Disposable General Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is categorized by three families: Blade, Needle and Ball. Each electrode family offers three series S, M and L in length and different insulation designs. The conductive post of electrode is inserted into the nozzle of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in electrosurgical procedure. This device is used in conjunction with a compatible monopolar electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.

AI/ML Overview

The provided document, a 510(k) summary for the "Disposable General Electrode" (K152059), primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study outlining acceptance criteria and device performance in the manner typically associated with clinical trials of AI/diagnostic devices.

Therefore, many of the requested fields cannot be directly answered from the given document as it describes a conventional medical device (electrosurgical electrode) and its safety and performance through comparison to a predicate device, rather than an AI-powered diagnostic tool. The document does not feature a typical AI/diagnostic device study with acceptance criteria, ground truth, expert review, sample sizes for training/test sets, or comparative effectiveness with human readers.

However, I will extract the information that is present and indicate where the information is not applicable or not provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated as such, but inferred from testing)	Reported Device Performance
Functional Performance (Electrosurgical Operation)	Comparative testing performed on porcine kidney, liver, and muscle for both Cut mode (at 50W, 100W, 200W, and 300W output power) and Coagulation mode (at 50W and 100W).
Specific acceptance criteria for cutting/coagulation effectiveness are not quantified in the document.	Demonstrates that the performance result of device operation is no significant difference between the proposed device and the predicate device.
Eschar Buildup	Comparative testing performed on porcine kidney, liver, and muscle for both Cut mode (at 50W, 100W, 200W, and 300W output power) and Coagulation mode (at 50W and 100W).
Specific acceptance criteria for eschar buildup are not quantified in the document.	Demonstrates that the amount of eschar buildup on the tip of the electrode is no significant difference between the proposed device and the predicate device.
Electrical Safety (IEC 60601-1 and IEC 60601-2-2)	Safety Testing was performed to comply with: - IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) - IEC60601-2-2: 2009 (Fifth Ed)
Compliance with these standards is the implicit acceptance criterion.	The device's safety testing was performed to comply with these standards. (Assumed compliance, as it's a 510(k) submission).
Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) Residue	EO and ECH residue test performed in accordance with ISO10993-7.
EO residue ≤ 4 mg per device ECH residue ≤ 10 mg per device	The residue level on the patient contact portion of the device shall be met below standard (interpreted as compliance was achieved).
Biocompatibility (ISO 10993-1)	Biological evaluation performed in accordance with ISO10993-1.
Specific acceptance criteria for biocompatibility tests are not stated, but compliance with the standard and passing the tests below are implied acceptance criteria.	Verified that the material use of the proposed electrode is biocompatible with intended use, through: - Intracutaneous Reactivity Test - In vitro Cytotoxicity Test - Skin sensitization tests

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

Sample Size for Test Set: The document mentions "comparative testing was performed on porcine kidney, liver, and muscle." The number of porcine samples or tests performed is not specified.
Data Provenance: The data is from laboratory testing performed using animal tissues (porcine kidney, liver, and muscle). The country of origin of the data is not explicitly stated, but the manufacturer is based in Hong Kong, China. The testing described is prospective, as it was conducted specifically for this submission.

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

This is Not Applicable as the device is an electrosurgical electrode, not a diagnostic device requiring expert interpretation for ground truth. The performance is assessed through objective measurements (cutting/coagulation effectiveness, eschar buildup, residue levels, biological reactions) and compliance with engineering standards.

4. Adjudication method for the test set

This is Not Applicable. Performance was assessed through direct measurements and comparison to a predicate device, not through subjective expert adjudication.

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

This is Not Applicable. This is a conventional medical device, not an AI-powered diagnostic tool, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted.

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

This is Not Applicable. The device is an electrosurgical electrode and does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through:

Objective performance comparison: "No significant difference" in operation result and eschar buildup compared to the predicate device on animal tissue (porcine kidney, liver, and muscle).
Compliance with international standards: Adherence to IEC 60601-1, IEC 60601-2-2, ISO 10993-7, and ISO 10993-1.
Chemical and biological tests: Measured EO/ECH residue levels and positive outcomes from intracutaneous reactivity, in vitro cytotoxicity, and skin sensitization tests.

