(272 days)
The LifeStyles Xtra Pleasure condom is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraceptive and prophylactic 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.
The LifeStyles Xtra Pleasure condom is a male contraceptive and prophylactic device, which is fabricated of a natural rubber latex. The condom is designed as a fitted sheath with an integral ring at the open end and a reservoir at the closed end to contain semen. While the shaft of the condom is straight, the closed end is flared and terminates to a nipple at the tip. The "flare" is intended to enhance stimulation by the condom.
The acceptable lengths of this condom are established at between 170-180mm. as permissible by ASTM standard D3492-96. Likewise, acceptable widths of the shaft range from 51-54mm, and thicknesses range from 0.060-0.075mm. The maximum bulb (or flared) width is not to exceed 81mm, per internal specifications.
The LifeStyles Xtra Pleasure Condom shall be packaged with the same polysiloxane fluid lubricant, as is applied to the predicate device.
The provided document is a 510(k) summary for a medical device (LifeStyles Xtra Pleasure Condom) and does not detail a study proving the device meets acceptance criteria in the manner requested (e.g., using AI, ground truth, experts, MRMC studies). The document describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.
Therefore, most of the requested information cannot be extracted from this document. However, I can provide what is available regarding acceptance criteria and the mechanism used to demonstrate compliance.
Here's the information that can be extracted, and where the document does not provide the requested detail:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ASTM Standard D3492-96 and internal specifications) | Reported Device Performance |
|---|---|
| Length: 170-180mm | Not explicitly stated, implied to be within range |
| Shaft Width: 51-54mm | Not explicitly stated, implied to be within range |
| Thickness: 0.060-0.075mm | Not explicitly stated, implied to be within range |
| Maximum Bulb (flared) Width: Not to exceed 81mm (per internal specifications) | Not explicitly stated, implied to be within range |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided.
- Data provenance: Not provided. This document focuses on the design specifications and comparison to predicate, rather than detailed testing data.
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)
- Not applicable. This is a physical device, and "ground truth" would relate to its physical properties, not interpretations by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically associated with subjective assessments or diagnostic interpretations, which are not relevant to the physical characteristics of a condom described here.
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 MRMC study was done. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device would be its physical measurements (e.g., actual length, width, thickness) obtained through standard metrology or testing methods, compared against the specified ranges. The document refers to ASTM standard D3492-96 for acceptable lengths, widths, and thicknesses, and internal specifications for the maximum bulb width. This implies industry-recognized standards and internal quality control for establishing compliance with physical criteria.
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. No training set for an AI device.
Summary of "Study" to Prove Acceptance Criteria:
The document indicates that the device's compliance is based on meeting physical specifications established by ASTM standard D3492-96 and internal specifications. The "study" mentioned is not a clinical trial or performance study with experts, but rather a demonstration of substantial equivalence to a predicate device.
The conclusion states: "Because of the strong similarities between the subject device and its predicate, no new safety and effectiveness issues are expected to be raised." This implies that by meeting the established physical specifications (length, width, thickness, and maximum bulb width) and sharing the same materials and manufacturing procedures as the predicate device (LifeStyles Lubricated), it is considered to inherently meet the necessary safety and effectiveness criteria. The physical measurements themselves, and their adherence to the standards, serve as the "proof" for acceptance criteria in this context. Detailed test reports or statistical analysis are not included in this summary.
§ 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.