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The Ansell or private label black condom is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condom should be applied before any such contact.

This condom is a male contraceptive and prophylactic device which is fabricated of a natural rubber latex. The condom is designed as a fitted sheath with an integral ring at the open end and a reservoir at the closed end to contain semen. This condom is designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074, and EN 600.

The provided document is a 510(k) Pre-market Notification for a latex condom, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its effectiveness against a set of acceptance criteria in the way medical diagnostic or AI-driven devices typically would.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, experts, adjudication methods, multi-reader studies, and ground truth types is not explicitly detailed within this regulatory submission.

However, I can extract the information related to conformance with required specifications and physical testing which implies a form of acceptance criteria and performance evaluation.

Here's an attempt to answer your request based on the available information, noting the absence of detail for many of your points:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria (Implied)	Reported Device Performance
   Conformance to ASTM D3492 standards	"revealed results in conformance with required specifications"
   Conformance to ISO 4074 standards	"revealed results in conformance with required specifications"
   Conformance to EN 600 standards	"revealed results in conformance with required specifications"
   Biocompatibility: Not toxic (local or systemic)	"The condom is not toxic (local or systemic)"
   Biocompatibility: Not sensitizing	"not sensitizing"
   Biocompatibility: Not locally irritating	"not locally irritating"
   Biocompatibility: Not otherwise harmful	"not otherwise harmful"
   Colorfastness	"revealed results in conformance with required specifications"
   Air inflation testing	"revealed results in conformance with required specifications"
   Other in-process and final release testing (physical properties)	"revealed results in conformance with required specifications"

2. Sample sizes used for the test set and the data provenance: Not explicitly stated. The document mentions "All physical testing, air inflation testing, colorfastness testing, including other in-process and final release testing." The provenance would be from manufacturing batches of the device, likely from India where the manufacturer is located. It is an intrinsic part of the manufacturing quality control process, not a separate clinical "test set" in the sense of a diagnostic device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for condom performance in this context refers to adherence to international and national standards for physical properties and biocompatibility. This is assessed through laboratory testing, not expert interpretation of results.

4. Adjudication method for the test set: Not applicable. Laboratory testing against predefined standards does not typically involve adjudication in the expert consensus sense.

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 physical product (condom), not an AI-driven diagnostic tool or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical device like a condom.

7. The type of ground truth used:

   • External Standards: ASTM D3492, ISO 4074, and EN 600 for physical properties.
   • Biocompatibility Standards: Methods of ISO 10993 Biological Evaluation of Medical Devices and ODE Guidance Memorandum G95-1 (for 24 hours or less contact with skin/mucosal membrane).

8. The sample size for the training set: Not applicable. There is no "training set" in the context of a physical product's regulatory submission for demonstrating substantial equivalence. All testing mentioned relates to quality control and final product verification against established standards.

9. How the ground truth for the training set was established: Not applicable.

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

A condom with silicone lubricant is a sheath which covers the penis with a closely fitted membrane

The provided text describes a 510(k) submission for latex condoms and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth, or AI/MRMC specific information.

The document is a traditional 510(k) summary for a physical medical device (condoms), comparing it to predicate devices based on adherence to voluntary standards and physical testing, and explicitly states "Discussion of clinical tests performed: Not applicable."

As such, I cannot provide a table of acceptance criteria and device performance in the context of an AI/ML device, nor address sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC/standalone study details.

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

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.

The provided text describes a 510(k) premarket notification for Latex Condoms - Spermicidal Lubricant - Natural and assorted colors (Royale brand or private label). This document focuses on demonstrating substantial equivalence to predicate devices based on adherence to voluntary standards and physical testing, rather than a clinical study involving human participants or AI algorithms.

Therefore, many of the requested categories related to clinical study design, AI performance, expert ground truth, and reader studies are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test. The document refers to "all physical testing" and "all other in-process, and final release testing," implying a comprehensive testing regimen rather than a specific test set sample size.
• Data Provenance: Not explicitly stated. The testing was conducted by Suretex Prophylactics (India) Limited, so the data would originate from their facilities. The document states "real-time testing data to support such claim" for shelf life, indicating prospective data collection for that specific criterion.

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

• Not Applicable. This submission is based on adherence to engineering standards and physical/material testing, not on clinical interpretation or expert ground truth for diagnostic accuracy.

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

• Not Applicable. No expert adjudication was relevant for the type of testing performed. Results were compared against established engineering and material specifications.

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 submission is for a medical device (condoms) and does not involve AI or human readers for interpretation.

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

• Not Applicable. This submission is for a physical medical device and does not involve an algorithm.

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

• Engineering and Material Specifications: The "ground truth" for the acceptance criteria was defined by internationally recognized standards (ASTM D3492-96, ISO 4074 parts 1 & 6) and FDA guidance (biocompatibility). For shelf life, it was "real-time testing data."

8. The sample size for the training set:

• Not Applicable. This submission does not involve a training set as it pertains to physical device testing, not machine learning or AI.

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

• Not Applicable. This submission does not involve a training set.

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