(17 days)
The LF1637 LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriad Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy 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 laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, 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 Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.
The LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively 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 laparoscopic general surgical procedures (as indicated) using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting.
The provided document is a 510(k) Summary for a medical device, the LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637). This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo safety and effectiveness through a traditional clinical study with explicitly defined acceptance criteria and statistical analysis as one might find for a novel device.
Therefore, the information requested regarding acceptance criteria, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic or AI-driven device is largely not applicable in the context of this 510(k) submission for a surgical instrument.
However, I can extract the relevant information from the document to address the spirit of your request within the confines of what is provided:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission of a surgical device like this, "acceptance criteria" are typically demonstrated through successful completion of specified engineering, mechanical, and preclinical tests, showing that the modified device performs comparably to the predicate device and meets safety standards. The document doesn't list specific numerical acceptance criteria for each test, but it states that the device "operated as intended and is as safe and effective as the predicate device."
| Test Category | Reported Device Performance | Acceptance Criteria (Implicit from 510(k) comparison) |
|---|---|---|
| Bench Testing | ||
| IEC 60601-1 compliance | Performed | Compliance with standard |
| IEC 60601-2-2 compliance | Performed | Compliance with standard |
| Mechanical testing (blade return, grasping performance, jaw temperature, jaw force, button activation force, knife deployment force, lever latching/unlatching force, power curve performance) | Performed | Performance comparable to predicate device and within design specifications |
| Renal and pulmonary burst pressure | Performed | Performance comparable to predicate device |
| Preclinical Testing | ||
| Sealing and dividing vessels up to 7mm | Demonstrated | Effective sealing and division of vessels up to 7mm |
| Ability to achieve hemostasis | Demonstrated | Effective hemostasis |
| Lymphatic burst pressure | Performed | Performance comparable to predicate device |
| Chronic animal study | Performed | No unexpected adverse events, long-term safety demonstrated |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as "test set" in the context of a diagnostic study. For mechanical and preclinical testing, the number of samples or animals used for each specific test is not detailed in the summary.
- Data Provenance: The testing was conducted by Covidien, the device manufacturer. The document does not specify the country of origin for the data (e.g., where animal studies were conducted if applicable) or if it's retrospective or prospective. Given the nature of a 510(k), it would be prospective testing specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a surgical instrument and a 510(k) submission, not a diagnostic or AI-driven device requiring expert-established ground truth for a test set in the conventional sense. The "ground truth" is established through the physical and physiological performance observed in bench and preclinical (animal) tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is not a diagnostic study requiring human adjudication for interpretation of results. The results of the mechanical and preclinical tests are objective measurements or observations of device performance.
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 study is for a surgical instrument, not an AI-assisted diagnostic tool. No human reader performance improvement with or without AI assistance was evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The "standalone performance" of the device is implicitly demonstrated through the bench and preclinical testing where the device is operated according to its intended use and evaluated against performance metrics. The device itself is an electrosurgical instrument operated by a surgeon, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: For this type of device, the "ground truth" is based on the objective physical and biological performance characteristics, verified through:
- Compliance with recognized electrical safety standards (IEC 60601-1, IEC 60601-2-2).
- Quantitative mechanical measurements (e.g., jaw force, burst pressure).
- Qualitative and quantitative observations in preclinical (animal) studies of vessel sealing, hemostasis, and tissue division.
- The predicate device's established safety and effectiveness.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that uses a "training set." The device is a physical surgical instrument.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI model, there is no ground truth established for it in this context.
§ 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.