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The LigaSure™ Curved, Small Jav, Open Sealer/Divider is a bipolar electrosurgical instrument intended to be used with the ForceTriad™ energy platform. The instrument is indicated for use in open general surgical procedures where ligation and division of vessels (up to 7 mm in diameter), tissue bundles, and lymphatics is performed, such as urologic, thoracic, plastic, and reconstructive; and including such procedures as bowel resections, gall bladder procedures, Nissen fundoplication, adhesiolysis, etc.

The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The LigaSure™ Curved, Small Jaw, Open Sealer/Divider is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). The ForceTriad's tissue-fusion (LigaSure) mode delivers precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion, and has been designed to produce minimal sticking, charring, or thermal spread to adjacent tissue. LigaSure instruments attach to the generator with a ten-foot containing a "smart" connector. This connector functions as a unique product identifier for device-specific recognition by the generator. The Curved, Small Jaw, Open Sealer/Divider instrument is designed to be both ergonomic and intuitive for the user. Its hemostat-style body and symmetrically placed controls facilitate handling by both left and righthanded users, and its small, curved jaws maximize visibility and access when the instrument is used in confined surgical spaces. Ring handles function to allow the user to grasp tissue by opening and closing the jaws of the instrument. The interior surfaces of the jaws contain the electrodes, which serve to ligate by delivering energy to the grasped tissue. RF energy can be activated by the user in two ways: (1) through the use of a single button incorporated into the handle body or (2) through the use of a footswitch attached to the generator. A cutting mechanism functions to mechanically divide tissue following tissue fusion. It consists of a stainless steel blade and is controlled by the user through a trigger located on the handle body.

The submission describes the device's technological and performance characteristics compared to predicate devices, drawing upon non-clinical (electrical/mechanical/functional) performance testing, preclinical (bench tissue/animal) evaluations, and usability studies to demonstrate substantial equivalence. It does not provide explicit "acceptance criteria" for novel performance metrics nor a "study that proves the device meets the acceptance criteria" in the format of a clinical trial with pre-defined endpoints and statistical analysis. Instead, it relies on comparative testing to known predicate devices and established safety standards.

Here's a breakdown of the requested information based on the provided text, indicating where information is not explicitly stated or is not applicable in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" as pass/fail thresholds for novel performance metrics in a tabular format. Instead, it demonstrates substantial equivalence through comparative performance testing to predicate devices and compliance with relevant safety standards. The "reported device performance" is qualitative and comparative for most aspects.

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

• Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of a clinical study. The evaluations involved various bench testing samples, excised porcine renal and pulmonary arteries, porcine and ovine models (for in vivo acute studies), and a porcine model (for in vivo chronic studies). The specific number of each type of sample/animal used is not detailed.
• Data Provenance:
  • In vitro: Excised porcine renal and pulmonary arteries.
  • In vivo: Porcine and ovine models.
  • Usability: "Simulated operating environments" with "users."
  • The origin (e.g., country) of these animal models or where the usability studies were conducted is not specified. All studies are preclinical/non-clinical, not human clinical data, so the retrospective/prospective distinction for human subjects is not directly applicable.

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

Not applicable in the context of this 510(k) submission. Ground truth for performance (e.g., burst pressure, thermal spread, healing) was established through objective measurements in bench and animal studies, not through expert human interpretation of images or other data typically requiring adjudicated ground truth. Usability studies involved "users," but these are for evaluating human factors, not for establishing diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in clinical imaging studies where multiple human readers interpret data. The evaluations here are based on objective physical measurements and animal model outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a surgical instrument, not an AI-powered diagnostic or assistive tool for human readers of medical images. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical electrosurgical instrument. It operates with a human user in the loop. The "standalone" concept refers to algorithms performing diagnostic tasks without human intervention, which is not relevant here.

7. The Type of Ground Truth Used

• Objective Measurements: For electrical, mechanical, and functional performance (e.g., jaw temperature, force, power curves).
• Biological Endpoints in Animal Models: For preclinical evaluations, the ground truth was based on measurable biological outcomes such as:
  • Isolated vessel burst pressures/hemostasis
  • Ligation (sealing) speed
  • Division (cutting) performance
  • Overall hemostasis
  • Overall activation time
  • Overall grasping performance
  • Lateral thermal damage
  • Chronic hemostasis and healing over a 21-day survival period.

8. The Sample Size for the Training Set

Not applicable. This device did not involve machine learning or AI that would require a "training set" for an algorithm. The development and testing focused on engineering, materials science, and preclinical biological performance.

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

Not applicable, as no training set for an algorithm was used.

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