(88 days)
The Durex Condom is used for contraception and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is nipple-ended with minimal dimensions of Width: 52 mm, Length: 160 mm min., Thickness: 0.03 mm min.
This document is not a study; it is a 510(k) premarket notification for a medical device. A 510(k) submission demonstrates that a device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials. Therefore, the information requested in the prompt regarding acceptance criteria, study design, and performance metrics is not directly applicable or available within this type of regulatory document.
However, based on the provided text, I can infer some aspects related to "acceptance criteria" through the lens of substantial equivalence and identify what is being presented as "device performance."
Here's an interpretation based on the 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k), "acceptance criteria" are not performance metrics in the clinical sense, but rather a demonstration that the new device shares the same fundamental scientific technology and intended use as the predicate device, and any differences do not raise new questions of safety or effectiveness. The "device performance" in this context refers to the characteristics that maintain substantial equivalence.
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance (Characteristics) |
|---|---|
| Intended Use: Same as predicate device (contraception and STD prevention). | The Durex Sensidom Male Latex Condom has the same intended use as the predicate: "for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)." |
| Technological Characteristics: Same fundamental technology as predicate, in conformance with relevant standards (ASTM D3492). | The device has "the same technological characteristics as the predicate device" and its design is in conformance with "ASTM Latex Condom Standard D3492." It is made of natural rubber latex. |
| Physical Dimensions: Equivalent to predicate device. | - Width: 52 mm |
- Length: 160 mm min.
- Thickness: 0.03 mm min.
The document states it has "the same dimensions" as the predicate. |
| Material: Same as predicate device (natural rubber latex). | "made of a natural rubber latex sheath." |
| Manufacturing Process & Quality Program: Same as predicate. | "manufactured on identical manufacturing equipment utilizing the same raw materials and formulation." "The same Quality Program is in effect." |
| Differences from Predicate: Any differences do not raise new questions of safety or effectiveness. | The only difference is "the substitution of an alternative lubricant (non-spermicidal)." The submission implies this change does not raise new questions of safety or effectiveness, as it received 510(k) clearance. |
| Labeling Compliance: Adherence to specific labeling regulations for latex condoms, including expiration dating (21 CFR 801.435). (Note: This is post-submission guidance, not pre-market performance data). | Though not explicitly "criteria" for the substantial equivalence determination, the FDA letter informs the applicant that "labeling for latex condoms... must comply with User Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435." This requires supporting test data for expiration dates (though not submitted in the 510(k)). This is a crucial post-market compliance "acceptance." |
For the remaining points, the information explicitly requested (sample sizes, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is typically found in dedicated performance studies or clinical trials, which are not part of this 510(k) submission.
Regarding the specific questions:
2. Sample sized used for the test set and the data provenance: Not applicable. This document does not describe a clinical study or a test set in the sense of performance evaluation. It refers to "test data developed under the conditions specified in 801.435(d)" for expiration dating, but provides no details on sample size or provenance for this data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no test set or ground truth established by experts described in this regulatory submission.
4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is 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: Not applicable. This is a condom, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device (condom), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a performance study for this device. The "ground truth" for substantial equivalence is primarily the legally marketed predicate device's characteristics and the relevant ASTM standards.
8. The sample size for the training set: Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. 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.