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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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The Disposable Electrosurgical Pencil is used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical surgery with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip.

The Disposable Electrosurgical pencils are used for the cutting and coagulation of soft tissue and have a conductive cable which is designed for use with high frequency surgical generator (Electrosurgical unit). The connector or plug fits into electrosurgical unit. The hand-pieces are made of plastic with two buttons (cutting and coagulation buttons) in the case of the handcontrolled pencils, while the foot controlled pencils is activated by a monopolar footswitch connected to the generator. One button or switch is to control the cutting mode, CUT, of the ESU while the other controls the coagulation mode, COAG. The applied electrosurgery, monopolar, is the emittance of the high frequency alternating current, HFAC, from the diathermy via an active electrode through the patient's body tissues and then returned back to the diathermy machine via a dispersive electrode (patient return pad). The proposed device mainly consists of electrode tip, hand piece handle, cable, and plug. For all applied device models, only one kind of dimension of electrode tip, standard hex blade electrode is available. However, two kind of cable length, 3m or 5m, and three kind of available hand-piece color, white/blue/green color, are available.

The provided text is a 510(k) Summary for the Cathay Manufacturing Corp.'s Disposable Electrosurgical Pencils (CP1001 Series). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for a novel AI/software medical device.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size and ground truth establishment for training set) are not applicable or not provided in this regulatory submission for a hardware device.

However, I can extract the acceptance criteria and the reported device performance based on the provided document within the context of a 510(k) submission, which relies heavily on bench testing and comparison to an existing device.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a number of devices. The "bench testing" involved using "three tissue types, liver, kidney and muscle tissue" for thermal effects evaluation. The number of devices tested for electrical safety, biocompatibility, and shelf-life is not specified.
• Data Provenance: The device manufacturer (Cathay Manufacturing Corp.) is located in Shanghai, China. The testing was conducted by a "Third party, TUV Rheinland," which is a German-based certification body with global operations. The location of the specific testing labs is not mentioned. The studies were conducted specifically for this 510(k) submission, implying they were prospective relative to the submission date.

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)

• Not applicable. This is a hardware device. Ground truth, in the context of AI/software, refers to definitively correct outputs for comparison. For this device, ground truth relates to established engineering standards (IEC, ISO) and physical measurements in a lab setting, not expert clinical interpretation.

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

• Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretation, which is not relevant for the type of bench testing performed for this device.

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 hardware electrosurgical pencil, not an AI/software 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 a hardware electrosurgical pencil, not an algorithm.

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

• The "ground truth" for this device's performance evaluation is based on:
  • International Electrotechnical Commission (IEC) Standards: IEC 60601-1 (General requirements for basic safety and essential performance) and IEC 60601-2-2 (Particular requirements for high-frequency surgical equipment and accessories).
  • International Organization for Standardization (ISO) Standards: ISO 11135 (Sterilization of health-care products), ISO 11607 (Packaging for terminally sterilized medical devices), and ISO 10993 (Biological evaluation of medical devices).
  • Regulatory Guidance: 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery.'
  • Physical Measurements: Measurements of thermal damage zones in tissue models.
  • Predicate Device Comparison: Performance equivalence was established by comparing the subject device's thermal effects to those of the legally marketed predicate device (K092634).

8. The sample size for the training set

• Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.

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

• Not applicable. As above, there is no training set for this hardware device.

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

The generator is enclosed in a metal and molded plastic enclosure and will have an angled front panel in the display and controls area. The front panel displays and controls will be sealed to facilitate cleaning and minimize the possibility of problems caused by accidental spills. The receptacles for the active electrosurgical accessories will be in a recessed area and will conform to IEC60601-1:2005/(R) 2012 And A1:2012.

Device components: Chassis and Cover, Front panel controls, Power supply board, Microprocessor board, Footswitch board, Interface circuits, Front panel receptacles.

Special features: Three CUT modes (Pure CUT, Blend 1, Blend 2), Three COAG modes (COAG1 (Spray), COAG2 (Forced), COAG3 (Soft)), Two Bipolar modes (Bipolar1 (Macro), Bipolar2 (Micro)), Memory (10 memory Presets), CQMS (contact quality monitoring system), Power ON self diagnostics, PPS (peak power system).

Here's a breakdown of the acceptance criteria and study information for the OBS Electrosurgical Generator (model: OBS-350A), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this document are primarily based on achieving "substantial equivalence" to a predicate device (Valleylab Force FX). This means the OBS-350A is considered acceptable if its performance is comparable to the predicate across various parameters, particularly regarding safety and effectiveness.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of number of devices or number of tissue samples for the bench testing. It refers to "evaluations" and "tests."
• Data Provenance: The testing was "bench" testing, comparing the performance of the OBS-350A against its own design specifications and against the predicate device (Valleylab Force FX). The document implicitly indicates the testing was done by the manufacturer (Baisheng Medical Co., Ltd.) as part of their submission for market clearance. No country of origin for test data is explicitly stated beyond the manufacturer's location in China. The testing is considered prospective in the sense that it was conducted directly to support this 510(k) submission.

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

• The document does not mention the use of experts to establish a "ground truth" for the test set. The evaluation is focused on direct comparison of physical and electrical characteristics and compliance with recognized standards. This is typical for electrosurgical generators, where performance is objectively measured rather than subjectively interpreted (like image analysis).

4. Adjudication Method for the Test Set

• No adjudication method is described, as the testing involves objective measurements rather than subjective assessments requiring reader adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical and animal studies were not deemed necessary to support substantial equivalence." This type of study would involve human readers (e.g., surgeons) evaluating the device's performance, which was not performed or required here.

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

• This question is not applicable in the context of an electrosurgical generator. A standalone "algorithm" performance is relevant for AI/software devices that make diagnostic or treatment recommendations. The OBS-350A is a physical medical device that applies energy. Its performance is measured directly, not via an algorithm operating independently to produce an outcome. The document does mention software validation for the device's embedded software, which would be a form of "standalone" software assessment, but not in the AI/human-in-the-loop sense.

7. The Type of Ground Truth Used

• The "ground truth" in this context is established by:
  • Design Specifications: The device's performance is compared against its own defined design specifications.
  • Predicate Device Performance: Direct comparison of electrical waveforms and tissue thermal effects against a legally marketed predicate device (Valleylab Force FX).
  • Recognized Standards: Compliance with international standards such as IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2.

8. The Sample Size for the Training Set

• This question is not applicable. The OBS-350A is an electrosurgical generator, not an AI/machine learning device that requires a "training set" of data.

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

• This question is not applicable, as there is no "training set" for this type of medical device.

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