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The Articulating Needle Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The Articulating Needle Knife is not intended for use in the central nervous system or in the central circulatory system.

The Ethicon Endo Surgery® (EES) Articulating Needle Knife is an endoscopic instrument intended for cutting, dissecting and cauterizing tissue via highfrequency electrical current waveform. The device consists of a flexible wire cable and needle knife electrode, which can be extended, rotated, articulated, and retracted from the flexible outer shaft using a three-finger actuator. When connected to an electrosurgical generator and activated, the Needle Knife delivers a monopolar electrical current to the surgical site. This device passes through endoscopes having a 3.2 mm or larger working channels. This device is supplied sterile for single-patient use.

The provided text describes a 510(k) premarket notification for the "Ethicon Endo Surgery Articulating Needle Knife". This device is an electrosurgical instrument. The information given focuses on bench testing and compliance with electrical safety standards, rather than a clinical study involving human readers or sophisticated AI algorithms.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. The "test set" here refers to the device itself being tested in a benchtop environment, not a dataset of patient images or information.
• Data Provenance: Not applicable. The performance data is derived from direct electrical and material testing of the manufactured device.

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

Not applicable. "Ground truth" in this context would typically refer to expert annotations on medical images or clinical outcomes. For this device, the "ground truth" for its performance is established by objective engineering standards and direct physical/electrical measurements, not human expert interpretation of data.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human interpretation or uncertain clinical outcomes. The performance of this device is assessed against objective engineering standards.

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

No. This document describes a medical device clearance for an electrosurgical instrument, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

Not applicable. This device is an electrosurgical instrument, not a standalone algorithm. Its performance is always predicated on human use connected to an electrosurgical generator.

7. The type of ground truth used

The "ground truth" for the device's performance is compliance with established electrical safety standards (AAMI / ANSI HF 18:2001, IEC/EN 60601-2-2:2000, IEC/EN 60601-2-18:1996) and biocompatibility standard (ISO 10993-1). Additionally, bench testing demonstrated the device performs its intended functions (cutting, dissecting, cauterizing).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI or machine learning model.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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