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The ETHICON™ Total Energy System is intended to supply energy to surgical devices.
The ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring cutting or coagulation of soft tissue.

The subject device, The ETHICON™ Total Energy System, is an electrosurgical generator that integrates Advanced Energy (Advanced Bipolar and Ultrasonic) and Core Monopolar and Bipolar energy modalities into one system, the Ethicon Total Energy System. The subject device consists of two modules: the Communications Module (ETHCM and ETHUSC) and the Energy Module (ETHEM). Atop the Energy Module is the Communications Module and the User Screen. The Communications Module contains the power button and speakers, connects to the User Screen, distributes power to the system, and provides external interfaces for other connectivity to external devices including Ethernet and USB. One or two Energy Modules can be connected to the Communications Module. When two Energy Modules are connected, each Energy Module can independently power any of the energy modalities. This feature allows for simultaneous use of two surgical instruments in one system to support complex surgical procedures where two surgeons are operating on a patient at the same time. The User Screen features a touch-operable graphical user interface (GUI) for system settings adjustment, user profile management, and alarm troubleshooting. The ETHICON™ Total Energy System accessories include a cart for system transport, footswitches (single, double, round), and an output verification key. The cart provides a mobile platform with adjustable shelves and accessory storage. Additionally, the cart has custom features to create stability for the system including cut-outs on the top shelf for holding the rubber feet of a second module layers. Casters provide 360° mobility with locking tabs that lock to prevent unwanted cart movement. Footswitches may be used to control power delivery to connected instruments, enabling surgeons to activate the energy output hands-free. The different footswitches can be used for various energy modalities and instruments. Up to four footswitches can be connected to the Communications Module of the Ethicon Total Energy System at the same time. The footswitches are assigned to the desired instrument port via the User Screen GUI. Output Verification is a service mode of the system used to periodically confirm that the power outputs of each energy modality are within the required specifications. The Energy Output Verification Key is used by biomed/hospital facility servicing personnel to complete this process for annual maintenance on the Energy Module, with on-screen guidance to assist in this process. The ETHICON™ Total Energy System is compatible with Ethicon HARMONIC™, Ethicon ENSEAL™, and Ethicon MEGADYNE™ monopolar and bipolar instruments.

The provided FDA 510(k) summary for "The ETHICON™ Total Energy System" does not contain the specific details regarding acceptance criteria and the comprehensive study results typically found in a full scientific report.

However, based on the information provided, I can infer the general nature of the acceptance criteria and the studies performed, and explain what is missing from a complete answer regarding detailed acceptance criteria and proof of meeting them:

General Conclusion from the Document:
The FDA 510(k) summary states, "The subject device showed either equivalent or improved performance compared to the predicate devices and met all functional requirements of its features. It successfully met the acceptance criteria for bench testing, animal studies, usability, and electrical testing, demonstrating no new safety or effectiveness issues compared to the predicate."

This indicates that acceptance criteria were established and met for various aspects, but the specific, quantifiable criteria and the detailed results proving they were met are not explicitly listed in the provided text.

Here's an attempt to answer your request based on the available information, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

Missing Information: The document states that the device "met the acceptance criteria for bench testing, animal studies, usability, and electrical testing" and "demonstrated equivalent output, stability, and thermal spread control" compared to predicates. However, specific quantitative acceptance criteria and their corresponding reported device performance values are not provided in this 510(k) summary. For example, it doesn't state "Acceptance Criterion: Vessel burst pressure > X mmHg, Reported Performance: Y mmHg."

To illustrate what would be in such a table, based on the mentioned tests:

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The ENSEAL X1 Curved Jaw and ENSEAL X1 Straight Jaw Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are indicated for use during open or laparoscopic surgery.

Indications for use include open and laparoscopic general surgical procedures (including bowel resections, gynecology, gastric, urologic and thoracic surgical procedures) where vessel ligation (sealing and cutting), division of lymphatics, tissue grasping and dissection is performed. The devices can be used on vessels and vascular bundles up to and including 7 mm in diameter.

The ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers are intended to cut and seal vessels, and to cut, grasp, and dissect tissue during surgery.

The ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers are sterile, single-patient-use surgical instruments used to coagulate and transect vessels up to and including 7 mm in diameter, tissue, and/or vascular bundles. These devices are 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 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 Curved and Straight JawTissue Sealers have separate seal and cut capabilities. The lower jaw of the ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers 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™ X 1 Curved and Straight Jaw Tissue Sealer instruments are designed for use exclusively with the Ethicon Generator G11(GEN11). software version 2016-1 or later, or other compatible Ethicon generators. Refer to the Ethicon Generator's Manual for more information.

