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The SurgRx EnSeal system includes bipolar electrosurgical instruments and a radiofrequency generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, 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 SurgRx EnSeal Vessel Sealing & Hemostasis System 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 SurgRx EnSeal devices are intended for use during open or laparoscopic general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue and/or seal vessels during surgery. The SurgRx EnSeal Vessel Sealing & Hemostasis System 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 EnSeal electrosurgical instruments are the same as the predicate devices utilizing RF powered bipolar distal ends.

The information provided is extremely limited regarding the acceptance criteria and study details. This 510(k) summary (K062949) for the SurgRx EnSeal Vessel Sealing & Hemostasis System states its substantial equivalence to a predicate device (K061526) based on design validation and preclinical laboratory (bench) and performance tests. However, it does not include any specific acceptance criteria or detailed study results.

Therefore, I cannot provide a table of acceptance criteria and reported performance, nor can I answer many of your specific questions as the information is simply not present in the provided text.

Based on the available information:

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

No specific acceptance criteria or reported device performance are detailed in the provided documents. The submission only states: "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications."

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

This information is not provided.

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.

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

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. Furthermore, this device is an electrosurgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

This device is not an algorithm; it is a physical electrosurgical instrument. The concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable here.

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

The submission mentions "Preclinical laboratory (bench) and performance tests." For an electrosurgical instrument, ground truth would typically be established through direct measurement of physical parameters (e.g., seal strength, burst pressure, thermal spread, cutting efficacy, tissue impedance) against engineering specifications and comparison to predicate devices, often using ex vivo or in vivo animal models. However, the specific type of ground truth and the metrics used are not detailed in this summary.

8. The sample size for the training set

This information is not provided. As this is an electrosurgical instrument, the concept of a "training set" in the context of machine learning is not directly applicable. If it refers to data used for initial design and optimization, those details are not given.

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

This information is not provided, and the concept of a "training set" for ground truth establishment, typically associated with AI/ML, isn't directly relevant to this type of device.

Summary of what we can glean from the provided text:

• Device Type: Electrosurgical Vessel Sealing & Hemostasis System.
• Purpose of Submission: Demonstrate substantial equivalence to a predicate device (K061526).
• Evaluation Method: Preclinical laboratory (bench) and performance tests.
• Conclusion: The device is considered safe, effective, and substantially equivalent to the predicate based on "design validation."
• Key Detail Gap: The submission lacks specifics on acceptance criteria, test methodologies, sample sizes, and detailed performance data, which are typically found in the full 510(k) submission, but not in this summary.

Ask a specific question about this device

The SurgRx EnSeal system includes bipolar electrosurgical instruments and a radiofrequency generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, 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 researcines, 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 SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

EnSeal™ Vessel Sealing & Hemostasis System. The functionality of the System is the same as the Predicate Device. The EnSeal electrosurgical instruments are the same as the predicate devices utilizing RF powered bipolar distal ends.

The provided 510(k) summary for the SurgRx EnSeal Vessel Sealing & Hemostasis System (K061526) states that preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications. The submission then concludes that the system is equivalent to its predicate device based on these design validation results.

However, the summary does not provide specific details about the acceptance criteria or the study that "proves the device meets the acceptance criteria" in the format of the requested table and detailed analysis. This type of information is typically considered proprietary and is not fully disclosed in a public 510(k) summary. The summary focuses on establishing substantial equivalence to a predicate device (K031133) rather than presenting a detailed performance study with explicit acceptance criteria and results.

Therefore, I cannot fully complete the requested table and analysis due to the limited information available in the provided document.

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

Inferred Information from the 510(k) Summary

The summary indicates that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." This implies that the device was evaluated for its ability to cut and seal vessels, grasp and dissect tissue effectively and safely, similar to its predicate device.

