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Disposable Laparoscopic Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is either coated or non-coated and the conductive post is either 2.36mm or 4mm. The conductive post is inserted into the electrode entry of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in laparoscopic procedure. During the operation, the electrode tip and the insulated shaft are to be inserted through a 5mm trocar. This device is used in conjunction with a compatible electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.

AI/ML Overview

This document describes a 510(k) premarket notification for a Disposable Laparoscopic Electrode. The submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove that the device meets specific acceptance criteria in the way a clinical study would for efficacy. Therefore, much of the requested information regarding clinical study parameters (sample size, ground truth, experts, MRMC studies, etc.) is not applicable to this type of submission.

However, based on the provided text, I can extract information related to performance testing to support the claim of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical study, but rather describes a comparative performance test to show equivalence. The "acceptance" is implied by demonstrating "no significant difference" to the predicate device.

Acceptance Criterion (Implied)	Reported Device Performance
Performance of device operation (Cutting & Coagulation modes)	"no significant difference between proposed device and predicate device" on porcine kidney, liver, and muscle at 30W, 50W, and 100W output power.
Result of eschar buildup on the tip of the electrode	"no significant difference between proposed device and predicate device" on porcine kidney, liver, and muscle at 30W, 50W, and 100W output power. The coated electrode eliminated the needs of using tip polisher to remove the eschar (This appears to be a design feature of some test articles being compared, not the outcome of the comparison).
Electrical Safety	Complies with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) and IEC60601-2-2: 2009 (Fifth Ed).
Biocompatibility (Ethylene Oxide sterilization residuals)	EO and ECH residue test performed to ISO10993-7, demonstrating "no residue on the patient contact portion of device after aeration."
Biocompatibility (Biological evaluation)	Performed in accordance with ISO10993-1. Specific tests: Intracutaneous Reactivity, In vitro Cytotoxicity, Acute Systemic Toxicity, Skin Sensitization, In Vitro Hemolysis Study. (Results are not detailed but the performance of these tests implies they met the standards).

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

Sample Size: Not explicitly stated as a number of "samples" in the context of a clinical trial. The comparative testing was performed on "porcine kidney, liver, and muscle." The number of animal units or tests conducted on these tissues is not provided.
Data Provenance: Porcine (animal) tissue. The study is a prospective experimental study in a laboratory setting, not a retrospective or prospective human clinical data study.

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

This is not applicable to the type of performance testing described. The "ground truth" was established by direct observation and measurement of physical effects (cutting, coagulation, eschar buildup) in the laboratory setting. There were no human "experts" establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was a comparative experimental study, not a study requiring adjudication of expert interpretations.

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 is a medical device for surgical procedures, not an AI/imaging device requiring human reader assessment.

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

Not applicable. This is a medical device for surgical procedures, not an algorithm.

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

The "ground truth" for the performance testing was the direct physical effect observed on biological tissue (porcine kidney, liver, and muscle) during cutting and coagulation, and the qualitative assessment of eschar buildup. For safety and biocompatibility, the ground truth was meeting established international standards (IEC and ISO).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable.

Summary of the Study:

The study was a comparative performance testing conducted in a laboratory setting using porcine tissues. The goal was to demonstrate that the Disposable Laparoscopic Electrode performed "no significant difference" compared to an existing predicate device (Megadyne E-Z Clean Disposable Laparoscopic Electrodes and Modern Medical Equipment Mfg. Ltd. - Laparoscopic Instrument, Electrode and Cable) in terms of cutting, coagulation, and eschar buildup across various power settings (30W, 50W, 100W). Additionally, the device underwent testing to ensure electrical safety (IEC standards) and biocompatibility (ISO standards), indicating compliance with these predefined safety "acceptance criteria." The specific quantitative results of the comparative tissue tests were not detailed, but the conclusion states "no significant difference."

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