Search Results

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.

Ask a specific question about this device

The Harmonic HD 1000i 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, plastic, pediatric, gynecologic, thoracic, exposure to orthopedic structures (such as spine and joint space), 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.

The HARMONIC HD 1000i 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 HD 1000i Shears are designed for use exclusively with the Ethicon Generator 11 (GEN 11), last cleared under K160554 on September 9, 2016.

Here's a breakdown of the acceptance criteria and study information for the HARMONIC HD 1000i Shears, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

This document primarily describes a substantial equivalence submission, meaning the acceptance criteria are largely based on demonstrating that the new device (HARMONIC HD 1000i Shears K191555) is as safe and effective as a legally marketed predicate device (HARMONIC HD 1000i Shears K160752). Therefore, "acceptance criteria" here refers to the aspects of the device that need to match or perform equivalently to the predicate. The "reported device performance" is implicitly that the subject device is substantially equivalent across these characteristics.

The document states: "Minor design modifications have been made to improve device performance. The fundamental technological characteristics (ie, design, material, chemical composition, energy source) of the HARMONIC HD 1000i Shears are equivalent to the predicate." and "Performance Data: Minor design modifications have been made to improve device performance. Verification testing for the design modifications was provided to demonstrate safety and effectiveness."

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

The provided document does not specify a sample size for a "test set" in the context of an independent performance study with defined metrics. Instead, it refers to "Verification testing for the design modifications" that was provided to demonstrate safety and effectiveness.

• Sample Size: Not explicitly stated for any specific test sets.
• Data Provenance: Not specified, but generally, premarket submissions like this would involve internal company testing. The document does not indicate country of origin or whether data was retrospective or prospective.

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

The document does not mention the use of external experts or the establishment of ground truth by experts for the purpose of a study to evaluate the device's performance against specific clinical outcomes or diagnoses. The submission focuses on demonstrating substantial equivalence based on engineering and performance characteristics compared to a predicate device.

4. Adjudication Method

As there's no mention of a study involving expert review or a "test set" requiring adjudication of results, an adjudication method is not discussed in this document.

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

An MRMC comparative effectiveness study was not mentioned or described in the provided document. The submission is for a surgical instrument, not an AI/imaging diagnostic device where such studies are common.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study (algorithm only) was not mentioned or described. This device is a physical surgical instrument, not a software algorithm.

7. Type of Ground Truth Used

For this 510(k) submission, the "ground truth" implicitly refers to the established performance and safety profile of the predicate device (HARMONIC HD 1000i Shears K160752). The new device is deemed acceptable because it maintains or improves upon these characteristics. The supporting data would be engineering tests and comparative data, rather than expert consensus on clinical findings, pathology, or outcomes data from independent clinical trials.

8. Sample Size for the Training Set

The document does not mention a "training set" as this is not an artificial intelligence/machine learning submission. If "training set" were interpreted as data used during the R&D phase to develop the minor design modifications, that information is not provided.

9. How Ground Truth for the Training Set Was Established

Since a "training set" in the context of AI/ML is not applicable, the method for establishing its ground truth is not discussed in the document.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device