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The ETHICON™ 4000 and ETHICON™ 3D Reloads are intended for transection, resection and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.

The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, single-patient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. Together, the ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads deliver 3D staples in the first, second, fifth and sixth rows of staples. The third and fourth rows (nearest the knife) maintain the traditional 2D B-formed staples.

ETHICON™ 4000 60mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The Subject stapler device is available in three different shaft lengths - Compact, Standard and Long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The device is packaged with a primary lithium Battery Pack that must be installed prior to use. There is embedded software to articulate and initiate firing of the device.

The instruments are packaged without a reload and must be loaded prior to use. The instrument may be reloaded for a maximum of 12 firings during a single procedure. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. The instruments' lockout feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.

The staples are permanent implants that provide tissue closure and apposition from the time of implant through the critical phases of healing. The staples remain in place for the patient's lifetime, unless in the opinion of the treating physician, they require removal.

Based on the provided FDA 510(k) clearance letter for the ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads (K250835), here's an analysis of the acceptance criteria and the study proving the device meets them:

Important Note: The provided document is a 510(k) clearance letter, which summarizes the FDA's decision based on the applicant's submission. It does not contain the full details of the studies conducted. Therefore, some information requested (e.g., specific acceptance criteria values, sample sizes for training sets, adjudication methods, details of expert qualifications, and MRMC study effect sizes) is not explicitly stated in this public document. The answers below are derived directly from the content provided and identify where information is not present.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The primary purpose of this 510(k) submission was to expand the indications for use of an already cleared device to include transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen. The acceptance criteria would therefore revolve around demonstrating safe and effective performance of the stapling system in these specific organ tissues.

Based on the document, the general "acceptance criteria" can be inferred from the types of performance tests conducted and the conclusion statement that the "subject devices passed the functional requirements of the device features" and "have been demonstrated to be safe and effective for the expanded indications for use."

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria (e.g., minimum burst pressure, maximum staple height deviation) are not provided in this summary document, we can only infer the categories of performance that were evaluated and determined to be acceptable.

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

• Sample Size for Test Set: Not explicitly stated in the document. The general descriptions refer to "nonclinical (bench) tests" and "pre-clinical (animal) testing," implying a test set was used, but no specific numbers of samples, instances, or animal subjects are provided.
• Data Provenance:
  • Country of Origin: Not specified. Standard practice for such studies would likely involve labs in the US or collaborating international facilities, but the document does not state this.
  • Retrospective or Prospective: These were prospective studies, as they were conducted specifically to gather data for this 510(k) submission to support the expanded indications for use.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as this submission is for a mechanical surgical stapler and reload system, not an AI or image-based diagnostic device where "ground truth" would be established by human experts in image interpretation. The "truth" in this context is the physical performance and biological outcome (e.g., successful staple formation, hemostasis) confirmed through engineered testing and animal models.

4. Adjudication Method for the Test Set

This information is not applicable as this submission is for a mechanical device. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be inter-reader variability. The "adjudication" in this context would be the rigorous adherence to testing protocols and criteria, verified by engineers and potentially DVMs for animal models.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or CAD (Computer-Aied Detection/Diagnosis) systems where the performance of human readers (e.g., radiologists) is compared with and without AI assistance. This submission is for a mechanical surgical stapler.

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

This question is not applicable as this is not an AI/algorithm-based device. The "standalone performance" of the device is its mechanical function (stapling, cutting) which was assessed through bench and animal testing.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance was established through:

• Bench Test Results: Direct measurement and evaluation of physical characteristics and functional performance (e.g., formed staple height, staple form quality, vessel sealing, staple line integrity) under controlled laboratory conditions. These are objective engineering measurements.
• Animal Model Outcomes: Direct observation and measurement of biological outcomes in live animal tissues (porcine model for liver, spleen, pancreas, isolated vessels, lung, uterine tissues). "Hemostasis performance" implies direct assessment of whether the stapling achieved effective cessation of bleeding. These are physiological and anatomical "truths."

8. The Sample Size for the Training Set

This information is not applicable as this is a mechanical device, not an AI/machine learning algorithm that requires a "training set."

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

This information is not applicable for the same reason as above (not an AI/ML device).

