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Condoms are latex sheaths, intended to completely cover the penis during sexual intercourse for contraception and prophylaxis, an aid to the prevention of sexually transmitted diseases (STDs). If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.

Caution Condoms - Male latex condoms lubricated, with and without Nonoxynol-9

This document is a 510(k) clearance letter for "Caution Condoms - Male latex condoms, lubricated, with and without Nonoxynol-9." It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or performance evaluation document for a diagnostic or AI-based device.

The letter confirms that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device's indications for use and general controls, rather than a specific performance study against defined acceptance criteria in the manner requested.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and performance study details from this document. The document primarily concerns regulatory clearance for a medical device (condoms) based on substantial equivalence, not a detailed performance study with specific metrics, sample sizes, or ground truth establishment relevant to the provided questions.

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The Double Springers Nonoxynol 9 condom, is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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The provided text is a letter from the FDA to Medtech Products Limited regarding the substantial equivalence of their "Double Springers Nonoxynol 9 Lubricated Condom." This document is an FDA clearance letter and does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it meets the regulatory requirements for marketing. However, it does not describe the specific performance characteristics or the studies conducted to demonstrate those characteristics.

Therefore, I cannot provide the requested table and study details based on the given input.

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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.

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These multiple-brand condoms are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases and HIV (AIDS).

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Based on the provided document, which is an FDA 510(k) clearance letter for the HardCover Condoms™ Male Latex Condoms, there is no information available regarding acceptance criteria, device performance studies, or the methodologies used to establish ground truth.

The document is a regulatory approval letter, confirming that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA has determined that the new device is as safe and effective as a legally marketed device and does not require a new Premarket Approval (PMA) application.

The letter explicitly states: "Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA." This indicates that while design and performance testing were conducted by the manufacturer, the detailed results and methodologies are not part of this public clearance letter.

Therefore, I cannot provide the requested information for the following points as they are not contained within the provided text:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sized used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
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 present (and not applicable as this is not an AI/software device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present (and not applicable as this is not an AI/software device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The only performance-related requirement mentioned in the document is about expiration dating for latex condoms and spermicidal lubricant shelf life, which must be "supported by test data developed under the conditions specified in 801.435(d)". However, the specifics of these tests and their acceptance criteria are not detailed in this letter.

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THESE DIFFERENT TYPES (NATURAL ORDINARY, NATURAL RIBBED, NATURAL DOTTED, AND NATURAL CONTOURED) OF NATURAL LATEX RUBBER CONDON (WITH NONOXYNOL-9) ARE USED FOR CONTRACEPTION AND FOR PROPHYLACTIC PURPOSES (TO PREVENT PREGNANCY AND THE TRANSMISSION OF SEXUALLY TRANSMITTED DISEASES (STD'S).

Natural Ordinary, Natural Ribbed, Natural Dotted and Natural Contoured (Multiple-Brand Male Latex Condom, Lubricated with Nonoxynol-9)

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria for the Natural Ordinary, Natural Ribbed, Natural Dotted, and Natural Contoured (Multiple-Brand Male Latex Condom, Lubricated with Nonoxynol-9).

The document is a 510(k) substantial equivalence letter from the FDA, addressing a correction to a previous letter and outlining regulatory requirements for the device. While it mentions the need for expiration dating supported by test data according to 21 CFR 801.435, it explicitly states: "Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA."

Therefore, I cannot provide the requested information from this document.

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The intended use of these latex coloured condoms with spermicidal lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)

Colored Latex Condom with Spermicidal Lubricant (Maxima, Trustex, Ria, Premium and, EL LES Condoms)

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Colored Latex Condom with Spermicidal Lubricant (Maxima, Trustex, Ria, Premium and, EL LES Condoms)".

This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance studies.

The letter explicitly states:

• "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..."
• It also mentions requirements for "Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435," and the need for "test data developed under the conditions specified in 801.435(d)" to support expiration dates. However, it clarifies that "Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA."

Therefore, based solely on the provided text, I cannot extract the requested information:

1. A table of acceptance criteria and the reported device performance: Not present. The letter does not describe specific performance metrics for the condom, only that it is substantially equivalent to predicates.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as no test set data is provided.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not present or applicable to this type of device clearance document.
6. Standalone performance study: The letter refers to "test data developed under the conditions specified in 801.435(d)" for expiration dating, but the details of this study (if it can be considered a standalone performance study in the context of device function beyond shelf-life) are not included.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (this is not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable (this is not an AI/ML device).

The letter merely grants clearance based on substantial equivalence to predicate devices and outlines ongoing regulatory compliance requirements for labeling and manufacturing. It does not disclose the technical performance data that would typically be used to demonstrate meeting acceptance criteria for a novel device.

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