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The Remed Preventor Strawberry Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Strawberry Tutti Frutti condom is a parallel sided, plain surfaced condom with strawberry flavor and no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.

The Remed Preventor Strawberry Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Strawberry Tutti Frutti condom is a parallel sided, plain surfaced condom with strawberry flavor and no color additives.

While this document describes a 510(k) clearance for a natural rubber latex condom, it does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance in the context of an AI/algorithm-based medical device.

The document is a clearance letter from the FDA for a medical device (condom). It states the device is substantially equivalent to legally marketed predicate devices for contraception and prevention of sexually transmitted diseases. It references general controls and regulations but does not include specific performance studies or acceptance criteria for that type of device, which typically involve different testing methodologies than those for AI algorithms.

Therefore, I cannot provide the requested table or information regarding:

1. A table of acceptance criteria and the reported device performance: This document doesn't provide specific quantitative acceptance criteria or detailed performance results in the way an AI study would (e.g., sensitivity, specificity thresholds).
2. Sample size used for the test set and the data provenance: Not applicable to this type of device clearance document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic device.
6. Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable in the context of an AI algorithm.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

To answer your request, I would need a document detailing the clinical validation or performance study of an AI/algorithm-based medical device, not a 510(k) clearance letter for a non-AI physical medical device.

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The Remed Preventor Coconut Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Coconut Tutti Frutti condom is a parallel sided, plain surfaced condom with coconut flavor and no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.

The Remed Preventor Coconut Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Coconut Tutti Frutti condom is a parallel sided, plain surfaced condom with coconut flavor and no color additives.

This document is a 510(k) clearance letter from the FDA for a condom, and it does not contain the specific information required to answer the questions about acceptance criteria and a detailed study.

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

To answer your questions, I would need access to a study report or a different type of FDA submission that details the performance data and acceptance criteria for a medical device. This document primarily confirms that the device is substantially equivalent to a predicate device, allowing it to be marketed.

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The Remed Preventor Banana Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Banana Tutti Frutti condom is a parallel sided, plain surfaced condom with banana flavor and no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.

The Remed Preventor Banana Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Banana Tutti Frutti condom is a parallel sided, plain surfaced condom with banana flavor and no color additives.

The provided documents are regulatory approval letters and indication for use statements for "Remed Pharma Male Coconut Tutti Frutti Natural Rubber Latex Condom" and "Remed Pharma Male Banana Tutti Frutti Natural Rubber Latex Condom." They do not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for a medical device's performance.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details to prove the device meets them from the provided text. The documents indicate the devices are substantially equivalent to previously marketed predicate devices and thus permitted to proceed to market under general controls. There is no mention of specific performance studies or their associated metrics.

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The Remed Preventor Double Whooper Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Double Whooper Condom has a ribbed and dotted surfaced, contoured shape with reservoir end, it is used for contraception and to help prevent the transmission of sexually transmitted diseases.

The Remed Preventor Double Whooper Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Double Whooper Condom has a ribbed and dotted surfaced, contoured shape with reservoir end.

This is a 510(k) clearance letter from the FDA for a condom. It does not contain the information requested about acceptance criteria and study details for a medical device's performance. The document 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 based on the provided text.

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The Remed Preventor Dotted Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Dotted condom is a dotted surfaced condom with no color additives, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.

Remed Pharma Male Dotted Condom is a dotted surfaced condom with no color additives.

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Remed Pharma Male Dotted Rubber Latex Condom." This document primarily addresses regulatory aspects of the device's clearance based on substantial equivalence to a predicate device.

Crucially, the document DOES NOT contain information regarding acceptance criteria, study details (like sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment relevant to the performance of the condom as a medical device for its stated indications (contraception and STD prevention).

The letter states: "We have reviewed your Section 510(k) notification... and we 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..."

This means the device was cleared because it was shown to be "substantially equivalent" to an already legally marketed device, not through a prospective clinical study proving its performance against new, specific acceptance criteria set for this particular device. The FDA essentially determined that because it's similar enough to an existing, safe, and effective device, it doesn't need to undergo new, extensive clinical trials defining performance metrics.

Therefore, I cannot fulfill the request for a table of acceptance criteria, study details, sample sizes, expert qualifications, or ground truth information based on the provided text. The document focuses on regulatory compliance and substantial equivalence, not a detailed performance study as would be required for novel devices or those undergoing a PMA pathway.

The only "acceptance criteria" mentioned indirectly pertains to labeling requirements for latex condoms (21 CFR 801.435) regarding expiration dating, which is a post-market requirement for all latex condoms, not a performance criterion for initial clearance based on a study presented in the 510(k).

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The Remed Preventor Classic Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Classic is a parallel sided, plain surfaced condom with no color additives, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.

