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RF Surgical Generator FW-120A is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.

RF Surgical Generator FW-120A, is a compact source of high power RF energy, enhanced capability of radiosurgery generator, which can be employed for a variety of radiosurgery procedures, such as cut and coagulate living human tissue.

The device which is consisted of a generator, an IEC Neutral Plate, and a Two Pedal Footswitch, provides 5 modes and corresponding output power ranges that is user/operator selectable based on the surgical procedure undertaken. The action is achieved by front panel selection of waveforms and power level. All selection is affected through push buttons and indicators which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays

The device is provided with safety features of automatically system initialize self-check after power on and continuously monitored during the device running. The device will provide error information and/ or alerts when detect following faults, such as a) Accessary fail connection, b) Overheating of Main Unit, c) Neutral plates Contact resistance exceed the limit, d) System initialize error. The error monitoring is interlocked with the controls to prevent operation when fault condition happened in the unit.

The generator is configured for Monopolar and Biopolar output and the final output power could be controlled by pedal foot switch and/or hand switches. Recommended Monopolar Handpieces 510(k) No.: K092634. Recommended IEC Neutral Plate 510(k) No.: K102372.

This document is a 510(k) premarket notification for an RF Surgical Generator (Model: FW-120A) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing details on a study to meet specific acceptance criteria for a new device.

Therefore, many of the requested categories about acceptance criteria, detailed study design, ground truth, and expert involvement are not applicable or not provided in this type of submission. This document primarily reports on verification testing against established standards and a comparison to a predicate device.

Here's a breakdown based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not outline specific numerical "acceptance criteria" in the way one might see for a diagnostic device (e.g., sensitivity/specificity targets). Instead, it relies on demonstrating compliance with recognized safety and performance standards and showing equivalence to a predicate device.

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

• Sample Size: Not specified in terms of number of human subjects or distinct test cases. The testing involved "lab bench testing" and "porcine muscle, liver, and kidney" tissue. The number of samples/tests for each tissue type is not detailed.
• Data Provenance: The testing was "lab bench testing" using "porcine" tissue. The country of origin for the data is not explicitly stated beyond the applicant being based in China. The data is from prospective testing conducted specifically for this submission.

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

• Not Applicable / Not Provided: This type of submission (510(k)) for an electrosurgical generator typically relies on objective physical measurements and engineering evaluations against standards, rather than expert-established ground truth like in diagnostic imaging. There is no mention of experts establishing a ground truth for a test set in this context.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided: As there's no mention of expert ground truth establishment, there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: An MRMC comparative effectiveness study is not mentioned as this device is an electrosurgical generator, not an interpretative diagnostic imaging device that involves human readers.

6. Standalone (Algorithm Only) Performance

• Yes, implicitly: The "performance data" section (Section 6) describes "System Performance and waveform outputs test," "Thermal effects testing," and "software verifications" which represent the standalone performance of the device itself and its integrated software. These tests involve direct measurement of the device's output and effects, independently of human interpretation of a diagnostic output.

7. Type of Ground Truth Used

• Objective Measurements and Physical Science Principles: The "ground truth" for this device's performance is established through objective measurements of electrical output parameters (waveform, power), physical effects on tissue (thermal damage size), and compliance with internationally recognized safety and performance standards (e.g., IEC 60601 series). For software, it's verification against design specifications and guidance documents.

8. Sample Size for the Training Set

• Not Applicable / Not Provided: This device, an RF Surgical Generator, does not utilize machine learning or AI models that require a "training set" in the conventional sense. Its functionality is based on established engineering principles and not on learning from a large dataset.

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

• Not Applicable / Not Provided: As there is no training set for a machine learning model, this question is not applicable.

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The Electrosurgical Generator – Model FW-350A is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.

Electrosurgical Generator-Model FW-350A has Monopolar and Bipolar modes that can satisfy the general requirements of electrosurgical field. The CQMS function can monitor the area of patient body applied with ESU pad during the operation every 40ps. Once the pad loses or that area shrinks, the computer will cut off all outputs within 40us to prevent patient from getting burnt. The PPS system ensure the safety of a constant output that send out compulsory stimulation at the initial instant of every CUT or COAG to make the operation process go smoothly. Moreover, the memory function can decrease the medical staff workload and human errors. At last, the Power ON self diagnostics function can diagnosis whether all working modes and functions are working normally and feedback information by code displaying and alarm voice prompt that the operational safety is improved greatly.

The provided text describes a 510(k) premarket notification for an Electrosurgical Generator, Model FW-350A. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details on novel acceptance criteria and comprehensive study results as would be typical for a de novo submission or a new technology.

Therefore, the information available in the document primarily addresses the safety and performance of the device relative to existing standards and a predicate device. It does not contain an "acceptance criteria" table in the classical sense, nor detailed study results that prove the device meets these criteria in a standalone, statistically robust manner. Instead, the "acceptance criteria" are implied by compliance with recognized standards and a demonstration of comparable performance to the predicate device through bench testing.

Here's a breakdown of the information that can be extracted, interpreted based on the context of a 510(k) submission:

1. Table of Implied Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating equivalence to the predicate device and compliance with relevant safety standards. The reported device performance is presented in comparison to the predicate.

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