The CONMED HelixAR ABC System is intended to deliver argon gas as well as high frequency electrical current for the cutting and/or coagulation of tissue.

Device Description

The HelixAR ABC System is composed of an electrosurgical generator with argon beam coagulation (ABC) and a mobile pedestal. The generator is designed with a graphic user interface (GUI) display which allows the user to select monopolar, bipolar, and ABC modes of operation, choose power and argon flow settings, adjust user settings options, and create, edit, or delete user programs. The HelixAR mobile pedestal (cart) houses two D-size argon gas cylinders and provides connection ports for the use of wired footswitches. The mobile pedestal is designed with an argon tank capacity monitor that provides the user with feedback on the argon gas cylinder pressure.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, specifically concerning the CONMED HelixAR ABC System, an electrosurgical device for cutting and coagulating tissue. As an electrosurgical device, it's not an AI/ML-driven diagnostic tool, which is typically where the detailed acceptance criteria and study designs (like MRMC studies) you've requested are relevant.

Therefore, many of the specific questions you've asked regarding AI/ML models (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this type of medical device submission.

However, I can extract information related to the device's performance and the general "acceptance criteria" presented in the context of device safety and effectiveness.

Here's a breakdown based on the provided document:

Device: CONMED HelixAR ABC System (Electrosurgical Cutting and Coagulation Device and Accessories)
Type of Device: Electrosurgical Generator with Argon Beam Coagulation

1. Acceptance Criteria and Reported Device Performance (as interpreted for an electrosurgical device):

For an electrosurgical device, "acceptance criteria" revolve around demonstrating that the device is safe and effective for its intended use, and performs comparably to a predicate device. This is primarily established through compliance with recognized standards and bench testing.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance / Evidence of Meeting Criteria
Safety	Risks associated with use are mitigated to an acceptable level. Compliance with electrical safety and electromagnetic compatibility standards.	"Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the HelixAR ABC System are mitigated to an acceptable level." "Design verification testing demonstrates the modified HelixAR ABC System complies with the electrical safety requirements of IEC 60601-1:2012 and IEC 60601-2-2:2009 and electromagnetic compatibility per IEC 60601-1-2:2007."
Performance	Meets design specifications. Performs for cutting and/or coagulation of tissue.	"Benchtop testing and software verification validation demonstrate the modified HelixAR ABC System meets design specifications." The device is cleared for its intended use: "cutting and/or coagulation of tissue."
Substantial Equivalence	No new risks of safety or efficacy compared to the predicate device. Substantially equivalent in design, intended use, principals of operation, and technical characteristics to the predicate.	"The differences between the predicate and modified device do not raise any new risks of safety or efficacy. Supporting information per this premarket submission confirms that the modified ConMed HelixAR ABC System is safe and effective for its intended use and is substantially equivalent in design, intended use, principals of operation, and technical characteristics to the CONMED HelixAR ABC System cleared under K152860."

Study Proving Device Meets Acceptance Criteria:

The document describes the studies and activities undertaken to demonstrate substantial equivalence and meet the acceptance criteria. These are primarily benchtop testing, software verification and validation, and risk management activities.

2. Sample size used for the test set and the data provenance: This is not an AI/ML device dealing with data sets of patient images/records. "Test sets" in this context refer to specific tests performed on the physical device and its software. The document does not specify the "sample size" in terms of number of patients or cases, as it's not a clinical study in that sense. The provenance would be internal laboratory testing by the manufacturer (ConMed Corporation). It's benchtop and software testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an electrosurgical device's performance is established through engineering and safety standards compliance, and verified through direct measurements or functional testing, not expert interpretation of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to clinical expert review for diagnostic AI, not electrosurgical device testing.
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 question for AI/ML diagnostic devices, not an electrosurgical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrosurgical tool, not an algorithm that performs a task autonomously. It is designed for human-in-the-loop operation during surgery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device's performance is based on established engineering and safety standards (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2) and the device's design specifications. Its function (cutting/coagulation) is directly observable and measurable through bench testing, not derived from complex clinical outcomes or expert consensus on interpretations.
8. The sample size for the training set: Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established: Not applicable, as there is no training set for a machine learning model. For the device itself, "ground truth" (i.e., correct operation and safety parameters) is established by adherence to recognized national and international electrical safety and performance standards for electrosurgical equipment.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 4, 2017

