The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are intended for use in standard electrosurgical chucks and pencil type accessories wherever standard monopolar electrosurgical cutting and coagulation blade electrodes are used.

Device Description

The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are similar in design to the predicate devices. They weigh about 2 grams, and have an industry standard 0.0937-inch (2.38 mm) diameter x 0.825inch (22.22 mm) connector pin, with various tip lengths and configurations. They are made from a stainless steel metal alloy. Some models are available with a stick resistant coating. The transition point between the shaft and the tip has a protective plastic insulator sheath. Electrodes are packaged individually in sealed pouches, sold sterile, and intended for single use.

AI/ML Overview

This document describes the ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes, and not a device that would typically have acceptance criteria and a study proving those criteria in the same way an AI/ML powered device would. The core of this submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo performance metrics with a "study" in the modern sense.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set) are not applicable to this type of medical device submission.

However, I can extract the relevant information from the provided text regarding the device's performance and the methods used to demonstrate its safety and effectiveness.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance (Adapted for Electrosurgical Electrodes)

The "acceptance criteria" for this device are framed around demonstrating safety, effectiveness, and substantial equivalence to legally marketed predicate devices, rather than specific quantitative performance thresholds like accuracy or sensitivity for an AI algorithm.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness when used as intended.	"The performance evaluations indicate that the ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes met all of the performance requirements, consistently performed within their design parameters; and performed equivalently or superior to the predicate devices, thus demonstrating that they are safe and effective when used as intended."
Compliance with relevant industry standards: (e.g., ANSI/AAMI HF18-1993 for Electrosurgical devices, ANSI/AAMI 11137 for Radiation sterilization).	"The ITI Medical Technologies, Inc. Electrosurgical Electrodes have been designed to comply with, and are manufactured to pertinent parts of the following standards: ANSI/AAMI HF18-1993 Electrosurgical devices, and ANSI/AAMI 11137 Sterilization of health care products." Also complied with FDA 510(k) Guidelines.
Functional equivalence to predicate devices: (MegaDyne Medical Products, Inc. K903302 and Aaron Medical Industries. Inc. K913623) in terms of intended use, design, materials, and technological characteristics.	"The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are similar in design to the predicate devices." "The intended use is identical to that of the predicate devices." "incorporate no significant change in design, materials, energy source or other technological characteristics than those found in the predicate devices." "Comparison tests following written protocols were conducted using the ITI devices and the predicate devices. No findings of adverse effects or complications were reported in any of the tests."
No adverse effects or complications during comparison tests.	"No findings of adverse effects or complications were reported in any of the tests."

Study Details (Adapted for a 510(k) Electrosurgical Electrode Submission)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of "cases" or "patients" in the same way an AI study would. The comparison tests involved using the ITI devices and the predicate devices. It is implied that a sufficient number of devices were tested to draw conclusions, but numerical details are absent.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests were "conducted" in support of the 510(k) submission, likely in a controlled laboratory setting or in a pre-clinical manner, and are specific to the performance of the devices themselves rather than clinical data from human subjects in a population.
  - Retrospective/Prospective: Not applicable in the traditional sense for this type of device comparison test.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The "ground truth" here is the established performance characteristics and safety profile expected of electrosurgical electrodes, and compliance with standards. This is likely assessed by engineers and quality control personnel, potentially with clinical input on expected function, but not "experts" establishing a diagnosis in the way a medical image review would.
- Qualifications of Experts: Not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This type of device testing does not involve subjective human interpretation of outputs that would require adjudication in the typical sense of AI/ML performance evaluation. The "adjudication" is through objective performance measurements and compliance checks.
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:
- MRMC Study: No, an MRMC study was not done. This device is an electrosurgical electrode, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device. Its "performance" is inherently standalone in the sense that it performs its function (cutting and coagulation) without a human "algorithm" in the loop determining its output. Human practitioners use it, but they are not part of its "performance algorithm."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" is based on established engineering specifications, performance standards (e.g., ANSI/AAMI HF18-1993), and the documented performance characteristics of legally marketed predicate devices. This involves objective measurements of electrical properties, material properties, sterility, and functional performance (e.g., ability to cut/coagulate effectively without issues) in controlled environments.
The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device does not use machine learning, so there is no "training set."
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary

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ITI Medical Technologies, Inc.

