The Remed Preventor Strawberry Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Strawberry Tutti Frutti condom is a parallel sided, plain surfaced condom with strawberry flavor and no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.

Device Description

AI/ML Overview

While this document describes a 510(k) clearance for a natural rubber latex condom, it does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance in the context of an AI/algorithm-based medical device.

The document is a clearance letter from the FDA for a medical device (condom). It states the device is substantially equivalent to legally marketed predicate devices for contraception and prevention of sexually transmitted diseases. It references general controls and regulations but does not include specific performance studies or acceptance criteria for that type of device, which typically involve different testing methodologies than those for AI algorithms.

Therefore, I cannot provide the requested table or information regarding:

A table of acceptance criteria and the reported device performance: This document doesn't provide specific quantitative acceptance criteria or detailed performance results in the way an AI study would (e.g., sensitivity, specificity thresholds).
Sample size used for the test set and the data provenance: Not applicable to this type of device clearance document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic device.
Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used: Not applicable in the context of an AI algorithm.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

To answer your request, I would need a document detailing the clinical validation or performance study of an AI/algorithm-based medical device, not a 510(k) clearance letter for a non-AI physical medical device.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2000

Remed Pharma c/o E. J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114

Dear Mr. Smith:

Re: K993403 Remed Pharma Strawberry Male Tutti Frutti Natural Rubber Latex Condom Dated: July 10, 2000 Received: July 11, 2000 Requiatory Class: II. 21 CFR 884.5300/Procode: 85 HIS

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 1975, 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 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Oode 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 Requlation (QS) 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 device in the Federal Recister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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 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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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INDICATION FOR USE STATEMENT

510(K) Number (if known): K993403

Device Name: Remed Pharma Male Strawberry Tutti Frutti Natural Rubber Latex Condom

Indications for Use:

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

Prescription Use

Over-the-Counter Use X

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.