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The Enseal® X1 Large Jaw Tissue Sealer instrument is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. It is a bipolar instrument for use with the Ethicon Generator G11 (GEN11). It is intended for use during open surgery to cut and seal vessels, cut, grasp, and dissect tissue during surgery. Indications for use include open general, gynecological, thoracic, and vascular procedures. These procedures include hysterectomies. Nissen fundoplication. adhesiolysis, oophorectomies, etc. The devices can be used on vessels (arteries, veins, pulmonary vasculature, lymphatics) up to and including 7 mm and tissue bundles.

The Enseal® X1 Curved Large Jaw instrument 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 efficacy of the Enseal® X1 Curved Large Jaw instrument for the indication of contraceptive tubal coagulation (permanent female sterilization) has not been evaluated and is unknown. The design of the EnSeal® Tissue Sealing Device is significantly different from bipolar designs that are marketed for the indication of contraceptive tubal coagulation. The design differences may affect the efficacy of the procedure and failure rates may not be comparable.

The Enseal® X1 Large Jaw Tissue Sealer device is a sterile, single patient use surgical instrument used 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 jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The curved 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. Bipolar energy is delivered when the seal button (blue button) or MIN foot pedal is pressed. Pressing the cut button advances the knife the length of the jaws to cut the targeted tissue. It should be noted that this device has independent seal and cut capabilities. The power cord is permanently attached to the device and connects the instrument directly to the Generator 11. The Enseal® X1 Large Jaw Tissue Sealer device 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 the studies performed for the ENSEAL X1 Large Jaw Tissue Sealer, based on the provided documents:

Acceptance Criteria and Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • Ex-vivo Bench Testing: The document does not specify an exact numerical sample size for "sealed vessel burst tests" or "thermal profile testing." It states that "maximum and minimum values, standard deviation and the mean were recorded," implying multiple tests were performed.
   • Acute Animal (Porcine) Testing: The document does not specify an exact numerical sample size. It states "Testing was performed in an acute animal study."
   • Survival Animal (Porcine) Testing: The document does not specify an exact numerical sample size. It states "Testing was performed in survival animal studies."
   • Data Provenance: The animal studies were performed on porcine subjects, indicating animal data, not human. The document does not specify the country of origin for the data, but the company is Ethicon Endo-Surgery, located in the USA (Cincinnati, Ohio, and Guaynabo, PR). The animal studies are prospective as they were conducted specifically for the device's validation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not mention the use of experts or a "ground truth" in the context of human interpretation for establishing performance metrics for these engineering and animal studies. Performance was measured objectively through physical tests (burst pressure, thermal profiles) and observed physiological effects in animal models.

3. Adjudication method for the test set:

   • Not applicable. The studies described are objective performance and animal studies, not human reader studies requiring adjudication.

4. 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:

   • No. This is a medical device (tissue sealer), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and AI assistance are not relevant to this submission.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable, as this is a physical medical device, not an algorithm. However, the device itself has "standalone" performance metrics that were evaluated through the bench and animal tests, independent of human surgical skill, to demonstrate its inherent capabilities.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Ex-vivo Bench Testing: Ground truth was based on objective physical measurements (e.g., burst pressure, temperature readings).
   • Animal Testing (Acute and Survival): Ground truth was established through physiological observations and potentially histological/pathological examination of tissue effects in the animal models, comparing the subject device to the predicate device.

7. The sample size for the training set:

   • Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for a physical medical device.

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ENSEAL X1 Large Jaw Tissue Sealer:
The Enseal® X1 Large Jaw Tissue Sealer instrument is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. It is a bipolar instrument for use with the Ethicon Generator G11 (GEN11). It is intended for use during open surgery to cut and seal vessels, cut, grasp, and dissect tissue during surgery. Indications for use include open general, gynecologic, thoracic, and vascular procedures. These procedures include hysterectomies, colectomies, Nissen fundoplication, adhesiolysis, oo. The devices can be used on vessels (arteries, veins, pulmonary vasculature, lymphatics) up to and including 7 mm and tissue bundles.

The Enseal® X1 Curved Large Jaw instrument 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 efficacy of the Enseal® X1 Curved Large Jaw instrument for the indication of contraceptive tubal coagulation (permanent female sterilization) has not been evaluated and is unknown. The EnSeal® Tissue Sealing Device is significantly different from bipolar designs that are marketed for the indication of contraceptive tubal coagulation. The design differences may affect the efficacy of the procedure and failure rates may not be comparable.

