(88 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to or better than predicate devices in terms of safety. | Preclinical laboratory (acute and chronic studies) and performance testing were performed to ensure the devices functioned as intended and met design specification. 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. (No specific numerical safety metrics are provided.) |
| Equivalence to or better than predicate devices in terms of effectiveness for vessel ligation (sealing vessels up to 7mm and vascular bundles as large as will fit in the jaws of the instruments). | 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 devices can be used on vessels up to 7 mm. and bundles as large as will fit in the jaws of the instruments. 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. (No specific numerical effectiveness metrics such as seal burst pressure or sealing time are provided in this summary.) |
| Device functions as intended and meets design specifications. | Preclinical laboratory (acute and chronic studies) and performance testing were performed to ensure the devices functioned as intended and met design specification. |
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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- How the ground truth for the training set was established: Not applicable.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.