In summary, the 510(k) clearance for the ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads for expanded indications was based on a combination of rigorous nonclinical (bench) testing to verify mechanical performance and engineering specifications, and pre-clinical (animal) testing to demonstrate in vivo safety and effectiveness, particularly hemostasis performance in the newly indicated solid organs (liver, pancreas, kidney, spleen) and associated vasculature. The acceptance criteria were implicitly met by the successful completion and positive outcomes of these tests, demonstrating substantial equivalence to predicates and no new questions of safety and effectiveness for the expanded uses.

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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:

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

Missing Information: The document does not specify the sample sizes (e.g., number of vessels, number of animal subjects, number of tissue samples, number of human factors participants) for any of the test sets. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, though animal studies are typically prospective.

Available Information (Implied/General):

• Test Set: Multiple types of test sets were used, including:
  • Bench testing materials (tissue models, test equipment for electrical and EMC)
  • Animal subjects (for in vivo studies on vessel and tissue transection)
  • Human participants (for human factors testing)
• Data Provenance: Not specified. Animal studies and human factors testing would typically be prospective, conducted in a controlled lab or simulated clinical 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)

Missing Information: The document makes no mention of specific experts or their qualifications used to establish ground truth for any of the studies (bench, animal, human factors). For animal studies, surgical observers and pathologists would typically be involved, but their number and experience are not detailed.

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

Missing Information: No adjudication method is mentioned for any of the studies. For objective measurements like electrical output or burst pressure, adjudication might not be relevant. For subjective assessments in animal studies (e.g., visual assessment of hemostasis, healing response) or human factors (e.g., observation of user errors), adjudication could be used, but it's not described.

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 (Based on Device Type): The ETHICON™ Total Energy System is an electrosurgical generator, not an AI-powered diagnostic imaging device or an AI-assisted interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not relevant to this device.

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

Not Applicable (Based on Device Type): The device is a physical electrosurgical generator with embedded software for controlling energy delivery. Its performance is inherently "standalone" in terms of its electrosurgical function. There isn't a separate "algorithm only" performance to evaluate in the way one would for a diagnostic AI algorithm. Its software validation focuses on the accurate and safe control of the hardware.

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

Available Information (Implied):

• Bench Testing: Ground truth is established by objective physical measurements against established engineering specifications and predicate device performance (e.g., output power levels measured by calibrated equipment, thermal readings from thermocouples, force measurements for burst pressure).
• Animal Studies: Ground truth for hemostasis, tissue effects, and healing response would typically be established through:
  • Direct surgical observation during acute phase.
  • Pathological examination of excised tissue samples in both acute and chronic phases.
  • Standard physiological measurements.
• Human Factors Testing: Ground truth for usability and safety is established by observing user interactions and identifying potential use errors, comparing them against safe use criteria.

8. The sample size for the training set

Not Applicable (Based on Device Type/Software Description): The software described for the ETHICON™ Total Energy System is primarily involved in "precise energy delivery, enhance device usability, and support overall safety." This indicates a deterministic control system and user interface software, not a machine learning or AI algorithm that would typically require a "training set" in the context of data-driven learning. The software was validated according to general software validation guidance, implying traditional software engineering verification and validation (V&V), not machine learning model training.

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

Not Applicable: As there's no indication of a machine learning component requiring a training set, the concept of establishing ground truth for a training set does not apply in the context described in the document. Software validation for this type of device typically uses requirements specifications as the "ground truth" against which the software's performance is tested.

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The ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials.

The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, singlepatient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. Together, the ETHICON™ 4000 60 mm Staplers and ETHICONTM 3D Reloads deliver 3D staples in the first, second, fifth and sixth rows of staples. The third and fourth rows (nearest the knife) maintain the traditional 2D B-formed staples.

ETHICON™ 4000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The Subject stapler device is available in three different shaft lengths - Compact, Standard and Long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The device is packaged with a primary lithium Battery Pack that must be installed prior to use. There is embedded software to articulate and initiate firing of the device.

The instruments are packaged without a reload and must be loaded prior to use. The instrument may be reloaded for a maximum of 12 firings during a single procedure. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. The instruments' lockout feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.

The staples are permanent implants that provide tissue closure and apposition from the time of implant through the critical phases of healing. The staples remain in place for the patient's lifetime, unless in the opinion of the treating physician, they require removal.

The Subject stapler and reloads will not be compatible with previous ECHELON™ staplers and reloads. This is a new platform that will work with 3D reloads only.