The provided text is a 510(k) summary for the ENSEAL X1 Curved and Straight Jaw Tissue Sealers. It details the device's indications for use, comparison to predicate devices, and performance data. However, it does not describe an AI/device performance study with the detailed acceptance criteria and study design requested in the prompt.

Specifically, the document states:

• "Bench Performance data was not included as part of this premarket notification. There is no change in the technological characteristics between the subject device ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers and cleared predicates; Curved Jaw Tissue Sealer (K201066) and Straight Jaw Tissue Sealer (K201696)."
• "An acute animal study was conducted that evaluated the performance of ENSEAL X1 Curved and Straight Jaw Tissue Sealers in gastric procedures."

This indicates that the submission relies on the substantial equivalence to predicate devices, and the animal study is for performance evaluation in a specific procedural context, not for evaluating an AI algorithm against a test set with ground truth established by experts.

Therefore, I cannot extract the information requested in points 1-9 of your prompt, as the provided text does not contain details about an AI-based device performance study, acceptance criteria for an AI algorithm, or details related to ground truth establishment by experts for AI evaluation.

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The IRIS Thermocoagulator and Digital Colposcope is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe, and to provide magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in selecting areas for biopsy and diagnosing as needed for a colposcopy exam.

The Liger Medical IRIS Thermocoagulator and Digital Colposcope is a portable thermal coagulator with integral colposcope that provides assistance for clinician examination of the cervix as well as utilizes a heated probe to ablate human tissue. It is specifically designed for use in resource-limited settings. The colposcope and thermal ablation modes can be used separately from each other. The device is a handheld, portable, battery-operated, ablator with an LCD display and optical camera to assist diagnosis and treatment, in a safe, effective, easy to use package with sufficient battery life to sustain work for 4 hours. Thermal coagulation can be used in hospital and non-hospital professional healthcare locations.

The IRIS colposcope/thermal ablation device is not intended on into the vaginal canal during colposcopic examination. The camera remains outside the vaginal cavity and functions comparably to a standard non-invasive colposcope in terms of providing magnified visual assistance to the clinician. There is no patient contact during the colposcopic examination. Contact between the clinician and the device is mitigated through good clinical practice of wearing protective gloves, limiting contact to intact skin protected by operating gloves.

The thermal ablation probe, which is reusable and provided non-sterile, is designed to perform low-power destruction of human tissue with high temperatures by tissue contact with an electrically heated probe tip. The biocompatibility of the probe materials conforms to all recommended endpoints per FDA's guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for limited duration mucosal membrane contact.

The provided text is a 510(k) Summary for the Liger Medical IRIS Thermocoagulator and Digital Colposcope. It details the device's intended use, comparison to predicate devices, and non-clinical performance testing. However, it explicitly states "Not Applicable" under "9. Clinical Performance Data."

Therefore, based solely on the provided text, a detailed response to points 1-7, 8, and 9 for a study proving the device meets acceptance criteria cannot be fully constructed, as the document states no clinical performance data was used for this submission. The device's substantial equivalence was demonstrated through non-clinical performance testing and comparison to predicate devices.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document describes various non-clinical tests performed, implying these tests have acceptance criteria, but the specific numerical acceptance criteria and the precise quantified performance results are not detailed in a comparative table format. We only get a list of tests performed.

Table of Acceptance Criteria (Implied) and Reported Device Performance (General):

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

• Sample size: Not specified as no clinical performance data was provided. The non-clinical tests would have involved specific test units, but the "sample size" in terms of patient data is not applicable here.
• Data provenance: Not applicable.

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

• Not applicable as no clinical performance data/test set with human expert ground truth was mentioned.

4. Adjudication method for the test set:

• Not applicable as no clinical performance data/test set requiring adjudication was mentioned.

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:

• No, a MRMC comparative effectiveness study was not done according to this document. The device includes a digital colposcope for magnified visualization to aid in selecting areas for biopsy and diagnosis, but the submission explicitly states "Not Applicable" for clinical performance data, meaning no study assessing human reader improvement with or without AI assistance was presented here.

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

• Not applicable. The device is a physical instrument (thermocoagulator and digital colposcope), not an AI algorithm in isolation. While it has a "Digital Colposcope" component capable of camera-assisted visualization, the document does not describe any standalone algorithm performance.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" would be the established engineering and safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 8600-1, ISO 8600-3, ISO 10993-1) against which the device's technical performance was measured. No clinical ground truth (e.g., pathology, outcomes data) was used or presented in this 510(k) summary.

