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The FAMA Male Latex Condoms are used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The FAMA Male Latex Condoms are single-use, non-sterile condoms made of a natural rubber latex sheath, which covers the penis with a closely fitted membrane. The condoms have a smooth, dotted or ribbed surface and have a straight-walled nipple-end (SWNE) style within specifications listed in ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms are lubricated with no colorants and fragrances added. The product is made of natural rubber latex, additives are sulfur, zinc oxide, promoter PX, promoter ZDC, antioxidant 264, stabilizer casein, and silicone oil as lubricant. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.

The provided text is a 510(k) summary for the FAMA Male Latex Condoms, a medical device. This document details the device's technical specifications, intended use, and its comparison to a predicate device to establish substantial equivalence for FDA clearance.

Crucially, the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML medical devices, specifying aspects like sample size for test/training sets, expert ground truth establishment, MRMC studies, and standalone performance.

However, the FAMA Male Latex Condoms are not an AI/ML medical device. They are a physical product (condoms) whose performance is evaluated based on physical and biological properties (e.g., length, width, thickness, burst pressure/volume, biocompatibility, shelf-life), not on an algorithm's diagnostic or predictive capabilities.

Therefore, the specific information requested regarding AI/ML device testing (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance, and adjudication methods) is not applicable to this document. The "studies" mentioned in the document are physical and biological performance tests, not AI model evaluations.

Summary of Device Performance and Acceptance Criteria (as applicable to a physical device):

The document provides acceptance criteria and performance data for the FAMA Male Latex Condoms based on physical and biological testing to meet established standards.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document states that "The FAMA Male Latex Condoms were tested at baseline and met all the requirements of ISO 4074:2015 -Natural rubber latex male condoms – Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms)."
• For Biocompatibility, "Biocompatibility studies... were performed in accordance with... ISO 10993-1, -5, -10, -11."
• For Shelf-Life, "accelerated stability evaluations conducted as required in 21 CFR 801.435."
• Specific sample sizes for each test are not detailed in this 510(k) summary. These details would typically be found in the full test reports referenced by the standards (e.g., how many condoms were burst-tested).
• Data Provenance: The manufacturing entity is "Shanghai Personage Hygiene Products Co.,Ltd." located in Shanghai, China. The testing was conducted by or on behalf of this company, presumably according to international standards. The nature of the physical and stability testing is inherently prospective in the sense that the manufactured devices are subjected to these tests to evaluate their properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a physical device. "Ground truth" for physical and biological properties is established by adherence to validated test methods and measurement protocols defined in international standards (ISO, ASTM, FDA regulations), not by expert consensus on interpretations of complex data like medical images.

4. Adjudication method for the test set:

• Not Applicable. As a physical device, testing involves quantitative measurements (e.g., length, burst pressure) and standardized biological assays, not subjective interpretations requiring adjudication.

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 not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For physical properties (length, width, thickness, burst pressure/volume): The "ground truth" is defined by the objective, measurable parameters specified in the ASTM and ISO standards, measured using calibrated equipment and standardized test methods.
• For biocompatibility: The "ground truth" is established by the results of validated biological assays (e.g., cytotoxicity, sensitization, irritation, systemic toxicity tests) as per ISO 10993 series. These tests have defined endpoints and criteria for determining toxicity.
• For shelf-life: The "ground truth" is established through stability testing that demonstrates the device maintains its performance and safety characteristics over time under specified conditions, according to 21 CFR 801.435.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

• Not Applicable. This is not an AI/ML device, so there is no "training set."

In conclusion, the document successfully demonstrates that the FAMA Male Latex Condoms meet the required physical and biological acceptance criteria by adhering to recognized international standards and FDA regulations for medical devices, thereby establishing substantial equivalence to the predicate device. The detailed questions regarding AI/ML device performance are not relevant to this product.

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The Latex Condom for Men is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

The Latex Condom for Men is a single-use, non-sterile condom made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is designed to conform to the standards including ASTM D3492 and ISO 4074. The condoms have either a smooth, dotted, or ribbed surface and have a straight walled nipple-end (SWNE) style within ASTM standard specifications D3492 Table 1 requirements, e.g., minimum length 160 mm, maximum width 54mm, and minimum thickness of 30μM.

The provided text describes a 510(k) premarket notification for a medical device: "Latex Condom for Men." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets individual acceptance criteria through a clinical trial or a multi-reader, multi-case study, which are typical for AI/CADe devices.

Therefore, the requested information elements related to AI/CADe studies (e.g., sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document as it pertains to a physical medical device (condom) and its regulatory approval based on material and performance standards.

However, I can extract the acceptance criteria and performance data that are presented in the context of this device.

