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The device is to be used in combination with a standard electrosurgical generator to cut and coagniate soft tissus by means of high frequency electrical current during an electrosurgical procedure.

The Single use electrosurgical pencil with electrode is a monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post. It directs high frequency alternating current to heat target tissue thereby bringing about cutting and coagulation during surgical procedures.

The electrosurgical pencil handpiece consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode.

The electrosurgical pencil handpiece is available in 3 models, differing only in their button configuration: Push Button Electrosurgical Pencil (Model #: GDSA), Electrosurgical Rocker Pencil (Model #: GDSB), and Electrosurgical Foot Control (Model #: GDJA).

The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball, needle and dermal tip. The electrode tip is either coated or noncoated. There may or may not be a heat shrink attached. There are 47 different types of electrodes.

The model number of each subjective device "Single use electrosurgical pencil with electrode" consists of two parts: the first four letters representing model number of the pencil, and the second part representing model number of the electrode. For example, model number: GDSA-DA-C66 is for Push Button Electrosurgical Pencil with Standard Blade 2.6". There are 141 different combinations of pencil and electrode.

The diameter of the conductive post is 2.36mm. The pencil with electrode attached is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure.

The switching method of this electrosurgical pencil may be push button, rocker switch or foot switch. The cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug.

The provided text describes a 510(k) premarket notification for a "Single use electrosurgical pencil with electrode". This is a medical device application for a new version of an existing device, aiming to demonstrate substantial equivalence to a previously cleared predicate device.

The document focuses on comparing the proposed device to its predicate, rather than providing a detailed acceptance criterion table with numerical performance metrics and a specific study that proves the device meets those criteria in a typical clinical or diagnostic sense with specificity/sensitivity.

Instead, the "acceptance criteria" here are largely compliance with international standards and equivalence to the predicate device in various performance aspects. The "study" refers to performance and safety testing conducted to ensure this compliance and equivalence.

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

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

Since this is a substantial equivalence submission for an electrosurgical pencil, the "acceptance criteria" are primarily related to safety, functional performance, and biocompatibility, benchmarked against standards and the predicate device. The "reported device performance" is a statement of compliance with these standards and equivalence to the predicate.

Since this is a 510(k) summary for a relatively straightforward electrosurgical device, the detailed metrics often found in AI/diagnostic device submissions are not present. The "study" mentioned for performance testing is a comparative study, implying the new device's performance was found to be similar to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench testing and biocompatibility testing.

• Performance Testing (Penetrating thermal tissue effects): The "test set" consisted of "Porcine Liver, Porcine Kidney, Porcine Muscle tissues." The sample size (number of tissue samples or repetitions) is not specified. The data provenance is ex-vivo (animal tissue), likely conducted in a controlled lab environment (implicitly, in China, based on the submitter's location). This type of testing is generally considered prospective in terms of data collection and analysis for the submission, even if it uses ex-vivo samples.
• Biocompatibility Testing: The specific sample sizes for tests like cytotoxicity, sensitization, systemic toxicity, and pyrogen testing are not specified. These tests typically involve in-vitro assays (cytotoxicity) and in-vivo animal models (sensitization, systemic toxicity, pyrogen). The provenance would be from lab testing, likely conducted in China or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable and not provided for this device. The "ground truth" for electrosurgical pencils involves objective physical/biological measurements (e.g., thermal effect depth, electrical parameters, biocompatibility reactions) rather than expert interpretation of images or clinical data. The standards themselves (IEC, ISO) define the "ground truth" for compliance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in expert assessment (e.g., in radiology studies). This submission relies on objective testing following defined international 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

Not applicable and not provided. MRMC studies are specific to AI-assisted diagnostic devices involving human readers. This device is an electrosurgical pencil, not a diagnostic AI system.

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

Not applicable and not provided. This is not an AI algorithm. Its performance is assessed through physical, electrical, and biological testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance and safety is established by objective measurements and adherence to recognized international standards.

• For electrical safety and EMC, the ground truth is defined by the parameters and limits specified in IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
• For biocompatibility, the ground truth is defined by the acceptable limits and biological responses outlined in ISO 10993 series standards.
• For performance (thermal tissue effects), the ground truth is the measured penetrating thermal effect compared to the predicate device's measured effects on porcine tissues. Implicitly, similar or equivalent effects are the "ground truth" for demonstrating equivalence.

8. The sample size for the training set

Not applicable and not provided. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

Not applicable and not provided for the same reason as point 8.

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