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Indications for Use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.

Device Description

This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two models, one for ABF01-F and the other for lock functions, ABF01-L. The two models are same except for lock function. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

AI/ML Overview

The document describes the ArtiSential Bipolar Fenestrated Forceps, a single-use electrosurgical instrument used in laparoscopic surgery for coagulation, dissection, and grasping of tissue. The device underwent several performance tests to demonstrate its safety and effectiveness and establish substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Test Clause and Test Requirement	Acceptance Criteria (Test Specification)	Reported Device Performance (Results - Remarks)
1. Appearance
No defects in the appearance; no problem in use.	Visual observation	No crack, stain, or no substances on the surface of the product.
2. Dimension
Within ± 5% of the indicated value.	Measure by Vernier calipers and dial gauge etc.	Pass (Refer to [Measurement data] on 65 page at attachment #3).
3. Operational Test
Jaw smoothly opened/closed, free from jamming. Jaw and hub bend up, down, left, right ≥ ±80°, 360° rotation.	Adjusting open and close the jaw by manipulating the grip and control ring; measure angle at bending and turning.	The jaw and hub are bent up, down, left and right within above 80°, and can rotate 360°.
4. Tensile Strength
Jaw and shaft connections not damaged from 20 N pull.	Hold the jaw and shaft connections and apply a force of 20 N using a Push pull gauge.	No damage to the connection when applying a force of 20N.
5. Feedthrough Test
Electricity transmitted between electrode tip and connector.	Electrical conduction between electrode tip and connector tested using DMM.	The resistance value between the electrode tip and the connector is less than 1Ω.
Biocompatibility	According to ISO 10993-1, assessed for Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity.	All evaluated endpoints passed.
Electrical Safety	According to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, and IEC 60601-2-2.	The device passed all performed tests (Active accessory insulation, hf leakage, hf dielectric strength, mains frequency dielectric strength, feedthrough test).
Sterilization	EO-Sterilization in accordance with ISO-11135.	The device is provided sterile via EO-Sterilization.
Shelf Life	Proposed expiration date is 2 years from manufacturing date (real-time testing for 3 years).	Proposed 2-year shelf life. (Real-time testing for 3 years to be performed).

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

The document does not explicitly state the sample size used for the performance tests. The data provenance is also not specified; however, given the applicant's address (Republic of Korea) and the FDA submission, it is likely that the testing data was generated in support of regulatory approval in the US. The nature of the tests (physical, electrical, and biocompatibility) suggests that they are laboratory-based and generally not dependent on patient data provenance.

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

This information is not applicable. The performance tests described are objective, engineering-based evaluations of the device's physical and electrical characteristics, and biological safety. They do not involve expert interpretation or ground truth derived from a clinical dataset (e.g., medical images).

4. Adjudication Method for the Test Set

Not applicable, as the tests are objective and do not involve human interpretation requiring adjudication.

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. The ArtiSential Bipolar Fenestrated Forceps is a medical instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable, as this is a medical instrument and not an algorithm. Performance tests mentioned are for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on objective, measurable engineering specifications, established international standards (e.g., ISO 10993-1, IEC 60601 series, ISO-11135), and visual inspection criteria. It is not dependent on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

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

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

Not applicable. There is no training set for this type of device.

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