The TTI ThermoMed device delivers controlled localized current field (LCF) radio frequency (RF) heat to selectively destroy certain diseased tissue. RF energy is delivered to the dermal surface via a hand held wand with an autoclaveable energy applicator. For convenience, an audial and visual signal indicates the elapsed treatment time in 30-second intervals after the selected target temperature is reached.

AI/ML Overview

This document is a 510(k) summary for a Special 510(k) submission, which means it describes a modification to an already legally marketed device (the predicate device). Special 510(k)s typically do not involve new clinical studies for acceptance criteria, as the modification is usually considered to have no negative effects on safety or effectiveness. The core of this submission is a change in a temperature controller from analog to digital. Therefore, the provided information does not contain a study proving device performance against acceptance criteria in the way a new device submission would.

However, I can extract and infer information based on the typical content of a 510(k) and the provided text.

Here's an analysis based on the provided text, addressing your points where possible:

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

Based on the provided text, specific quantifiable acceptance criteria and reported device performance from a new study are not explicitly stated. This is because this is a Special 510(k) for a modification (changing an analog temperature controller to digital), and the statement mentions: "No negative effects on safety or effectiveness have been found after the risk analysis and risk mitigation process." This implies that the device is expected to maintain the performance of the predicate device, not necessarily meet new, specific numerical criteria through a separate study.

Inferred "Acceptance Criteria" (based on predicate device equivalence and risk analysis):

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Maintain safety profile of predicate device	No negative effects found after risk analysis and risk mitigation.
Maintain effectiveness for intended use (treatment of specified dermatological conditions)	No negative effects found after risk analysis and risk mitigation; predicates efficacy based on predicate device.
Digital temperature control functions as intended	Assessed through risk analysis and mitigation; no issues identified.
Device continues to deliver controlled localized current field (LCF) radio frequency (RF) heat	Assessed through risk analysis and mitigation; no issues identified.
Treatment indications (warts, molluscum, angioma, etc.) remain valid	Not impacted by the change in temperature controller.

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

Not applicable/Not provided. Since this is a Special 510(k) for a component change, a new test set with patient data for clinical performance evaluation is not typically required or mentioned. The assessment would likely involve engineering verification and validation of the new digital controller, potentially through bench testing rather than a clinical 'test set'.

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/Not provided. As there is no clinical test set for performance evaluation described, there's no mention of experts establishing ground truth for such a set.

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

Not applicable/Not provided. No clinical test set is described.

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 device is an electrosurgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This device is a physical electrosurgical instrument for direct treatment, not an algorithm.

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

Not applicable/Not provided for this modification. For the original predicate device, the ground truth for its effectiveness would have been established through clinical trials or accepted medical practice demonstrating the efficacy of localized current field RF heat for the listed dermatological conditions, likely involving clinical outcomes data (e.g., clearance of lesions, symptom improvement) and potentially pathology for confirmation of diagnosis in some cases. However, for this modification, no new ground truth determination is described.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

Not applicable. As above, no training set is relevant for this type of device modification.

Summary

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

MAY 0 2 2002

KO21117

510(k) Summary

1. Submitter name and address:
  Thermosurgery Technologies Inc. (formerly RDM International, Inc.) 2901 West Indian School Road Phoenix, AZ 85017-4162

Establishment registration:

Phone:

Contact person:

Date summary was prepared:

1. Trade name:
  Common name:

Classification name:

Product code / Regulation no .:

1. Predicate device:
  Product code / Regulation no.:
1. Description of device:
1. Intended Use:
Technological comparison: 6.
urgery
(formerly RDM International, Inc.)
2901 West Indian School Road
Phoenix, AZ 85017-4162

2027460

602-264-7300

Gene R. Hedin, CEO

March 15, 2002

TTI ThermoMed™ Model 1.8 Instrument

Localized current field radio frequency instrument

Device, Electrosurgical, Cutting and Coagulation Accessories, Class II GEI / 878.4400

K894166 - RDM Thermosurgery™ Localized Current Field RF Instrument GEI / 878.4400/ClassII

The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, fibroma, seborrheic keratoses, acrochordon, svringoma, hydrocystoma, clavus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis.

Treatment of patients with implanted electronic devices, patients with metallic implants and pregnant women is contraindicated.

This Special 510(k) device modification is submitted to provide notification of a change in the temperature controller from analog to digital control. No negative effects on safety or effectiveness have been found after the risk analysis and risk mitigation process. This change is rated as a "minor level of concern" per the May 1998 software quidance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

ood and Drug Administration 0 Corporate Boulevard Rockville MD 20850

Mr. Gene R. He

MAY 02 2002

Mr. Gene R. Hedin President and CEO. Thermosurgery Technologies, Inc. 2901 West Indian School Road Phoenix, AZ 85017-4162

Re: K021117

Trade/Device Name: TTI ThermoMed™ Model 1.8 Instrument Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 5, 2002 Received: April 8, 2002

Dear Mr. Hedin:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surved in the encreativent of the enactment date of the Medical Device Amendments, or to conniner or proc to The) 2017 - 11:55 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 I ou may) are se or visions of the Act include requirements for annual registration, listing 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 If your de rior is oldsined tontrols. 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 r head be a note 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 Of It Fat 607); accember (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. Gene R. Hedin

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 i 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" (21CFR 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,

Miriam C. Provost

for 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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Special 510(k): Device Modification TTI ThermoMed™ Model 1.8 Instrument

PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

(As required by ODE for all 510(k) received after Jan. 1, 1996.)

510(k) Number:

Kozilly

Device Name:

TTI ThermoMed™ Model 1.8 Instrument

Indications For Use:

The TTI ThermoMed™ Model 1.8 Instrument provides the therapeutic modality to treat the following benign diseases and conditions:

Warts 1.
Molluscum Contagiosum 2.
Anqioma 3.
Fibroma 4.
Seborrheic Keratoses ട.
Acrochordon 6.
Syringoma 7.
Hydrocystoma 8.
Clavus த.
Actinic Keratoses 10.
Keloids 11.
Epidermoid Cysts 12.
Cystic Acne 13.
Cutaneous Leishmaniasis 14.
Atypical Mycobacteria 15.
Dermatophytosis 16.

(Do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

/510(k) Number K021117

Prescription Use _ (Per 21 CFR 801.109) ਾ

Over-The-Counter Use

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.