8. The sample size for the training set:

• Not applicable. This document is for a physical medical device, not an AI/ML algorithm that requires a training set of data.

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

• Not applicable.

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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, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tisue bundles is performed (e.g. bowel resections, 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 X1 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 instrument is a sterile, single patient use surgical instrument to coagulate and transect vessels up to and including 7mm 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 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 has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer 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 instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.

The provided document describes the substantial equivalence of the "ENSEAL X1 Tissue Sealer" to a predicate device, the "ENSEAL G2 Tissue Sealer." The acceptance criteria and the study that proves the device meets those criteria are primarily focused on performance data from bench and animal testing rather than a clinical trial with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list a table of "acceptance criteria" alongside specific numerical results for all tests in a single cohesive table. However, it states that "Data generated from the bench testing met the predetermined acceptance criteria." The primary measurable acceptance criterion mentioned is for vessel seal performance.

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

• Bench Testing (Vessel Burst Pressure):

  • Sample Size: Not explicitly stated as a number of vessels, but mentioned as "Porcine arteries were used."
  • Data Provenance: Porcine (animal tissue). Retrospective (if referring to previously obtained tissue) or Prospective (if tissue was freshly obtained for the study) is not specified.

• Acute Animal Testing:

  • Sample Size: Four animals for each device (ENSEAL X1 Tissue Sealer and predicate device).
  • Data Provenance: Porcine (animal model). Prospective (as these were conducted tests).

• Chronic/Survival Animal Testing:

  • Sample Size: Ten animals for each device (ENSEAL X1 Tissue Sealer and predicate device).
  • Data Provenance: Porcine (animal model). Prospective (as these were conducted tests).

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

The document does not mention the involvement of human experts to establish "ground truth" in the context of radiologists or similar interpretations for the animal or bench studies. The testing methodologies (e.g., burst pressure measurements, observation of tissue effects) inherently provide the "ground truth" for the performance criteria.

4. Adjudication Method for the Test Set

Not applicable, as the data collection from bench and animal studies does not typically involve human adjudication in the way clinical image interpretation studies do. The measurements and observations are direct.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document explicitly states: "This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence." Thus, no MRMC study was conducted.

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

Not applicable. This is a medical device (electrosurgical instrument), not an AI algorithm. Its performance is evaluated directly through physical and biological tests, not through an algorithm's output.

7. The Type of Ground Truth Used

• Bench Testing: Direct physical measurements (e.g., force, pressure, visual observation of sealing/cutting) on porcine vessels.
• Animal Testing: Direct observation and evaluation of tissue effects (e.g., vessel sealing, tissue dissection, complications) in live porcine models, both acutely and chronically. The "ground truth" here is the biological and mechanical outcome in the animal models.

8. The Sample Size for the Training Set

Not applicable. The device is a physical instrument, not an AI/ML algorithm that requires a "training set."

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

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

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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, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tisue 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 bundles as large as will fit in the jaws of the instruments.

The ENSEAL X1 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 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 jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. 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 has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer 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. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL X1 Tissue Sealer instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.

The provided text describes the acceptance criteria and the study conducted to prove that the ENSEAL X1 Tissue Sealers meet these criteria. The device is an electrosurgical instrument for cutting and sealing vessels and tissues.

Acceptance Criteria and Reported Device Performance

The core performance acceptance criterion for the ENSEAL X1 Tissue Sealers is its vessel seal performance, measured by burst pressure. Other criteria relate to electrical safety, sterility, mechanical integrity, and biocompatibility.

Study Proving Device Meets Acceptance Criteria

The study conducted to prove the device meets acceptance criteria involved a combination of bench testing and animal studies.

1. Sample Size and Data Provenance:

   • Bench Testing: Used porcine arteries for sealed vessel burst pressure testing. The exact number of samples is not explicitly stated, but it is indicated that "Data generated from the bench testing met the predetermined acceptance criteria."
   • Acute Animal Testing: Performed in four animals for each device (subject and predicate) targeting arteries, veins, and vessel pedicles less than or equal to 7mm in diameter. Data provenance is from an acute porcine study.
   • Chronic/Survival Animal Testing: Performed in ten animals for each device (subject and predicate) targeting arteries, veins, and vessel pedicles less than or equal to 7mm in diameter. Data provenance is from a 30 (±2) day chronic survival study in animals (implied porcine).
   • The studies were pre-clinical (animal and bench), not human clinical trials. The country of origin for the data is not specified but is implicitly associated with the manufacturer's testing facilities.

