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The LigaSure Sealer/Divider, comprised of a single use electrode and a reusable clamp, is intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.

The LigaSure Electrode is a single use component that attaches to the LigaSure Clamp. After assembly, 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, reconstructive, and gynecologic . Procedures may include, but are not limited to, bowel resections, hysterectomy, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

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 LigaSure Clamp is a reusable handpiece to which the LigaSure Electrode attaches. Refer to the labeling of the compatible electrode for specific indications.

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 Jaw, Open Sealer/Divider (LF3225, LF3225C) is a hand-held bipolar electrosurgical vessel sealing device intended for use with compatible Covidien generators that include LigaSure™ vessel sealing capabilities to ligate (seal) and divide (cut) blood vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). It is composed of a reusable hemostat-style clamp and a sterile single-use electrode.

The device creates a seal by application of RF electrosurgical energy delivered from the compatible Covidien generators to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the instrument to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charing, and thermal spread to adjacent tissue. Once the seal cycle is complete, surgeon actuates a blade within the electrode of the instrument to divide the tissue along the seal line. The proposed device does not contain software.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device, the LigaSure™ Curved Jaw, Open Sealer/Divider Electrode (LF3225) and LigaSure™ Curved Jaw Open Reusable Clamp (LF3225C). The document confirms the device's substantial equivalence to predicate devices and lists the types of verification and validation activities performed. However, it does not provide specific acceptance criteria or detailed results of these studies in a format that allows for a direct comparison table of acceptance criteria vs. device performance, or details on sample sizes, ground truth establishment, or human-in-the-loop studies as requested.

Here's a breakdown of the information that can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly available in the provided document. The document states that "Verification and validation activities were successfully completed and establish that the LigaSure™ Curved Jaw, Open Sealer/Divider performs as intended and is substantially equivalent to its predicates." It lists types of testing conducted but does not provide specific metrics, acceptance thresholds, or reported performance values for those criteria. For example, it mentions "thermal effects and vessel sealing capabilities" but without quantified criteria or results.

2. Sample Size Used for the Test Set and Data Provenance

This information is not explicitly available in the provided document.

• Sample Size: The document mentions "Ex vivo and in vivo testing using porcine tissue and a porcine model" but does not specify the number of samples, vessels, or animals used in these tests.
• Data Provenance: The testing was conducted using "porcine tissue and a porcine model." The country of origin for the data is not specified, but the applicant's address is in Shanghai, China, and Covidien is a global company. The studies are inferred to be prospective experimental studies given their nature (ex vivo and in vivo testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not explicitly available in the provided document. The document describes engineering, functional, and biological testing, typically overseen by engineers, scientists, and veterinarians/surgeons, but it does not specify the role or number of "experts" in establishing ground truth for a test set in the way this question implies (e.g., for image analysis or diagnostic accuracy).

4. Adjudication Method for the Test Set

This information is not explicitly available in the provided document. Given the nature of the device (electrosurgical vessel sealing), "adjudication" methods like "2+1, 3+1" commonly seen in diagnostic device studies are not relevant or described. Performance would typically be assessed by objective measurements (e.g., burst pressure, thermal spread, seal integrity) performed by testing personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

This information is not applicable/not available. The device is an electrosurgical tool, not a diagnostic imaging or AI device that relies on "human readers." Therefore, an MRMC comparative effectiveness study is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/not available. The device is a physical electrosurgical tool, not an algorithm. Its performance is inherently tied to its use by a human (surgeon) but its "standalone" performance would refer to its inherent functional capabilities, which were assessed through engineering, functional, and preclinical studies. These studies implicitly evaluate the device's performance independent of the variables introduced by individual human technique, focusing on the device's physical and biological effects. The document states, "The proposed device does not contain software." Thus, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The ground truth for this type of device performance would be based on:

• Physical/Engineering Metrics: Measured properties like electrical performance, mechanical integrity, precise temperature readings, and sealing capabilities (e.g., burst pressure, seal quality, tissue necrosis).
• Biological Outcomes: Direct observation of tissue effects in ex vivo and in vivo models, such as thermal spread, complete tissue fusion, absence of bleeding, and histological analysis of sealed vessels. This can be considered a form of pathology/histology and direct outcomes data from preclinical models.

8. The Sample Size for the Training Set

This information is not applicable/not available. Since the device is a physical electrosurgical tool and not an AI or machine learning algorithm, there is no "training set" in the computational sense. The "training" to develop and refine such a device would be part of its engineering design and iterative testing process.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not available for the same reasons as point 8.

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