(361 days)
The intended use of these latex coloured condoms with flavour lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)
Natural and Colored Lubricated Latex Condoms with Flavors (Maxima, Trustex, Ria, Premium and EL LES)
This document is a 510(k) clearance letter from the FDA for several brands of colored latex condoms with flavored lubricant. As such, it does not contain the kind of detailed information about acceptance criteria and a study proving a device meets them that one would find for a more complex medical device, especially software or AI-driven diagnostic tools.
This letter is primarily concerned with establishing "substantial equivalence" to a predicate device already on the market. The key "test" mentioned is compliance with existing regulations for latex condoms, particularly regarding labeling and expiration dating.
Therefore, many of your requested points cannot be answered from the provided text.
Here's an attempt to answer based on the information available, and highlighting what is not present:
Description of Acceptance Criteria and the Study:
The primary "acceptance criteria" discussed are regulatory compliance and substantial equivalence to legally marketed predicate devices. The "study" referenced implicitly is the manufacturer's internal testing to support shelf-life claims for expiration dating, which is not detailed in this document but is required to be maintained by the manufacturer for FDA inspection.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|
| Substantial Equivalence to legally marketed predicate devices | The FDA has "determined the device is substantially equivalent... to legally marketed predicate devices." |
| Compliance with 21 CFR 884.5300 (Latex Condoms) and 884.5310 (Spermicidal Condoms) | Implied as met for clearance. |
| Compliance with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435 | The letter states that "labeling for latex condoms... must comply" with this regulation, and an "expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly." The manufacturer must "maintain this data and that it be available for inspection by FDA." The FDA assumes compliance with Current Good Manufacturing Practice requirements (21 CFR Part 820). The letter does not explicitly state that the company provided this data in the 510(k) submission, only that it must maintain it. |
| Compliance with Current Good Manufacturing Practice (GMP) requirements (21 CFR Part 820) | "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements... and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions." |
| Indications for Use as stated | Stated as: "The intended use of these latex coloured condoms with flavour lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)" The FDA's clearance refers to these stated indications. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document. The document refers to "test data developed under the conditions specified in 801.435(d)" for expiration dating, but no specifics on sample size, data provenance, or study design are given. This data is to be maintained by the manufacturer, not necessarily submitted with the 510(k). The device manufacturer is LS Rubber SDN.BHD., located in Malaysia.
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. This type of information would be relevant for devices involving expert assessment or diagnostic accuracy, which is not the primary focus of this condom clearance letter.
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. This document is for a physical medical device (condoms), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" implicitly referred to would be established through laboratory testing to confirm properties like burst pressure, tensile strength, freedom from holes, and shelf-life stability, as required by standards for condoms (e.g., ISO, ASTM, and FDA regulations like 21 CFR 801.435). This involves objective measurements rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set
- Not applicable/Not provided. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.