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The Veraxis Int'l Inc. Naked™ condom is to be used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

By creating an actual physical barrier between partners engaged in sexual activity, the condom represents the best available solution to two of the world's major health challenges: sexually transmitted diseases/AIDS and unwanted pregnancy.
The design of the condom is essential to its effectiveness. The closed end has a reservoir tip to contain semen. The condom described herein has an integral ring at its base and a snug fit along its lower portion in order to ensure a safe, secure seal and barrier.
The design of the Naked™ condom described herein addresses these deficiencies so that condom usage will significantly improve among sexually active populations. The condom described herein provides a slightly relaxed fit along the main body of the product between the snug base and reservoir tip. This relaxed fit provides a more natural feel during intercourse, an easier application process, and improved sensation, while maintaining a safe, secure seal and barrier.
This product is designed to fully conform to ISO 10993 and ISO 4074. It also conforms to ASTM D3492.
This condom has the same technical characteristics as the predicate condoms identified above. The product described herein features a slightly relaxed fit along the main body of the product. The relaxed fit at the closed end of the condom provides a greater lay flat width than the width of the snug base and safety seal it creates at the open end of the condom.
The Naked ™ condom comes in a range of sizes that provide increased customization for each individual which makes for a safer, more secure, and better fit. These two technical characteristics (relaxed fit and various sizes) maximize product effectiveness and sensation, and thereby increase product usage among the sexually active populations.
As stated in the product description, this product is designed to fully conform to ISO 10993 and ISO 4074. It also conforms to ASTM D3492.

Here’s an analysis of the provided text regarding the acceptance criteria and study for the Naked™ condom, structured as requested.

The provided text is a 510(k) summary and FDA clearance letter for a medical device (condom). It describes the device's characteristics and its substantial equivalence to predicate devices. However, it does not contain information about a study proving the device meets acceptance criteria in the manner typically understood for an AI or diagnostic imaging device. The "acceptance criteria" here refer to regulatory standards for condoms, and the "study" is more accurately a conformance to these standards, primarily through design and material properties.

It's important to note that the request's framework (e.g., test set, ground truth, MRMC study, human-in-the-loop) is primarily applicable to AI/diagnostic imaging devices, not typically for devices like condoms. The information below is extracted and adapted to the extent possible, but many sections will be marked as "Not Applicable" or "Not Provided" due to the nature of the device and the document.

Acceptance Criteria and Device Performance

Study Details (Adapted for this Device Type)

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

   • Sample Size: Not explicitly stated as a separate "test set" in the context of an AI device. Conformance to standards (ISO 10993, ISO 4074, ASTM D3492) would imply testing of product samples for various physical and biological properties. The exact number of condoms tested for these physical/material properties is not provided in this document.
   • Data Provenance: Not stated. Testing to ISO and ASTM standards would typically be conducted by accredited laboratories.

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

   • Not Applicable / Not Provided. For a condom, "ground truth" relates to adherence to specified material properties and performance characteristics defined by international and national standards. This is typically assessed through laboratory tests, not expert consensus on interpretations of data.

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

   • Not Applicable / None. Adjudication methods like 2+1 are used in medical imaging interpretation when there's subjective assessment. For a condom, conformance to physical and biological standards is typically determined by objective measurements and passing predefined thresholds in laboratory tests.

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. An MRMC study is relevant for AI-assisted diagnostic or interpretive devices. This is a physical barrier contraceptive device.

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

   • Not Applicable. This device does not have an "algorithm" in the context of AI or data processing. Its performance is inherent in its physical design and material properties.

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

   • For this device, the "ground truth" is defined by the specifications and required performance characteristics outlined in international and national standards such as ISO 10993, ISO 4074, and ASTM D3492. These standards specify physical properties (e.g., dimensions, burst pressure, freedom from holes) and biological compatibility. Conformance is determined by objective measurements against these predefined standards.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of AI model development for this device. The design and manufacturing process would be based on engineering principles and knowledge of material science to meet the performance standards.

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

   • Not Applicable. As there's no training set, this question is not relevant. The "ground truth" for the device's performance is established by the engineering and regulatory standards it aims to meet.

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