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The Reprocessed 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 Reprocessed LigaSure Sealer/ Divider can be used on yessels (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, adhesiolysis, hysterectomy, oophorectomy, etc.

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 without Nano-coating Large Jaw, Open Sealer/Divider (LF4418) 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 LF4418 is designed for use with Covidien electrosurgical generators that include vessel sealing capability. The LigaSure Sealer/Divider can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7mm.

The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

The following controls are located on the instrument handle:

• A lever for opening and closing the instrument iaws. 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 triager 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 compatible electrosurgical generator via a cord with a cable connector that identifies the instrument type to the generator.

For the LF4418, the Original Manufacturer applies a non-stick coating to the jaws of the device to reduce tissue sticking. When reprocessing the LF4418, Stryker Sustainability Solutions will not apply a non-stick coating to the iaws of the device.

The scope of this submission only includes the reprocessed Covidien™ sealer/divider device and not the ForceTriad™ Energy Platform or Valleylab™ FT10 Energy Platform that are 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.

This submission describes the reprocessing of a LigaSure Impact surgical device, not an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects like training sets, ground truth establishment for training data, expert adjudication, multi-reader multi-case studies, and standalone algorithm performance are not applicable to this document. The provided text primarily focuses on bench and laboratory testing, as well as preclinical animal studies.

Here's an analysis of the provided text based on the applicable criteria:

Acceptance Criteria and Device Performance

The general acceptance criteria are implied to be that the reprocessed device is "as safe and effective as the predicate and operate as originally intended." The specific quantitative acceptance criteria are not explicitly detailed in numerical thresholds. However, the performance data section lists the types of tests conducted to demonstrate this equivalence.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify the exact number of devices or animal subjects used in the various tests.
   • Data Provenance: The testing was "bench and laboratory testing" and "preclinical laboratory evaluations in an animal model." No country of origin for the data is specified, but it can be inferred to be conducted by Styker Sustainability Solutions or its contracted labs. The data is prospective as it was generated specifically for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable to this type of device and testing. The "ground truth" for the functional tests is objective measurements (e.g., burst pressure, temperature) and observation of physical outcomes (e.g., successful sealing, coagulation, cutting). For animal studies, the "ground truth" would be observed physiological outcomes and histological analysis conducted by veterinary pathologists or similar experts, though their number and qualifications are not specified.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/specified. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where there might be disagreement among reviewers. The tests described are primarily objective physical and functional tests.

4. 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, this is a reprocessed surgical instrument, not an AI/ML-powered device. Therefore, an MRMC study and AI-related effect sizes are not applicable.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No, this is a reprocessed surgical instrument. Standalone algorithm performance is not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth used for the functional and preclinical tests is based on objective physical measurements (e.g., burst pressure, maximum jaw temperature), adherence to engineering standards (e.g., IEC 60601 series), and observed physiological outcomes (e.g., achievement of hemostasis, thermal spread evaluation) in animal models, likely supported by pathology or histological analysis in the animal studies.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set.

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