(120 days)
The Royal Condoms are used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The subject condoms are made of a natural rubber latex sheath, which completely covers with a closely fitted membrane. They are single use, non-sterile and available in five versions (natural, black grape, coffee, strawberry and chocolate favored). These condoms are of smooth surface, natural colored in cylindrical shape, straight parallel walled with a reservoir nipple at the closed end and a rim at the open end. These condoms have a minimum length of 182mm, width of 53 - 54mm, and wall thickness between 0.065 - 0.075mm, which comply with ISO 4074.
This looks like a 510(k) summary for a medical device (condoms), not an AI/ML powered device. The document describes traditional medical device performance testing rather than an AI model's performance.
Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The document discusses:
Acceptance Criteria for Royal Condoms (based on ISO 4074 and general safety/effectiveness):
| Acceptance Criteria Category | Specific Criteria/Standard Met | Reported Device Performance |
|---|---|---|
| Physical Dimensions | Minimum length of 182mm, width of 53-54mm, wall thickness between 0.065-0.075mm (complying with ISO 4074) | The device dimensions (length 182mm, width 53-54mm, wall thickness 0.065-0.075mm) are stated to comply with ISO 4074. |
| Performance (Bench) | Met all requirements of ISO 4074 (specific mechanical properties related to strength, integrity, etc., not detailed here but implied by ISO 4074 compliance). | Bench testing demonstrated that the subject condoms met all the requirements of ISO 4074. |
| Shelf-Life | Ability to maintain performance over time. | Accelerated shelf-life study supports a shelf-life of five years from the date of manufacture. Real-time shelf-life study is in progress (as required by 21 CFR § 801.435). |
| Biocompatibility | Met standards for biological evaluation (cytotoxicity, irritation, skin sensitization, systemic toxicity). | Passed biocompatibility testing in accordance with ODE Guidance Memorandum G95-1 and standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-11 (systemic toxicity), and ISO 10993-12 (sample prep). |
| Indications for Use | Used for contraceptive and prophylactic purposes (to prevent pregnancy and STIs). | Stated indications are for contraceptive and prophylactic purposes, which are the same as the predicate device. |
Study Information (Traditional Device Testing):
- Sample size used for the test set and the data provenance: Not explicitly stated for bench testing, but compliance with ISO 4074 would imply standard sample sizes as defined in that standard. Data provenance is not applicable in the context of AI/ML; these are lab-based physical tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing is based on objective, standardized measurements against ISO standards.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: ISO 4074 standards for physical properties and performance, and established biocompatibility standards.
- The sample size for the training set: Not applicable (no "training set" in this context).
- How the ground truth for the training set was established: Not applicable.
§ 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.