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The Laparoscopic FMsealer is an electrosurgical instrument intended for use in open and laparoscopic surgical procedures, including general and gynecologic procedures where ligation and division of vessels, including lymph vessels, is desired. It can be used to ligate and divide vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instrument.

The Laparoscopic FMsealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these purposes.

Electrosurgical cutting and coagulation devices (and accessories) are devices intended to remove tissue and control bleeding by use of high-frequency electrical current (see 21 CFR §878.4400). They are classified as Class II (510(k)) devices.

The Laparoscopic FMsealer is a sterile, single-patient use, hand-held surgical instrument intended for ligation and division of vessels. The Laparoscopic FMsealer must be connected to a generator (Domain Surgical's FMwand Generator) by an accessory cable (Domain Surgical's FMwand Power Module). It is capable of blunt dissection, grasping and division of tissue enclosed within its jaws during open or laparoscopic procedures. The outer diameter of the instrument shaft is 5mm, with a working length of 36cm.

The Laparoscopic FMsealer includes a rotation knob, front lever and two actuation buttons. The rotation knob, located at the distal end of the handle, allows for a full 360 degrees of rotation of the jaws to improve visibility of the tissue as well as permit access to tissues on differing planes. The front lever closes the jaws of the device which allows pressure to be applied to the tissue between the jaws. The actuation buttons activate the transfer of current from the generator to the tip of the device which creates the heat necessary for sealing and dividing.

This system creates sealing, cutting and coagulation of heat and compression (from the opposing jaws of the device) to tissue bundles and vessels interposed between the jaws of the instrument.

The Laparoscopic FMsealer has been shown to cut and seal vessels (veins and arteries) up to and including 7mm in diameter.

This document describes the Premarket Notification for the "Laparoscopic FMsealer." The acceptance criteria and the study that proves the device meets them are outlined.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" with quantitative performance metrics for the Laparoscopic FMsealer, such as specific burst pressures for sealed vessels. Instead, it states that the device "passed all bench tests performed" and details the types of tests conducted. The key performance claim is its ability to seal vessels up to and including 7mm. The comparison to predicate devices focuses on technological characteristics and overall safety and effectiveness.

Here's a summary of the implicit acceptance criteria based on the described tests and the reported performance:

2. Sample Sized Used for the Test Set and the Data Provenance:

The document provides the following information regarding test samples:

• Ex-Vivo Vessel Sealing Test Results: 2mm-7mm Porcine Arteries. (The exact number of arteries or samples tested is not specified in this summary. "Porcine" indicates animal origin, not human.)
• In-vivo GLP Acute Animal Study - Laparoscopic Stress Testing: Animal study. (The specific species and number of animals are not detailed in this summary.)
• In-vivo GLP Chronic Animal Study - Vessel Sealing: Animal study. (The specific species and number of animals are not detailed in this summary.)
• Provenance: All animal studies (Ex-vivo and In-vivo) are based on animal tissue/models. The GLP (Good Laboratory Practice) designation indicates a regulatory standard for non-clinical laboratory studies. The studies are prospective in nature as they are specifically conducted to evaluate the device.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for the animal studies or ex-vivo tests. In medical device submissions, animal studies are typically overseen by veterinarians and surgical specialists, and their observations and measurements serve as the "ground truth" for success or failure criteria (e.g., successful hemostasis, lack of thermal injury, absence of late complications). However, these details are not provided in this summary.

4. Adjudication Method for the Test Set:

The document does not explicitly state an adjudication method (like 2+1 or 3+1). For the reported tests (Ex-Vivo and In-vivo Animal Studies), results would typically be objectively measured (e.g., burst pressure, direct observation of tissue integrity, histological evaluation) rather than requiring consensus among human experts for interpreting results in the same way clinical image interpretation studies might. Data analysis would follow standard statistical methods for the parameters measured.

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 is not applicable to this device submission. The Laparoscopic FMsealer is an electrosurgical instrument for vessel sealing, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant. The studies performed were for direct device performance and safety.

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

This is not applicable to this device. As an electrosurgical instrument, its performance is inherently human-in-the-loop as it is manipulated by a surgeon. There is no "algorithm only" performance to evaluate in this context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance studies primarily relies on:

• Direct observation and measurement: In both ex-vivo and in-vivo animal studies, the success of vessel sealing (e.g., hemostasis, lack of bleeding, integrity of the seal) would be directly observed.
• Pathology/Histology: For chronic animal studies, tissue samples would likely be sent for histological examination to assess seal quality, thermal injury, and healing over time.
• Functional outcomes: For the animal studies, the functional outcome related to the intended use (ligation and division of vessels) is evaluated.

8. The Sample Size for the Training Set:

This is not applicable. The Laparoscopic FMsealer is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. Device development involves engineering design, prototyping, and iterative testing, not explicit data training sets.

9. How the Ground Truth for the Training Set was Established:

This is not applicable as there is no "training set" for this type of device.

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