(263 days)
The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.
This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom design features a patented illuminated ring on the underneath side of the rolled condom. It is lubricated with silicone and cornstarch is used as a dressing material.
This condom is a straight walled with a reservoir tip; nominal length 180mm, nominal flat width 52mm, and nominal thickness 0.07 +/- 0.01 mm.
This condom is designed to conform to established national and international voluntary standards (ISO 4074).
The provided text is a 510(k) summary for the O-RING Condom, a male natural rubber latex condom. It outlines the device's characteristics, intended use, and performance testing to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (meets...) | Reported Device Performance |
|---|---|---|
| Burst Volume | ISO 4074 requirements | meets ISO 4074 requirements |
| Burst Pressure | ISO 4074 requirements | meets ISO 4074 requirements |
| Water Leakage | ISO 4074 requirements | meets ISO 4074 requirements |
| Visual Defects | ISO 4074 requirements | meets ISO 4074 requirements |
| Package Integrity | ISO 4074 requirements | meets ISO 4074 requirements |
| MEM Elution (Cytotoxicity) | non-cytotoxic | non-cytotoxic |
| Guinea Pig Maximization Sensitization | no elicit sensitization response | no elicit sensitization response |
| Mucosal (Vaginal) Irritation | non-irritant | non-irritant |
| Acute Systemic Injection (Toxicity) | no signs of toxicity | no signs of toxicity |
| Shelf Life | Per 21 CFR 801.435 guidelines | 5 years |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each performance test (Burst Volume, Burst Pressure, Water Leakage, Visual Defects, Package Integrity, and biocompatibility tests). It only states that the tests conformed to ISO 4074 requirements for the physical tests and GLP reports for biocompatibility.
The data provenance is not explicitly stated in terms of country of origin. The study is retrospective in the sense that the testing has already been completed and the results are being presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a condom, and the performance criteria are based on physical and biological standards (ISO 4074 and GLP for biocompatibility), not expert interpretation of outputs like radiological images. Therefore, "ground truth" as established by experts in a diagnostic context is not relevant here.
4. Adjudication method for the test set
Not applicable. As noted above, the performance assessment relies on objective physical and biological tests against established standards, not on expert adjudication of interpretations.
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 is a medical device (condom), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance for human readers are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The O-RING Condom is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests used verifiable, measurable standards:
- Physical Strength and Integrity: ISO 4074 requirements. These are internationally recognized standards for latex condoms, which define performance thresholds for burst properties, leakage, and visual defects.
- Biocompatibility: GLP (Good Laboratory Practice) compliant studies (MEM Elution, Guinea Pig Maximization Sensitization, Mucosal Irritation, Acute Systemic Injection) with defined endpoints (non-cytotoxic, no sensitization, non-irritant, no signs of toxicity).
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.
§ 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.