2. Number of Experts and Qualifications for Ground Truth (Test Set):

   • This section is not applicable as the studies described are pre-clinical bench and animal studies (not human-in-the-loop diagnostic studies). Ground truth was established through physical measurements (e.g., burst pressure) and direct observation of tissue effects in animals.

3. Adjudication Method for the Test Set:

   • This section is not applicable for the type of pre-clinical studies conducted. The evaluation involved objective measurements and observations, not expert consensus on interpretations.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. The studies were focused on the device's technical performance and comparative equivalence to a predicate device in an animal model, not on human reader performance with or without AI assistance.

5. Standalone Performance:

   • Yes, the studies essentially evaluated the "standalone" performance of the algorithm/device. The bench testing directly measured the device's ability to seal vessels and achieve a certain burst pressure. The animal studies assessed its performance in vivo (tissue effects, sealing/dividing vessels) independent of human interpretive input. The description directly evaluates the device's inherent functional capabilities.

6. Type of Ground Truth Used:

   • The ground truth for the performance evaluations was based on:
     • Physical Measurements: E.g., burst pressure (mmHg) for vessel sealing, precise diameter measurements of vessels used (up to 7mm).
     • Direct Observation/Pathological Assessment: Evaluation of tissue effects, ability to seal and divide vessels, and assessment of outcomes in animal models (both acute and chronic survival, looking at tissue health and healing post-procedure).

7. Sample Size for the Training Set:

   • This concept is not applicable to this type of device and study. The ENSEAL X1 Tissue Sealers are a physical electrosurgical instrument, not an AI/machine learning algorithm requiring a "training set" of data. The "training" for such a device involves engineering design, manufacturing, and preclinical validation.

8. How the Ground Truth for the Training Set Was Established:

   • This concept is not applicable for the reasons stated above.

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HARMONIC 1100 Shears: The HARMONIC 1100 Shears instrument is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, thoracic, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.

Ethicon Generator G11: 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.

HARMONIC 1100 Shears: The HARMONIC 1100 Shears are sterile, single-patient use devices for the dissection, grasping, coagulation, and cutting of soft tissue between the blade and clamp arm. The device consists of an ergonomic grip housing assembly with two-hand control buttons: 1) Energy button for power levels 1-5, and 2) Energy with Advanced Hemostasis button for large vessel sealing. The device is available in two shaft lengths (20 cm and 36 cm), and both device shafts can be rotated continuously to facilitate visualization and access to targeted tissue. An integrated audible and tactile mechanism in the grip housing indicates full trigger closures. The device has a clamp arm and coated curved blade that is designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The Energy button is indicated for vessels up to 5 mm in diameter. When the Energy button is used, cutting speed is the fastest. The Energy with Advanced Hemostasis button is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. When the Energy with Advanced Hemostasis button is used, cutting speed is reduced and hemostasis is maximized. The device utilizes Adaptive Tissue Technology (the technological characteristics of which were first cleared under K120729 on May 17, 2012 and incorporated into multiple Ethicon devices). This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output, as well as provide audible feedback to the user as appropriate. The HARMONIC 1100 Shears are designed for use exclusively with the Ethicon Generator 11 (GEN11), last cleared under K160554 on September 9, 2016.

Generator G11: The Generator G11 supplies energy to the HARMONIC® and ENSEAL® surgical instruments. The generator uses a touchscreen display interface and has a unique receptacle port that accepts either a HARMONIC or an ENSEAL instrument. Connectors (HGA11 for HARMONIC and EGA11 for ENSEAL) are used to enable the generator to power legacy instruments. All ENSEAL and HARMONIC devices compatible with the generator and provided by Ethicon and authorized manufacturers undergo an extensive verification and validation process. The Ethicon Endo-Surgery Generator G11 System is not designed to operate unauthorized devices. Such use is not in accordance with the design and use parameters, instructions and guidelines for the product.

The provided text is a 510(k) Summary for the Ethicon HARMONIC 1100 Shears and the Generator G11. It focuses on demonstrating substantial equivalence to predicate devices rather than describing a study with acceptance criteria and device performance in the context of AI or diagnostic accuracy.

