(125 days)
The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Not Found
The provided text is a 510(k) clearance letter from the FDA for a Non-Spermicidal Lubricated Male Latex Condom. This document is a regulatory approval, not a scientific study report. It does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving device performance as it refers to these elements implicitly through the substantial equivalence determination rather than explicitly detailing them.
Therefore, I cannot provide a complete answer to your request based solely on the provided text. The document refers to compliance with existing regulations and suggests that supporting test data for expiration dating must be maintained, but the specifics of that test data are not included in this letter.
However, I can extract the information that is present and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of specific acceptance criteria or detailed reported device performance. The clearance is based on substantial equivalence to a predicate device, meaning it meets the regulatory requirements for condoms as defined in 21 CFR 884.5300. These regulations would implicitly define performance standards (e.g., burst strength, freedom from holes, dimensions, etc.), but the actual data from the study demonstrating compliance is not in this letter.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The manufacturer is Secure Scientific SDN. BHD. from Malaysia, suggesting the device and potentially test data originate from there. The letter mentions "test data developed under the conditions specified in §801.435(d)" for expiration dating, but doesn't detail this data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The "ground truth" for a medical device like a condom is typically established through direct physical testing against performance standards (e.g., burst tests, visual inspection for holes), not through expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable and not provided. Adjudication methods are typically relevant for interpretive tasks where human judgment of complex data (like medical images) is involved. Condom testing involves direct physical measurement and objective pass/fail criteria.
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 and not provided. This type of study is relevant for medical imaging or diagnostic AI systems, not for a physical medical device like a condom.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable and not provided. A condom is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for a medical device like a condom would involve adherence to specified physical and material properties, assessed through objective testing methods and comparison against codified standards (e.g., ISO standards for condoms). The document does not detail these specific test methods or standards but references the regulation 21 CFR §801.435 for expiration dating.
8. The sample size for the training set:
Not applicable and not provided. Training sets are relevant for machine learning algorithms, which are not involved in the regulatory approval of this physical device.
9. How the ground truth for the training set was established:
Not applicable and not provided.
Summary of what the document does provide:
- Device: Non-Spermicidal Lubricated Male Latex Condom
- Regulatory Class: II
- Regulation Number: 21 CFR 884.5300
- Indications for Use: Contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
- Approval Basis: Substantial equivalence to a legally marketed predicate device.
- Key Requirement Highlighted: Labeling must comply with "Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435," requiring an expiration date supported by test data. The manufacturer must maintain this data for inspection.
To answer your questions fully, the actual 510(k) submission document from Secure Scientific SDN. BHD. for K023128, along with the test reports referenced within that submission, would be required. This letter only confirms the FDA's decision based on its review of that submission.
§ 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.