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The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

The Jiangsu Rong Fu Kang Medical Instruments Co. Ltd (here and after RFK) Electrosurgical Pencils and Electrodes are handheld instruments that are used for cutting and coagulation of soft tissue. They consist of a plastic handle, a connecting cable and plug, control buttons, internal PCB, and either a stainless steel uncoated or non-stick electrode tip. The Electrosurgical Pencils and electrodes are disposable and are supplied sterile.

The connecting cable is plugged into an Electro-Surgical Generator Unit (ESU) which provides the high-frequency energy to be deployed in the surgical procedure. The plastic handle has two buttons: cutting and coagulation. The cutting button activates the CUT mode of the ESU and the coagulation button activates the COAG mode of the ESU.

The electrode tip makes contact with the target tissue and delivers high frequency energy from the ESU to the target organs for the purposes of cutting and coagulation. This energy then passes through the body tissues and returns to the ESU via a return electrode (ground pad).

The provided document is a 510(k) premarket notification from the FDA for a medical device: a Sterile Single Use Electrosurgical Pencil with Non-Coated and Non-Stick Electrode. While it describes the device, its intended use, and substantial equivalence to a predicate device, it does not contain the level of detail typically found in a clinical study report or a submission for an AI/ML-based medical device that would include specific acceptance criteria for algorithm performance, sample sizes for test sets, expert ground truth establishment, or MRMC studies.

The document focuses on "Non-Clinical Bench Testing" to demonstrate substantial equivalence, primarily comparing physical characteristics, energy type, sterilization, and material properties, as well as thermal effects on tissue and electrical safety (EMC).

Therefore, based on the provided text, I cannot extract the information required to answer your prompt about acceptance criteria and a study proving the device meets those criteria, as it would be relevant for an AI/ML-based device. The device in question is a physical instrument, and its performance evaluation relies on different types of testing.

However, I can interpret the available information to frame a response in the context of what is provided for this electrosurgical pencil.

Interpretation Based on Provided Document (Electrosurgical Pencil - Not an AI/ML Device):

This document describes the regulatory submission for a physical medical device, an electrosurgical pencil. The "acceptance criteria" in this context are not for an algorithm's performance (e.g., accuracy, sensitivity, specificity) but rather for the device's physical and functional characteristics demonstrating substantial equivalence to a legally marketed predicate device. The "study" proving acceptance is the non-clinical bench testing performed.

Here's how the information can be mapped:

1. A table of acceptance criteria and the reported device performance:

Since this is not an AI/ML device with performance metrics like accuracy or AUC, the "acceptance criteria" are implicitly the functional and safety equivalence to the predicate device. The "reported device performance" are the results of the bench tests confirming this equivalence.

• Energy Type: High-Frequency Monopolar
• Sterilization Type: EO Sterilization
• Single Use
• Electrode Type: Monopolar
• Electrode Material: Stainless Steel
• Standards Applied: IEC 60601-1, IEC 60601-2-2, ISO 11135, ISO 11607
• Biocompatibility: Conforms to ISO 10993
• Labeling: Conforms to 21 CFR Part 801
• Stability and Shelf Life: 3 Years | All characteristics are identical or demonstrably equivalent.
• Electrode non-stick coating: Subject device uses Silicon oxide; predicate uses Teflon. Demonstrated to be "similar" in performance without craters.
• Handle Length: Subject: 145mm; Predicate: 165mm. (Difference noted, but not deemed critical enough to prevent equivalence).
• Total Device Length: Subject: 190mm; Predicate: 210mm. (Difference noted, but not deemed critical enough to prevent equivalence). |
  | Thermal Effects Equivalence: Similar thermal damage zone sizes on ex-vivo tissues (kidney, liver, muscle). | "These tests showed that the thermal effects of our electrode are virtually identical to those shown in the predicate device." |
  | Non-Stick Performance Equivalence: Similar non-stick performance to predicate. | "The non-stick performance of our non-stick electrode was found to be similar to the predicate device but without occurring holes and craters as in the predicate device's non-stick coating." |
  | Electrical Safety (EMC) Compliance: Pass specified electrical tests. | "The device K231405 successfully passed the following electrical tests: Conducted Emissions, Radiated Emissions (30MHz-1GHz, 1GHz-18GHz), Electrostatic Discharge (ESD), Radio frequency electromagnetic field radiation immunity, Power frequency magnetic field." |
  | Package Integrity & Functional Performance for Shelf Life: Maintain integrity and function after aging. | "Subject device package integrity and functional performance tests were performed in-house in our Jiangsu facilities after aging and real-time stability tests to confirm the proposed shelf life." |

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

• Sample Size: Not explicitly stated as a numerical count of units tested. For the "Thermal Effects on Tissue", it mentions "Ex-vivo kidney, liver, and muscle tissues were used." The quantity of each tissue type or the number of device samples tested is not provided. For electrical testing, it's typically a set number of units for compliance, but not specified here.
• Data Provenance: The thermal effects and package integrity/functional performance tests were conducted "in-house in our Jiangsu facilities." Electrical (EMC) testing was conducted by "Suzhou Yipin Quality Technical Service Co., Ltd." in Suzhou, China. Biocompatibility testing was performed by "Sanitation & Environment Technology Institute, Soochow University" in Suzhou, China. This indicates retrospective testing performed specifically for the 510(k) submission.

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

This concept is not applicable here as the device is a physical instrument, not an AI/ML algorithm requiring expert annotations for ground truth on images or data. The "ground truth" for this device's performance is established by direct physical measurements, electrical tests, and tissue studies.

4. Adjudication method for the test set:

Not applicable for this type of device testing.

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 not an AI/ML device that assists human readers.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" for this medical device's performance relies on:

• Direct measurements and physical properties: Comparing specifications like dimensions, materials, and sterile status to the predicate device.
• Ex-vivo tissue studies: For thermal effects, the "ground truth" is the empirically measured thermal damage zone size on animal tissues, compared to the predicate device's effects.
• Standardized electrical test results: Compliance with international electrical safety standards.
• Material properties and biocompatibility studies: Compliance with ISO standards for materials and biological safety.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

Not applicable.

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