Ethicon Generator 11:
The Generator G11 provides radiofrequency power to drive Enseal electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissues. In addition, the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Enseal and Harmonic instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.

The Enseal® X1 Large Jaw Tissue Sealer instrument is a sterile, single patient use surgical instrument used 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 jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The curved 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. Bipolar energy is delivered when the seal button or MIN foot pedal is pressing the cut button advances the knife the length of the jaws to cut the targeted tissue. It should be noted that this device has independent seal and cut capabilities. The power cord is permanently attached to the device and connects the instrument to the generator.

The device system has three essential components: the generator, the footswitch and the subject device. The Generator 11 supplies energy to the Enseal® electrosurgical instruments and Harmonic® ultrasonic surgical instruments. The generator utilizes a touchscreen display interface and has a receptacle port that accepts either Enseal® or Harmonic® devices. Connectors (one for Enseal® and one for Harmonic® devices) are used to enable the generator to power currently cleared surgical instruments. The Generator 11 hardware has not changed since the predicate device was cleared under K101990. The Enseal® X1 Large Jaw Tissue Sealer instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, which has been updated to increase the maximum Power output to 200W.

The provided FDA 510(k) summary for the Enseal® X1 Large Jaw Tissue Sealer does not describe a study involving an AI/CADe device. Instead, it details the testing and evaluation of a medical device (an electrosurgical instrument and its generator) against a predicate device to demonstrate substantial equivalence for regulatory approval.

Therefore, many of the typical questions for an AI study, such as expert consensus, MRMC studies, standalone performance, and training set details, are not applicable here.

However, I can extract the acceptance criteria and performance data for the electrosurgical device as presented in the 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 "sealed vessel burst test were evaluated" and involved "evaluation of the devices performance and ability to seal and divide vessels up to 7 mm." Specific sample sizes (e.g., number of vessels tested) are not provided.
• Acute Animal (Porcine) Testing: "Testing was performed in an acute animal study." The number of animals or specific test cases is not provided. The data provenance is described as "acute animal study" using "porcine" models. This is prospective animal data.
• Survival Animal (Porcine) Testing: "Testing was performed in survival animal studies." The number of animals or specific test cases is not provided. The data provenance is described as "survival animal studies" using "porcine" models. This is prospective animal data.

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

This is not applicable as this is not an AI/CADe study requiring expert interpretation of medical images or data for ground truth. The "ground truth" (or rather, performance validation) was established through direct physical and biological testing (burst pressure, tissue effects, etc.) against pre-defined criteria and comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable, as this is not an AI/CADe study involving human readers or adjudicators for setting ground truth. Performance was measured directly through physical and biological tests.

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 is not an AI/CADe device or an MRMC study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is not an AI/CADe device. The performance data refers to the standalone performance of the electrosurgical device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on several methods:

• Pre-defined Performance Specifications: For bench testing, criteria related to burst pressure, ability to seal specific vessel sizes, and maintenance of tissue integrity.
• Comparative Performance to a Predicate Device: For animal studies, the "ground truth" for "safety and effectiveness" effectively means demonstrating performance "as well as" the legally marketed predicate device, with no significant differences in tissue effects.
• Compliance with Standards: For sterilization, biocompatibility, EMC, and software, adherence to established international and FDA standards (ISO, IEC, FDA guidance documents).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/CADe device; there is no "training set."

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

Not applicable. There is no training set for an AI model.

Summary of the Study:

The study was a series of non-clinical tests (bench, acute animal, and survival animal studies) conducted to demonstrate the safety and effectiveness of the Enseal® X1 Large Jaw Tissue Sealer and its Generator 11. The primary objective was to demonstrate substantial equivalence to existing legally marketed predicate devices. The studies focused on physical performance characteristics (e.g., vessel sealing capabilities up to 7mm), tissue effects, and compliance with various regulatory standards (sterilization, biocompatibility, electrical safety, software validation). The device met all predetermined acceptance criteria in these tests, indicating it performed as safely and effectively as the predicate devices. No human clinical trial data was used for this premarket notification.

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