(51 days)
The LigaSure™ 5 mm, Maryland Jaw, Open / Minimally Invasive Sealer/Dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of versels and lymphatics is desired. The instrument creates a seal by application of RF electrosirgical onergy 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 open and minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic. and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted, vaginal hysterectomy, Nissen fundoplication, colectorny, adhesiolysis, oophorectorny, 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 5 mm Maryland Jaw Sealer/Dividers can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.
The LigaSure™ 5 mm Maryland Jaw Sealer/Divider One-step Sealing (LF17XX series) devices are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws without having to latch the lever, which includes a clicking mechanism that indicates to the user that the jaws are in the grasping zone, a button (switch) to activate the LigaSure™ mode by closing the handle against the button (switch) for vessel sealing, and a trigger to actuate an independent cutting blade.
The provided text describes a 510(k) summary for a medical device and outlines various tests performed to demonstrate its safety and effectiveness. However, it does not present a table of specific acceptance criteria with corresponding performance data. It also does not involve a study related to AI or human readers, as it is a physical surgical device.
Based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that evidence of safety and effectiveness was obtained from both bench and preclinical testing. While specific quantifiable acceptance criteria and their precise results are not explicitly listed in a table format, the document indicates that the device's performance was compared to predicate devices and found to be substantially equivalent.
Here's a breakdown of the types of tests performed:
| Type of Test | Implied Acceptance Criteria (Not Explicitly Stated) | Device Performance (Implied from "operated as intended" and "substantially equivalent") |
|---|---|---|
| Bench Testing | ||
| IEC 60601-1 Compliance | Adherence to general requirements for basic safety and essential performance. | Compliant |
| IEC 60601-2-2 Compliance | Adherence to particular requirements for high frequency surgical equipment and accessories. | Compliant |
| Blade Return | Proper and consistent return mechanism. | Satisfactory |
| Grasping Performance | Secure and effective tissue grasping. | Satisfactory |
| Jaw Temperature | Within safe operating limits to prevent thermal injury. | Satisfactory |
| Jaw Force | Adequate force for effective sealing and grasping. | Satisfactory |
| Button Activation Force | Operable within ergonomic limits. | Satisfactory |
| Knife Deployment Force | Operable within ergonomic limits. | Satisfactory |
| Lever Force | Operable within ergonomic limits. | Satisfactory |
| Power Curve Performance | Consistent and effective energy delivery. | Satisfactory |
| Preclinical Testing | ||
| Renal and Pulmonary Burst Pressure | Ability to withstand physiological pressure after sealing. | Effective sealing up to and including 7 mm vessels. |
| Sealing of Vessels & Lymphatics (up to 7mm) | Effective and durable seal formation. | Effective sealing. |
| Hemostasis of Tissue & Vessels | Ability to stop bleeding effectively. | Achieved hemostasis. |
| Tissue Bundles | Effective sealing and division of tissue bundles. | Effective sealing and division. |
| Thermal Spread | Minimal spread of thermal energy to surrounding tissue. | Minimal and acceptable. |
| Lymphatic Burst Pressure | Ability to withstand physiological pressure after sealing. | Effective sealing. |
| Chronic Animal Study | Long-term safety and effectiveness in vivo. | Satisfactory, results support substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each test. It broadly mentions "bench and preclinical testing." It also does not specify the country of origin for the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Given that this is a physical electrosurgical device for which "ground truth" would be established through physical measurements, physiological responses, and potentially expert observation during preclinical studies (e.g., assessing hemostasis), the concept of "experts establishing ground truth for a test set" as described in the prompt (e.g., radiologists) is not directly applicable in the same way it would be for an AI-powered diagnostic device.
4. Adjudication Method for the Test Set
This information is not provided and would not typically be relevant for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are more commonly used in studies involving human interpretation of data, such as medical image analysis.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI algorithms on human performance in diagnostic tasks, which is not applicable to this physical electrosurgical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This question is not applicable. The device is a physical electrosurgical instrument and does not involve an "algorithm only" component in the sense of a software-based diagnostic tool. The performance studies described are for the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria appears to be established through:
- Physical measurements and engineering standards: For bench tests like blade return, jaw temperature, forces, and power curves. These would be compared against predefined specifications and industry standards (e.g., IEC 60601).
- Physiological outcomes in preclinical (animal) studies: For burst pressure, hemostasis, thermal spread, and the success of vessel/tissue bundle sealing and division. These outcomes would be assessed by observing the effects on biological tissue.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device development process described does not involve a "training set" in the context of machine learning (AI). The device's design and engineering are based on established principles and iterative development, not data-driven machine learning models.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated above (no AI training set).
§ 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.