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510(k) Data Aggregation
(130 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with 21 CFR 801.435 for expiration dating. | Not explicitly reported in this letter, but compliance is required. |
| Supported by test data developed under 801.435(d). | Not explicitly reported in this letter, but data must be maintained by the manufacturer. |
| Shelf life not more than five years. | Not explicitly reported; if real-time data fails to confirm estimated shelf life, relabeling is required. |
| For spermicidal condoms, shelf life of spermicide compared to condom shelf life and labeled accordingly. | Not applicable, as this device's indication does not mention spermicide. |
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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