A condom with a spermicidal lubricant is a sheath which covers the penis with a closely fitted membrane with a lubricant that contains a spermicidal agent, nonoxynol-9.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, specifically Royale® Brand Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical studies in the same way a Premarket Approval (PMA) would. Therefore, the information typically requested in your prompt regarding detailed study designs, expert panels, and specific effect sizes is largely not applicable in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with established voluntary standards and internal testing specifications for condoms. The performance is reported as meeting these specifications.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Physical Testing	ASTM-D-3492-96	Conformed to required specifications
	ISO 4074, Part 1 & Part 6	Conformed to required specifications
Air Inflation Testing	Not explicitly stated (implied by general testing)	Conformed to required specifications
Color Fastness Testing	Not explicitly stated (implied by general testing)	Conformed to required specifications
Biocompatibility	May 1, 1995 FDA Biocompatibility Guidance, FDA Modified Matrix of ISO-10893	Biocompatibility testing revealed no new questions of safety or effectiveness.
Shelf-Life	5 years	Supported by real-time testing data.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify the exact sample sizes used for the various physical and biocompatibility tests. It only states that "All physical testing, air inflation testing and color fastness testing, including all other in-process, and final release testing, revealed results that conformed to the required specifications."
Data Provenance: The data provenance is internal to the manufacturer (G. Premjee (USA) Inc.) and is likely from laboratory testing performed on their product. The country of origin for the data is not explicitly stated. The testing would have been retrospective in the sense that it was performed on samples of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For this type of device and submission, "ground truth" is not established by expert consensus on clinical findings (e.g., radiology reads). Instead, it's based on objective measurements against established engineering and material standards (ASTM, ISO). The "experts" involved would be the testing engineers and quality control personnel within the manufacturing process who conducted the standardized tests. Their qualifications would typically involve expertise in materials science, quality assurance, and relevant testing methodologies, but specific details are not provided.

4. Adjudication method for the test set

Not Applicable. Since "ground truth" is not established by human interpretation or clinical outcomes, an adjudication method for conflicting interpretations is not relevant. Pass/fail criteria are defined by the adherence to the numerical or qualitative specifications of the standards (e.g., burst pressure, freedom from holes, biocompatibility assay results).

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 a condom, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related comparative effectiveness analysis is entirely irrelevant.

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

Not Applicable. As stated above, this is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective measurements against established performance standards and specifications (e.g., ASTM-D-3492-96, ISO 4074, biocompatibility guidelines). For example, a condom either passes or fails a water leak test, or its burst volume and pressure meet or do not meet the specified minimums. It also relies on the composition of the device being identical or highly similar to a predicate device for determining substantial equivalence.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which is not what this submission is about. The manufacturer produces condoms and tests them against pre-defined standards.

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

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

Summary

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EXHIBIT #1 2 Pages

OCT 22 1997

Pi92
K972836

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is: _______________________________________________________________________________________________________________________________________________

Submitter's Identification: 1.

G. Premiee (USA) Inc. 304 B East Lawrence Blvd. Avondale, Arizona 85323

Date Summary Prepared: July 28, 1997

2. Name of the Device:

Royale ® Brand Latex Condoms - Spermicidal Lubricant - Colored and Assorted Colors

3. Predicate Device Information:

Suretex Ltd., K#942858A, Latex condoms with Spermicidal Lubricant Sime Health Ltd., K#932982, Spermicidal Lubricated Condoms (Essential ™, Mi Vida™ and Jiffi™).

4. Device Description:

A condom with a spermicidal lubricant is a sheath which covers the penis with a closely fitted membrane with a lubricant that contains a spermicidal agent, nonoxynol-9.

5. - Intended Use:

The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal diseases).

દ. Comparison to Predicate Devices:

The Royale ® Brand Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors, is identical in all aspects to the Suretex Ltd. Latex Condoms with Spermicidal Lubricant and similar in design, composition (latex) and function to the Sime Health Ltd. Spermicidal Lubricated Condoms.

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The following voluntary standards were adhered to and their device was tested in accordance with all requirements of these standards.

a. ASTM-D-3492-96
ISO 4074, Part 1 and Part 6 b.
May 1, 1995 FDA Biocompatibility Guidance, FDA Modified C. Matrix of ISO-10893

All physical testing, air inflation testing and color fastness testing, including all other in-process, and final release testing, revealed results that conformed to the required specifications. In addition, a shelf-life of 5 years is claimed, with real-time testing data to support such claim.

1. Discussion of Clinical Tests Performed:
  Not Applicable

9. Conclusions:

The Royale ® Brand Latex Condoms- Spermicidal Lubricant - Colored and Assorted Colors - has the same intended use and similar technological characteristics as the Sime Heath Ltd. Condom and identical technological characteristics as the Suretex Ltd. Condom. All non-clinical testing and biocompatibility testing revealed no new questions of safety or effectiveness. Thus, when compared to the predicate devices, the Royale ® Brand Latex Condoms - Spermicidal Lubricant - Colored and Assorted Colors did not incorporate any significant changes in intended use, method of operations, material, or design that could affect safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, which is a traditional symbol of medicine, with a staff entwined by two snakes and topped with wings. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 1997

G. Premjee (USA), Inc. c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Boulevard, Suite 410 Great Neck, New York 11021

Re: K972836

Royale® Brand Latex Condoms - Spermicidal Lubricant Colored or Assorted Colors Dated: July 28, 1997 Received: July 31, 1997 Regulatory class: II 21 CFR §884.5310/Product code: 85 LTZ

Dear Ms. Goldstein-Falk:

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 ise 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, 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 misbrantion.

If your device is classified (see above) into either class II (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 Register. 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 vitts diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (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,

Wiliam Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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EXHIBIT B

510(%) Number (if known):

1972836

Royale ® Brand Latex Condoms -Spermicidal Lubricant Colored -Device Name: or Assorted Colors

Indications For Use:

The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal disease).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF HEEDED)

Concentence of CDRH, Office of Device Evaluation (ODE)

Robert D. Natting

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K972836

Prescription Use (Per 21 CFR 801-109)

Over-The-Counter Use

(Options) Forced 1-2-96)

Regulation Number and Section

§ 884.5310 Condom with spermicidal lubricant.

(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).