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The ENSEAL® G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures.

The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. 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® G2 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices for these procedures.

The Ethicon Endo-Surgery ENSEAL G2 Tissue Sealers are for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with a foot switch.

The document provided is a 510(k) summary for the ENSEAL® G2 Tissue Sealers, an electrosurgical device. It describes the device, its intended use, and states that performance data was collected, but it does not provide specific acceptance criteria or the detailed results of a study demonstrating the device meets those criteria, nor does it describe an AI/ML algorithm.

Therefore, I cannot populate the requested table or answer most of the questions related to acceptance criteria, device performance, sample sizes, expert involvement, adjudication, or AI/ML study details, as this information is not present in the provided text.

Here's what I can extract based on the given document:

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

The document does not specify quantitative acceptance criteria or report specific performance metrics. It generally states that "Bench testing and laboratory evaluations in an animal model including an acute and a 30-day chronic survival study were conducted to demonstrate that the Ethicon Endo-Surgery ENSEAL G2 Tissue Sealers perform as intended."

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

The document mentions "Bench testing and laboratory evaluations in an animal model including an acute and a 30-day chronic survival study," but does not specify the sample size for these studies or the provenance of the data. It does indicate animal models were used.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

This document describes an electrosurgical device, not an AI/ML algorithm. Therefore, no MRMC comparative effectiveness study involving AI was conducted or reported.

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

This document describes an electrosurgical device, not an AI/ML algorithm. Therefore, no standalone algorithm performance study was conducted or reported.

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

The document refers to "Bench testing and laboratory evaluations in an animal model," implying that the "ground truth" would be based on direct observation of sealing efficacy, tissue transection, and adverse events in the animal models, likely evaluated by experts in veterinary medicine or surgical research, potentially supplemented by histological (pathology) examination. However, specific details are not provided.

8. The sample size for the training set

This document describes an electrosurgical device, not an AI/ML algorithm. Therefore, there is no training set mentioned.

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

This document describes an electrosurgical device, not an AI/ML algorithm. Therefore, this question is not applicable.

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The Generator GI I 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 tissue. In addition the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.

EnSeal® and Harmonic® instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.

The Ethicon Endo-Surgery Generator G11 supplies energy to EnSeal® electrosurgical instruments and Harmonic ultrasonic surgical instruments. The generator utilizes a touchscreen display interface and has a receptacle port that accepts either EnSeal® or Harmonic® devices. Connectors (one for Harmonic and one for EnSeal® instruments) are used to enable the generator to power currently cleared surgical instruments.

This document describes the 510(k) submission for the Ethicon Endo-Surgery Generator G11. The submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and performance data, rather than specific acceptance criteria for AI performance. Therefore, many of the requested categories are not applicable to this type of device submission.

Here's an analysis based on the provided text, addressing the requested points where possible:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission is for a surgical generator, a hardware device, not an AI/software device. Therefore, many of the requested categories related to AI performance, such as sample size for test sets, ground truth establishment, MRMC studies, and training set details, are not applicable to this submission. The performance data provided is focused on demonstrating the generator's ability to power surgical instruments safely and effectively, consistent with its intended use and comparable to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a hardware device (electrosurgical and ultrasonic generator) and not an AI or software product, the concept of "acceptance criteria" for AI performance metrics (like sensitivity, specificity, AUC) is not relevant. The "performance data" provided refers to engineering and animal model testing to ensure the generator functions as intended and is safe.

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

• Not Applicable (N/A) for AI/software test sets. The performance data involved "Bench testing and laboratory evaluations in an animal model."
• Sample Size: Not specified in the summary. For bench testing, this would refer to the number of tests performed on the device or its components. For animal models, it would be the number of animals used. This information is typically found in the detailed test reports submitted to the FDA, not in the public summary.
• Data Provenance: The studies were conducted by Ethicon Endo-Surgery, LLC. The specific country of origin for the studies is not stated but is presumably the USA, where Ethicon Endo-Surgery, Inc. is located (Cincinnati, OH). The studies would be prospective in nature, designed specifically to test the G11 generator.

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

• Not Applicable (N/A). This device is a surgical generator, not an AI diagnostic tool requiring expert-established ground truth for image interpretation or similar tasks. The "ground truth" for this device would be its ability to generate specified power outputs and enable its associated instruments to perform their intended surgical functions (e.g., cutting, sealing tissue) effectively and safely. This is typically assessed by engineers and veterinary surgeons/pathologists in animal studies.

4. Adjudication Method for the Test Set

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts when establishing ground truth for AI algorithms. This is not relevant for a surgical generator. Performance would be assessed against engineering specifications and observable surgical outcomes in animal models.

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 (N/A). This is a hardware device; no AI assistance for human readers is involved.

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

• Not Applicable (N/A). This is a hardware device; there is no algorithm or AI component to be tested in a standalone fashion. The generator itself is "standalone" in the sense that its functionality (power generation) can be tested independently of a human operator's skill, but its intended use is always with human-operated surgical instruments.

