(28 days)
The LigaSure 5mm. Blunt tip. Laparoscopic Sealer- Divider is a bipolar electrosurgical instrument intended for use the ForceTriad Generator in general and gynecologic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.
Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorecotmy etc. The device 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 5mm Blunt tip Laparoscopic Sealer-Divider can be used on vessels and lymphatics up to and including 7mm and tissue bundles as large as will fit in the jaws of the instrument.
The LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider is a multifunctional electrosurgical instrument for use with the ForceTriad™ generator when performing laparoscopic surgery. The instrument is capable of sealing vessels and lymphatics, dividing tissue (including vessels) clamped between the jaws, grasping tissue, and blunt dissection. The outer diameter of the instrument shaft is 5mm, with a working length of 37 cm. The following controls are located on the instrument handle: A lever for opening and closing the instrument jaws. The mechanism incorporates a latch to hold the jaws in the closed position during vessel sealing and cutting. An activation button for generator power to initiate vessel sealing. A trigger for actuating the cutter. The cutter can only be actuated when the jaws are closed and latched. A knob to rotate the instrument jaws. The jaws can rotate 179 degrees to facilitate surgeon access and visibility. All controls can be operated with either the right or left hand. Vessel scaling can be initiated using the activation button, or utilizing a footswitch connected to the generator. The instrument attaches to the ForceTriad generator via a ten foot cord with a "Smart" connector that identifies the instrument type to the generator. The instrument is supplied sterile for single use.
The provided text is a 510(k) summary for the LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider. It describes the device, its intended use, and states that non-clinical testing was performed, but no specific acceptance criteria or detailed study results are provided in the document. The summary only generally states that "The data obtained showed that the device is substantially equivalent to the predicate and meets the safety and effectiveness criteria," without listing criteria or performance metrics. Furthermore, it explicitly states, "No clinical testing was conducted."
Therefore, I cannot fulfill all parts of your request with the given information.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- The document does not provide a table of acceptance criteria or specific reported device performance metrics that can be accurately tabulated. It only states that the device "meets design specifications" and "meets the safety and effectiveness criteria."
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "ex-vivo tissue studies" and "in-vivo tissue studies (porcine and canine model)" but does not detail the number of samples or animals used.
- Data Provenance: The studies were non-clinical, involving ex-vivo and in-vivo (porcine and canine model) tissue studies. The country of origin for these studies is not specified, but the applicant's address is Boulder, CO, USA. The studies were retrospective, as they were conducted to support a Special 510(k) for a modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As this was non-clinical testing (ex-vivo and in-vivo animal models), the concept of "experts establishing ground truth" in the context of clinical interpretation of data (e.g., radiologist consensus) is not relevant. The ground truth would likely be established through physical measurements, histological analysis, and observed physiological outcomes in the animal models, rather than expert interpretation of images or clinical assessments.
4. Adjudication method for the test set
- Not applicable. Given that the testing was non-clinical and did not involve human interpretation of results requiring adjudication (like image analysis in a clinical study), an adjudication method is not described or relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, What was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study was not done. This device is a surgical instrument, not an AI-assisted diagnostic or interpretive tool that would involve human readers or AI assistance in that context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual surgical instrument. The concept of an "algorithm only" or "human-in-the-loop performance" does not apply to its function.
7. The type of ground truth used
- Non-clinical (Ex-vivo/In-vivo observations): Ground truth would have been established through direct measurements, histological examination of sealed tissues, observation of immediate and delayed physiological effects in live animal models (e.g., vessel patency, bursting strength, thermal spread), and technical performance assessment against design specifications.
8. The sample size for the training set
- Not applicable. This device is a physical surgical instrument, not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
§ 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.