarding the Ethicon Endo-Surgery ENSEAL® Tissue Sealing Devices and their acceptance criteria, based on the information provided in the 510(k) summary:

Note: The provided document is a 510(k) summary for a medical device seeking an additional indication (ENT procedures) based on substantial equivalence to existing predicate devices. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of establishing substantial equivalence for this new indication, rather than a de novo approval requiring extensive novel clinical trials with specific numerical performance targets.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a number of animals or specific tests. The text refers to "preclinical laboratory evaluations of ENT surgical procedures in an animal model" and "a successful 30-day chronic survival study."
• Data Provenance: The studies were "preclinical laboratory evaluations in an animal model." The country of origin is not specified, but typically these studies are conducted in facilities compliant with GLP (Good Laboratory Practice) standards. The studies were prospective in nature, as they were conducted to specifically support this submission.

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

This information is not provided in the text. Given that the studies were "preclinical laboratory evaluations in an animal model" and "bench testing," the "ground truth" would likely be established by quantitative measurements (e.g., burst pressure for vessel sealing, thermal imaging for thermal spread, and histopathology/gross examination for animal survival studies) performed by laboratory personnel or veterinary pathologists rather than clinical experts adjudicating outcomes from human cases.

4. Adjudication Method for the Test Set

The text does not specify an adjudication method. For preclinical and bench testing, adjudication typically involves adherence to a pre-defined protocol and objective measurement criteria, often with blind assessment where applicable, rather than multi-expert consensus on subjective observations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve human readers interpreting output. The evaluation focused on substantial equivalence through bench and preclinical testing.

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

This question is not applicable as the device is a surgical instrument, not an algorithm. Performance was evaluated in standalone physical testing (bench) and biological models (preclinical animal studies).

7. The Type of Ground Truth Used

The ground truth for the performance evaluations likely involved a combination of:

• Quantitative measurements: For bench testing (e.g., burst pressure of sealed vessels, measurement of thermal spread zones).
• Pathology/Histology and Gross Examination: For the animal model, evaluating hemostasis, tissue healing, thermal injury, and overall animal health/survival.
• Survival Data: For the 30-day chronic survival study.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical surgical instrument, not an AI/machine learning algorithm that requires a training set.

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

This question is not applicable as there is no training set for this type of device.

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