This document, a 510(k) summary, does not contain the information requested about acceptance criteria and a study proving a device meets those criteria.

The provided text is a summary prepared for the FDA's 510(k) premarket notification process for the WARTNER® Wart Removal System. Its primary purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present detailed performance study results against specific acceptance criteria.

Therefore, I cannot extract the following information from the given text:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
If a standalone performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

The document focuses on:

Contact information of the submitter.
Device name.
Predicate devices used for comparison.
The FDA's letter granting substantial equivalence.
The intended indications for use.

These elements are standard for a 510(k) summary and do not delve into the specifics of performance studies as you've requested.

Summary

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Wartner USA b.v.

WARTNER® Wart Removal System - Plantar Warts Indication

510(k) Summary

1. Submitter's Name, Address and Contact Person

Submitter	Contact Person
Wartner USA b.v.	Nancy Lum-Wilson
World Trade Center	N. Wilson Consulting Inc.
Beursplein 37 (Room 405)	65 Ava Crescent
The Netherlands	Richmond Hill, Ontario
	CANADA L4B 2X5
Telephone: +31 10 405 6406	Telephone: 905-884-7855
Facsimile: +31 10 405 5027	Facsimile: 905-508-8599

Date Summary Prepared: June 30, 2003

2. Name of Device

WARTNER® Wart Removal System (for OTC use)

3. Name of Predicate Device(s)

Wartner® Wart Removal System for OTC use, by Wartner Medical Products . (Primary Predicate)
Histofreezer® Portable Cryosurgical System, by Orasure Technologies Inc. . KC? 2499 (Labeling predicate)
Tinamed® Plantar Patch, by Stiefel laboratories, Inc. (Labeling predicate) .
DuoFilm® Salicylic Acid Wart Remover indicated for common warts and plantar . warts, by Schering-Plough HealthCare Products, Inc. (Labeling predicate)
Clear Away® System Planiar Wart Remover for Feet, by Schering-Plough . HealthCare Products, Inc. (Labeling predicate)
Wartner Pro®, by Wartner Medical Products (Labeling predicate) ●

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird, with three curved lines forming the body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2003

Wartner USA b.v. c/o Ms. Nancy Lum-Wilson N. Wilson Consulting, Inc. 65 Ava Crescent Richmond Hill, Ontario Canada L4B 2X5

Re: K032271

Trade/Device Name: WARTNER® Wart Removal System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: July 18, 2003 Received: July 23, 2003

Dear Ms. Lum-Wilson:

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.

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 - Ms. Nancy Lum-Wilson

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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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Wartner USA b.v. WARTNER® Wart Removal System - Plantar Warts Indication

STATEMENT OF INDICATIONS FOR USE

K032271 510(k) Number:

WARTNER® Wart Removal System Device Name:

Indications for Use: WARTNER® Wart Removal System is indicated for the over-the-counter treatment of common warts and plantar warts.

Miriam C. Provost

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

510(k) Number K032271

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 878.4350 Cryosurgical unit and accessories.

(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.