(26 days)
The LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
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™ Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue.
The surgeon first grasps the vessel or tissue with the jaws of the instrument. Once the surgeon is confident that the instrument is placed correctly, he or she initiates a seal by pressing a handswitch or footswitch. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Once the seal cycle is complete, the surgeon actuates a blade within the instrument to divide tissue along the seal line.
The purpose of this submission is to propose the use of an alternate dot material for the LigaSure Curved, Small Jaw, Open Sealer/Divider devices (K141153). There have been no prior submissions for the proposed change. The proposed devices do not contain software.
This document is a 510(k) summary for a medical device called the "LigaSure™ Curved, Small Jaw, Open Sealer/Divider (LF1212A)". This submission is for a modification to an existing device, specifically changing the material of ceramic spacers and adding an etched wetting ring feature. Therefore, the information provided focuses on demonstrating that the modified device is substantially equivalent to the predicate device and that the changes do not negatively impact its safety or performance.
The document does not describe a study involving AI, human readers, or a typical diagnostic device's acceptance criteria like sensitivity, specificity, or AUC. Instead, it describes hardware device performance criteria based on engineering specifications and safety standards.
Here's an analysis of the provided text in relation to the requested information, acknowledging that many requested points are not directly applicable due to the nature of this particular device submission (a modification to a non-AI surgical instrument):
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported device performance in the format typically seen for AI/diagnostic devices (e.g., sensitivity/specificity thresholds). Instead, it states that "design verification testing... confirmed the continued conformance to applicable technical design specifications and performance requirements". These performance requirements are listed as:
| Acceptance Criterion (Type of Testing) | Reported Device Performance |
|---|---|
| Biocompatibility evaluation | Conforms to ISO 10993-1:2009 |
| Basic safety and essential performance | Conforms to IEC 60601-1:2005, A1:2012 and IEC 60601-2-2:2009 |
| Electromagnetic compatibility | Conforms to IEC 60601-1-2:2007, CORR: July 31, 2010 |
| Design verification testing: Jaw gap | Conformance confirmed |
| Design verification testing: Force | Conformance confirmed |
| Design verification testing: Cut length | Conformance confirmed |
| Design verification testing: Hyperextension | Conformance confirmed |
| Design verification testing: Resistance | Conformance confirmed |
| Design verification testing: Renal burst pressure | Conformance confirmed |
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 data for an AI algorithm. The device is a surgical instrument, and testing involves physical evaluation and engineering measurements. The document states "design verification testing", which implies a set of physical devices were tested. However, the exact sample size (number of devices or tests performed) is not provided. No data provenance related to "country of origin for data" is relevant here, nor is retrospective or prospective as it's not a data-driven model.
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)
This question is not applicable. The device is a surgical instrument, not an AI diagnostic tool. "Ground truth" for this device is based on objective engineering specifications and international safety standards, not expert consensus on medical images or diagnoses. The "truth" is whether the physical properties and performance characteristics of the instrument meet defined regulatory and design standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as there is no "test set" in the context of medical images or diagnoses requiring adjudication by experts.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument and does not involve AI or human readers for diagnostic interpretation. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device does not contain an AI algorithm. The document explicitly states: "The proposed devices do not contain software."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by engineering specifications, international safety standards (ISO, IEC), and design verification requirements. For example, "renal burst pressure" testing has an objective, measurable outcome that is compared against a predefined standard for acceptable sealing strength.
8. The sample size for the training set
This question is not applicable as the device does not involve an AI algorithm or a training set.
9. How the ground truth for the training set was established
This question is not applicable as the device does not involve an AI algorithm or 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.