7. The Type of Ground Truth Used

• Engineering Specifications and Animal Model Outcomes: The "ground truth" for this device's performance would be:
  • Engineering Specifications: Successful delivery of specific power, voltage, current, and frequency outputs as designed for the EnSeal® and Harmonic® instruments.
  • Animal Model Outcomes: Observable biological effects (e.g., effective vessel sealing, tissue cutting, dissection, hemostasis) consistent with the intended use of the respective instruments when powered by the G11 generator, and comparison to established performance of predicate devices or clinical standards. Pathology might be used to confirm tissue effects.

8. The Sample Size for the Training Set

• Not Applicable (N/A). This device does not have an AI component that requires a training set.

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

• Not Applicable (N/A). This device does not have an AI component requiring a training set with established ground truth.

Summary of Device and Performance Data:

The Ethicon Endo-Surgery Generator G11 is a hardware device designed to power both electrosurgical (EnSeal®) and ultrasonic (Harmonic®) surgical instruments. Its 510(k) clearance was based on demonstrating "substantial equivalence" to existing predicate devices. Performance data included "Bench testing and laboratory evaluations in an animal model" to show that the generator "performs as intended" by successfully delivering the necessary power to the surgical instruments for their specified indications (cutting, sealing vessels, dissecting tissue, achieving hemostasis). The technological characteristics, such as the ability to power both types of instruments and a touchscreen interface, were detailed, but the core performance validation focused on the output characteristics and biological effects consistent with safe and effective surgical use.

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The 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.

The Ethicon Endo-Surgery Ligamax 5 is a 5 mm endoscopic multiple clip applier. This sterile, single patient use, instrument is designed to provide a means of ligation on tubular structures or vessels through an appropriately-sized trocar. The instrument contains 15 medium-large titanium clips for occluding tissue, structures, and vessels.

The provided text describes a 510(k) Premarket Notification for the Ligamax™ 5 endoscopic multiple clip applier. However, it does not contain any information about specific acceptance criteria or a study designed to prove the device meets those criteria.

The "Performance Data" section merely states: "Bench testing was performed to demonstrate that the device will perform as intended." This is a general statement and lacks the detailed information required to answer your questions.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other specifics related to a study proving the device meets acceptance criteria. The document focuses on the device description, indications for use, and a comparison to a predicate device for the purpose of achieving substantial equivalence for regulatory clearance.

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The ETHICON ENDO-SURGERY Single Site Laparoscopic Seal Cap Assembly with accessories and Fixed-Length Access Retractors have application in abdominal, colorectal, urologic, and gynecologic minimally invasive procedures to establish a path of entry for multiple minimally invasive instruments and for extraction of large specimens.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. The document is a 510(k) clearance letter from the FDA for a medical device called "Ethicon Endo-Surgery Single Site Laparoscopic Seal Cap Assembly with accessories and Fixed-Length Access Retractors."

This letter primarily focuses on:

• FDA's determination of substantial equivalence to a predicate device.
• Regulatory classification and requirements for the device.
• Indications for Use for the device.

It does not include any technical specifications, performance metrics, clinical study designs, results, or data related to acceptance criteria for the device itself.

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The Echelon Endoscopic Linear Cutters and Cartridges are intended for transaction, resection, and/or anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing 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 devices are sterile, single-use instruments that deliver staples while simultaneously dividing tissue between rows. These devices may be used in either open or Endoscopic procedures, depending upon the design. The device is intended for use in transection and resection of tissue during multiple open or minimally invasive surgical procedures. They are intended for use in the creation of anastomoses in these procedures. The instruments are reloadable and, as such, they may be reloaded with various cartridges depending on the thickness of tissue that is to be transected or resected.

The Echelon Zebra cartridge is a storage case that contains implantable staples. The cartridge is loaded into an Echelon instrument. When the instrument is deployed, it cuts a surgical wound while simultaneously delivering the staples into the tissue. As in the predicate Echclon cartridge, the Zebra cartridges are available in 60 mm lengths. Zebra cartridges will also be available in a 45 mm length for use with the 45mm instruments. There are 70 staples in the 45mm length cartridge and 88 staplers in the 60 mm length cartridge.

Cartridges deliver the staples in a predetermined staple row configuration or pattern in relation to the cut line. The staple row configurations of both the predicate and the new device have 6 staples, 3 staples on either side of the cut line. The staple row configuration (or pattern) of the prodicate device is straight. That is to say, all 6 staples are of the same height and formation. The Zebra cartridge staple row configuration is step-wise. This means that of the 6 staples, the two outer most staples are of a taller height and formation than the 4 inner staples.

The provided 510(k) summary for the Echelon Zebra Cartridges is for a medical device (stapling device) and describes its function and comparison to predicate devices. It does not present information about software or AI, nor does it describe specific acceptance criteria, performance metrics, or study designs typically associated with AI/software performance validation.

Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) as it is not present in the provided text.

The text states: "Performance Data. Bench testing was performed to demonstrate that the new device will perform as intended." This indicates that physical bench testing was done for the mechanical device, but no details of that testing, nor any information related to AI or software, are provided.

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