Search Results

The EnSeal PowerTip is an electrosurgical instrument for use with the EnSeal Universal electrosurgical generator. It is intended for use during open or faparoscopic, 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), 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 cutting tip feature is intended for use in the dissection of tissue planes and the creation of enterotomies and gastrotomies.

The EnSeal PowerTip 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 PowerTip with EnSeal Universal. The functionality of the devices are the same as the predicate devices.

The provided text indicates that the K081129 submission for the "EnSeal PowerTip with EnSeal Universal" is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical studies with defined acceptance criteria and detailed performance reporting.

Therefore, the documentation does not contain the specific information requested in your prompt regarding acceptance criteria, a dedicated study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's what can be inferred from the provided text in relation to your request:

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

• Not Applicable. The submission is a 510(k) for substantial equivalence. It does not present new acceptance criteria or clinical performance data in this format.

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

• Not Applicable. No explicit "test set" in the context of a de novo clinical study is described. The device's safety and effectiveness are established by demonstrating functional similarities and preclinical testing in comparison to predicate devices.
• The provenance is "Preclinical laboratory (bench) and performance tests," suggesting in-house testing rather than human clinical data.

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

• Not Applicable. Ground truth, in the sense of expert consensus on clinical outcomes, is not established or reported for this type of submission.

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

• Not Applicable. No adjudication method is mentioned as there is no described test set requiring one.

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 is an electrosurgical instrument, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant or performed.

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

• Not Applicable. This is an electrosurgical instrument, not an algorithm, so this concept does not apply.

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

• Not Applicable (in the clinical sense). For a 510(k) based on substantial equivalence, the "ground truth" essentially revolves around the performance characteristics of the predicate devices and whether the new device functions similarly and meets its design specifications during preclinical (bench) testing. The text states: "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications."

8. The sample size for the training set:

• Not Applicable. This is an electrosurgical instrument, not a learning algorithm or AI.

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

• Not Applicable. This is an electrosurgical instrument, not a learning algorithm or AI.

Summary based on the provided text:

The submission K081129 is a 510(k) for an electrosurgical instrument. Its approval is based on demonstrating substantial equivalence to existing predicate devices (e.g., K031133, K063195, K031079, K051644). The "study" proving the device met criteria was primarily preclinical laboratory (bench) and performance tests aimed at ensuring the device functions as intended and meets design specifications, consistent with the performance of its predicates. There are no detailed clinical study results, acceptance criteria tables, sample sizes for test sets, expert ground truth establishment, or AI-related metrics (like MRMC or standalone performance) reported in this summary.

Ask a specific question about this device