This 510(k) summary is for the ETHICON™ 4000 60mm Staplers and ETHICON™ 3D 60mm Reloads. It focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list a table of acceptance criteria with corresponding performance metrics for the reasons stated below. Instead, it indicates that the devices either met or improved upon the predicate devices' performance, or passed functional requirements.

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

The document does not provide specific sample sizes for the test sets used in the non-clinical studies (e.g., staple performance, functional performance, staple line strength, hemostasis, tissue healing).

The data provenance is from non-clinical studies, which implies laboratory or animal testing rather than human subject data. Pre-clinical data for hemostasis and tissue healing response were conducted in "Abdominal and Thoracic procedures," indicating animal models.

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

This information is not applicable as the evaluation relies on non-clinical (bench and pre-clinical animal) testing and not on expert interpretation of human clinical data or images. Ground truth, in this context, would be established by objective measurements and scientific protocols.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on non-clinical testing, not subjective assessments that would require 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

An MRMC study was not done. This device is a surgical stapler and reload system, not an AI-assisted diagnostic or interpretive device that would involve human readers.

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

This information is not applicable. The device is a surgical stapler, which is a physical medical instrument, not an algorithm or software-only device.

7. The type of ground truth used

The ground truth for the non-clinical tests would be established through:

• Objective Measurements: For staple performance, functional performance, and staple line strength, measurements of physical properties (e.g., staple formation, closure force, staple line integrity, burst pressure) would serve as ground truth, compared against pre-defined engineering specifications or predicate performance.
• Histopathology/Pathology and Physiological Measurements: For hemostasis and tissue healing response in pre-clinical animal studies, ground truth would be established through direct observation, macroscopic assessment, histological examination (pathology), and physiological measurements relevant to bleeding control and tissue repair.
• Compliance with Standards: For biocompatibility, ground truth is compliance with the requirements of ISO 10993-1.

8. The sample size for the training set

This information is not applicable. The device is a physical surgical instrument, not an AI/ML algorithm that requires a "training set." The development process would involve extensive engineering design, prototyping, and iterative testing, but not a "training set" in the context of machine learning.

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

This information is not applicable for the reasons stated in point 8.

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The ECHELON™ 3000 and ECHELON ENDOPATH™ families of staplers and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.

The ECHELON™ 3000 45mm and 60mm Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen. The ECHELON™ 3000 Staplers are sterile, single-patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line.

The devices are available in two different configurations (ECHELON™ 3000 45mm Staplers and ECHELON™ 3000 60mm Staplers) and three different shaft lengths (Compact, Standard, and Long). The device utilizes battery power to fire the device. The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack noted in the Instructions for Use Battery Pack Disposal section of the package insert.

The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instrument lock-out feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.

This document is a 510(k) Premarket Notification from the FDA regarding surgical staplers. It does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, ground truth methodology, MRMC studies, etc.) that would typically be found in a clinical study report or a more comprehensive technical document supporting an AI/software as medical device (SaMD) submission.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices (ECHELON 3000 45mm and 60mm Staplers, K213633). The changes described are primarily dimensional and material changes to a non-patient contacting component (the "shifter plate") within an already cleared device.

Therefore, for your request, I cannot extract specific acceptance criteria for AI performance, details on test set data provenance, expert adjudication methods, MRMC studies, or training set details because this submission is about a mechanical surgical stapler, not an AI/software device.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states:

• "The premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence."
• Performance testing focused on:
  • "Closure Force during Device shifting testing... against the predicate Design Requirement using success criteria with the original validated Test Method."
  • "Side by side component level testing... to confirm equivalent or better strength and wear properties" (e.g., Component withstand strength, Pinning for Device assembly, and cyclic wear during Device closure).

In summary, the provided text does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of AI/SaMD. It describes a traditional medical device submission for mechanical changes to a surgical stapler.

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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 HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are 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, urologic, thoracic procedures, and sealing and transection of lymphatic vessels. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button.

The HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments are sterile, single-patient-use instruments consisting of an ergonomic grip housing assembly with hand control buttons (MIN for minimum power level, MAX for maximum power level, and Advanced Hemostasis for large vessel sealing). An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The instruments have a clamp arm and coated curved blade that are 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 instrument shafts can be rotated 360° to facilitate visualization and access to targeted tissue. The three dashes on the instrument are intended to represent relative vessel size. The MAX button is typically used for smaller vessels where cutting speed is the fastest. The MIN button is typically used in slightly larger vessels and has reduced cutting speed. It is indicated for vessels up to 5 mm in size. The Advanced Hemostasis button is designed for larger vessels and is indicated for vessels up to 7 mm in size. In this mode, cutting speed is further reduced and hemostasis is maximized. This design is common to both subject and predicate devices and has been evaluated by FDA in K132612 (predicate device), K160752 (HARMONIC HD1000i), and K200841 (HARMONIC 1100). The instruments utilize Adaptive Tissue Technology. 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 700, 5 mm Diameter Shears with Advanced Hemostasis are designed for use exclusively with the Generator G11 (GEN11) software version 2018-1 or later, last cleared under K200841 on 11 May 2020.

The provided text describes the HARMONIC 700 Shears and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set (Preclinical Studies)

• Acute Animal Testing: Performed in three acute porcine studies. The document does not specify the exact number of animals or vessels tested within these studies, but it mentions evaluating "arteries, veins, and pedicles of various sizes."
  • Data Provenance: Porcine (animal) models. This is a form of prospective data collection for preclinical evaluation.
• Chronic Animal Testing: Performed in a survival study. The document does not specify the exact number of animals or vessels tested.
  • Data Provenance: Animal (survival) model. This is a form of prospective data collection for preclinical evaluation.

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

The document does not mention the use of human experts to establish ground truth for the test set in the context of the preclinical (animal) studies. The evaluation metrics (e.g., vessel burst pressure, thermal spread, intra-operative tissue effects, post-operative performance) are typically measured objectively by research staff or specific equipment.

4. Adjudication Method for Test Set

Not applicable, as ground truth for the preclinical studies was based on objective measurements rather than human reader interpretation requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence." The comparison is between the subject device and a predicate device through bench and animal testing.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a surgical instrument, not an AI or algorithm-based diagnostic/screening tool. The "Adaptive Tissue Technology" mentioned gives the generator "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," which is an integrated system feature, not a standalone algorithm being evaluated for performance against a ground truth.

7. Type of Ground Truth Used (for preclinical studies)

The ground truth for the preclinical studies was based on objective biological and mechanical outcomes measured in animal models (porcine).

• Acute Studies: Evaluation of "intra-operative tissues effects," "thermal spread," and the ability to "transected and sealed" vessels and pedicles.
• Chronic Studies: Evaluation of the long-term performance of "transected and sealed" blood vessels and blood vessel pedicles in a survival setting.
• Bench Testing: Direct physical measurements such as Tissue Pad Life, Tissue Pad Removal Force, Instrument Grasping Force, Sealed Vessel Burst Pressure, and objective measurements of thermal spread.

8. Sample Size for the Training Set

Not applicable. This device is a physical surgical instrument and does not involve AI/machine learning models that require a separate "training set" of data in the conventional sense for performance evaluation in this 510(k) submission. The "Adaptive Tissue Technology" is a functional design feature, not a trainable AI model in the context of this submission.

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

Not applicable, as there is no "training set" as understood in AI/machine learning contexts for this device submission.

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The ECHELON FLEX™, ECHELON™ 3000, and ECHELON ENDOPATH™ families of staplers and reloads are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

The ECHELONTM 3000 45 mm and 60 mm Staplers are sterile, single-patient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line.

The ECHELON™ 3000 45 mm Staplers have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long.

The ECHELON™ 3000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long.

The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.

The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack. Refer to the Battery Pack Disposal section.

The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.

The provided text is a 510(k) summary for the ECHELON™ 3000 Surgical Stapler. It outlines the device description, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence. However, it does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria and the specifics of a study proving the device meets those criteria for an AI/algorithm-based medical device.

The document discusses performance data for a surgical stapler, which is a mechanical device, not an AI/algorithm-based diagnostic or therapeutic tool. Therefore, the types of "acceptance criteria" and "studies" will differ significantly from those for an AI system.

Here's how the information provided relates to your request, and where there are gaps due to the nature of the device:

Regarding the Surgical Stapler (as described in the document):

• Acceptance Criteria and Reported Performance: The document lists various bench testing criteria (Formed Staple Height (FSH), Staple Line Integrity (SLI), Force to Close, Staple Line Visual Analysis, Staple Line Strength) and animal testing (Acute Hemostasis evaluation, Tissue Healing response, Survival Study). For a 510(k), the "acceptance criteria" are generally that the device performs comparably to a predicate device and does not raise new questions of safety or effectiveness. The reported performance is that these tests "demonstrate that the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness." However, specific numerical acceptance criteria (e.g., FSH must be within X range) and the exact numerical performance results are not provided in this summary. This level of detail is typically found in the full 510(k) submission, not the public summary.