1. A table of acceptance criteria and the reported device performance

The device's performance is demonstrated through adherence to recognized standards and specific physical properties. The acceptance criteria are implicit in the "Specification" column for the physical parameters and explicit in meeting the relevant ISO and ASTM standards.

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 document. The document refers to "non-clinical tests" but does not specify sample sizes or data provenance for these tests. It indicates the location of the manufacturer (Zhejiang, China) and the correspondent (Shanghai, China).

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 is not applicable as this is not a study requiring expert readers for ground truth determination, but rather laboratory testing against physical and chemical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. The "tests" mentioned are non-clinical, laboratory-based evaluations of the condom's material properties and physical dimensions against established international 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 is not applicable. This document is for a physical medical device (condom), not an AI/CADe device that involves human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This document is for a physical medical device (condom), not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on established international and national standards and specifications for natural rubber latex condoms (e.g., ASTM D3492-16, ISO 4074:2015, ISO10993 series for biocompatibility). The device's physical properties and material safety are evaluated against these objective, quantifiable criteria.

8. The sample size for the training set

This is not applicable. This document is for a physical medical device (condom) and does not involve AI or machine learning algorithms that require training sets.

9. How the ground truth for the training set was established

This is not applicable. This document is for a physical medical device (condom) and does not involve AI or machine learning algorithms that require training sets with associated ground truth.

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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 Power Stick Male Latex Condom is used for controptive fic fower belen cric purposes (to help prevent pregnancy and for prophylaction of sexually transmitted diseases).

This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. These two types of condoms, ribbed and dotted-ribbed, are at a nominal length of 170mm., a nominal width of 52 mm (±2mm) and are at a nominal thickness of .06 mm (±.02 mm).

The provided text describes a 510(k) premarket notification for a male latex condom device, not an AI/ML powered device. Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or present in this document.

The document focuses on demonstrating substantial equivalence to a predicate device by conforming to established standards for male latex condoms.

Here's an analysis based on the provided text, using the closest applicable information:

Acceptance Criteria and Reported Device Performance

Study Information (as applicable to a physical device/510(k))

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "All physical testing and final release testing," which implies that a sample of manufactured condoms would have been tested against the specified standards. The provenance of this testing data (e.g., in-house testing by the manufacturer or third-party lab) is not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device like a condom, "ground truth" is established by physical measurement and testing against international and domestic standards, not by expert consensus in an observational or diagnostic context.
3. Adjudication method for the test set: Not applicable. The testing would involve objective measurements (e.g., length, width, thickness, burst pressure tests as per standards) rather than subjective interpretation requiring adjudication.
4. 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 physical medical device, not an AI/ML diagnostic or assistive technology.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used: The "ground truth" for this device's performance would be the specifications outlined in the referenced standards (ASTM D3492, ISO 4074, EN 600) and the device's own design specifications (e.g., nominal length, width, thickness). These standards define acceptable ranges for various physical properties and performance characteristics (e.g., integrity under stress, lubricity).
7. The sample size for the training set: Not applicable. There is no "training set" in the context of a physical device like a condom. Manufacturing processes are refined through engineering and quality control, not machine learning training.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) submission for a conventional male latex condom, demonstrating conformance to recognized standards for physical devices. It does not contain the types of studies or data relevant to AI/ML powered devices.

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The Innolatex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled or contoured with a reservoir tip; nominal length 180mm, nominal width 52mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is colored and flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

The provided text describes a 510(k) premarket notification for a Male Latex Condom and does not contain information about acceptance criteria, device performance, or a study proving it meets acceptance criteria for an AI/ML medical device. This document is related to a physical medical device (condom) and discusses its characteristics and intended use, comparing it to predicate devices.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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These multiple-brand condoms are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases and HIV (AIDS).

Not Found

Based on the provided document, which is an FDA 510(k) clearance letter for the HardCover Condoms™ Male Latex Condoms, there is no information available regarding acceptance criteria, device performance studies, or the methodologies used to establish ground truth.

The document is a regulatory approval letter, confirming that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA has determined that the new device is as safe and effective as a legally marketed device and does not require a new Premarket Approval (PMA) application.

The letter explicitly states: "Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA." This indicates that while design and performance testing were conducted by the manufacturer, the detailed results and methodologies are not part of this public clearance letter.

Therefore, I cannot provide the requested information for the following points as they are not contained within the provided text:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sized used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
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 present (and not applicable as this is not an AI/software device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present (and not applicable as this is not an AI/software device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The only performance-related requirement mentioned in the document is about expiration dating for latex condoms and spermicidal lubricant shelf life, which must be "supported by test data developed under the conditions specified in 801.435(d)". However, the specifics of these tests and their acceptance criteria are not detailed in this letter.

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