(101 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 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 Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation 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 such surgical specialities as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.
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 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, veins, pulmonary veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, etc.
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™ Sealer/Dividers are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators 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 mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to active a knife, which divides the tissue along the seal line.
This document is a 510(k) premarket notification for electrosurgical devices (LigaSure Sealer/Dividers). It primarily concerns a change in the indications for use for existing, legally marketed devices, rather than the introduction of a completely new device or a new AI algorithm. Therefore, the information typically found in an AI/ML device submission regarding acceptance criteria and performance studies in the context of AI (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance) is largely not applicable to this document.
The document discusses performance in the context of the physical device's functionality and safety, not the performance of an AI algorithm.
Here's an analysis based on the provided text, addressing your questions where applicable and explaining why some are not relevant:
1. A table of acceptance criteria and the reported device performance
The document does not provide explicit acceptance criteria in the format of a table with numerical targets for performance metrics like sensitivity, specificity, or accuracy that would typically be associated with an AI device. Instead, it refers to general performance testing for electrosurgical devices.
The "reported device performance" is described qualitatively as:
- Compatibility with the ForceTriad™ Energy Platform.
- Ability to seal and divide vessels up to and including 7 mm.
- Ability to achieve hemostasis of tissue and vessels.
- Ability to fuse tissue bundles.
- Maintenance of hemostasis during recovery from surgery.
- Lack of delayed adverse events in chronic animal studies.
A simplified interpretation of "acceptance criteria" related to the device's functionality, derived from the "Performance" section:
| Acceptance Criteria (Inferred from Performance Testing) | Reported Device Performance |
|---|---|
| Compliance with electrical safety standards | Testing in accordance with IEC 60601-1 and IEC 60601-2-2. |
| Mechanical functionality and integrity (e.g., blade return, grasping, jaw force, button/knife deployment, lever force) | Mechanical testing performed, including blade return, grasping performance, jaw temperature, jaw force, button activation force, knife deployment force, and lever force. |
| Effective vessel sealing and burst pressure resistance | Renal and pulmonary vessel burst pressure testing performed. Sealing and dividing vessels up to and including 7 mm demonstrated. |
| Ability to achieve and maintain hemostasis for tissue and vessels | Demonstrated ability to achieve hemostasis of tissue and vessels. Chronic animal study demonstrated hemostasis is maintained during recovery from surgery and no delayed adverse events. |
| Tissue fusion capability | Demonstrated ability to fuse tissue bundles. |
| Acceptable thermal spread | Thermal spread measurements performed. (No specific threshold or result provided, but implied to be acceptable for the intended use and safety profile). For LF1212A, indicated for ENT procedures 2-3 mm away from thermally-sensitive structures. |
| Lymphatic vessel sealing and burst pressure resistance | Lymphatic vessel burst pressure testing performed. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "bench and preclinical testing" and "chronic animal study," but does not specify sample sizes (e.g., number of vessels, animals) or data provenance (country, retrospective/prospective nature). This is typical for submissions focused on physical device modifications or indications without AI.
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 information is not applicable/provided. The performance studies are related to the physical electrosurgical functionality (e.g., burst pressure, hemostasis, thermal spread), not diagnostic interpretations or image analysis that would require expert human review to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessment, which is not the case for the physical performance testing described here.
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
This information is not applicable. This document is not about an AI device, so MRMC studies involving human readers improving with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical electrosurgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance studies would be based on:
- Physical measurements and scientific principles: e.g., pressure sensors for burst pressure, thermometers for thermal spread, visual inspection and objective criteria for hemostasis, histological analysis in chronic animal studies for tissue fusion and adverse events.
- Compliance with engineering standards: IEC 60601-1, IEC 60601-2-2.
There's no mention of human-interpreted ground truth like expert consensus or pathology reports in the context of determining the device's fundamental physical performance.
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it is irrelevant.
In summary: K141153 is a 510(k) submission for changes to the Indications for Use of existing electrosurgical devices, not for a new AI/ML device. Therefore, most of the requested information pertaining to AI algorithm evaluation (sample sizes, expert ground truth, MRMC studies etc.) is not present or applicable in this document. The "performance" section describes engineering and preclinical testing for the physical function and safety of the electrosurgical tools.
§ 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.