(83 days)
The LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LigaSure Impact LF4318 is intended to be used with the ForceTriad™ energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies. Nissen fundoplication, colectorny, adhesiolysis, oophorectorny, etc. The LigaSure Impact LF4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7mm and tissue bundles.
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 Impact™, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ Energy Platform (cleared under K051644, K070162) to seal and divide vessels (including pulmonary) up to and including 7mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's tissue-fusion (LigaSure) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion.
The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol grip style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10 foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device-specific recognition by the generator.
The provided text is a 510(k) summary for a medical device (LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider) and does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically assessed for AI/software devices.
Instead, it describes the performance testing undertaken to demonstrate substantial equivalence to predicate devices, which is the regulatory pathway for this type of medical device. Therefore, I cannot extract the information required by your prompt as it pertains to AI/software acceptance criteria and studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size).
However, I can extract the information provided about the device's performance testing for its 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of numeric acceptance criteria and corresponding performance metrics in the way your prompt expects for AI/software. Instead, the performance is described qualitatively in the "Performance" section:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Testing | Involved safety and performance testing in accordance with IEC 60601-1 and IEC 60601-2-2. |
| Verification/Comparative Testing | Performed against predicate devices. |
| Bench Testing | Evaluation of the device's performance and ability to seal and divide vessels up to 7mm. |
| Pre-clinical Testing | Performed both acute and chronic testing. Evaluated thermal spread and ability to achieve hemostasis of tissue and vessels in a variety of simulated clinical settings. Confirmed that the LF4318 is as safe and effective as the predicate devices and operated as intended. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified quantitatively. The text only mentions "extensive functional, bench and pre-clinical testing."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for this kind of hardware device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is a surgical instrument, not an AI/software device requiring expert-established ground truth on a dataset. Performance was evaluated through engineering tests and pre-clinical studies.
4. Adjudication method for the test set:
Not applicable.
5. 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 is a hardware surgical instrument, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used:
For this device, "ground truth" would be established through physical measurements (e.g., sealing strength, thermal spread, hemostasis) and direct observation in pre-clinical studies, rather than expert labels on data.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. 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.