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The LigaSure™ Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.

The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where ligation of vessels is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy. etc. The devices can be used on vessels up to 7mm and bundles as large as will fit in the jaws of the instruments.

The LigaSure™ Vessel Sealing System 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™ Vessel Sealing System consists of a microprocessor-based radiofrequency (RF) generator and a selection of instruments designed to be used exclusively with the LigaSure™ generator. All of the instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure™ instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that the seal cycle is complete.

No changes are being made to the design or operation of any of the devices within the current system. The change as proposed in this 510(k) notification is to the intended use as described above and the resulting labeling changes.

This document is a 510(k) premarket notification for the LigaSure™ Vessel Sealing System. The primary purpose of this notification is to advise the FDA of a change in the intended use and resulting labeling for the device, not to introduce a new device or demonstrate a new level of performance. As such, the information you're requesting regarding acceptance criteria and performance studies for a new device or algorithm development is largely not present in this submission.

The document confirms the safety and effectiveness of the device for its expanded indications based on pre-clinical studies and its substantial equivalence to a legally marketed predicate device.

Here's an attempt to answer your questions based on the provided text, highlighting what is explicitly stated and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria (e.g., target accuracy, sensitivity, specificity) are defined or reported in this document. The document states that pre-clinical studies were conducted.

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

The document mentions "pre-clinical studies" but does not specify the sample size, the type of test set (e.g., animal models, cadaveric tissue), or the data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided. The pre-clinical studies likely involved laboratory measurements and potentially histological analysis by trained personnel, but no details on expert consensus for ground truth are given.

4. Adjudication Method for the Test Set

This information is not provided.

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

No MRMC study is mentioned. This is a medical device for surgical procedures, not an AI diagnostic tool, so such a study would not be typically performed in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the LigaSure™ Vessel Sealing System is a physical medical device operated by a surgeon, not an AI algorithm.

7. Type of Ground Truth Used

Based on the "pre-clinical studies," the ground truth likely involved:

• Measurement of burst pressures: This is a direct physical measurement.
• Visual and/or histological examination of sealed vessels: To confirm complete and effective sealing.
• Functional tests: To ensure the seals withstand physiological pressures.

8. Sample Size for the Training Set

This information is not provided, nor is it directly relevant in the context of this type of device where "training set" for an algorithm is not applicable. The device's "training" refers to its design and engineering iterations.

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

This information is not provided, and the concept of a "training set ground truth" in the AI sense does not apply to this device. The design and validation of this medical device would have relied on engineering principles, material science, and pre-clinical testing to establish its performance and safety characteristics.

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The LigaSure™ Vessel Sealing System is intended for use in general, laparoscopic, and gynecologic procedures where ligation of vessels is desired and as an alternative to mechanical claming (clips or staples) or suturing. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.

Indications for use for this type of ligation include general, laparoscopic and gynecological procedures such as urological, thoracic, plastic and reconstructive, bowel resections, hysterectomies (LAVH and abdominal) cholesystectomics, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc. The devices can be used on vessels up to 7 mm. and bundles as large as will fit in the jaws of the instruments.

The LigaSure™ Vessel Sealing Generator is an isolated, microprocessor based, bipolar only electrosurgical generator which incorporates three bipolar modes; standard, macro and vessel sealing. The generator will accept standard bipolar devices. In addition, the generator will also accept dedicated LigaSure™ Open and Laparoscopic Instruments for use in vessel sealing.

The LigaSure™ Open instruments are reusable forceps type devices with "snap-in" single use, disposable electrodes which are placed in the jaws of the devices. The LigaSure™ laparoscopic instrument is a sterile, single use device for use in grasping and vessel sealing in laparoscopic procedures. The device outer diameter is 5 mm and the working length is approximately 32 cms.

The system creates vessel ligation by the application of bipolar electrosurgical RF energy (coagulation/desiccation) to vessel tissue or vascular bundles interposed between the electrodes of the device.

The provided text does not contain detailed acceptance criteria with numerical targets. Instead, it describes general claims of effectiveness and safety, and outlines specific performance data evaluated.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that "Sufficient data was obtained to show the LigaSure™ Vessel Sealing system was equivalent to or better than the predicate devices and meet safety and effectiveness criteria." This implies the acceptance criteria were based on demonstrating equivalence or superiority to predicate devices in terms of safety and effectiveness, but specific quantitative metrics for these criteria are not provided.

Details of the Study

The document generally refers to "Preclinical laboratory (acute and chronic studies) and performance testing." It does not provide detailed specific study information such as sample sizes, data provenance, ground truth establishment, or specific types of studies often associated with AI/software device evaluation.

1. Sample size used for the test set and the data provenance: Not specified in the provided text. The text mentions "preclinical laboratory (acute and chronic studies) and performance testing," but does not detail the size of the test sets (e.g., number of vessels, animals, or human subjects) or the origin of the data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. This information is typically relevant for studies involving subjective medical image interpretation or clinical expert consensus, which is not the primary focus of this device (an electrosurgical system).
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not specified in the context of this device type and the provided information.
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: Not applicable. This device is an electrosurgical system for vessel sealing, not an AI-powered diagnostic or interpretive tool that assists human readers.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. As mentioned, this is a hardware electrosurgical system, not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for device performance (e.g., sufficient sealing, lack of adverse events) would likely be established through direct observation, physical measurements (e.g., burst pressure), and histological analysis in preclinical studies, rather than expert consensus on interpretive data. However, the specific methods for establishing ground truth are not detailed.
7. The sample size for the training set: Not applicable as this is a hardware device, not a machine learning algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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