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Ansell condoms are male contraceptive devices, fabricated of latex, which are designed to completely cover the penis during sexual intercourse. These condoms are intended to be used for contraceptive and prophylactic purposes. If used properly, these condoms will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, these condoms 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 condoms should be applied before any such contact.

Ansell condoms are male contraceptive and prophylactic devices, which are 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. Ansell condoms are designed to conform to established national and international voluntary standards including ASTM D 3492, ISO 4074 and EN 600.

This document is a 510(k) premarket notification for Ansell Condoms and primarily focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with reported performance metrics. Therefore, many of the requested details about a study and acceptance criteria are not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that Ansell condoms are "designed to conform to established national and international voluntary standards including ASTM D 3492, ISO 4074 and EN 600." These standards inherently contain acceptance criteria for male latex condoms (e.g., burst strength, freedom from holes, dimensions). However, the document does not report the actual device performance against these specific criteria (e.g., specific burst pressures, number of holes per 10,000, etc.). It only states that the device conforms.

Therefore, a table with specific performance values cannot be constructed from this document.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The submission is a 510(k) for substantial equivalence and does not detail the testing protocols, sample sizes, or provenance of data used to demonstrate conformity to standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for condom standards would typically be defined by the specifications laid out in the aforementioned ASTM, ISO, and EN standards. Testing laboratories (either internal to Ansell or third-party) would then perform tests to verify adherence to these standards. The document does not describe the individual experts involved in ground truth establishment or testing.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This is not applicable to this type of device (male latex condoms) and the type of submission (510(k) for substantial equivalence). MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable to this device. As noted above, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for demonstrating the device's quality and safety is adherence to established national and international voluntary standards for male latex condoms. These standards (ASTM D 3492, ISO 4074, and EN 600) define the physical and performance characteristics considered acceptable for the device.

8. The Sample Size for the Training Set

This is not applicable to this device. As a physical product, there isn't a "training set" in the context of an algorithm or AI. The manufacturing process and quality control would involve ongoing testing, but this isn't analogous to a training set for machine learning.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set in the context of an algorithm. The "ground truth" for manufacturing and quality control would be the specifications outlined in the voluntary standards the company claims to conform to.

Summary based on the document:

The provided document, a 510(k) summary, asserts that Ansell condoms conform to established national and international voluntary standards (ASTM D 3492, ISO 4074, and EN 600). This claim of conformity to these standards serves as the primary evidence for the device meeting safety and effectiveness requirements, rather than presenting a detailed study with specific performance metrics against pre-defined acceptance criteria. The document does not provide details on sample sizes, data provenance, expert involvement, or adjudication methods related to specific performance testing. It focuses on the comparison to predicate devices and adherence to general standards.

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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

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.

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