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The LigaSure™ Open Dissector Divider is a bipolar electrosurgical instrument intended for use with the LigaSure™ Generator in open, general, surgical procedures where dissection, ligation and division of vessels is desired. This device creates ligation by application of bipolar electrosurgical RF anerizy and pressure to vessels/tissue interposed between the jaws of the device. The ligation can then be transected using the built in cutting mechanism. The device can be used for vessels up to and including 7 mm in diameter and tissue bundles as large as will fit into the jaws of the instrument.

Indications for use include general, open procedures including urologic, vascular, thoracic, and plastic and reconstructive, procedures where dissection, ligation and division of vessels are performed such as: spleenectomies, thryoidectomies, nephrectomies, prostatectomies, bowel resection are clobe vomy.

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 Open Dissector Divider is a multi-functional, electrosurgical instrument intended for use with the LigaSure Vessel Sealing Generator (K981916) when performing open surgery. The instrument is capable of sealing and dividing vessels and tissue clamped between its jaws, grasping tissue, and dissection. Sealing of vessels and tissue containing vessels can be activated using the activation button on the device or via a footswitch. The instru incorporates a mechanical cutting mechanism that divides tissue.

The instrument attaches to the LigaSure™ generator with a ten (10) foot cable and a "smart" connector that identifies the instrument type to the generator. The instrument is supplied sterile for single-use.

The provided text describes the Valleylab LigaSure™ Open Dissector Divider (K041587) and its clearance by the FDA without extensively detailing specific acceptance criteria or a comprehensive study report in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance metrics against pre-defined acceptance criteria.

However, based on the information provided, I can infer and extract some relevant details regarding the device's performance and the nature of the evaluation.

Inferred Acceptance Criteria and Reported Device Performance (based on the summary's scope):

The document states that performance (bench) testing and a preclinical study were conducted to ensure the device "functions as intended" and "meets design specifications," and that "sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." While specific numerical targets for acceptance criteria are not explicitly given, the general criteria can be inferred from the device's intended use and comparison to predicates.

Study Details:

The provided text only briefly mentions the types of studies conducted without providing extensive details on their methodology or results.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. The document only states "Performance (bench) testing and a preclinical study were done."
   • Data Provenance: Not specified, but generally, bench testing and preclinical studies for FDA submissions are conducted domestically (USA) or in accredited labs globally. The document does not indicate if it was retrospective or prospective, though preclinical studies are inherently prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The document does not mention the involvement of experts in establishing ground truth for the performance studies, other than the general oversight and review by the manufacturer's regulatory and R&D teams.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified. The document does not describe any expert adjudication process for the performance testing.

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:

   • No. This device is an electrosurgical instrument, not an AI/imaging device. Therefore, an MRMC study with human readers/AI assistance is not applicable to its evaluation. The "improvement with AI vs. without AI" is not relevant here.

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

   • Yes, implicitly. The "Performance (bench) testing" and "preclinical study" described are likely standalone evaluations of the device's physical and functional capabilities, independent of human interaction for interpretation (as would be the case for an imaging algorithm). The device's performance (e.g., sealing strength, cutting efficacy) is assessed directly.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For bench testing, ground truth would be based on engineering specifications and measurements (e.g., burst pressure for sealed vessels, tensile strength, cut precision).
   • For the preclinical study, ground truth would involve direct observation, potentially physiological measurements, and possibly pathology if tissue samples were analyzed for sealing integrity or thermal damage. The document does not specify.

7. The sample size for the training set:

   • Not applicable. This device is a physical electrosurgical instrument, not a machine learning model, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

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The LigaSure™ 5mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is surgeonactuated to divide tissue.

Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Vessel Sealing System has not been shown to be effective for tubal sterilization or tubal coaqulation for sterilization procedures, and should not be used for these procedures.

The LigaSure 5mm Vessel Sealer-Divider 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 LigaSure 5mm Laparoscopic Sealer-Divider is a multi-functional electrosurgical instrument for use with the LigaSure Vessel Sealing Generator (K981916) when performing laparoscopic surgery. The instrument is capable of sealing vessels, dividing vessels and tissue clamped between its jaws, grasping tissue, and blunt dissection. The outer diameter of the instrument shaft is 5mm, with a working length of 37 cm. Controls are located on the instrument handle. All controls can be operated with either the right or left hand.

The instrument attaches to the generator with a "smart" connector that identifies the instrument type to the LigaSure generator, and a ten (10) foot cable. The instrument is supplied sterile for single-use.

The provided text is a 510(k) premarket notification for a medical device, the Valleylab LigaSure™ 5mm Laparoscopic Sealer-Divider. It asserts substantial equivalence to predicate devices and describes the device's intended use and technological characteristics. However, it does not contain detailed information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or adjudication methods for performance data demonstrating the device meets acceptance criteria.

The document states: "Performance testing and pre-clinical studies were performed to ensure that the LigaSure™ 5mm Laparoscopic Sealer-Divider functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria."

This statement confirms that studies were done, but the specifics of how "design specifications" and "safety and effectiveness criteria" were defined, measured, and met are not included in the provided text.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, sample sizes used, data provenance, number and qualifications of experts, adjudication methods, details of MRMC or standalone studies, or how ground truth was established, as this information is not present in the provided K031011 document.

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