(193 days)
Condomi brand latex condoms are intended to be used as a contraceptive (for the prevention of pregnancy) and/or for the prevention of the transmission of sexually transmitted diseases.
Like other natural latex condoms on the market, the Condomi brand condoms are latex sheaths, which completely cover the penis with a closely fitting membrane. The following condom styles, colors, and flavors will be offered:
a) Standard transparent lubricated with silicon oil
b) Colored pink, studded, lubricated with silicon oil
c) Colored gold, lubricated with silicon oil, and vanilla flavor.
d) Transparent, form-fitting condom, lubricated with spermicidal lubricant N-9
e) Extra large condom transparent, lubricated with silicon oil
f) Extra strong condom, transparent, lubricated with silicon oil
The provided document is a 510(k) summary and FDA clearance letter for Condomi brand male latex condoms. It details the device's characteristics, intended use, and comparison to predicate devices, focusing on non-clinical testing. It explicitly states "No clinical testings were completed" and therefore does not contain information about a study proving the device meets acceptance criteria derived from clinical trials, nor human reader studies with AI.
However, based on the information provided regarding non-clinical tests, here's a description of the acceptance criteria and how the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D3492-97 (Standard Specifications for Rubber Contraceptives - male condoms) | Meets this standard. |
| ISO Standard 4074 (Requirements for Rubber Condoms, parts 1,2,3,5,6,7,9 1996) | Meets this standard. |
| ISO 10993 (Biological Evaluation of Medical Devices) | Meets this standard. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for testing against these standards, nor does it detail the provenance of the test data (e.g., country of origin, retrospective or prospective nature). It only states that "Methods and results were provided" for meeting the standards.
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)
This information is not applicable and not provided. The "ground truth" for condom performance in this context is defined by the established international and national standards (ASTM, ISO). Compliance with these standards is typically assessed through laboratory testing, not expert consensus in the same way clinical images might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for expert review of human-interpreted data, often in clinical studies. The testing described here involves laboratory methods to meet pre-defined performance standards.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical product (condom), and the submission explicitly states "No clinical testings were completed." Therefore, there is no AI component or human reader improvement associated with this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a physical medical device (condom), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by the specified international and national consensus standards (ASTM D3492-97, ISO Standard 4074, and ISO 10993). Meeting the technical specifications and performance requirements outlined in these standards serves as the ground truth for demonstrating safety and effectiveness for non-clinical testing.
8. The sample size for the training set
This information is not applicable and not provided. The development and testing of condoms against established standards do not typically involve "training sets" in the context of machine learning or AI. The tests are designed to verify product specifications.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no "training set" in the context of this device's submission. The "ground truth" for product performance is defined by the aforementioned industry standards.
§ 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.