The PlasmaKinetic Generator section of the GII RF Workstation is indicated for ablation of coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including: Adenoidectomy, Cysts, Head, Neck, Oral, and Sinus Surgery, Mastoidectomy, Myringotomy with effective Hemorrhage Control, Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates, Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking, Neck Mass, Papilloma Keloids, Submucosal Palatal Shrinkage, Tonsillectomy, Traditional Uvulopalatoplasty (RAUP), Tumors, Tissue in the Uvula/Soft Palate for the Treatment of Snoring.

The Gyrus ENT Somnoplasty TCRF Generator section of the GII RF Workstation with the Temperature Controlled Radio-frequency (Somnoplasty®) Electrodes is indicated for coagulation of soft tissue including: The coagulation of enlarged tonsils in patients 13 years of age and older; the reduction of the incidence of airway obstructions, e.g., base of tongue, soft palate, etc., in patients suffering from UARS or OSAS; tissue coagulation in the inferior turbinates; and tissue coagulation in the uvula/soft palate which may reduce the severity of snoring in some individuals.

Device Description

The Gyrus ENT G II RF Workstation is a combination of two previously cleared radio-frequency generators: 1. The Gyrus ENT Somnoplasty Temperature-Controlled Radio-frequency Generator -K020067, and 2. The Gyrus Medical Inc. (formerly Everest Medical Corporation) PlasmaKinetic™ Generator - K003060.

The Gyrus ENT G II Radio-frequency Workstation has two modes of operation: The monopolar mode has controls for maximum temperature and energy delivered. The unit has readouts for total energy delivered, impedance, temperature for two thermocouples and time of energy delivery. The bipolar mode has controls for output waveform type and power. The unit has readouts for set power and waveform. Connectors on the front panel include the monopolar connector for active electrode and dispersive electrode and separate dual bipolar connectors for PlasmaCision electrodes and bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the G II Radiofrequency Workstation include the PlasmaCision electrodes, bipolar instruments, connector cable, footswitch and a power cable.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the Gyrus ENT G II Radio-frequency Workstation & Accessories, submitted in 2002. It describes the device, its intended uses, and its substantial equivalence to predicate devices. It does not contain information about pre-defined acceptance criteria or a specific study proving the device meets acceptance criteria in the manner applicable to AI/ML devices.

The information provided relates to a medical device from 2002, which is an electrosurgical generator, not an AI/ML device as implied by the detailed questions about ground truth, sample sizes for training/test sets, expert consensus, and MRMC studies. These types of studies and acceptance criteria are standard for AI/ML-driven diagnostics or assistive technologies, but not for a radio-frequency workstation as described.

Therefore, many of the requested fields cannot be directly answered from the provided text, as the underlying technology and regulatory requirements are different.

However, based on the context of a 510(k) submission, the "acceptance criteria" and "study" are interpreted as the demonstration of substantial equivalence to predicate devices through comparison and performance testing.

Here's an attempt to answer the questions based on the provided text, noting where the information is not applicable or not present for this type of device:

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

For a 510(k) submission of this type (electrosurgical generator), the "acceptance criteria" is typically demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety/effectiveness. The "reported device performance" is the claim that this equivalence has been met through comparison and testing.

Acceptance Criteria (Implicit for 510(k) Equivalence)	Reported Device Performance (Claimed)
Safety and Effectiveness comparable to predicate devices for stated indications.	"The comparison and validation results presented show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use." (Page 2, "Comparison to Predicate Devices")
Intended Use matching or being a subset of predicate devices.	The G II RF Workstation is a combination of two previously cleared generators with their respective indications: - Somnoplasty TCRF Generator section: Indications are coagulation of enlarged tonsils, reduction of airway obstructions (base of tongue, soft palate), tissue coagulation in inferior turbinates, and uvula/soft palate for snoring. These align with predicate device K020778, K982717, K971450, K973618. - PlasmaKinetic Generator section: Indications include ablation, resection, coagulation, and hemostasis for various ENT surgeries (Adenoidectomy, Cysts, Head/Neck/Oral/Sinus Surgery, Mastoidectomy, Myringotomy, Nasal Airway Obstruction, Nasopharyngeal/Laryngeal indications, Neck Mass, Papilloma Keloids, Submucosal Palatal Shrinkage, Tonsillectomy, RAUP, Tumors, Uvula/Soft Palate for Snoring). These align with predicate device K014290.
Technological Characteristics similar to predicate devices.	The G II RF Workstation combines two previously cleared RF generators: The Gyrus ENT Somnoplasty Temperature-Controlled Radio-frequency Generator (K020067) and The Gyrus Medical Inc. PlasmaKinetic™ Generator (K003060). The submission states "The Gyrus ENT G II Radio-frequency Workstation has been carefully compared to legally marketed devices with respect to intended use and technological characteristics." (Page 2, "Comparison to Predicate Devices")
Performance Testing demonstrating similar function to predicate devices where applicable.	For the PlasmaKinetic Generator section: "Testing was presented in our July 19, 2002, supplement to K021777 that demonstrated the The PlasmaKinetic Generator section of the GII RF Workstation performed similarly to the ArthroCare ENTec Plasma Wand." (Page 1) No specific test results or metrics are provided in the summary.

