(114 days)
The Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider LF4318 is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation of vessels is desired. The Reprocessed 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, oophorectomy, etc. The Reprocessed LigaSure Impact™ LF4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7 mm and tissue bundles.
The LigaSure™ system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure™ system for these procedures.
The Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer / Divider is a hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ Energy Platform to seal and divide vessels (including pulmonary) up to and including 7 mm 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. A blade within the instrument is surgeon actuated to divide tissue.
The instrument has a shaft diameter of 13.5 mm (square), shaft length of 18 cm, and jaw length of 36 mm. 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.
- A knob to rotate the instrument jaws.
All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attaches to the ForceTriad™ Energy Platform via a ten-foot cord with a LiqaSure™ cable connector that identifies the instrument type to the generator.
The instrument is compatible with the Covidien™ ForceTriad™ Energy Platform running software version 3.50 or greater.
The scope of this submission only includes the reprocessed Covidien™ sealer/divider device and not the ForceTriad™ Energy Platform that is used to power the device or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generator or footswitch.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Dividers. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a study of AI system performance. As such, many of the requested elements for AI device studies are not applicable to this document.
Here's the relevant information based on the provided text, and an explanation of why other requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria in a table format for performance metrics relevant to an AI model (e.g., sensitivity, specificity, AUC). Instead, it lists various types of tests performed to demonstrate that the reprocessed device is "as safe and effective as the predicate" and "operate as originally intended."
| Test Type | Reported Performance / Conclusion |
|---|---|
| Biocompatibility | Performed |
| Validation of Reprocessing | Performed |
| Sterilization Validation | Performed |
| Functional Performance Tests | Performed. Involved electrical safety, electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2), and verification/comparative testing to the predicate device. Bench testing evaluated: burst pressure, thermal spread, max jaw tip temperature, jaw cooling time, device functionality, and device reliability testing. |
| Electrical Safety Testing | Performed in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2. |
| Electromagnetic Compatibility Testing | Performed in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2. |
| Packaging Validation | Performed |
| Acute and Chronic Pre-clinical Testing | Evaluated thermal spread and the ability to achieve hemostasis of vessels and tissues. |
| Overall Conclusion | "The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended." "Stryker Sustainability Solutions concludes that the Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider is at least as safe and effective to the predicate device as described herein." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of an AI model's performance on a dataset of patient data. The tests performed are on device samples (reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Dividers). The sample sizes for these bench and pre-clinical tests are not detailed in this summary. Data provenance for clinical data is not applicable as this is a device reprocessing submission, not an AI efficacy study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth in the context of AI models (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device would be its ability to perform its intended function (seal and divide vessels) in a safe and effective manner, which is assessed through a combination of engineering tests and pre-clinical studies, not through expert reading of diagnostic outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used to establish ground truth for diagnostic AI models where there might be disagreement among human experts. This document describes physical device testing.
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 not an AI-assisted diagnostic device, so MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical electrosurgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through a combination of:
- Engineering specifications and regulatory standards: (e.g., IEC 60601-1 for electrical safety, performance parameters like burst pressure, thermal spread, max jaw tip temperature, jaw cooling time). The predicate device's performance also serves as a benchmark for what constitutes acceptable performance.
- Pre-clinical testing: Acute and chronic studies evaluating hemostasis and thermal spread in tissues, often involving animal models or cadaveric tissue.
- Functionality and reliability testing: Verification that the device's components operate as intended.
8. The sample size for the training set
Not applicable. This device does not use a training set as it is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. As there is no AI algorithm, there is no training set and no ground truth for a 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.