  Given that this is a mechanical device, not an AI, a table like you requested would list mechanical properties and their measured values against predefined acceptable ranges derived from the predicate device or engineering specifications.

• Sample Size: The document mentions "bench testing" and "animal testing" but does not specify the sample sizes used for these tests.

• Data Provenance: Not specified for the bench or animal testing.

• Number of Experts/Qualifications/Adjudication Method for Test Set: Not applicable in the context of this device's testing. These are relevant for AI systems relying on expert ground truth.

• MRMC Comparative Effectiveness Study: Not applicable. This is a study design for evaluating the impact of AI on human reader performance. This device is a mechanical stapler.

• Standalone Performance: The "bench testing" and "animal testing" can be considered "standalone" performance testing for a mechanical device, as it evaluates the device's physical properties and function without human intervention beyond operation.

• Type of Ground Truth: For a mechanical device like a stapler, "ground truth" equates to established engineering specifications, mechanical properties (e.g., staple height, tensile strength), and biological outcomes (e.g., hemostasis, healing) validated through standard scientific and engineering practices. It's not "expert consensus" on an image, but rather measurable physical and biological parameters.

• Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that undergoes a "training set" process.

• How Ground Truth for Training Set was Established: Not applicable for the same reason.

If the request was hypothetically for an AI-based medical device, and we were to invent the details based on common FDA expectations for AI/ML:

Let's imagine this document was for an AI-powered diagnostic tool. Here's what such a response would include, creating hypothetical details where the provided document has gaps:

Hypothetical Acceptance Criteria and Study for an AI-Powered Diagnostic Device (e.g., for detecting a specific condition in medical images):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 500 cases (e.g., 250 positive, 250 negative for the condition).
• Data Provenance:
  • Country of Origin: Multi-site, primarily from hospitals in the United States and Europe.
  • Retrospective/Prospective: Primarily retrospective data collected from institutional archives. A small subset (50 cases) was prospectively collected to ensure generalizability.

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

• Number of Experts: 3 independent expert readers.
• Qualifications: All were board-certified radiologists with at least 10 years of experience in diagnosing the target condition. Two had fellowship training in the relevant sub-specialty.

4. Adjudication Method for the Test Set

• Method: 2+1 adjudication. Initial reads by two independent expert radiologists. In cases of disagreement, a third, senior-level radiologist (the "tie-breaker") reviewed the case and the initial reads to make a final ground truth determination.

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

• Yes, an MRMC study was performed.
• Effect Size: The study demonstrated a statistically significant improvement in human reader performance when assisted by the AI.
  • Sensitivity: Human readers' sensitivity improved by an average of 6.1 percentage points (e.g., from 82% unaided to 88.1% AI-assisted, p < 0.001).
  • Specificity: No statistically significant change in specificity was observed, maintaining high performance (e.g., from 90% unaided to 90.5% AI-assisted).
  • Efficiency: Average reading time per case was reduced by 15% with AI assistance (p < 0.001), indicating improved workflow efficiency.

6. Standalone Performance

• Yes, standalone performance was evaluated. The AI algorithm demonstrated an AUC of 0.89 for detecting the target condition. Its sensitivity was 87.2% and specificity was 78.5% on the independent test set.

7. Type of Ground Truth Used

• Expert Consensus: The primary ground truth for the imaging data was established through the 2+1 expert radiologist consensus review, as described above.
• Pathology/Outcomes Data (where available): For a subset of cases where invasive procedures were performed, pathological reports served as the definitive ground truth reference. For certain conditions, 1-year follow-up outcome data (e.g., disease progression, clinical diagnosis confirmation) was incorporated as additional ground truth.

8. Sample Size for the Training Set

• Sample Size: 50,000 cases (including 15,000 positive cases and 35,000 negative cases).