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

This information is not provided in the 510(k) Summary. For a device of this nature, performance testing would typically involve bench testing and possibly animal or cadaveric studies, rather than a "test set" of clinical data in the AI/ML sense. Clinical data (if any was used for specific performance claims beyond basic safety) details are not included in this summary document.

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 information is not applicable/not provided. "Ground truth" in the context of expert consensus on diagnostic images is specific to AI/ML diagnostic tools. For an electrosurgical device, performance would be assessed through objective measurements of its physical output (e.g., power, temperature control, tissue effects) rather than human interpretation.

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

This information is not applicable/not provided. Adjudication methods are relevant for human interpretation tasks, not for the performance assessment of an electrosurgical generator.

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 device is an electrosurgical generator, not an AI-assisted diagnostic or decision-support tool for human readers. Therefore, an MRMC study is outside the scope of its evaluation.

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

This is not applicable. The device is a physical electrosurgical workstation, not an algorithm. Its operation requires a human operator ("qualified medical personnel trained in the use of electrosurgery").

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

This is not applicable in the context of AI/ML ground truth. For an electrosurgical device, the "ground truth" equivalent for performance testing would be objective physical measurements and observations of tissue effects (e.g., coagulation depth, ablation rates) against predetermined specifications or compared to the predicate devices' known performance. The summary does not detail these specific "ground truths" but rather refers to "performance testing."

8. The sample size for the training set

This information is not applicable/not provided. Training sets are relevant for machine learning algorithms. The development of this electrosurgical generator would involve engineering design, prototyping, and testing, not algorithmic training on data.

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

This information is not applicable/not provided for the same reasons as #8.

Summary

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R.O.A.T.Y.

510(k) Summary of Safety and Effectiveness

G II Radio-frequency Workstation & Accessories

Submitted by:	Gyrus ENT2925 Appling Rd.Bartlett, TN 38133
Contact Person:	Jeffrey W. Cobb
	Vice President, Regulatory/Clinical Affairs & Quality
Telephone:	901-373-2673
Facsimile:	901-373-0242
Date Summary Prepared:	August 19, 2002
Name of the Device:	G II Radio-frequency Workstations
Common/Usual Name:	Electrosurgical Generator and Accessories
Classification Name:	Electrosurgical Cutting & Coagulation Device andAccessories (per 21 CFR 878.4400)
Predicate Devices:	- Gyrus ENT Somnoplasty Generator (K020067)- Gyrus Medical Inc PlasmaKinetic Generator(K003060)- Arthrocare Sinus Electrosurgery Generator (K973478)- Arthrocare ENTec Plasma Wands (K014290)- ENTec EVac Plasma Wands (K011279)- Gyrus ENT (Smith & Nephew) Hemostatix Scalpel(K002021)- Gyrus ENT TCRF Somnoplasty Electrodes(K982717), (K973618), (K971450), & (K020778)

Description:

The Gyrus ENT G II RF Workstation is a combination of two previously cleared radio-frequency generators:

1. The Gyrus ENT Somnoplasty Temperature-Controlled Radio-frequency Generator -K020067, and
1. The Gyrus Medical Inc. (formerly Everest Medical Corporation) PlasmaKinetic™ Generator - K003060.