The Remed Preventor Classic Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Classic is a parallel sided, plain surfaced condom with no color additives.

This document is an FDA 510(k) clearance letter for three brands of male natural rubber latex condoms manufactured by Remed Pharma. It is not a study report or a technical document detailing acceptance criteria and performance data for a medical device in the way you've outlined.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) because this document does not contain that level of detail. It is a regulatory approval letter based on a submission that would have contained such data, but the data itself is not present in this letter.

The letter primarily focuses on:

• Confirming the device is substantially equivalent to legally marketed predicate devices.
• Regulatory classification (Class II).
• General controls and specific regulations applicable to the device (e.g., GMP, labeling requirements for expiration dating).
• The intended use of the device itself (contraception and prevention of STDs).

To answer your questions, one would need the actual 510(k) submission and the test reports referenced within, not just the FDA's clearance letter.

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The Remed Preventor Ribbed Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Ribbed condom is a ribbed surfaced condom with no color additives, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.

The Remed Preventor Ribbed Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Ribbed condom is a ribbed surfaced condom with no color additives.

The provided document is an FDA 510(k) clearance letter for the "Remed Pharma Male Ribbed Rubber Latex Condom." This type of document declares a device substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

Crucially, this document is not a study report or clinical trial summary. Therefore, it does not contain the detailed information needed to answer many of the questions about acceptance criteria, study design, sample size, ground truth, or expert qualifications. The FDA clearance is based on the claim of substantial equivalence to a predicate device, meaning it's assumed to perform similarly to what's already on the market, rather than requiring a detailed new performance study as would be the case for a novel device or a Premarket Approval (PMA) application.

However, I can extract what is explicitly stated or can be reasonably inferred from the document:

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

The document does not provide a table of acceptance criteria or specific reported device performance data in the format typically found in a study report. It acknowledges the device as a "Male Ribbed Rubber Latex Condom" and states its intended uses for "contraception and to help prevent the transmission of sexually transmitted diseases."

The only performance-related requirement mentioned is regarding expiration dating:

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

Not provided. This document is a regulatory clearance letter, not a study report. The FDA's 510(k) process for substantial equivalence typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new large-scale clinical trials or specific sample sizes for "test sets" in the manner of an AI/ML device study.

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):

Not applicable/Not provided. The concept of "ground truth" established by experts for a test set (as in an AI/ML context) is not relevant to this 510(k) clearance for a condom.

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

Not applicable/Not provided.

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/Not provided. This is relevant for AI/ML device evaluations, not for a condom.

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

Not applicable/Not provided.

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

Not applicable/Not provided in the context of typical clinical study ground truth. For a condom, "ground truth" regarding its effectiveness would typically relate to physical properties, barrier integrity, and contraceptive/disease prevention efficacy established through standardized testing methods, not expert consensus on image interpretation or pathology. The letter mentions that expiration dates must be "supported by test data," implying physical integrity and efficacy over time, but details of these tests are not provided.

8. The sample size for the training set:

Not applicable/Not provided. This is an AI/ML concept.

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

Not applicable/Not provided. This is an AI/ML concept.

In summary, the provided document is a regulatory approval, not a scientific study report. It confirms that the device is "substantially equivalent" to existing devices but does not detail the specific performance studies, sample sizes, or ground truth methodologies that would be pertinent to a comprehensive evaluation of an AI-powered medical device. The only "acceptance criteria" discussed relate to regulatory compliance, particularly regarding labeling and expiration dating based on pre-existing regulations.

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The Remed Preventor Extra Strength Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Extra Strength condom is a parallel sided, extra strong, plain surfaced condom with no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.

The Remed Preventor Extra Strength Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Extra Strength condom is a parallel sided, extra strong, plain surfaced condom with no color additives.

The provided document is an FDA 510(k) clearance letter for a medical device: Remed Pharma Male Latex Condom (Extra Strength). It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered medical device. This letter is for a traditional medical device (condom) and primarily addresses regulatory clearance based on substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information based on the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study, or effect size with AI assistance.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

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The Remed Preventor Super Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Super Condom has a ribbed and dotted surfaced, contoured shape with reservoir end, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.

The Remed Preventor Super Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Super Condom has a ribbed and dotted surfaced, contoured shape with reservoir end.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for the "Remed Pharma Male Super Duper Rubber Latex Condom," which primarily discusses regulatory aspects, substantial equivalence to predicate devices, and labeling requirements for the product.

Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details about any study performed to demonstrate device performance. This includes information about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.
• The type of ground truth used.

The letter references relevant regulations and historical information for the product category but does not include the technical performance data or study methodology that would typically be part of a 510(k) submission itself. This letter is the FDA's decision based on a review of such a submission, not the submission itself.

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