Therefore, the document does not contain the information requested in most of the points of your prompt. It describes a regulatory submission for a medical device (ultrasonic surgical instruments and generator) and details about its intended use, technological characteristics, and comparison to predicate devices, but lacks the specific elements of an AI-related study or performance evaluation against defined acceptance criteria.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

• Missing. The document talks about "Verification testing for the design modifications was provided to demonstrate safety and effectiveness" but does not specify acceptance criteria or quantitative performance results (e.g., sensitivity, specificity, accuracy, etc.) in a table format.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Missing. This type of information is not relevant to a 510(k) submission focused on substantial equivalence of an electrosurgical device based on design modifications and technological characteristics.

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

• Missing. This is not an AI/diagnostic study, so there is no "ground truth" in this context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Missing. Not applicable to this type of regulatory submission.

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:

• Missing. This is not an AI-assisted diagnostic device.

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

• Missing. Not an AI algorithm.

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

• Missing. Not an AI/diagnostic study.

8. The sample size for the training set:

• Missing. Not an AI algorithm.

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

• Missing. Not an AI algorithm.

Summary of available information (related to the device in general, not an AI study):

The document states that "Verification testing for the design modifications was provided to demonstrate safety and effectiveness" for both the HARMONIC 1100 Shears and the Generator G11. This suggests that some form of testing was conducted to ensure the device performs as intended and is safe. However, the specifics of these tests, including acceptance criteria and detailed performance results, are not included in this summary.

Key takeaway: This document is a regulatory submission demonstrating substantial equivalence for a medical device. It does not describe an AI-related study or a study with specific acceptance criteria and detailed performance metrics as would be expected for an AI-powered diagnostic tool.

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Indications for Use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.

This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two models, one for ABF01-F and the other for lock functions, ABF01-L. The two models are same except for lock function. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

The document describes the ArtiSential Bipolar Fenestrated Forceps, a single-use electrosurgical instrument used in laparoscopic surgery for coagulation, dissection, and grasping of tissue. The device underwent several performance tests to demonstrate its safety and effectiveness and establish substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the performance tests. The data provenance is also not specified; however, given the applicant's address (Republic of Korea) and the FDA submission, it is likely that the testing data was generated in support of regulatory approval in the US. The nature of the tests (physical, electrical, and biocompatibility) suggests that they are laboratory-based and generally not dependent on patient data provenance.

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

This information is not applicable. The performance tests described are objective, engineering-based evaluations of the device's physical and electrical characteristics, and biological safety. They do not involve expert interpretation or ground truth derived from a clinical dataset (e.g., medical images).

4. Adjudication Method for the Test Set

Not applicable, as the tests are objective and do not involve human interpretation requiring adjudication.

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. The ArtiSential Bipolar Fenestrated Forceps is a medical instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable, as this is a medical instrument and not an algorithm. Performance tests mentioned are for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on objective, measurable engineering specifications, established international standards (e.g., ISO 10993-1, IEC 60601 series, ISO-11135), and visual inspection criteria. It is not dependent on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

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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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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 X1 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 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 jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The ENSEAL X1 Tissue Sealer has a curved jaw and a straight jaw configuration. 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 has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer 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 instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.

The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue. The study used to demonstrate the device meets acceptance criteria involved a combination of bench testing and animal studies.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance (for test set/performance studies):

• Bench Testing (Vessel Burst): The document does not specify a precise sample size for the vessel burst test, only stating that "maximum and minimum values, standard deviation and the mean were recorded." The data source was porcine arteries. This is retrospective data in the sense that it's performed in a lab setting.
• Acute Animal Testing: Two animals were used for each device (ENSEAL X1 Tissue Sealers and the predicate device). The data provenance is from an acute porcine study.
• Survival Animal Testing: Five animals were used for each device (ENSEAL X1 Tissue Sealers and the predicate device). The data provenance is from a chronic survival porcine study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

Not applicable. The performance studies described are bench tests and animal studies, which do not involve human expert interpretation for ground truth.

4. Adjudication Method (Test Set):

Not applicable, as human expert adjudication is not relevant for the types of studies conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence." The studies focused on comparing the device's technical performance and biological effects to a predicate device in controlled lab and animal settings.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The ENSEAL X1 Tissue Sealers are a medical device (electrosurgical instruments), not an algorithm or AI system. Their performance is inherent to the device itself.

7. Type of Ground Truth Used:

• Bench Testing: Objective measurements of mechanical properties and vessel burst pressure.
• Animal Studies: Observed tissue effects, ability to seal and divide vessels, and biological responses in live animal models. The "ground truth" here is the direct physiological and mechanical outcome.

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI or machine learning system that requires a "training set."

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

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

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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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