(349 days)
The LifeStyles Lubricated Polyisoprene Latex Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).
The LifeStyles condom is a male contraceptive and prophylactic device fabricated from synthetic rubber polyisoprene latex with a lubricant coating. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple-end) at the closed end to contain semen. The condom has a nominal length of 185 mm and nominal width of 53 mm. The condom is designed to conform to established national and international voluntary standards including ASTM D3492 Standard Specification for Rubber Contraceptives (Male Condoms) and ISO 4074:2002Cor.1:3002(E): Natural Latex Rubber Condoms - Requirements and Test Methods, Technical Corrigendum.
The provided text describes a 510(k) summary for a condom device and a subsequent FDA clearance letter. It does not contain information about a study proving the device meets acceptance criteria in the context of typical medical image analysis or diagnostic device studies.
Instead, the acceptance criteria for this device (LifeStyles Lubricated Polyisoprene Latex Male Condom) are based on established national and international voluntary standards for condoms. The "study" mentioned isn't a clinical trial in the way it's usually considered for AI/medical imaging, but rather testing to ensure the device conforms to these established standards.
Therefore, for your requested information points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conforms to ASTM D3492 Standard Specification for Rubber Contraceptives (Male Condoms) | The device "is designed to conform to established national and international voluntary standards including ASTM D3492 Standard Specification for Rubber Contraceptives (Male Condoms)" and "conforms to national and international standards: ASTM D3492 Standard Specification for Rubber Contraceptives (Male Condoms)". |
| Conforms to ISO 4074:2002Cor.1:3002(E): Natural Latex Rubber Condoms - Requirements and Test Methods, Technical Corrigendum | The device "is designed to conform to established national and international voluntary standards including... ISO 4074:2002Cor.1:3002(E): Natural Latex Rubber Condoms - Requirements and Test Methods, Technical Corrigendum" and "conforms to national and international standards:... ISO 4074:2002Cor.1:3002(E): Natural Latex Rubber Condoms – Requirements and Test Methods, Technical Corrigendum". |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. While it states the device conforms to standards, it doesn't detail the specific testing methodology, sample sizes, or data provenance used to verify this conformance.
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 in the given text. "Ground truth" in this context would likely refer to the results of standardized physical and mechanical tests on the condoms, not expert interpretation as in medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the given text. Adjudication methods are typically relevant for subjective expert reviews, not instrumental testing against predefined 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
This information is not applicable and not provided in the given text. This device is not an AI-powered diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the given text. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" implicitly used would be the physical and mechanical properties of the condom as measured against the specifications outlined in the ASTM D3492 and ISO 4074 standards (e.g., burst strength, freedom from holes, dimensions).
8. The sample size for the training set
This information is not applicable and not provided in the given text. Training sets are relevant for machine learning algorithms, which this device is not.
9. How the ground truth for the training set was established
This information is not applicable and not provided in the given text.
§ 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.