Missing Information - Cannot be Extracted from the Provided Document

1. Table of Acceptance Criteria and Reported Device Performance

Reason for missing information: The 510(k) summary did not disclose the specific quantifiable acceptance criteria or the detailed results of the performance tests. It broadly states that tests were done to "meet design specifications."

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

Reason for missing information: The document does not specify the sample size (e.g., number of vessels, tissues, or animals tested) used in the preclinical laboratory and performance tests. It also does not mention the country of origin of the data or whether it was retrospective or prospective.

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

Reason for missing information: The document does not mention the involvement of experts for establishing ground truth, as this type of preclinical testing typically involves engineers and researchers evaluating physical performance rather than clinical expert consensus.

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

Reason for missing information: This is not applicable to the preclinical bench and performance tests described. Adjudication methods are typically used in clinical studies involving human readers or evaluators.

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

Reason for missing information: This information is not relevant to the device described. The EnSeal system is an electrosurgical instrument, not an AI-powered diagnostic or assistive technology for human readers.

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

Reason for missing information: This is not applicable. The EnSeal system is a medical device requiring direct human operation, not a standalone algorithm.

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

Reason for missing information: For preclinical bench testing of an electrosurgical device, the "ground truth" would typically be established by objective measurements against engineering specifications and validated experimental methods (e.g., bursting pressure measurements for seals, microscopic analysis of tissue effects, temperature readings). The document does not specify these methods.

8. The sample size for the training set

Reason for missing information: Not applicable to this type of device. "Training set" is a concept used in machine learning and AI development, not for the validation of an electrosurgical instrument in the manner described. The device's design is based on engineering principles and previous predicate device experience, not a "training set" in the AI sense.

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

Reason for missing information: Not applicable for the same reason as point 8.

In summary, the provided 510(k) summary states that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications," leading to the conclusion of substantial equivalence. However, it explicitly lacks the granular detail regarding acceptance criteria, sample sizes, expert involvement, and specific performance results that would be needed to fulfill the request.

Ask a specific question about this device

The SurgRx EnSeal system includes bipolar electrosurgical instruments and an accessory adapter for use with standard electrosurgical generators. It is intended for use during open or laparoscopic, general and general and general to cut and seal vesses, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including unologic, 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 SurgHx EnSeal Vessel Sealing & Hemostasis System 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 EnSeal Laparoscopic devices are tubular instruments with grasping jaws at the distal end, which are actuated by a handle at the proximal end of the device. The distal end contains bipolar electrodes for sealing vessels, and a mechanical cutting blade for transecting vessels. The EnSeal Open devices are reusable forceps-type devices with one snap-in single use, disposable bipolar electrode, and one permanent, reusable electrode in the jaws of the device. Connectors attached to an electrical cable connect the device to the ECA (EnSeal Controller Adapter) accessory which connects the device to a standard O.R. electrosurgical generator.

{
  "1. A table of acceptance criteria and the reported device performance": null,
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "Preclinical laboratory (bench studies) were executed, but specific sample sizes are not provided. The data provenance is described as 'preclinical laboratory (bench studies)', which typically implies prospective testing conducted in a controlled 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)": "The human factors evaluation involved 'physicians' who provided input in pre-clinical and bench testing. The specific number and qualifications of these physicians are not detailed.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The study primarily involved preclinical laboratory (bench studies) and user feedback, not a standard adjudication process for a diagnostic or AI device.",
  "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "Not applicable. This document describes a medical device for surgical procedures (vessel sealing and hemostasis system), not an AI-based diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This device is a surgical instrument that requires a human operator, not an autonomous algorithm.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "For the preclinical laboratory (bench studies), the 'ground truth' would be the objective performance metrics established by the design specifications, such as sealing strength, transection effectiveness, and tissue dissection capabilities. These are typically measured directly in a lab setting.",
  "8. The sample size for the training set": "Not applicable. This is not an AI/ML device that requires a training set in the typical sense.",
  "9. How the ground truth for the training set was established": "Not applicable. This is not an AI/ML device."
}

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