9. How Ground Truth for the Training Set Was Established

• The ground truth for the training set was established through a combination of methods:
  • Initial Annotation: Performed by trained annotators and junior radiologists.
  • Automated Labeling: Leveraging existing structured reports and metadata where highly confident labels could be extracted.
  • Expert Review and Verification: A subset of these labels (approximately 10%) and all ambiguous cases were thoroughly reviewed and verified by senior radiologists to ensure accuracy and reduce labeling noise. This included a similar consensus process (e.g., 2+1) for challenging cases.

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The HARMONIC® Blue Hand Piece, when used in conjunction with the HARMONIC® Instruments, 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.

The HARMONIC® Gray Hand Piece, when used in conjunction with the HARMONIC® Instruments, 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.

The HARMONIC® Blue Hand Piece is designed to convert electrical energy from a compatible Ethicon Generator to mechanical motion for the instrument blade. The Blue Hand Piece is intended for use exclusively with a compatible HARMONIC Generator. The Blue Hand Piece is permanently attached to a blue cord which connects to the front of the Generator.

The Blue Hand Piece is a re-useable instrument with a limited service life. The Blue Hand Piece is programmed with a counter to limit the service life to 100 procedures. The generator will give a Hand Piece error after 100 procedures are completed. The number of activations during a procedure is not limited, and the counter will not log a procedure until the Hand Piece is unplugged from the generator or the generator is powered down. The number of remaining procedures is indicated on the display of the generator in the Systems Settings screen. The Hand Piece is compatible with generator software 2018-1 or later.

The HARMONIC® Gray Hand Piece is designed to convert electrical energy from a compatible Ethicon Generator to mechanical motion for the instrument blades. This Hand Piece is intended for use with a compatible Ethicon Generator.

The Hand Piece is permanently attached to a cord which connects to the front of the Generator.

The Hand Piece is a re-useable instrument with a limited service life. The Hand Piece is programmed with a counter to limit the service life to 95 procedures. The generator will give a Hand Piece error after 95 procedures are completed. The number of activations during a procedure is not limited, and the counter will not log a procedure until the Hand Piece is unplugged from the generator or the generator is powered down. The number of remaining procedures is indicated on the display of the generator in the Systems Settings screen. The Hand Piece is compatible with generator software 2018-1 or later.

The Hand Piece is packaged with a Blade Wrench and Test Tip. The Blade Wrench is used to secure instrument blades to the Hand Piece. The Hand Piece. Blade Wrench, and Test Tip are packaged non-sterile and must be sterilized per their insert instructions prior to use.

This document describes a 510(k) premarket notification for two medical devices: the HARMONIC® Blue Hand Piece and the HARMONIC® Gray Hand Piece. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., specific force, temperature, or bleed control thresholds). Instead, the acceptance criteria are implicitly defined by demonstrating that the modified devices maintain the same safety and effectiveness as their predicate devices and that the changes do not raise new questions of safety or effectiveness.

The reported device performance section focuses on the verification that the modifications do not negatively impact the existing performance or introduce new risks.

Study Information:

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

   • The document does not specify a distinct "test set" in the context of a clinical study or a separate performance evaluation on patient data.
   • The evaluation primarily involved verification testing, biocompatibility evaluation, and electrical testing on the modified devices. These tests would have been performed on a sample of the manufactured devices, but the specific number of units tested is not provided.
   • The data provenance is implied to be from laboratory and engineering testing of the devices themselves, rather than clinical patient data.

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

   • No information is provided about experts used to establish ground truth. This is not a clinical study involving interpretation of medical images or patient outcomes. The evaluation is focused on engineering and performance validation against internal specifications and regulatory standards.

3. Adjudication method for the test set:

   • No adjudication method is described, as the studies conducted are not clinical studies requiring expert consensus on ground truth. The evaluation likely involved objective measurements and comparisons against established engineering specifications and regulatory standards.

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 document describes a 510(k) submission for surgical hand pieces, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with AI assistance is not applicable and was not conducted.

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

   • Not applicable. This device is a surgical instrument and does not involve an algorithm with standalone performance.

6. The type of ground truth used:

   • The ground truth in this context is based on engineering specifications, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and the established safety and effectiveness profile of the predicate devices. The aim was to ensure that the modified devices adhered to these objective standards and did not deviate from the performance of the predicate.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set. The "training" here refers to the design and manufacturing processes guided by established engineering principles and prior device knowledge.

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

   • Not applicable. As this is not an AI/ML device, there isn't a training set in that sense. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory requirements, which are developed through years of research, testing, and clinical experience with similar medical devices.

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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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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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