This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is smooth surfaced, straight-walled, teat-ended, silicone lubricated condom with minimum length 160mm, maximum width 54mm, and minimum thickness of 30μm as required by ASTM Standard D3492.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a new condom product, OKAMOTO ULTRA THIN Male Natural Latex Condom. However, it does not contain a detailed study report with specific acceptance criteria, sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies as requested in the prompt.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and adherence to ASTM standards for condom manufacturing.

Here's a breakdown of what can be extracted and what information is missing based on your request:

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

The document states the device's design is in conformance with ASTM Standard D3492-03 Specification for Rubber Contraceptives (Male Condoms). While the specific acceptance criteria from this standard are not explicitly listed in the text, the document implies that the device performance meets these standards.

The key performance characteristic mentioned for the new device is:

Nominal thickness: 0.04 +/- 0.01 mm

For predicate devices, the nominal thickness was 0.05 +/- 0.01 mm.

Missing Information: The explicit breakdown of all acceptance criteria from ASTM Standard D3492-03 (e.g., burst pressure, freedom from holes, dimensions, etc.) and the precise reported performance values for each of these criteria for the OKAMOTO ULTRA THIN condom are not present in this document.

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

Missing Information: The document does not specify any sample size for a test set, nor does it describe data provenance (country of origin, retrospective/prospective). This type of detail would typically be found in a more comprehensive testing report.

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)

Missing Information: This information is not applicable and therefore not present. The device is a physical product (condom), and its performance is evaluated against engineering standards rather than expert-established ground truth like in medical imaging.

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

Missing Information: Not applicable. Performance testing for condoms against ASTM standards does not typically involve adjudication methods like those used for expert consensus in medical diagnostics.

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

Missing Information: This type of study is entirely irrelevant to a physical product like a condom and is therefore not present. It's a concept used for AI-assisted diagnostic tools.

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

Missing Information: This is also irrelevant to a physical product and is not present.

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

The "ground truth" for the device's performance would be the objective measurements taken on the condoms themselves against the specifications defined in ASTM Standard D3492-03. This standard outlines various tests (e.g., burst tests, visual inspections for holes,
dimensional measurements) and acceptable limits.

8. The sample size for the training set

Missing Information: This is not applicable to the development of a physical product like a condom. There is no "training set" in the context of an AI/algorithm. The "training" in manufacturing would relate to process control and quality assurance, not a dataset for an algorithm.

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

Missing Information: Not applicable for the reasons stated above.

In summary, the provided text is a regulatory submission for premarket clearance of a physical medical device (condom) and therefore does not contain the types of information (AI study data, expert consensus, MRMC studies) that would be relevant for software/AI-based diagnostic devices. The "study" referenced implicitly is the adherence to the ASTM standard for condom manufacturing and performance.

Summary

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2100 SUMMARY

MAR 3 1 2009 OKAMOTO U.S.A., INC. Submitted by: 18King Street Stratford, CT 06615 Phone: 203-378-0003 Mr. Jeffery N. Gibbs, Esq., Hyman Phelps & McNamara Contact Person: Ms. Jennifer Calderon, Okamoto USA., Inc. December 1, 2008 Date Prepared: OKAMOTO ULTRA THIN Proprietary Name: Male Latex Condom Common Nams Condom (21 CFR §884.5300) Classification Name: Predicate Device: BEYOND SEVEN®, CROWN® 1) Brand Name: OKAMOTO INDUSTRIES, INC. Company Name: 510(k) Document Control Number: K872812/A *Beyond Seven® and Crown® are under the same 510(k) Number. 2) Brand Name: KIMOTO MICRO THIN® SAGAMI RUBBER INDUSTRIES CO., LTD. Company Name: 510(k) Document Control Number: K946374

Description of the Device:

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane.

This device is smooth surfaced, straight-walled, teat-ended, silicone lubricated condom with minimum length 160mm, maximum width 54mm, and minimum thickness of 30μm as required by ASTM Standard D3492.

Intended Use of the Device:

The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).

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Reason for 510(k) submission:

The nominal thickness of the currently marketed product is 0.05+/-0.01mm. Recently the market is demanding thinner condoms, and therefore, we decided to submit a new 510(k) for thinner condoms with nominal thickness of 0.04+/-0.01 mm.

Technological Charactoristics:

The subject condom has the same technological characteristics as the prodicate condoms. The design of this condom is in conformance with ASTM Standard D3492-03 Specification for Rubber Contraceptives (Male Condoms) and the condoms are made of natural rubber latex. The comparison with the predicate condoms is provided in Exhibit #I .

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the bird's wing and body. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2009

Okamoto USA, Inc. c/o Jeffrey N. Gibbs, Esq. Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W. Suite 1200 WASHINGTON DC 20005

Re: K090259

Trade/Device Name: OKAMOTO ULTRA THIN Male Natural Latex Condom Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: January 30, 2009 Received: February 2, 2009

Dear Mr. Gibbs:

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.

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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number.

259

Device Name: OKAMOTO ULTRA THIN Male Natural-Latex Condom

Intended Use of the Devices

The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).

( 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 5801.109)

Over-The-Counter Use

Hess

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K0902-

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.