2452 Armstrong Street Livermore, CA 94550 (510) 371-8305 FAX (510) 371-8222

K973234

SUMMARY OF SAFETY AND EFFECTIVENESS

August 25, 1997

Contact Person:	Roger W. Werne, Ph.D., President
Common or Usual Name:	Electrosurgical Electrode
Proprietary Name:	Midas Touch™ Electrosurgical Electrodes
Classification Name:	Unit, Electrosurgical and Coagulation with accessories21 CFR § 878.4400
Class and Panel:	Regulatory Class IIProduct Code: GEI General and Plastic Surgery 79
Predicate Devices:	MegaDyne Medical Products, Inc. K903302Aaron Medical Industries. Inc. K913623

The ITI Medical Technologies, Inc. Midas Touch™ Description of Device: Electrosurgical Electrodes are similar in design to the predicate devices. They weigh about 2 grams, and have an industry standard 0.0937-inch (2.38 mm) diameter x 0.825inch (22.22 mm) connector pin, with various tip lengths and configurations. They are made from a stainless steel metal alloy. Some models are available with a stick resistant coating. The transition point between the shaft and the tip has a protective plastic insulator sheath. Electrodes are packaged individually in sealed pouches, sold sterile, and intended for single use.

Statement of intended use: The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are intended for use in standard electrosurgical chucks and pencil type accessories wherever standard monopolar electrosurgical cutting and coagulation blade electrodes are used.

The intended use is identical to that of the predicate devices, i.e. a standard electrosurgical electrode to be used with most standard electrosurgical chucks and pencils by a trained medical practitioner. There are no differences in the devices concerning intended use or the safety or effectiveness when used as labeled.

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Statement of technological characteristics:

The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes incorporate no significant change in design, materials, energy source or other technological characteristics than those found in the predicate devices. Their form factors are similar to the predicate devices. They can be used with the same standard Electrosurgical units and accessories as the predicate devices.

The only difference between the Midas Touch™ electrodes and the predicate devices, other than minor configuration differences, is the type of blade coating on some models. The ITI blades are made from a stainless steel alloy with some models having ITI's own stick resistant coating as compared to the predicate devices: 1.) For MegaDyne Medical, stainless steel electrodes with a Teflon™ coating and, 2.) For Aaron Medical, stainless steel electrodes with a "high-tech polymer coating".

Special Controls: Although there are no performance standards established by the FDA for electrosurgical electrode devices, the ITI Medical Technologies, Inc. Electrosurgical Electrodes have been designed to comply with, and are manufactured to pertinent parts of the following standards:

ANSI/AAMI	American National Standard HF18-1993 Electrosurgical devices
ANSI/AAMI	American National Standard 11137 Sterilization of health careproducts – Requirements for validation and routine control –Radiation sterilization, Third edition.

In addition, the device and its development process also comply with pertinent parts of:

FDA, CDRH, ODE DGRD: October 19, 1993, 510(k) Guideline General Surgical . Electrosurgical Devices and;
FDA, CDRH, ODE DRAERD: August 16, 1995 510(k) Checklist for Endoscopic . Electrosurgical Unit (ESU) and Accessories used in Gastroenterology and Urology.

Data regarding special controls are summarized in the submission, and support the safety and efficacy of the device.

Comparison tests following written protocols were conducted using the ITI devices and the predicate devices. No findings of adverse effects or complications were reported in any of the tests.

The performance evaluations indicate that the ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes met all of the performance requirements, consistently performed within their design parameters; and performed equivalently or superior to the predicate devices, thus demonstrating that they are safe and effective when used as intended.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are abstract and created with thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Roger W. Werne, Ph.D. President ITI Medical Technologies, Inc. 2452 Armstrong Street Livermore, California 94550

OCT 2 7 1997

K973234 Trade Name: Midas Touch TM Electrosurgical Electrodes Regulatory Class: II Product Code: GEI .... Dated: August 25, 1997 Received: August 28, 1997

Dear Dr. Werne:

Re:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Roger W. Werne, Ph.D.

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

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ITI Medical Technologies, Inc. Electrosurgical Electrode PREFACE - Page 3 510(k) Premarket Notification

973234 510(k) Number (if known): _

Device Name: Midas Touch™ Electrosurgical Electrodes

Statement of intended use:

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

Prescription Use (Per 21 CFR 801.109)

Over - The - Counter - Use

(Optional Format 1-2-96)

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.