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Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic.
Extra strength nonlubricated rubber male condom for use as a contraceptive and prophylactic.

The device which is the subject of this application is a latex rubber condom (Class II medical device defined as "Condom (rubber) Contraceptive 85-HIS") and is defined by ASTM 3492-93 as a Type I, Style 2, Class A rubber condom, and further defined by ISO 4074-6 (currently under revision). The device which is defined by these standards can be lubricated or nonlubricated, and for the purposes of selection for labeling as "extra strength" is tested in the strength categories to a higher standard (See Exhibit A in K970767 and K970792 as well as Exhibit 1) with added FDA certified color. The purpose of this medical device is for the prevention of pregnancy and the protection against sexually transmitted diseases, including HIV.

Here's an analysis of the provided text regarding the condom's acceptance criteria and study information:

This document is a 510(k) summary for a condom device, not an AI/ML medical device. Therefore, many of the requested fields related to AI/ML device studies (e.g., sample size for AI test and training sets, AI reader studies, ground truth establishment for AI) are not applicable and cannot be found in the provided text.

The information primarily focuses on the device's classification, intended use, and substantial equivalence to predicate devices, along with adherence to established standards for condom manufacturing.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only refers to existing standards and a higher quality standard for "extra strength" without detailing specific quantitative acceptance criteria or reporting precise performance metrics from a study beyond asserting it meets these standards.

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

Not applicable for this type of device submission. The submission doesn't describe a "test set" in the context of an AI/ML study, but rather conformity to existing product specifications and standards.

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

Not applicable. Ground truth for a condom device is established through manufacturing standards and physical property testing, not expert interpretation in the way it is for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable.

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/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on physical property measurements and adherence to established industry standards (ASTM 3492-93, ISO 4074-6) for condom manufacturing and performance. The statement "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom" indicates that the ground truth for "extra strength" is derived from specific laboratory measurements rather than expert consensus or pathology in a medical imaging context.

8. The Sample Size for the Training Set

Not applicable for this type of device. There isn't a "training set" for physical product testing; instead, samples are taken from production batches for quality control.

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

Not applicable.

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