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The Okamoto Studded Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is textured surface (dotted), tapered shape with reservoir tip, silicone lubricated condom with nominal length 180 mm, nominal flat width 54 mm measured at 30 mm from the open end, a maximum width of 58 mm at the closed end, and nominal thickness of 0.070 mm. The air burst pressure is ≥ 1 kPa and air burst volume is ≥ 17 dm3. It is lubricated with silicone (viscosity 200 cps) and cornstarch is used as a dressing material. This condom conforms to current established national standard ASTM D3492: 2008. The term Studded refers to the irregular surface of the irregular surface is not applied externally but is achieved in the molding process. The glass mold has an engraved pattern of semispherical pits replicated as a pattern of small round tips on the surface of the condom. This results in an exterior surface that has a pattern of small raised areas best described as a dotted pattern. The new condom is defined as a condom of increased thickness relative to some of other Okamoto condoms (e.g., Crown condom, K893039).

The provided text is a 510(k) summary for the Okamoto Studded Condom. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance results in the context of an AI/medical device study. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this text.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the device "Complied with ASTM D3492:2008". The specific acceptance criteria within this standard are not explicitly listed in the 510(k) summary, nor are detailed quantitative performance results for each criterion. The document states that "The air burst pressure is ≥ 1 kPa and air burst volume is ≥ 17 dm3," which are performance metrics, but not framed as "acceptance criteria" in a table alongside reported device performance.

2. Sample Size for Test Set and Data Provenance:

The document does not detail specific sample sizes for particular tests (e.g., air burst pressure, biocompatibility). It mentions "studies conducted on the similar condoms" for shelf life. Data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of Experts and Qualifications for Ground Truth:

This information is not applicable to this type of device submission. The evaluation is based on compliance with established standards and direct physical testing, not expert consensus on interpretations.

4. Adjudication Method:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This device is not an AI algorithm for diagnostic interpretation where human reader improvement would be measured.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical medical device (condom), not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device is based on objective measurements conforming to established industry standards (ASTM D3492:2008, ISO 10993). For example, air burst pressure is a direct physical measurement.

8. Sample Size for Training Set:

Not applicable, as this is a physical device, not an AI model.

9. How Ground Truth for Training Set was Established:

Not applicable.

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