(75 days)
Lubricated rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic.
Additional Statement: This condom contains a latex condom and a spermicidal lubricant. The spermicide, Nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your erection before withdrawal and some semen spill outside the condom. However the extent of the decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom
Condom, smooth surface, reservoir end, approximately 180 mm in length and 52 mm in width (Type 1, Style 2, Class A) colored rubber contraceptive device, lubricated with silicone and the active ingredient Nonoxynol-9 spermicide.
Here's a breakdown of the acceptance criteria and study information for the device, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Metric) | Reported Device Performance (Claimed by Manufacturer) |
|---|---|
| Air burst testing (ISO 4074-6) | Meets 1 mPa to 20 liters of air |
| Leakage (AQL level) | 0.4% (no leakage detected) |
| Tensile strength | Not less than 15 mPa |
| Minimum breaking force | 18 N |
| Minimum elongation | 625% |
| Nonoxynol-9 spermicide content | 30 mg ± 5 mg (minimum 25 mg required by FDA) |
| Dimensions (ASTM 3492-93) | 180 mm ± 20 mm length, 52 mm ± 2 mm width, 0.03 mm min. thickness |
| Colorants | FDA certified, approved for long-term food contact in polymers (used in rubber) |
| Shelf Life (Mechanical Standards) | Complies with 5-year standard (latex component) |
| Shelf Life (Nonoxynol-9) | Labeled for two years (based on supplier testing of Nonoxynol-9), with ongoing studies to potentially extend this. |
Study Details
-
Sample size used for the test set and the data provenance:
- Test set sample size: "Production samples were collected over a period of six 8-hour shifts, spread over multiple days." The samples were divided in half to provide "as manufactured" and "aged" samples. The exact number of samples or condoms is not specified beyond this description.
- Data provenance: While the manufacturing facility is in the People's Republic of China, the text doesn't specify the country of origin for the data itself. The study appears to be prospective in the sense that the manufacturer performed testing specifically to demonstrate substantial equivalence, including accelerated aging.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information is provided regarding the use of experts or their qualifications for establishing ground truth on the test set. The testing relies on established industry standards (ASTM, ISO) and laboratory methods.
-
Adjudication method for the test set:
- No information about an adjudication method is provided. The testing appears to be objective, based on physical and chemical measurements against pre-defined standards.
-
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:
- No MRMC or comparative effectiveness study involving human readers or AI assistance was conducted. This device is a physical product (condom), not an AI-assisted diagnostic tool.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm or software.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on established voluntary standards (ASTM 3492-93 and ISO 4074-6, under revision), and regulatory guidance from the FDA (e.g., minimum Nonoxynol-9 content, requirements for avoiding misbranding/adulteration). These standards define the acceptable physical properties and chemical composition of the medical device.
-
The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model requiring a "training set."
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of 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).