8. The sample size for the training set

This is Not Applicable. This is not an AI/machine learning device, so there is no training set.

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

This is Not Applicable, as there is no training set for an AI/machine learning device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 21, 2016

Modern Medical Equipment Manufacturing Limited Thomas Chan Tsz Fung Regulatory Supervisor 35-41 Tai Lin Pai Rd., Unit F, 4th Fl., Gold King Ind. Bldg, Kwai Chung, N.T. Hong Kong, China

Re: K152059

Trade/Device Name: Disposable General Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: July 24, 2015 Received: July 24, 2015

Dear Thomas Chan Tsz Fung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152059

Device Name Disposable General Electrode

Indications for Use (Describe)

The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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1. 510(k) Owner
Name:	Modern Medical Equipment Manufacturing Limited
Address:	Modern Medical Equipment Mfg., Ltd.
	35-41 Tai Lin Pai Rd., Unit F,
	4th Fl., Gold King Ind. Bldg
	Kwai Chung, N.T. Hong Kong, China
Telephone:	(852) 2420 9068
Fax:	(852) 2481 1234
Contact person:	Thomas, Chan Tsz Fung
Date of preparation:	20 Jul, 2015
2. Device
Name of Device:	Disposable General Electrode
Trade or proprietary name:	Disposable General Electrode
Common or usual name:	Disposable General Electrode
Classification name:	Electrosurgical, Cutting & Coagulation & Accessories
Classification Panel:	General & Plastic Surgery
Product Code:	GEI
Class:	II

3. Device description

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and IEC60601-2-2.

4. Indication for Use

The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure.

5. Predicate device

Disposable Electrode Series with 510(k) number K091672.

6. Technological characteristic

The proposed Disposable General Electrode is a stainless steel shaft insulted by wrapping different electrical insulation materials included of Polyolefin Shrink Wrap, Teflon Shrink Wrap or ABS/HIPS overmold or their combinations. The shaft diameter is about 2.36mm. One end of shaft acts as the electrode tip which is shaped as Blade, Needle or Ball and the other end as conductive post which insert into the nozzle of electrosurgical pencil from which it receives the electrical current..

The conductive electrode tip delivers high frequency current onto a target tissue for cutting and/or coagulation during an electro-surgery. The insulation material prevents accidental conduction of the electrosurgical current from this point to the patient.

The construction of proposed electrode and the predicted device is identical. There are no new questions raised regarding to effectiveness and safety.

7. Substantial Equivalence

The technological characteristic in both proposed device and predicate device is identical. Moreover, performance testing data showed that operation result by using proposed device and predicate device shall be the same.

8. Performance Testing Data

Validation and Verification testing was performed on the device and packaging.

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Simulation Tests include comparative testing was performed on porcine kidney, liver, and muscle for both Cut mode at 50W, 100W, 200W and 300W output power and Coagulation mode at 50W and 100W. It demonstrates that the performance result of device operation and amount of eschar buildup on the tip of electrode are no significant difference between proposed device and predicate device.

Safety and Biocompatibility testing data Safety Testing was performed to comply with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC60601-2-2: 2009 (Fifth Ed)

EO and ECH residue test was performed in accordance to ISO10993-7 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals after aeration in ETO sterilization process. The residue level on the patient contact portion of device shall be met below standard

EO residue ≤ 4 mg per device ECH residue ≤ 10 mg per device

The biological evaluation was performed in accordance with ISO10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. Below tests verified that the material use of the proposed electrode is biocompatibility with intended use.

Intracutaneous Reactivity Test
In vitro Cytotoxicity Test
Skin sensitization tests

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10. Conclusion

Based on comparing technological characteristic and performance testing data, we believe the proposed device, Disposable General Electrode is substantial equivalence to predicate device (K091672).

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.