ConMed Corporation Lisa Anderson Manager, Regulatory Affairs 525 French Road Utica, New York 13502

Re: K172671

Trade/Device Name: HelixAR ABC System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 1, 2017 Received: September 5, 2017

Dear Lisa Anderson:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):

{1}------------------------------------------------

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 (DICE) 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 (DICE) 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, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices

Center for Devices and Radiological Health

Office of Device Evaluation

Enclosure

{2}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K172671

Device Name HelixAR ABC System

Indications for Use (Describe)

The CONMED HelixAR ABC System is intended to deliver argon gas as well as high frequency electrical current for the cutting and/or coagulation of tissue.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary of Safety and Effectiveness

CONMED HelixAR ABC System

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number

A. Submitter

ConMed Corporation 525 French Road Utica, NY 13502

Establishment Registration: 1320894

B. Company Contact

Lisa Anderson Manager, Requlatory Affairs T: (941) 713-2035 F: (315) 624-3225

C. Device Name

Proprietary Name:	HelixAR
Common Name:	Electrosurgical Generator with Argon Beam Coagulation
Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number:	878.4400
Product Code:	GEI
Regulatory Class:	II
Panel:	General and Plastic Surgery

D. Predicate Device

Primary Device Name:	HelixAR ABC System
Company Name:	CONMED Corporation
510(k):	K152860

This predicate has not been subject to a design-related recall.

E. Device Description

{4}------------------------------------------------

capacity monitor that provides the user with feedback on the argon gas cylinder pressure.

F. Intended Use / Indications for Use

The ConMed HelixAR ABC System is intended to deliver argon gas as well as high frequency electrical current for the cutting and/or coagulation of tissue.

G. Technological Characteristics

The modified HelixAR ABC System has similar technological characteristics as the predicate HelixAR ABC System cleared under K152860. Both systems include an electrosurgical generator used in conjunction with monopolar and bipolar handpieces and footswitches and an accessory cart. The HelixAR ABC System output panel provides receptacles for monopolar and bipolar hand- and foot-controlled devices. Footswitch receptacles for monopolar, bipolar, and ABC footswitches are provided on the accessory cart which also accommodates the use of a smoke evacuation system. The HelixAR ABC System provides Automatic Return Monitoring (ARM) for dual dispersive electrodes and includes the same visual and audible alerts as the predicate design. The HelixAR generator design includes the monopolar, bipolar, and ABC modes present in the predicate device. The modified HelixAR ABC System includes the following improvements:

Wireless footswitch re-pairing capability; —
-Improved flow control;
Enabling Pulse mode in the ABC® Flex minor mode; —
Updates to GUI, User Settings, and system start-up for improved user experience.

H. Performance Characteristics

Modifications to the HelixAR ABC System do not alter the safety or performance. Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the HelixAR ABC System are mitigated to an acceptable level. Design verification testing demonstrates the modified HelixAR ABC System complies with the electrical safety requirements of IEC 60601-1:2012 and IEC 60601-2-2:2009 and electromagnetic compatibility per IEC 60601-1-2:2007. Benchtop testing and software verification validation demonstrate the modified HelixAR ABC System meets design specifications.

-Substantial Equivalence

The differences between the predicate and modified device do not raise any new risks of safety or efficacy. Supporting information per this premarket submission confirms that the modified ConMed HelixAR ABC System is safe and effective for its intended use and is substantially equivalent in design, intended use, principals of operation, and technical characteristics to the CONMED HelixAR ABC System cleared under K152860.

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.