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Somnoplasty TCRF Generator Section of the GII RF Workstation

Statement of Intended Use: The Gyrus ENT Somnoplasty Generator section of the G II Radiofrequency Workstation is indicated for coagulation of soft tissue including:

	Indication	Predicate Device 510(k)
1.	The coagulation of enlarged tonsils in patients 13 years of age and older	K020778
2.	The reduction of the incidence of airway obstructions, e.g., base of tongue, softpalate, etc., in patients suffering from UARS or OSAS	K982717 K971450
3.	Tissue coagulation in the inferior turbinates	K973618
4.	Tissue coagulation in the uvula/soft palate which may reduce the severity ofsnoring in some individuals	K982717 K971450

PlasmaKinetic Generator Section of the GII RF Workstation

The PlasmaKinetic Generator section of the GII RF Workstation uses those bipolar and PlasmaCision instruments described in our original submission (K021777) dated May 29, 2002, and subsequent correspondence related to K021777 dated July 10, 2002, and July 19, 2002.

As stated in the original submission, K021777, the PlasmaKinetic Generator section of the GII RF Workstation is substantially equivalent to the ArthroCare ENTec Plasma Wand cleared under 510(k) Nos. K014290, K013463, K011279, K000228, and K973478. Testing was presented in our July 19, 2002, supplement to K021777 that demonstrated the The PlasmaKinetic Generator section of the GII RF Workstation performed similarly to the ArthroCare ENTec Plasma Wand.

Statement of Intended Use: The PlasmaKinetic Generator section of the GII RF Workstation is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

	Indication	Predicate Device 510(k)
1.	Adenoidectomy	K014290
2.	Cysts	K014290
3.	Head, Neck, Oral, and Sinus Surgery	K014290
4.	Mastoidectomy	K014290
5.	Myringotomy with effective Hemorrhage Control	K014290
6.	Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates	K014290
7.	Nasopharyngeal / Laryngeal indications including Tracheal Procedures,Laryngeal Polypectomy, and Laryngeal Lesion Debulking	K014290
8.	Neck Mass	K014290
9.	Papilloma Keloids	K014290
10.	Submucosal Palatal Shrinkage	K014290
11.	Tonsillectomy	K014290
12.	Traditional Uvulopalatoplasty (RAUP)	K014290
13.	Tumors	K014290
14.	Tissue in the Uvula/Soft Palate for the Treatment of Snoring	K014290

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

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The Gyrus ENT G II Radio-frequency Workstation has two modes of operation:

The monopolar mode has controls for maximum temperature and energy delivered. The unit ﮯ has readouts for total energy delivered, impedance, temperature for two thermocouples and time of energy delivery.
-The bipolar mode has controls for output waveform type and power. The unit has readouts for set power and waveform.

Connectors on the front panel include the monopolar connector for active electrode and dispersive electrode and separate dual bipolar connectors for PlasmaCision electrodes and bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the G II Radiofrequency Workstation include the PlasmaCision electrodes, bipolar instruments, connector cable, footswitch and a power cable.

Comparison to Predicate Devices:

The Gyrus ENT G II Radio-frequency Workstation has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, performance testing has been done to validate the performance of the device. The comparison and validation results presented show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2002

Gyrus ENT Jeffrey W. Cobb Vice-President, Regulatory/Clinical Affairs & Quality 2925 Appling Road Bartlett, Tennessee 38133

Re: K021777

Trade/Device Name: Gyrus G II Radio-frequency Workstation & Accessories Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting & coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 29, 2002 Received: May 30, 2002

Dear Mr. Cobb:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Jeffrey W. Cobb

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit A

Indications for Use

510(k) Number (if known):

K021777

Device Name:

G II Radio-frequency Workstation & Accessories

Indications For Use:

· Adenoidectomy

Cysts
· Head, Neck, Oral, and Sinus Surgery
· Mastoidectomy
· Myringotomy with effective Hemorrhage Control
· Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
· Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
· Neck Mass
Papilloma Keloids
· Submucosal Palatal Shrinkage
· Tonsillectomy
· Traditional Uvulopalatoplasty (RAUP)
Tumors
· Tissue in the Uvula/Soft Palate for the Treatment of Snoring

The coagulation of enlarged tonsils in patients 13 years of age and older; the reduction of the incidence of airway obstructions, e.g., base of tongue, soft palate, etc., in patients suffering from UARS or OSAS; tissue coagulation in the inferior turbinates; and tissue coagulation in the uvula/soft palate which may reduce the severity of snoring in some individuals.

The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment and familiar with potential complications that may arise during or following Head and Neck surgery.

Contraindications for Use:

There are no known absolute contraindications to the use of radio-frequency surgery. The use of the GNT G II Radio-frequency Workstation is contraindicated when, in the physician, electrosurgical procedures would be contrary to the best interests of the patient. The use of the system is also contraindicated for patients with heart pacemakers or other electronic device implants.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use X(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number	K021777
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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.