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The Kwikeze Male Condom Applicator facilitates correct positioning (donning) of a male latex condom prior to sexual intercourse. The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

The Kwikeze™ Male Condom Applicator is an elliptical ring made of polyethylene plastic. When packaged, the applicator is collapsed on self-scored lines in a manner that allows the condom to be loosely positioned within the inner-folds of the ring. The collapsed applicator is held in position with a polyurethane band. The condom is stretched slightly to position it on top of the applicator. This configuration allows the condom to rest un-stretched until time of use. After opening the sealed foil package, and prior to use, the band is removed allowing the ring and condom to expand to its original oval shape. The device when pulled opened expands the attached condom enough to allow for easy insertion and correct positioning of the condom on the erect penis.

This document is a 510(k) summary for the Kwikeze™ Male Condom Applicator. It's a pre-market notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The document does not contain specific acceptance criteria or an explicit study proving the device meets those criteria, as such detailed performance data is typically not required for a 510(k) submission unless an entirely new technological principle is involved.

For devices like a condom applicator, the substantial equivalence relies more on demonstrating that the new device does not raise new questions of safety or effectiveness compared to the predicate, and that it performs as intended without compromising the function of the condom itself. The key elements presented are:

• Intended Use: The Kwikeze™ applicator facilitates correct orientation and donning of a male condom for contraception and prophylactic purposes, similar to the predicate device.
• Technological Characteristics: It's a single-use polyethylene plastic ring. Condoms used with it must have 510(k) clearance and conform to ASTM Latex Condom Standard D3492. This emphasizes that the primary safety and effectiveness of the condom itself is established separately, and the applicator's role is ergonomic.

Given the nature of the device and the 510(k) summary, the document does not include detailed clinical study data with acceptance criteria for performance metrics like sensitivity, specificity, or reader agreement, which are typically found in submissions for diagnostic or more complex therapeutic devices.

Therefore, many of the requested fields cannot be directly answered from the provided text.

Here's an attempt to fill in the table and information based on the provided text, noting where information is not available due to the nature of a 510(k) for this type of device:

1. Table of acceptance criteria and the reported device performance

"The study that proves the device meets the acceptance criteria"

The provided document does not describe a specific study with quantitative data to demonstrate meeting acceptance criteria in the typical sense of a clinical trial for a diagnostic or therapeutic device. Instead, the 510(k) process for a device like this relies on demonstrating "substantial equivalence" to a predicate device based on:

1. Similar intended use.
2. Similar technological characteristics impacting safety and effectiveness.
3. Meeting recognized standards (e.g., ASTM for condoms used with the applicator).
4. Not raising new questions of safety or effectiveness.

The FDA's letter of "substantial equivalence" (K031007) is the primary "proof" that the device is deemed safe and effective for its intended use, based on the information provided in the 510(k) submission, which would include descriptions of the device, its function, materials, and comparison to the predicate. The 510(k) summary provided here is a high-level overview.

Detailed Information (as far as available from the text):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Available. The document does not describe a test set or specific performance data from a study. As a condom applicator, its primary safety and effectiveness are tied to whether it aids in correct condom placement without damaging the condom or harming the user. Such assessment might involve usability testing or non-clinical verification, but details are not provided here.

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 / Not Available. There is no mention of a "test set" requiring ground truth established by experts in the context of this 510(k) summary.

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

   • Not Applicable / Not Available. No test set or adjudication method is described.

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 relevant to a condom applicator, which is a physical medical device, not an AI-assisted diagnostic tool.

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)

   • Not Available. No formal "ground truth" as typically defined for diagnostic performance is mentioned. The ground truth for this type of device would likely be its ability to correctly apply a condom without tearing or misplacement, and this would be assessed through usability and non-clinical testing rather than expert-adjudicated clinical cases.

8. The sample size for the training set

   • Not Applicable / Not Available. The document does not describe a training set for an algorithm.

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

   • Not Applicable / Not Available. The document does not describe a training set for an algorithm.

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