(86 days)
The Simplex brand condom is a male contraceptive device, fabricated of natural latex. which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraception and for prophylactics purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100 % effectiveness. Failure to use as directed, may further result in loss of protection. Furthermore. sexually transmitted diseases can be transmitted through lesions and various body fluids, during intimate contact. Therefore, the condom should be applied before any such contact.
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is made of first grade latex material, teatended, single wall and contoured. Its dimensions are: length 170mm minimum, width: 51mm, thickness: 0.04-0.06 mm (single wall), weight: 1.0-1.3 gm/piece.
This is a 510(k) premarket notification for a medical device, specifically Simplex Condoms. It is not a study about an AI/ML device, therefore, the requested information about acceptance criteria and device performance in the context of AI/ML is not applicable.
The document describes the device, its intended use, and technological characteristics, and then states that it is substantially equivalent to a predicate device (Trustex aromatic, 510(K) # K991892). The FDA concurred with this assessment in their letter.
The submission focuses on meeting regulatory requirements for substantial equivalence to a legally marketed predicate device, rather than providing a study comparing the performance of the Simplex condom against specific, quantifiable acceptance criteria through controlled testing, as would be expected for an AI/ML device.
However, based on the provided text, I can infer some "acceptance criteria" through the lens of regulatory compliance, even though they are not explicitly presented as a table or study results in the traditional sense for AI/ML.
Here's an analysis based on the provided text, addressing the points where information is available or inferable, and explicitly stating where information is not applicable or available given the nature of the document:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a physical medical device (condoms) and not an AI/ML device, the concept of "acceptance criteria" and "reported device performance" is framed in terms of substantial equivalence to a predicate device and compliance with established standards, rather than performance metrics of an algorithm.
| Acceptance Criteria (Inferred from regulatory compliance) | Reported Device Performance (Inferred from substantial equivalence) |
|---|---|
| Technological Characteristics: Match predicate device (e.g., material, design) | Simplex Condoms have the "same technological characteristics as the predicate condoms". Design conforms to WHO, ISO, EN 600, DIN, and ASTM D3492-96. |
| Intended Use: Match predicate device (contraception, STD prevention) | Simplex Condoms have the "same intended use as the predicate condom". |
| Material: Natural rubber latex sheath | Made of "first grade latex material". |
| Dimensions: Meet specified ranges (length, width, thickness, weight) | Length: 170mm minimum; Width: 51mm; Thickness: 0.04-0.06 mm (single wall); Weight: 1.0-1.3 gm/piece. (These are part of the description, implying they meet expected standards). |
| Manufacturing Process: Conform to quality standards | Made using a "German-made automatic dipping line". |
| Labeling/Shelf Life: Comply with 21 CFR 801.435 for expiration dating. | Shelf life data must be developed and maintained as per 21 CFR 801.435(d). Product must be relabeled if real-time data doesn't confirm shelf life. Max shelf life 5 years. (This is a requirement for post-market, not a reported performance metric within the 510(k) itself). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as this is a 510(k) for a physical medical device, not an AI/ML study. There is no "test set" in the context of an algorithm's performance. The documentation instead relies on demonstrating conformity to standards and substantial equivalence to a predicate device.
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. "Ground truth" in the context of expert consensus for AI/ML is not relevant here. The "truth" in this submission relies on established standards for condom manufacturing and performance, as well as the design and material comparison to a predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. There is no "test set" or adjudication method relevant to an algorithm's performance being described.
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
This information is not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for regulatory approval is based on:
- Compliance with recognized standards: WHO, ISO, EN 600, DIN, and ASTM D3492-96. These standards specify physical properties, test methods, and performance criteria for condoms.
- Established performance of the predicate device: The Simplex Condoms are stated to have "the same intended use" and "same technological characteristics" as the predicate device (Trustex aromatic, K991892), which is already legally marketed.
- Physical and material specifications: The stated dimensions, material (natural rubber latex), and manufacturing process (German-made automatic dipping line) are expected to meet the requirements for safe and effective condoms.
8. The sample size for the training set
This information is not applicable. There is no "training set" for an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" for an AI/ML algorithm.
§ 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.