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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 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 RF-60 generator/controller which is used in conjunction with the EnSeal System. The functionality and remaining components of the System are the same.

The provided 510(k) summary for the SurgRx EnSeal Vessel Sealing & Hemostasis System (K043008) does not include detailed acceptance criteria or a specific study designed to prove the device meets such criteria.

Instead, the submission relies on the concept of substantial equivalence to a predicate device (EnSeal™ Vessel Sealing and Hemostasis System # K031133). The performance data section broadly states:

"Preclinical laboratory (bench & live animal studies) and performance tests were executed to ensure the devices function as intended and meet design specifications."

This phrasing indicates that internal testing was conducted, but it doesn't provide the level of detail requested in the prompt regarding specific acceptance criteria and the study design to evaluate them.

Therefore, I cannot provide the requested information in the table or answer most of the follow-up questions because the necessary details are not present in the provided document.

However, I can extract what is explicitly stated:

Information Not Available in the Provided Document:

• A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence rather than explicit performance benchmarks for this specific device.
• Sample size used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
• Adjudication method: Not provided.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not indicated.
• 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 AI algorithm.
• The type of ground truth used: Not explicitly stated for bench or animal studies beyond "function as intended and meet design specifications."
• The sample size for the training set: Not applicable/not provided. This is a medical device, not a machine learning model with a training set.
• How the ground truth for the training set was established: Not applicable/not provided.

Information that can be inferred or is broadly stated:

• Study Type: Preclinical laboratory (bench & live animal studies) and performance tests. These are internal validation studies, not typically large-scale clinical trials with human subjects for product clearance in this context.
• Purpose of Studies: "to ensure the devices function as intended and meet design specifications." This broadly implies that the "acceptance criteria" were the device's design specifications for functionality and safety.
• Conclusion: "The EnSeal System is equivalent to the predicate devices based on results of design validation." and "We believe that the RF-60 generator/controller used in conjunction with the EnSeal devices is safe and effective and substantially equivalent to the predicate devices."

In summary, the 510(k) submission describes a reliance on the existing predicate device's safety and effectiveness, supported by internal "preclinical laboratory (bench & live animal studies) and performance tests" to demonstrate that the functionality and design specifications of the new component (RF-60 generator/controller) are met and maintain substantial equivalence. Specific, quantifiable acceptance criteria and detailed study designs for those criteria are not part of this public summary.

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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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