(284 days)
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:
- 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.
- Sample size used for the test set and the data provenance: Not present.
- 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.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not present or applicable to this type of device clearance document.
- 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.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (this is not an AI/ML device).
- 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.
§ 884.5310 Condom with spermicidal lubricant.
(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).