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Non-spermicidal Lubricated Male Latex Condoms are intended to prevent pregnancy, HIV/AIDS and other sexually transmitted infections.

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The provided document is a 510(k) clearance letter from the FDA for a Non-spermicidal Lubricated Male Latex Condom. This type of device is subject to performance standards and does not typically involve the kind of AI-driven performance criteria, ground truth studies, or human-in-the-loop assessments described in your request. Your request is tailored for an AI/ML medical device, which this product is not.

Therefore, I cannot extract the information you requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI-specific performance metrics from this document because it is not relevant to a condom.

The document primarily focuses on:

• The device being substantially equivalent to a legally marketed predicate device.
• Compliance with general controls provisions of the Act (e.g., registration, labeling, good manufacturing practices).
• Indications for Use (preventing pregnancy, HIV/AIDS, and other STIs).
• Classification as an Over-The-Counter device.

To provide the information you're looking for, I would need a document related to an AI/ML-based medical device.

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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).

Male Natural Rubber Latex Condom

This is a 510(k) clearance letter for a Male Natural Rubber Latex Condom, not a study describing the approval of an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment for an AI/ML device is not applicable and cannot be extracted from the provided text.

The document discusses the regulatory clearance process for a medical device (condom) based on its substantial equivalence to a predicate device, and it outlines general regulatory requirements under the Federal Food, Drug, and Cosmetic Act.

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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.

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