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The Valleylab LigaSure Advance™ is a 5mm laparoscopic, electrosurgical instrument that incorporates both monopolar and LigaSure™ tissue fusion (bipolar) functionality. It is intended for use with the Valleylab ForceTriad™ energy platform (electrosurgical generator) in general and gynecological, laparoscopic, surgical procedures where ligation of vessels, including lymph vessels, is desired. The monopolar feature of the instrument will be used where electrical dissection through tissue planes and creation of enterotomies or gastrotomies is desired.

Indications for use include general and gynecological, laparoscopic surgical procedures (including urologic, vascular, thoracic and thoracoscopic) where electrosurgical ligation and division of vessels, including lymph vessels, is performed. These procedures include: laparoscopic gastric bypass, laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, laparoscopic colectomy, adhesiolysis, oophorectomy, ctc.

The Valleylab LigaSure Advance™ can be used on vessels up to and including 7mm diameter and tissue bundles as large as will fit in the jaws of the instrument.

The Valleylab LigaSure Advance™ has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The LigaSure Advance™ is a 5mm laparoscopic vessel sealer and divider with integrated monopolar capability for energy-based dissection. The Valleylab LigaSure Advance™ is for use only with the Valleylab ForceTriad™ energy platform (electrosurgical generator), reference 510(k) notification K051644. The device will be offered in two lengths, 34 cm and 44 cm.

The LigaSure Advance™ device will be used to seal vessels, including lymph vessels, up to and including 7mm in diameter and tissue bundles. The sealed vessels and other tissue structures may be divided by the deployment of a mechanical knife that will reside within the shaft of the instrument and extends forward in a slot within the jaws when actuated by a mechanism residing within the handle of the device.

The monopolar capabilities of the device will be used to electrically dissect through tissue planes and to create openings in bowel (enterotomies) and stomach (gastrotomies). This is accomplished through a small electrode that protrudes from the distal end of one of the jaws of the device.

The controls for the device are all located on the handle. The instrument attaches to the generator with "smart" connectors, that identify the instrument type to the LigaSure generator, and a ten (10) foot cable. The instrument is supplied sterile for single-use.

The Valleylab LigaSure Advance™ is a laparoscopic electrosurgical instrument with both monopolar and bipolar (LigaSure™ tissue fusion) functionality. It is intended for use in general and gynecological laparoscopic surgical procedures for vessel ligation and division, and for electrical dissection, enterotomies, and gastrotomies using its monopolar feature. The device can be used on vessels up to 7mm in diameter and tissue bundles that fit within its jaws.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria in a table format. However, it states that "Performance testing and pre-clinical studies were performed to ensure that the LigaSure Advance™ functions as intended, and meets design specifications." The overall acceptance criterion is that the device is "substantially equivalent to the predicate devices, and meets safety and effectiveness criteria."

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

The document mentions "Performance testing and pre-clinical studies" but does not specify the sample size used for these tests.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the nature of pre-clinical studies for a medical device prior to market release, it is highly likely that these were prospective studies, typically conducted in animal models or ex vivo tissue models.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the provided document. The focus is on demonstrating substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.

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

This device is an electrosurgical instrument for use by surgeons; it is not an AI algorithm. Therefore, the concept of a "standalone" study for an algorithm is not applicable to this device. The performance testing would inherently involve the device being used by operators (likely skilled surgeons or technicians) in pre-clinical settings.

7. The Type of Ground Truth Used:

The document does not explicitly state the specific type of ground truth used for performance testing. However, for a surgical device like this, ground truth would typically involve:

• Direct observation and measurement of seal integrity, burst pressure of sealed vessels, tissue damage, cutting effectiveness, and performance of monopolar dissection in pre-clinical models (e.g., animal studies, ex vivo tissue).
• Histopathological assessment of sealed tissues to confirm effective vessel occlusion and absence of thermal damage affecting surrounding structures.
• Functional assessment of mechanical knife deployment and cutting.

8. The Sample Size for the Training Set:

This device is a hardware electrosurgical instrument, not an AI algorithm that requires a training set. Therefore, the concept of a "training set" sample size is not applicable.

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

As explained above, this device is not an AI algorithm, so there is no training set and therefore no ground truth established for a training set.

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