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The Invigra Condom is used for contraception and for prophylactic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.

Invigara Male Latex Condom, Lubricated and Black Colored

This document is a 510(k) clearance letter from the FDA for a medical device: "Invigra Male Latex Condom, Lubricated and Black Colored." As such, it does not describe a study involving an algorithm or AI. The document primarily confirms substantial equivalence to a predicate device and outlines regulatory requirements for condom labeling and manufacturing.

Therefore, many of the requested details about acceptance criteria, device performance, study design, expert involvement, and ground truth are not applicable to this type of regulatory document.

However, I can extract the following relevant information:

• Device Name: Invigra Male Natural Rubber Latex Condom
• Indications for Use: Contraception and prophylactic purposes (reducing the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis).
• Regulatory Class: Class II
• Product Code: 85 HIS
• Regulation Number: 21 CFR 884.5300 (Condom)

Regarding "Acceptance Criteria" and "Reported Device Performance":

For a condom, "acceptance criteria" and "device performance" are typically defined by performance standards that relate to physical properties like burst volume, burst pressure, tensile strength, and freedom from holes, rather than AI performance metrics like sensitivity or specificity. While these criteria are crucial for device approval, they are not detailed in this FDA clearance letter. The letter assumes compliance with these standards (e.g., through good manufacturing practices and required testing for expiration dating) but doesn't explicitly list them or report specific performance values.

Therefore, many parts of your request are not directly addressed by the provided document.

Here's how I would answer based on the provided text, indicating what is not applicable (N/A) or not provided (NP):

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

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

• N/A. This document refers to the regulatory clearance of a physical medical device (condom), not an AI/algorithm-based device. No specific "test set" for an algorithm is mentioned or required for this type of submission. Data provenance for performance testing (e.g., burst testing) would be part of the manufacturer's quality system but is not detailed in this 510(k) letter.

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)

• N/A. As above, this is for a physical device, not an AI. "Ground truth" for condom performance would be established through laboratory testing against recognized standards, not expert clinical interpretation.

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

• N/A. Not applicable for a physical device 510(k) submission.

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

• N/A. No AI or human reader component for this device.

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

• N/A. Not an algorithm.

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

• Ground Truth (for condom performance): Based on established international and national standards (e.g., ISO, ASTM, FDA guidance) for physical properties like burst volume, burst pressure, and freedom from holes. The document also specifically mentions "test data developed under the conditions specified in §801.435(d)" for expiration dating.
• Ground Truth (for substantial equivalence): The "ground truth" for regulatory clearance is the performance and safety profile of the legally marketed predicate device. The applicant (Indus Medicare Limited) demonstrated that their Invigra condom is "substantially equivalent" to this predicate.

8. The sample size for the training set

• N/A. No AI training set.

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

• N/A. No AI training set.

Ask a specific question about this device

The Invigra Condom is used for contraception and for prophylactic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.

Invigra - Male Natural Rubber Latex Condom

The provided document is an FDA 510(k) clearance letter for the INVIGRA Male Latex Condom and does not contain information on acceptance criteria for a device performance study nor a description of such a study. Instead, it confirms the device is substantially equivalent to legally marketed predicate devices.

The document refers to labeling requirements for latex condoms (21 CFR §884.5300 and 21 CFR §801.435) which include an expiration date supported by test data. However, the specific acceptance criteria for these tests, the study design, or the results are not detailed in this document.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence and post-market labeling requirements rather than a detailed performance study with acceptance criteria.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The Invigra Condom is used for contraception and for prophylactic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HTV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.

Invigra - Male Natural Rubber Latex Condom

This document is a marketing authorization letter from the FDA for a male latex condom. It does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it is a regulatory approval document rather than a study report. Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The Invigra Plus condom is used for contraception and for prophytic purposes. Invigra Plus Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphliss. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.

Invigra Plus (With Spermicidal Lubricant) - Male Natural Rubber Latex Condom

The provided document does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

The document is a US FDA 510(k) clearance letter for a medical device (Invigra Plus Brand Male Latex Condom with Spermicidal Lubricant). This letter indicates that the FDA has found the device to be "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

While 510(k) submissions typically include data to demonstrate substantial equivalence, this specific letter from the FDA does not report those data. It focuses on the regulatory decision and relevant general controls and labeling requirements.

Therefore, I cannot fulfill your request for:

1. Table of acceptance criteria and reported device performance: This information is not in the document.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth establishment for a study: All of this information pertains to device performance studies, which are not detailed in this FDA clearance letter.

The document only provides:

• Device Name: Invigra Plus (With Spermicidal Lubricant) - Male Natural Rubber Latex Condom
• Indications for Use: Used for contraception and for prophylactic purposes, highly effective against pregnancy, and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. Also states, "No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used."

To get the information you are looking for, you would need to access the original 510(k) submission (K992438) filed by INDUS Medicare LTD, where they would have presented the data demonstrating equivalence to predicate devices and adherence to relevant standards. That submission would contain the details of the testing performed.

Ask a specific question about this device

The Invigra Condom is used for contraception and for prophytic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphliss. contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The text is a letter from the FDA regarding the 510(k) clearance of the INVIGRA Male Latex Condom and discusses regulatory aspects, labeling requirements, and indications for use, but it does not detail specific performance acceptance criteria or study results.

Ask a specific question about this device